Davita careers

MBAs in Healthcare

2023.06.01 03:18 that_otter_do_it MBAs in Healthcare

Hey all, I'm in the final stretch of my MBA program at Scheller College of Business at Georgia Tech. I wrap up Spring 24 (Thank god) and am looking toward potential summer internships leading to roles that will ideally put me in a good place to build a career and make a difference. In addition to being a full-time MBA student at Tech, I am also working full-time as a Consultant and Project Manager with a huge consulting firm and have since MAR22.
I come with a decade as a combat medic / flight paramedic in the Army, with a Masters in Healthcare Administration from Purdue.
The only healthcare MBA internship I'm aware of in healthcare is Davitas Redwoods program, but I was told by a recruiter that I do not have enough civilian industry experience for that and likely wouldn't be selected.
Does anyone have other recommendations for internships that wouldn't make me feel like I wasted a decade of my life? Thanks, I appreciate this wonderful community.
submitted by that_otter_do_it to MBA [link] [comments]


2023.05.01 16:24 sfgreen How bad is the PE problem in Ophthalmology?

Time and again, I have seen posts of how private equity is buying practices left and right. How bad do you think will it get? I was talking to a healthcare executive who is aware of this and he said it is similar to how dialysis was about 20 years ago where private equity bought up clinics and now there are only 2 large dialysis companies (Davita and Fresenius) and nephrology is one of the least desired specialties out there. Will ophthalmology go the way of nephrology? The lobbying done by optometrists to gain more independence can provide PE practices with a cheaper option to replace ophthalmologists for some of the high volume procedures. The sheer demand for ophthalmology services combined with a shortage of ophthalmologists almost guarantee optometry independence (NPs used similar strategy to gain independence). The PE chains grow bigger and bigger, then consolidate increasing their overall market power. and also use their financial strength to edge out the local practices which in turn increases their market power. They benefit from a positive feedback loop that ends up creating this giant monster that a small partnership cannot compete against. This is their usual playbook but I am not sure how successful they will be in ophthalmology, but I am concerned.
As an aspiring ophthalmologist, I am apprehensive of going into a career with high market concentration, lower job prospects, low compensation and would love to get your perspective.
Reference:
  1. https://www.beckersasc.com/ophthalmology/how-10-eye-care-chains-compare-in-2022.html
  2. https://www.reviewofophthalmology.com/article/update-private-equity-in-ophthalmology ("Many surgeons say they’ve had a positive experience—but proceeding with caution is advised")
submitted by sfgreen to Ophthalmology [link] [comments]


2022.11.04 11:03 PictureSenior7520 How to keep your mental and physical health

How to keep your mental and physical health
Many employees are constantly refining work environments that blur the distinctions between home, career, life, and family in the face of so much ambiguity and uncertainty. While working from home can be beneficial for many people, it can also present unique mental and physical health challenges, especially for those who spend more time sitting, streaming, and snacking. Protecting your mental and physical health while working from home requires only a little extra planning, communication, and discipline. Developing a healthy work-from-home strategy entails more than just creating a productive and positive environment that supports your work. It's also about figuring out how to deal with the stress that comes with this new way of working.
https://preview.redd.it/glaupcaarwx91.jpg?width=5343&format=pjpg&auto=webp&s=c118da53b040ea30054868450bd7e67eae418b36
submitted by PictureSenior7520 to u/PictureSenior7520 [link] [comments]


2022.10.26 00:32 ponitail39 Got some Ace themed stickers from my University’s LGBTQ+ center for Ace week and added them to my laptop

Got some Ace themed stickers from my University’s LGBTQ+ center for Ace week and added them to my laptop submitted by ponitail39 to Asexual [link] [comments]


2022.08.24 15:53 Head-Huntress91 [HIRING] Virtual Hiring Event - Louisville, KY

Sign Up Here!
Join us on September 8th from 9am-6pm EST for a virtual hiring event - no dialysis experience required!
DaVita is seeking a Registered Nurse who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease.
If you haven’t considered Nephrology before, read on as we think that you should. Dialysis Experience is NOT required.
What you can expect:
What We’ll Provide:
More than just pay, our DaVita Rewards package connects teammates to what matters most including:
Some details about this position:
DaVita is an equal opportunity employer – Vet and Disability.
submitted by Head-Huntress91 to nursingjobs [link] [comments]


2022.08.20 16:07 RetiredTwidget Multiple Insurances and Medicare/SSI Question

Long time lurker, first time poster here. I've a question about insurance and dialysis.
I (late 40s retired active duty Navy, currently government employee) am the care partner to my wife (late 30s, also government employee), who just started CAPD this spring. We both have BCBS Federal Employee Program as our primary insurance, and Tricare Select as our secondary insurance. Davita automatically sent in a consultation paperwork to SSA for Medicare, and she was told that she would have to apply for Medicare to keep her Tricare benefits. This doesn't make sense to either of us... everything we've encountered so far seems to equate ESRD to retired seniors on SSI using Medicare, which is not the case. The Tricare website is not particularly helpful, as it's all predicated on Tricare being the primary (or so it seems to me).
Both of us have a while before retirement is even a consideration, and my wife is adamant to maintain her career without dipping into Social Security for as long as humanly possible. Maybe that's arrogance/hubris on our part, but it's bad enough she has to deal with ESRD and the "kid gloves" everyone seems to treat her with because of that.
Does anyone here have experience with this situation, or a similar experience? If so, what was the determination?
We're still waiting on Davita to set up Tricare as secondary (after several calls), and to bill what wasn't covered by BCBS to them 😠😠😠 so it would be nice to know how this situation plays out before we have to shake things up and give them another insurance to bungle.
submitted by RetiredTwidget to dialysis [link] [comments]


2022.08.08 04:26 ProctologistRN I found the most anti-work nursing job possible

So I'm an RN in Texas (that's as specific as I'll get for anonymity reasons). I did ICU nursing for four years and I've been doing Acute Dialysis nursing for two years now. Acute Dialysis is doing dialysis treatments for patients admitted to facilities such as hospitals, rehabs, and nursing homes, rather than doing dialysis treatments at an outpatient dialysis center. I knew I didn't want to work in an outpatient dialysis center because I've had friends and coworkers who have done that and they've expressed that the workload is extraordinary and it's extremely stressful due to the fast pace and workload. Acute Dialysis jobs have for the longest time belonged only to contract dialysis companies such as Fresenius, Davita, and various other smaller contract companies. These contract companies charged exorbitant prices to the facilities they serviced but the facilities got the benefit of not having to buy or maintain their own equipment and not have to hire, train, and retain their own dialysis staff. Well a new machine came on the market relatively recently that costs about $4,000 dollars per machine rather than the $20,000-$80,000 for other models. Because of this lots of hospitals are now buying their own machines, hiring their own staff, and taking their whole dialysis programs in house rather than contracting them out to these other companies. It's saving the hospitals TONS of money. Do you think patient's are going to see any benefit from that? Of course not, but that's a different post all together. What this post is about is the job I've found that I intend to stay at and milk for all it is worth.
Let it be known, I went into the medical field and nursing because I wanted to help people, so my anti-work sentiment is NEVER to the patient's detriment. I always aim my anti-work sentiments towards the employers. My patients always receive my absolute best care because I do have a heart and I do care for them. I treat them like I would treat my own family and I would expect that from any other healthcare professionals. Be angry at the system but don't take it out on the people who need help.
Now that that is out of the way, since hospitals have started taking their dialysis programs in house I have worked for three different employers. One I was a dialysis staff RN at a single hospital in a major hospital system in a very densely populated city in Texas. The pay was mid tier and the benefits were crappy. The workload was heavy, but manageable. I only stayed there 7 months. The second, I was a staff RN in a float pool covering 5 hospitals. We had a home facility where we worked most of the time, but we did have to float to other facilities pretty regularly. The pay was good and the benefits were really good, especially the insurance, but the workload was EXTRAORDINARY. I mean crazy hours. I stayed for about 9 months because the money was good and the overtime and callback pay made the checks pretty great but it was at an absolute burnout pace and the management was awful. Now, we get to my current job and the best anti-work job I think the medical field has to offer:
When I left the float pool job I took a job at a rural hospital that was taking it's dialysis program in house. They hired me and one other nurse (a friend of mine, we applied together and got the jobs together so that has been great too. We work very well together.) to help them set up the program before their contract ended with the previous company. We helped write and review policies and procedures, we helped determine what construction and plumbing upgrades or remodels the dialysis room needed, we helped determine where and how to create our own storage room for supplies, and we helped create the program of how we would participate with the nephrologists to carry out orders and treat patients. Ultimately, the pretty much let us build our own program with a little bit of administrative oversight. We were stoked about that but once we went live is when I realized the true gold of this job: it is an INCREDIBLY low volume facility. Meaning we might do 15 treatments a month. So half of the days we work we don't have any treatments. What does that mean for us? We do routine machine maintenance, which takes maybe 20-30 minutes cumulatively in a day, and we might have one treatment a day which is like 4-5 hours of work (not hard work, mind you). Our shifts are 12 hours. On the days when we don't have a treatment, I sit and play on my phone for like 11 hours. I schedule doctor's appointments, dentist appointments, call friends, play mobile games, read books, walk laps around the hospital for exercise, and take 90+ minute lunches. You might think, wouldn't administration try to find something for us to do so we're not just riding the clock? They ask for a little help here and there in dire situations. I think in the three months I've been at this job I've been asked to go help out somewhere else three times and it's never been for longer than a couple of hours, and it's never been hard work. If we're going to help out they always give us the easy stuff to do. And the reason administration doesn't mind if we're just sitting riding the clock is because paying us is VASTLY cheaper than it was costing them to pay the company they were contracting with. Even with us doing nothing half of the days we come to work, the hospital is STILL saving money. And that brings me to pay and benefits: The hourly pay is great, the most I've made in my career. I'm at $41/hour and at this job I'm doing almost NOTHING for that wage. It's amazing. Secondly, the benefits: the insurance is pretty good and the various other benefits are about average but the tuition reimbursement combined with the partnership they have with an online university makes it so you can get a Masters degree and even a Doctorate degree for no money out of pocket. It's insane. So all that explanation for this summary:
TL;DR: The job I have now is 12 hours shifts and half the days I might do 4-6 hours of work in a shift and the other half I do about 30 minutes of work. The pay is great, the benefits are great, and I get to do basically whatever I want while on the clock. I'm going to use the benefits to get free graduate degrees all while doing little to no actual work. I get to take good care of my patients while doing very little actual work and sucking a great salary out of a major national hospital system.
American healthcare is a scam. I'll take great care of you if you need my care, but I will take advantage of my employer in every way possible because that's what they do to the American people.
Edit for additional context: My friend and I also received hefty sign on bonuses negotiated on our own behalves. I got $12K and she got $8K.
submitted by ProctologistRN to antiwork [link] [comments]


2022.06.15 01:56 david_k_robertson food for thought on - health

Dear GOP Legislators, We Found Your Food Stamp Fraud Crooks and Liars
2/25/16 8:00am


Decades-old CIA crack-cocaine scandal gains new momentum — RT USA
Published time: October 11, 2014 01:47
Edited time: October 13, 2014 14:52
Nearly two decades after a US reporter was humiliated for connecting the CIA to a drug-trafficking trade that funded the Nicaraguan Contras, important players in the scandal – which led to the journalist’s suicide – are coming forward to back his claims.
Back in 1996, Gary Webb of the San Jose Mercury News broke a story stating not only that the Nicaraguan Contras – supported by the United States in a rebellion against their left-leaning government – were involved in the US crack cocaine epidemic of the 1980s, but also that the CIA knew and turned a blind eye to the operation.
As a result, Webb concluded, the CIA was complicit in a drug trade that was wreaking havoc on African American communities in Los Angeles.
The bombshell report sparked outrage across the country, but when national newspapers like the Los Angeles Times, New York Times, and Washington Post weighed in on the matter, they dismissed Webb and attacked his story to the point that it was disowned by the Mercury News. Webb was forced out of journalism and ultimately committed suicide in 2004.
Now, however, the whole ordeal is being looked at with fresh eyes in the form of two new films: “Kill the Messenger” and a documentary called, “Freeway: Crack in the System.” Additionally, several figures involved in the operation have recently spoken out, lending further credibility to Webb’s original reporting.
Coral Baca, who had a close relationship with prominent Nicaraguan drug dealer Rafael Cornejo, told the Huffington Post that she remembered numerous occasions in which she meet Contra leader Adolfo Calero near San Francisco. During these meetings, she said Calero handled bags full of money, and he clearly knew that money was made through the drug trade.
“If he was stupid and had a lobotomy,” he might not have realized, Baca added. “He knew exactly what it was. He didn't care. He was there to fund the Contras, period.”
If true, the news would contradict multiple reports made by national media outlets at the time, which doubted just how much cash was going to the Contras – or even if the Contras knew it was coming from crack cocaine sales.
Meanwhile, Nicaraguan drug importer Danilo Blandon recently confirmed to documentary filmmaker Marc Levin that he was involved in drug trafficking, and that he supported the Contras. Back in 1996, Blandon was asked in court if he ran the LA drug operation, which he confirmed. Then, too, he said all the profits went to the Contras.
Despite a 1986 LA County arrest warrant detailing allegations that Brandon “filtered” drug money to the Contras, other newspapers dismissed Webb’s allegation that the Contras’ drug trafficking operation directly impacted the increased use of crack in the US – primarily, they said, because Blandon split off from the group and ran his own drug venture.
Last year, though, former LA Times reporter Jesse Katz apologized for attacking Webb’s story and reputation.
“As an L.A. Times reporter, we saw this series in the San Jose Mercury News and kind of wonder[ed] how legit it was and kind of put it under a microscope,” Katz said, according to LA Weekly. “And we did it in a way that most of us who were involved in it, I think, would look back on that and say it was overkill. We had this huge team of people at the L.A. Times and kind of piled on to one lone muckraker up in Northern California.”
“We really didn't do anything to advance his work or illuminate much to the story, and it was a really kind of tawdry exercise. ... And it ruined that reporter's career.”
While Webb was also criticized for suggesting the CIA intentionally devastated African American communities with crack, he defended himself saying that was not the case.
“It’s not a situation where the government or the CIA sat down and said, 'Okay, let’s invent crack, let’s sell it in black neighborhoods, let’s decimate black America,’” Webb reportedly says in the upcoming documentary. “It was a situation where, 'We need money for a covert operation, the quickest way to raise it is sell cocaine, you guys go sell it somewhere, we don’t want to know anything about it.'”
Following the scandal, in 1998 the CIA quietly published an internal inspector general’s report into the matter, which prior to its release was much-touted for whitewashing the agency’s reputation. Instead, it seemed to add legitimacy to the accusations, saying, “CIA knowledge of allegations or information indicating that organizations or individuals had been involved in drug trafficking did not deter their use by CIA.” At other times, the “CIA did not act to verify drug trafficking allegations or information even when it had the opportunity to do so.”
“No information has been found to indicate that CIA informed Congress of eight of the ten Contra-related individuals concerning whom CIA had received drug trafficking allegations or information,” the report added.
In a new post on Democracy Now, a transcript from the documentary “Shadows of Liberty” reveals investigative journalist Robert Parry saying this watchdog report was even more damning for the CIA than the original story.
“The contents of the reports, if you go into the actual nitty-gritty of them,” he said, “what you find is that there was a serious problem, that the US government knew about, and that the Contras were far more guilty of drug trafficking and the CIA was more guilty of looking the other way than even Gary Webb had suggested.”



Establishment Dems Fight to Defeat 'Medicare-for-All' in Colorado Common Dreams Breaking News & Views for the Progressive Community
Pro-Clinton Democrats join Big Pharma and state Republicans in fighting to defeat first-in-the-nation ballot measure for statewide single-payer plan
by Nika Knight, staff writer
Published on Friday, May 20, 2016
Prominent Colorado Democrats, including Gov. John Hickenlooper, pictured above, have co-opted the Republican Party's stance and worked to defeat the state's ballot measure for universal, government-run healthcare. (Photo: AP)
Highlighting the divisions in the Democratic party this election, Colorado's ballot measure for a universal, single-payer healthcare plan is facing unexpected resistance from the very same party that has been calling for such a healthcare plan since the 1990s.
"There is a disconnect between the powers that be and the people," said state senator Irene Aguilar, a former doctor and the chief architect of the statewide 'Medicare-for-all,' called ColoradoCare, in an interview with the Guardian. "The powers that be are incrementalists. There hasn't been a courage of conviction to try and deal with [healthcare coverage]."
If it passes, ColoradoCare would make Colorado the first state in the nation with universal healthcare.
Most Americans support replacing Obamacare with a single-payer system, and Bernie Sanders has made his support for universal healthcare a central pillar of his presidential campaign. His rival Hillary Clinton, on the other hand, continues to support the least popular position of maintaining the Affordable Care Act (ACA) with only incremental and modest changes.
Clinton's position is echoed by establishment Democrats in Colorado, including Clinton supporter and former governor Bill Ritter, who argued to the Guardian that ColoradoCare was not "practical or feasible."
John Hickenlooper, the state's current governor another prominent pro-Clinton Democrat, said in a statement, "Our reforms are just beginning to bear fruit and it would be premature to dramatically remake our health care system at this time."
(Hickenlooper is in fact so close to Clinton that he may be on the campaign's shortlist for a vice presidential pick, according to The Hill.)
Clinton's campaign is directly linked to Coloradans for Coloradans, the most prominent organization opposing ColoradoCare. Formed solely to defeat the measure, Coloradans for Coloradans is being funded by the very same consultant firm currently working for the Clinton super PAC Priorities USA, as Lee Fang reported in the Intercept.
While a stance for the ACA and against single payer is the least popular with the public, it is the most popular within a certain sector of the population: pharmaceutical and healthcare companies.
Indeed, in Colorado the "anti-single-payer effort is funded almost entirely by health care industry interests," Fang reported, "including $500,000 from Anthem Inc., the state’s largest health insurance provider; $40,000 from Cigna, another large health insurer that is current in talks to merge with Anthem; $75,000 from Davita, the dialysis company; $25,000 from Delta Dental, the largest dental insurer in the state; and $100,000 from SCL Health, the faith-based hospital chain."
Moreover, Clinton herself "has received $13.2m in donations from the health sector over the years, according to nonpartisan Center for Responsive Politics. This well-funded industry is also the chief financial backer of the effort to destroy ColoradoCare," notes the Guardian.
"There is huge money from the [health insurance] industry involved in financing not only the campaign against ColoradoCare, but also in financing the politicians who decide on health care legislation," Owen Perkins, communications director for ColoradoCareYes, a group advocating for the ballot measure, told the Guardian.
"The role that big money, big medicine plays in funding campaigns and influencing political votes is certainly a good reason to take [healthcare] out of the insurance industry and politicians and put it in the hands of the people," Perkins added.
While the health sector pours funds into the fight against single payer, ColoradoCareYes told the Guardian that their fight for universal healthcare is being funded largely by small, individual donors—much like Sanders' presidential run, which has made its average donation of $27 into a touchstone of the campaign.
Sanders himself has lent support to the ballot measure. In a statement to the Colorado Independent, Sanders said, "Colorado could lead the nation in moving toward a system to ensure better health care for more people at less cost. In the richest nation on earth, we should make health care a right for all citizens. No one should go bankrupt or skip getting the care they need because they cannot afford it."


Facing $1 billion deficit, Arizona sharply limits welfare - Yahoo News
By RYAN VAN VELZER
PHOENIX (AP) — Facing a $1 billion budget deficit, Arizona's Republican-led Legislature has reduced the lifetime limit for welfare recipients to the shortest window in the nation.
Low-income families on welfare will now have their benefits cut off after just 12 months.
As a result, the Arizona Department of Economic Security will drop at least 1,600 families — including more than 2,700 children — from the state's federally funded welfare program on July 1, 2016.
The cuts of at least $4 million reflect a prevailing mood among the lawmakers in control in Arizona that welfare, Medicaid and other public assistance programs are crutches that keep the poor from getting back on their feet and achieving their potential.
"I tell my kids all the time that the decisions we make have rewards or consequences, and if I don't ever let them face those consequences, they can't get back on the path to rewards," Republican Sen. Kelli Ward, R-Lake Havasu City, said during debate on the budget. "As a society, we are encouraging people at times to make poor decisions and then we reward them."
Cutting off these benefits after just one year isn't fair, said Jessica Lopez, 23, who gave birth to her son while living in a domestic violence shelter and has struggled to hold onto jobs because she has dyslexia and didn't finish high school.
"We're all human," said Lopez, who got $133 per month for about a year until she qualified for a larger federal disability check. "Everybody has problems. Everybody is different. When people ask for help, we should be able to get it without having to be looked at wrong."
Most states impose a five-year limit on welfare benefits. Thirteen states limit it to two years or less, and Texas has a tiered time limit that can be as little as 12 months but allows children to continue to receive funding even after the parents have been cut, welfare policy analyst Liz Schott said.
Long-term welfare recipients are often the most vulnerable, suffering from mental and physical disabilities, poor job histories and little education, she said. But without welfare, they'll likely show up in other ways that will cost taxpayers, from emergency rooms to shelters to the criminal justice system, Schott said.
"The reason they are on public assistance is because many of them are not really succeeding in the workforce," said Schott, a senior fellow at the Center of Budget and Policy Priorities, a non-partisan research organization.
Arizona's Legislature cut the budgets of an array of programs to meet the governor's no-tax-increase pledge. The bill that included the welfare cuts received overwhelming support earlier this spring from Republicans, with just one Democrat voting in favor.
The Legislature also passed a law seeking to force anyone getting Medicaid to have a job, and cutting off those benefits after five years. And Republican leaders are suing their own state to block a centerpiece of President Barack Obama's health care law, which expanded Medicaid to give more poor people health insurance.
If they prevail, more than 300,000 poor Arizonans could lose their coverage.
Republican Gov. Doug Ducey's office called all these cuts necessary to protect taxpayers and K-12 classrooms — even though the source of the money is the federal government.
Arizona's welfare is entirely federally funded through the Temporary Assistance for Needy Families program, but that money comes in a block grant, and Republicans want to use it instead for agencies such as the state's Department of Child Safety.
"The bipartisan, balanced budget passed by the Legislature and signed by the governor protects Arizona's most vulnerable, while avoiding a tax increase," said Daniel Scarpinato, governor's office spokesman.
Democratic Rep. Andrew Sherwood, D-Tempe, said the Republicans made these cuts hastily, voting in the middle of the night in March to avoid transparency.
"This is a very small investment, but it is critical to people who need it the most," Sherwood said. "You're talking about desperate families, those who are unemployed and underemployed. Single mothers and parents with kids."
Former President Bill Clinton signed the block grant law in 1997, making good on a campaign promise to "end welfare as we know it." The federal government still requires states to make sure recipients have a job, are looking for work, going to school or trying to go to school, but states retain broad discretion in imposing restrictions.


GOP Says the Right to Know What You're Eating is Burdensome to Corporations
PoliticusUSA
By Hrafnkell Haraldsson on Sat, Feb 13th, 2016 at 7:45 am
Despite the protests of many medical organizations, Republicans ignore the health cost to Americans in favor of corporate profits
House Speaker Paul Ryan (R-WI) issued the following statement Friday on House passage of H.R. 2017, sponsored by Rep. Cathy Rodgers (R-WA) the so-called Common Sense Nutrition Disclosure Act, arguing that it’s just too expensive to inform consumers, and showing once again that House Republicans don’t care about the burden – cost or health-wise – to the general public:
“The government should not be placing more harmful barriers in the way of hardworking small businesses. This important legislation would roll back the FDA’s burdensome menu labeling rule, giving American restaurants, grocery and convenient stores the flexibility they need to be successful. I commend Cathy for her work on this measure.”
Right. Calories? Who cares? Never more, if congressional Republicans get their way, will restaurant, convenience store, grocery store, and pizzeria chains, have to tell you what you’re eating. If you’re on a diet – especially when it is a medically necessary diet to you know, keep you alive – you’ll just have to take your chances and forget that night out or game-day pizza.
This is not about small businesses. There is not even a pretense that this is not a giveaway to big corporations who want to rake in profits at your expense.
Paul Ryan argues it’s only “common sense” that Americans don’t need to know what is in the food they’re eating. Apparently, being able to make your own choices is “burdensome.” But what else to expect from a party that thinks even having access to healthcare is burdensome.
Rep. Fred Upton (R-MI) claimed in defense of this nonsensical piece of legislation that, “We have a classic example of the administration overreaching with a top-down, big government approach.”
Because a top-down, big corporation approach is so much better. At least the government wants to protect us while corporations just want to make money.
President Obama has stated his opposition to the so-called Common Sense Nutrition Disclosure Act. Rep. Jan Schakowsky (D-IL) protested that is low on common sense, saying “This unnecessary legislation would deny consumers critical information about the food that we eat.” Critical is never burdensome.
Numerous organizations have signed “A Joint Statement in Opposition of H.R. 2017,” providing a cogent and powerful defense of the consumer’s right to know:
We, the undersigned organizations and researchers, oppose the “Common Sense Nutrition Disclosure Act of 2015.” We do not think that it is common sense to weaken a policy that would allow people to make their own, informed choices about how many
calories to eat at a time when obesity rates are at a record high. The bill would undercut the Food and Drug Administration’s (FDA) menu labeling regulations and undermine congressional intent to provide access to calorie labeling in a broad range of
chain food service establishments.
The national menu labeling law requires chain restaurants and similar food establishments to provide consumers with calorie information for standard food and beverage items on menus and menu boards. Studies show that providing nutrition
information at restaurants can help people make lower calorie choices, and a national poll found that 80 percent of Americans support calorie labeling at supermarkets and restaurants. H.R. 2017 would undermine the benefits of the national menu labeling law
and confuse and mislead consumers.
The signatories include the American Academy of Sports Dietitians and Nutritionists, American Cancer Society Cancer Action, the
American Council on Exercise, the American Diabetes Association, the American Heart Association, the American Institute for Cancer Research, American Nurses Association, the American Public Health Association, the American School Health Association, and the American Society of Bariatric Physicians.
Obviously, if you are on a diet for health reasons, as many people are, whether for your heart or diabetes or because you had bariatric surgery, it is very important to know and keep track of what you’re eating. This is not simply a matter of convenience to many people if they want to stay healthy or even alive. It is, as Rep. Schakowsky put it, critical.
Because the requirements being struck down are in the Affordable Care Act, this legislation qualifies as yet another Republican attack on Obamacare.
Naturally, the American Pizza Community (APC), which includes Domino’s, Little Caesars, Papa Murphy’s and Papa John’s – Peyton Manning’s safety-net hating buddy – love H.R. 2017. They already oppose paying employees a living wage. Why not get a dig in at their customers while they’re at it.
As an example of their opposition, you can view Domino’s specially made video here. Yes, telling you what you’re eating is, says Domino’s, “ridiculous.” For the record, the pizza industry gives 88 percent of its donations to Republicans.
Interestingly, however, Restaurant Business informs us, those requirements “are supported by the National Restaurant Association, which was urged by national chains to accept a federal mandate rather than leave them to contend with a patchwork of state, county and municipal laws.”
Obviously, the National Restaurant Association feels the Republican alternative is the burdensome option.
The Senate, of course, has its own version of this appalling piece of legislation (S. 2217), introduced by Sen. Roy Blunt (R-MO) currently under consideration by the Senate Health, Education, Labor, and Pensions Committee. For a bill to become law, both House and Senate must pass it, and the president must sign it. Republicans can count on Obama’s veto where this legislation is concerned.
submitted by david_k_robertson to Food_for_Thought_on [link] [comments]


2022.04.28 13:23 OhioKing_Z Spencer/Olivia prediction

The most conflict we’ve seen between the two so far this season has been minor disagreements. They try to prove to each other why they are the ones who are right and it always ends up in a flirty/playful resolution where one apologizes to the other and admits that the other was right all along. However, I think Olivia’s NIL story and Spencer’s need to build his brand for NIL purposes will directly collide soon and it won’t be pretty. Spencer says he will support her decisions no matter what but what happens when those decisions directly affect his career in a negative manner? Even though Olivia acknowledges the advantages of NIL through her conversations with Spencer and Davita, perhaps her going after Wade will unintentionally affect Spencer with unforeseen consequences. Obviously they’ll likely end up getting through the conflict and be stronger from it but I believe this season long build up over their differing NIL stances will be the most adversity that their relationship has faced to this point. The season might even end on a cliffhanger where we question if their relationship will survive. Thoughts?
submitted by OhioKing_Z to AllAmericanTV [link] [comments]


2022.03.03 18:35 No_Competition4897 [HIRING] 25 Jobs in UT Hiring Now!

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Cardinal Logistics CDL A Truck Driver Holladay
Weatherford Oil Field Team Leader VERNAL
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The Hillman Group Field Service Rep Sandy City
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Lockheed Martin Corporation Systems Engineer Early Career Hill Air Force Base
Avalon Health Care CNA Ivins
Glacier Bancorp Customer Care Representative Pleasant Grove
Camping World Detailer Draper
ESA Management, LLC General Manager Full Time-GMB-203110 Midvale
Easterseals-Goodwill Northern Rocky Mountain Goodwill Driver Millcreek
DaVita Share a Soda With the Hiring Team - DaVita RN Hiring Event Orem
Rotech Healthcare Inc. Patient Account Audit Specialist Roy
Cox Enterprises Inventory Control Coordinator Woods Cross
PepsiCo Beverages North America Warehouse Person (Loader) Hurricane
Utah State University Youth Program Coordinator Junction
PepsiCo Beverages North America Merchandiser -Territory is Layton, Ogden, Logan areas Layton
Hey guys, here are some recent job openings , feel free to comment here if you have any questions, I'm at the community's disposal! If you encounter any problems with any of these job openings please let me know that I will modify the table accordingly. Thanks!
submitted by No_Competition4897 to UtahJobsforAll [link] [comments]


2022.01.11 16:16 GoldBug236 Spectral Medical inc

$EDT.TO $EDTXF
Market cap ~$50M CAD
Share price ~.27 CAD @ DEC 20, 2021
Shares out 228M
Ideal time horizon for our investment: 1 Year
Spectral Medical (EDT.TO or EDTXF USA) is a small cap (~$50M CAD) medical device company listed on the TSX in Canada that is on the cusp of commercializing multiple products that they either already have FDA approval or are just at the cusp of requesting approvals for. Its flagship project is a treatment for severe sepsis that is in an FDA stage 3b confirmatory trial. As far as the writers know this is the only company with a Phase 3 trial for sepsis in North America.
Corporate Presentation
PowerPoint Presentation (spectraldx.com)
UPDATE AT THE BOTTOM OF WRITEUP
BACKGROUND & WRITE UP
Here is an investment thesis for Spectral Medical ($EDT.TO) written by a couple of retail investors; one with a degree in commerce and the other with a PhD in science. Disclaimer: A warning to the reader that we are by no means experts on biotech stocks or very knowledgeable about FDA trials. This is not an endorsement to buy or sell shares of the company. A more detailed disclaimer can be found at the bottom. We had spent a significant amount of time doing research and reading to get to where we are with this investment. How well we did is up for debate. In this paper we attempt to address as much as we could. There is an abundance of information rendering it impossible for us to comprehensively discuss all of the strengths and weaknesses that we saw, however, after many iterations we have boiled it down to the following points that we wanted to highlight. The first 6 points establish the basis and essence of our high conviction trade and things we, and probably any investor, would like to see in any company.
WHY WE LIKE IT?
  1. IF APPROVED, NO COMPETITORS IN THE SEPSIS SPACE FOR AT LEAST 5 YEARS (HUGE MOAT)
  2. SOLVING HOLY GRAIL OF MEDICAL PROBLEMS, SEPSIS (LARGE MARKET)
  3. GROUP OF HIGHLY PUBLISHED AND ACCOMPLISHED PROFESSIONALS (TEAM IS TOP SHELF)
  4. LAST YEAR THE COMPANY SIGNED A DISTRIBUTION AGREEMENT AND RECEIVED UPFRONT PAYMENT WITH ONE OF LARGEST MEDICAL HEALTHCARE COMPANIES LISTED ON NYSE (BUY IN FROM MAJOR - SALES STRATEGY)
  5. TRIAL IS REASONABLY CLOSE TO COMPLETION (1 YEAR TIME HORIZON)
  6. COMPANY IS WELL FUNDED FOR PMX TRIAL (NO DILUTION EXPECTED)
BONUS POINTS:
  1. ALREADY APPROVED IN EUROPE AND JAPAN WHERE IT HAS TREATED 300 000+ PATIENTS
  2. SPECULATION AS TRIAL(S) NEAR(S) COMPLETION COULD CAUSE UPWARDS PRICE PRESSURE AS IT HAS DONE IN THE PAST
  3. IF THE COMPANY LIVES UP TO ITS US LISTING PROMISE IN THE SHORT TERM WE SEE A MUCH LARGER INVESTING AUDIENCE
  4. NEW CMO HIRE OPENS WORLD OF POTENTIAL OPPORTUNITIES
  5. ADDITIONAL PRODUCT PIPELINE IN HOME DIALYSIS PARTIALLY FDA APPROVED AND PROVIDES BACKSTOP
GENERAL OVERVIEW
Spectral Medical is a small cap (~$80M USD) medical device company that is on the cusp of commercializing multiple products that they either already have or are nearing the corner for FDA approvals. Its flagship project is a treatment for severe sepsis that is currently in an FDA Stage 3b confirmatory trial with an expectation for completion in late 2021. This product is known as “PMX” and has NO COMPETITORS as there are NO FDA approved solutions for sepsis in the market and none coming any time soon. PMX has been licensed to Spectral ($EDT) with exclusivity to the North American market. The product has already been in use in real clinical settings as it has already been approved for use in Japan and Europe by the licensor (Toray Industries) and has thus far treated 300 000+ patients to date and counting. Spectrals nearest competitor, Cytosorbent has a market cap that is multiples of where Spectral currently sits even though they are only in phase 2 and as such years behind in North America. Cytosorbents does have approval for its product in Germany with about 8.2M in revenue per quarter and growing. Having said that, North America is where we think the real opportunity lies. Noteworthy is that Spectrals ability to get the product to market is highly de-risked through an exclusive distribution agreement with Baxter, one of the largest multinational health care companies listed on NYSE. The company also has a stacked board and C suite of top notch professionals. We paid particular attention to a recent CMO hire that happens to be “the world authority in Blood Purification and Renal Replacement Therapy”. A simple google search of his name will detail numerous industry connections that we think could spell a roadmap to success at a later time. A major reason that the writers can see for the market cap to be sitting where it is, is that it has not been cross listed in the US, yet. Biotech stocks do not get a lot of love in Canada.
For Spectral, the focus on a Canadian-only listing could change in the near term. This is where we think the opportunity lies in the short term. For the long term, aside from hitting FDA milestones, we believe that there is some information asymmetry that sits with their newest CMO hire. In the latest investor deck the company states an intention to possibly list on a senior US exchange. In fact, they have already taken steps in this direction having received shareholder approval for a share consolidation in 2021 to meet listing requirements. Why would they if that’s not something they were actively pursuing? As such, we propose that they could see a significant re-rating of share price for this reason alone. There are others that we will outline below. This paper will not get into the specifics of the science and will give a general overview of the company as we see it. There is no amount of due diligence that the writers here can do regarding the science that Baxter hasn’t already done. Armed with the knowledge that Baxter has given Spectral a $6.5M CAD upfront payment for which they presumably did the most thorough due diligence, one can reasonably conclude that the science has merit. For those who want to read more about it or the company and its milestones in general, we encourage you to check out FDA filings, the company’s own presentation, or contact them directly to answer technical questions. This paper will also not get into modelling or sales predictions and will assume there is a market, the market is large, there is a credible partner in place to make sure said product is sold and revenues come in if approvals are granted. Rather, we will focus on a general overview of the company, where the information asymmetry could potentially sit, namely the lack of awareness by both retail and institutional investors in the US, as well as, their newest CMO hire.
PRODUCT PIPELINE SNAPSHOT
They have two separate product pipelines that could be/are being commercialized in the near future. PMX and DIMI. The combined addressable market size for both of the company products is $6.5B USD. There are other FDA/Health Canada fully approved products that the company currently has but they will not be discussed in any detail here as they are compliments to the grand finale.
Screenshot taken from company presentation
Product 1: PMX
PMX is intended for the treatment of patients in septic shock and has been licensed for distribution and commercialization in North America from Toray Industries in Japan where it has already been approved since 2002 and has treated over 300 000+ patients and counting. It has also been approved in Europe since 1994.
PMX has already been through 3 phases with the FDA and failed to gain approval in 2016 at the conclusion of the trial. However, they did find a subset of patients with significant relative risk reduction in mortality. A phase 3b open label trial dubbed “Tigris” has been approved since September 2019 and is currently well underway with an estimated completion at the end of 2021. Commercialization could begin as early as 2022. As the trial nears completion we see it as highly likely that the price will continue to rise in anticipation of the results as speculators arrive. It is far enough out right now to get in at what we find to be attractive prices. Interim results are expected Q2 2021. The FDA has allowed them to use the favorable data of the benefit receiving subset of patients from their failed phase 3 for this phase 3b confirmatory trial. De-risking the Phase 3b study in the sense that they are already starting with statistically significant results. The likelihood of Spectral actually having decent market penetration for PMX, if it were to be approved, is high given the fact that they have an Exclusive Distribution Agreement with Baxter, one of the largest multinational health care companies in the world. Baxter is buying exclusivity rights to distribute PMX in North America via an already completed upfront rights payment and various non dilutive milestone payments moving forward. Should the company hit these targets moving forward there is a high possibility that the company will not need to dilute any further.
Screenshot taken from company presentation
A press release for the partnership can be found on both Baxter and Spectrals websites:
https://www.baxter.com/baxter-newsroom/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-blood-filter
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
Product 2: DIMI
DIMI is a device intended for easy portable hemodialysis. DIMI, a portable dialysis machine has already been recently approved by the FDA in 2020 for in hospital use and the company is currently in the process of trying to obtain approval for home dialysis. Home dialysis is a growing market trend as it cuts down cost and risk of transporting patients. It also increases patient autonomy and comfort. From what we understand there is also a government push towards home dialysis in the US. Read more in the corporate presentation.
Screenshot taken from company presentation
US LISTING. It is our belief that the company is relatively unknown to its neighbors south of the border. If it is introduced to a much larger US investing audience it is quite possible that shareholders may see immediate benefit. Moreover, it is our unprofessional opinion that even the narrower Canadian space is not aware that the company is in pursuit of a US listing.
CMO HIRE. We have found it to be of interest that the new CMO is an established collaborator with multiple successful companies in both the dialysis and sepsis space. {Screenshot at 19 Seconds https://youtu.be/jeGXkKBHo28 } Notable mentions include its much higher market cap direct comparables NxStage and Cytosorbents. Why would this accomplished researcher at the peak of his career, fully understanding the science and risks begin working with a company that he believes could fail? After all, this isn’t a major industry player that has a massive cash cushion in the event of a failure. We would hope that he sees something of value here. A similar company, producing similar products to Spectral, that he was on the scientific advisory board for, NxStage, was sold to Fresenius for $2 Billion for what we see as an arguably inferior, albeit fully FDA approved for home use, product. Note that Spectral is well on its way. Cytosorbents has a current market cap of $400M USD and is in behind Spectral in FDA trials. He has also published numerous research articles sponsored by Baxter. On the face of it, it would appear that this small community of leading scientists and the respective companies in the field of sepsis and blood purification have all done very well market cap wise, except Spectral. In addition to the thesis that the price could go up based on a US listing we find it possible that the new CMO hire is likely to provide new opportunity to the company through his network. If the charts of any of these other companies that the CMO has advised for foreshadow what’s to come for Spectral we see this as a compelling investment.
https://spectraldx.com/spectral-medical-appoints-dr-john-kellum-as-chief-medical-office
https://www.fresenius.com/7461
https://www.modernhealthcare.com/article/20190226/NEWS/190229935/fresenius-medical-care-closes-2-billion-nxstage-acquisition
UPDATE:
We waited with this update until we were fairly confident that the company was very near term in its US listing ambitions, had a number of catalysts met and within close reach, and most importantly would not suprise us with further dilutive events.
Promises made, promises kept. The positive developments regarding the TIGRIS trial and corporate progress overall:
A US listing on a senior exchange announcement should be coming any day now as the company had stated they were aiming for early 2022 according to a December company presentation. The company stated that it was important for major milestones to line up in order for the listing to make sense and are of the belief that timing is now right. A link to the update regarding US listing can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72
It turns out their new CEO and CMO have been delivering results as there are rumors circling various chat forums about a potential partnership with DaVita, one of two largeset nursing home operators in the US ($10.69B Market Cap). The company, after the rumors began circulating, mentioned DaVita multiple times during an investor conference call (a recording of the conference call can be found here: https://www.webcaster4.com/Webcast/Page/2813/43726 ). Additionally DaVita put out a press release regarding a new hire for a division that will specificially focus on Kidney care and more importantly home dialysis, for which Spectral is trying to provide a solution. The press release potentially had a large impact on the volume of Spectral shares traded that afternoon. (DaVita Press Release: https://finance.yahoo.com/news/davita-integrated-kidney-care-expands-110200664.html )
Spectral has gotten an additional 5 sites up and running potentially increasing enrolement by 50% over last years 10 sites. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The FDA has allowed the company to include SOFA scores for patient selection which should increase enrolement by roughly 25-50%. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The math behind the price fall
The company had failed to materialize an attempted direct investment and spin out of its medical device division Dialco. It has been in the dog house since and was forced to exercise $3M in 40 cent warrants and take a $10M financing completed in June 2021 for business continuity. The authors did not see this coming but saw and used the opportunity to average down (have not sold a single share). The current price is at a 50% discount to what accredited and institutional investors paid just months ago. Since the hiccup, the company has been executing milestones according to plan and seems to be finally rounding the corner. https://ca.finance.yahoo.com/news/spectral-medical-inc-closes-10-130500091.html
Seasonal Tax Loss selling seems to have finally ended and double bottom appears to have passed the smell test. Hence the update at this time once we were fairly sure the financing and weak hands had blown their paper out. Volume over the last two days has increased 10 fold and we suspect that we are in the midsts of a reversal.
Trades made
Various buys with .35 cent average
Research
https://www.globenewswire.com/news-release/2019/09/24/1919871/0/en/Spectral-Medical-Launches-the-Tigris-Trial.html
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
https://spectraldx.com/spectral-medical-provides-corporate-update-3/
“Early Tigris trial observations in-line with Euphrates post-hoc results”
https://spectraldx.com/u-s-fda-grants-510k-clearance-for-spectrals-dimi/
· Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
· U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
· Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
· Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
· Spectral to receive upfront exclusive rights payment
https://spectraldx.com/spectral-medical-provides-corporate-update-2/
Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players.
ANALYST COVERAGE
https://www.cantechletter.com/2019/11/paradigm-capital-launches-coverage-of-spectral-medical-with-a-buy/
Disclaimer contd.: We own Spectral Medical shares and as such, in that regard, are biased. We are not affiliated in any way with the company or their contractors nor do we even know anyone that knows someone that works or contracts for at the company. Also, we are not financial advisors nor are we qualified to give financial advice. This is not an endorsement to buy or sell shares of the company. If you plan on investing in this stock or any other you should first speak to a qualified investment advisor. Our risk tolerances may also drastically differ from yours. This may be a given, but we also wanted to highlight that there is a risk that the company does not obtain the approvals they seek or that they run out of cash. The intent of this write-up is to shed light on a company that we perceive to be severely under undervalued and puzzlingly unknown. A fair warning that at any time and without warning we may buy or sell shares.
We did our absolute best to try and not be misleading in any way and will include references to most of what was written here using hyperlinks to credible sources and the company’s own documents. Having said that, we too, are human and it is possible that in this write-up we have made mistakes. It is not out of malice, we encourage everyone that reads this thread to do their own due diligence.
We welcome all opposing views and hope that if we have made mistakes, shortcomings, flaws, gaps in our research you will point them out. It will only help us save money if we have overlooked something of importance. This is an ongoing conversation.
submitted by GoldBug236 to pennystocks [link] [comments]


2022.01.10 21:52 evesrevenge (25f)Becoming my dad’s (65m) care partner. Need an objective viewpoint

Hello everyone,
Not quite sure if this the right place for my questions, so I apologize in advance if this belongs somewhere else.
Before I get into the details, let me first ask my main questions:
Am I getting myself into overwhelming, highly stressful situation?
Should my dad just hire a home health nurse to administer his treatments?
I recently resigned from teaching fourth grade to help take care of my dad and to start looking for a new career. I was told for months that my dad needed help since he’d be transitioning to doing his treatments at home, but my dad never really went into details about how tedious the process was. However, i was always fine with coming home to help. The idea of helping my dad never bothered me. My dad is older, immigrant man, and he tends to be prideful and withholds a lot of information.
I was given 5 days of training through Davita with my dad present. I then learned I was supposed to receive 15 days, but the training was cut short because I got Covid and had to quarantine during the time I was to start training.
My dad went through the training 2 separate times, but was not approved to be a solo patient due to his poor eyesight. Although, my training was cut short, I picked up on the process pretty quickly, and I’m not afraid to call the on call nurses when I have questions. My dad also participates in the administration of his treatment and we work together.
However, I’m concerned that maybe I’m in over my head. Even though my dad undersold how tedious and involved the process of home dialysis is, I didn’t feel burdened by it, I only feel extremely anxious because I don’t want to make him sick, especially since the main point of home dialysis is for it to more gentle on your body.
My sister, my mom, and a couple of my close friends are constantly asking “are you sure you can handle this?” , “maybe you can’t do this?” And it makes me feel like maybe I am being shortsighted and misunderstanding what exactly I’m committing too.
Lastly, I need to add that I’m only helping until him until April, and then he’s returning to the center. He has his own reasons for doing this. We’ve done one treatment at home, and it was successful.
I’d really appreciate any opinions from y’all since some y’all have more perspective on home dialysis.
Thank you.
ETA 1/13: Thank you all so much for your encouragement and opinions! Your comments helped put things into perspective for me and I feel much more confident. My dad and I are getting better with each treatment and I definitely have been discussing boundaries with him so I can still have my own life that doesn’t solely revolve around caring for him. I also don’t want him to lose the independence he has now by relying too much on me.
submitted by evesrevenge to dialysis [link] [comments]


2021.12.21 17:49 GoldBug236 SPECTRAL MEDICAL $EDT.TO $EDTFX

$EDT.TO $EDTXF
Market cap ~$50M CAD
Share price ~.27 CAD @ DEC 20, 2021
Shares out 228M
Ideal time horizon for our investment: 1 Year
Spectral Medical (EDT.TO or EDTXF USA) is a small cap (~$50M CAD) medical device company listed on the TSX in Canada that is on the cusp of commercializing multiple products that they either already have FDA approval or are just at the cusp of requesting approvals for. Its flagship project is a treatment for severe sepsis that is in an FDA stage 3b confirmatory trial. As far as the writers know this is the only company with a Phase 3 trial for sepsis in North America.
Corporate Presentation
PowerPoint Presentation (spectraldx.com)
UPDATE AT THE BOTTOM OF WRITEUP
BACKGROUND & WRITE UP
Here is an investment thesis for Spectral Medical ($EDT.TO) written by a couple of retail investors; one with a degree in commerce and the other with a PhD in science. Disclaimer: A warning to the reader that we are by no means experts on biotech stocks or very knowledgeable about FDA trials. This is not an endorsement to buy or sell shares of the company. A more detailed disclaimer can be found at the bottom. We had spent a significant amount of time doing research and reading to get to where we are with this investment. How well we did is up for debate. In this paper we attempt to address as much as we could. There is an abundance of information rendering it impossible for us to comprehensively discuss all of the strengths and weaknesses that we saw, however, after many iterations we have boiled it down to the following points that we wanted to highlight. The first 6 points establish the basis and essence of our high conviction trade and things we, and probably any investor, would like to see in any company.
WHY WE LIKE IT?
  1. IF APPROVED, NO COMPETITORS IN THE SEPSIS SPACE FOR AT LEAST 5 YEARS (HUGE MOAT)
  2. SOLVING HOLY GRAIL OF MEDICAL PROBLEMS, SEPSIS (LARGE MARKET)
  3. GROUP OF HIGHLY PUBLISHED AND ACCOMPLISHED PROFESSIONALS (TEAM IS TOP SHELF)
  4. LAST YEAR THE COMPANY SIGNED A DISTRIBUTION AGREEMENT AND RECEIVED UPFRONT PAYMENT WITH ONE OF LARGEST MEDICAL HEALTHCARE COMPANIES LISTED ON NYSE (BUY IN FROM MAJOR - SALES STRATEGY)
  5. TRIAL IS REASONABLY CLOSE TO COMPLETION (1 YEAR TIME HORIZON)
  6. COMPANY IS WELL FUNDED FOR PMX TRIAL (NO DILUTION EXPECTED)
BONUS POINTS:
  1. ALREADY APPROVED IN EUROPE AND JAPAN WHERE IT HAS TREATED 300 000+ PATIENTS
  2. SPECULATION AS TRIAL(S) NEAR(S) COMPLETION COULD CAUSE UPWARDS PRICE PRESSURE AS IT HAS DONE IN THE PAST
  3. IF THE COMPANY LIVES UP TO ITS US LISTING PROMISE IN THE SHORT TERM WE SEE A MUCH LARGER INVESTING AUDIENCE
  4. NEW CMO HIRE OPENS WORLD OF POTENTIAL OPPORTUNITIES
  5. ADDITIONAL PRODUCT PIPELINE IN HOME DIALYSIS PARTIALLY FDA APPROVED AND PROVIDES BACKSTOP
GENERAL OVERVIEW
Spectral Medical is a small cap (~$50M CAD) medical device company that is on the cusp of commercializing multiple products that they either already have or are nearing the corner for FDA approvals. Its flagship project is a treatment for severe sepsis that is currently in an FDA Stage 3b confirmatory trial with an expectation for completion in late 2021. This product is known as “PMX” and has NO COMPETITORS as there are NO FDA approved solutions for sepsis in the market and none coming any time soon. PMX has been licensed to Spectral ($EDT) with exclusivity to the North American market. The product has already been in use in real clinical settings as it has already been approved for use in Japan and Europe by the licensor (Toray Industries) and has thus far treated 300 000+ patients to date and counting. Spectrals nearest competitor, Cytosorbent has a market cap that is multiples of where Spectral currently sits even though they are only in phase 2 and as such years behind in North America. Cytosorbents does have approval for its product in Germany with about 8.2M in revenue per quarter and growing. Having said that, North America is where we think the real opportunity lies. Noteworthy is that Spectrals ability to get the product to market is highly de-risked through an exclusive distribution agreement with Baxter, one of the largest multinational health care companies listed on NYSE. The company also has a stacked board and C suite of top notch professionals. We paid particular attention to a recent CMO hire that happens to be “the world authority in Blood Purification and Renal Replacement Therapy”. A simple google search of his name will detail numerous industry connections that we think could spell a roadmap to success at a later time. A major reason that the writers can see for the market cap to be sitting where it is, is that it has not been cross listed in the US, yet. Biotech stocks do not get a lot of love in Canada.
For Spectral, the focus on a Canadian-only listing could change in the near term. This is where we think the opportunity lies in the short term. For the long term, aside from hitting FDA milestones, we believe that there is some information asymmetry that sits with their newest CMO hire. In the latest investor deck the company states an intention to possibly list on a senior US exchange. In fact, they have already taken steps in this direction having received shareholder approval for a share consolidation in 2021 to meet listing requirements. Why would they if that’s not something they were actively pursuing? As such, we propose that they could see a significant re-rating of share price for this reason alone. There are others that we will outline below. This paper will not get into the specifics of the science and will give a general overview of the company as we see it. There is no amount of due diligence that the writers here can do regarding the science that Baxter hasn’t already done. Armed with the knowledge that Baxter has given Spectral a $6.5M CAD upfront payment for which they presumably did the most thorough due diligence, one can reasonably conclude that the science has merit. For those who want to read more about it or the company and its milestones in general, we encourage you to check out FDA filings, the company’s own presentation, or contact them directly to answer technical questions. This paper will also not get into modelling or sales predictions and will assume there is a market, the market is large, there is a credible partner in place to make sure said product is sold and revenues come in if approvals are granted. Rather, we will focus on a general overview of the company, where the information asymmetry could potentially sit, namely the lack of awareness by both retail and institutional investors in the US, as well as, their newest CMO hire.
PRODUCT PIPELINE SNAPSHOT
They have two separate product pipelines that could be/are being commercialized in the near future. PMX and DIMI. The combined addressable market size for both of the company products is $6.5B USD. There are other FDA/Health Canada fully approved products that the company currently has but they will not be discussed in any detail here as they are compliments to the grand finale.
Screenshot taken from company presentation
Product 1: PMX
PMX is intended for the treatment of patients in septic shock and has been licensed for distribution and commercialization in North America from Toray Industries in Japan where it has already been approved since 2002 and has treated over 300 000+ patients and counting. It has also been approved in Europe since 1994.
PMX has already been through 3 phases with the FDA and failed to gain approval in 2016 at the conclusion of the trial. However, they did find a subset of patients with significant relative risk reduction in mortality. A phase 3b open label trial dubbed “Tigris” has been approved since September 2019 and is currently well underway with an estimated completion at the end of 2021. Commercialization could begin as early as 2022. As the trial nears completion we see it as highly likely that the price will continue to rise in anticipation of the results as speculators arrive. It is far enough out right now to get in at what we find to be attractive prices. Interim results are expected Q2 2021. The FDA has allowed them to use the favorable data of the benefit receiving subset of patients from their failed phase 3 for this phase 3b confirmatory trial. De-risking the Phase 3b study in the sense that they are already starting with statistically significant results. The likelihood of Spectral actually having decent market penetration for PMX, if it were to be approved, is high given the fact that they have an Exclusive Distribution Agreement with Baxter, one of the largest multinational health care companies in the world. Baxter is buying exclusivity rights to distribute PMX in North America via an already completed upfront rights payment and various non dilutive milestone payments moving forward. Should the company hit these targets moving forward there is a high possibility that the company will not need to dilute any further.
Screenshot taken from company presentation
A press release for the partnership can be found on both Baxter and Spectrals websites:
https://www.baxter.com/baxter-newsroom/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-blood-filter
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
Product 2: DIMI
DIMI is a device intended for easy portable hemodialysis. DIMI, a portable dialysis machine has already been recently approved by the FDA in 2020 for in hospital use and the company is currently in the process of trying to obtain approval for home dialysis. Home dialysis is a growing market trend as it cuts down cost and risk of transporting patients. It also increases patient autonomy and comfort. From what we understand there is also a government push towards home dialysis in the US. Read more in the corporate presentation.
Screenshot taken from company presentation
US LISTING. It is our belief that the company is relatively unknown to its neighbors south of the border. If it is introduced to a much larger US investing audience it is quite possible that shareholders may see immediate benefit. Moreover, it is our unprofessional opinion that even the narrower Canadian space is not aware that the company is in pursuit of a US listing.
CMO HIRE. We have found it to be of interest that the new CMO is an established collaborator with multiple successful companies in both the dialysis and sepsis space. {Screenshot at 19 Seconds https://youtu.be/jeGXkKBHo28 } Notable mentions include its much higher market cap direct comparables NxStage and Cytosorbents. Why would this accomplished researcher at the peak of his career, fully understanding the science and risks begin working with a company that he believes could fail? After all, this isn’t a major industry player that has a massive cash cushion in the event of a failure. We would hope that he sees something of value here. A similar company, producing similar products to Spectral, that he was on the scientific advisory board for, NxStage, was sold to Fresenius for $2 Billion for what we see as an arguably inferior, albeit fully FDA approved for home use, product. Note that Spectral is well on its way. Cytosorbents has a current market cap of $400M USD and is in behind Spectral in FDA trials. He has also published numerous research articles sponsored by Baxter. On the face of it, it would appear that this small community of leading scientists and the respective companies in the field of sepsis and blood purification have all done very well market cap wise, except Spectral. In addition to the thesis that the price could go up based on a US listing we find it possible that the new CMO hire is likely to provide new opportunity to the company through his network. If the charts of any of these other companies that the CMO has advised for foreshadow what’s to come for Spectral we see this as a compelling investment.
https://spectraldx.com/spectral-medical-appoints-dr-john-kellum-as-chief-medical-office
https://www.fresenius.com/7461
https://www.modernhealthcare.com/article/20190226/NEWS/190229935/fresenius-medical-care-closes-2-billion-nxstage-acquisition
UPDATE:
We waited with this update until we were fairly confident that the company was very near term in its US listing ambitions, had a number of catalysts met and within close reach, and most importantly would not suprise us with further dilutive events.
Promises made, promises kept. The positive developments regarding the TIGRIS trial and corporate progress overall:
A US listing on a senior exchange announcement should be coming any day now as the company had stated they were aiming for early 2022 according to a December company presentation. The company stated that it was important for major milestones to line up in order for the listing to make sense and are of the belief that timing is now right. A link to the update regarding US listing can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72
It turns out their new CEO and CMO have been delivering results as there are rumors circling various chat forums about a potential partnership with DaVita, one of two largeset nursing home operators in the US ($10.69B Market Cap). The company, after the rumors began circulating, mentioned DaVita multiple times during an investor conference call (a recording of the conference call can be found here: https://www.webcaster4.com/Webcast/Page/2813/43726 ). Additionally DaVita put out a press release regarding a new hire for a division that will specificially focus on Kidney care and more importantly home dialysis, for which Spectral is trying to provide a solution. The press release potentially had a large impact on the volume of Spectral shares traded that afternoon. (DaVita Press Release: https://finance.yahoo.com/news/davita-integrated-kidney-care-expands-110200664.html )
Spectral has gotten an additional 5 sites up and running potentially increasing enrolement by 50% over last years 10 sites. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The FDA has allowed the company to include SOFA scores for patient selection which should increase enrolement by roughly 25-50%. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The math behind the price fall
The company had failed to materialize an attempted direct investment and spin out of its medical device division Dialco. It has been in the dog house since and was forced to exercise $3M in 40 cent warrants and take a $10M financing completed in June 2021 for business continuity. The authors did not see this coming but saw and used the opportunity to average down (have not sold a single share). The current price is at a 50% discount to what accredited and institutional investors paid just months ago. Since the hiccup, the company has been executing milestones according to plan and seems to be finally rounding the corner. https://ca.finance.yahoo.com/news/spectral-medical-inc-closes-10-130500091.html
Seasonal Tax Loss selling seems to have finally ended and double bottom appears to have passed the smell test. Hence the update at this time once we were fairly sure the financing and weak hands had blown their paper out. Volume over the last two days has increased 10 fold and we suspect that we are in the midsts of a reversal.
Trades made
Various buys with .35 cent average
Research
https://www.globenewswire.com/news-release/2019/09/24/1919871/0/en/Spectral-Medical-Launches-the-Tigris-Trial.html
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
https://spectraldx.com/spectral-medical-provides-corporate-update-3/
“Early Tigris trial observations in-line with Euphrates post-hoc results”
https://spectraldx.com/u-s-fda-grants-510k-clearance-for-spectrals-dimi/
· Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
· U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
· Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
· Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
· Spectral to receive upfront exclusive rights payment
https://spectraldx.com/spectral-medical-provides-corporate-update-2/
Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players.
ANALYST COVERAGE
https://www.cantechletter.com/2019/11/paradigm-capital-launches-coverage-of-spectral-medical-with-a-buy/
Disclaimer contd.: We own Spectral Medical shares and as such, in that regard, are biased. We are not affiliated in any way with the company or their contractors nor do we even know anyone that knows someone that works or contracts for at the company. Also, we are not financial advisors nor are we qualified to give financial advice. This is not an endorsement to buy or sell shares of the company. If you plan on investing in this stock or any other you should first speak to a qualified investment advisor. Our risk tolerances may also drastically differ from yours. This may be a given, but we also wanted to highlight that there is a risk that the company does not obtain the approvals they seek or that they run out of cash. The intent of this write-up is to shed light on a company that we perceive to be severely under undervalued and puzzlingly unknown. A fair warning that at any time and without warning we may buy or sell shares.
We did our absolute best to try and not be misleading in any way and will include references to most of what was written here using hyperlinks to credible sources and the company’s own documents. Having said that, we too, are human and it is possible that in this write-up we have made mistakes. It is not out of malice, we encourage everyone that reads this thread to do their own due diligence.
We welcome all opposing views and hope that if we have made mistakes, shortcomings, flaws, gaps in our research you will point them out. It will only help us save money if we have overlooked something of importance. This is an ongoing conversation.
submitted by GoldBug236 to Wallstreetbetsnew [link] [comments]


2021.12.21 17:46 GoldBug236 SPECTRAL MEDICAL $EDT.TO $EDTFX

$EDT.TO $EDTXF
Market cap ~$50M CAD
Share price ~.27 CAD @ DEC 20, 2021
Shares out 228M
Ideal time horizon for our investment: 1 Year
Spectral Medical (EDT.TO or EDTXF USA) is a small cap (~$50M CAD) medical device company listed on the TSX in Canada that is on the cusp of commercializing multiple products that they either already have FDA approval or are just at the cusp of requesting approvals for. Its flagship project is a treatment for severe sepsis that is in an FDA stage 3b confirmatory trial. As far as the writers know this is the only company with a Phase 3 trial for sepsis in North America.
Corporate Presentation
PowerPoint Presentation (spectraldx.com)
UPDATE AT THE BOTTOM OF WRITEUP
BACKGROUND & WRITE UP
Here is an investment thesis for Spectral Medical ($EDT.TO) written by a couple of retail investors; one with a degree in commerce and the other with a PhD in science. Disclaimer: A warning to the reader that we are by no means experts on biotech stocks or very knowledgeable about FDA trials. This is not an endorsement to buy or sell shares of the company. A more detailed disclaimer can be found at the bottom. We had spent a significant amount of time doing research and reading to get to where we are with this investment. How well we did is up for debate. In this paper we attempt to address as much as we could. There is an abundance of information rendering it impossible for us to comprehensively discuss all of the strengths and weaknesses that we saw, however, after many iterations we have boiled it down to the following points that we wanted to highlight. The first 6 points establish the basis and essence of our high conviction trade and things we, and probably any investor, would like to see in any company.
WHY WE LIKE IT?
  1. IF APPROVED, NO COMPETITORS IN THE SEPSIS SPACE FOR AT LEAST 5 YEARS (HUGE MOAT)
  2. SOLVING HOLY GRAIL OF MEDICAL PROBLEMS, SEPSIS (LARGE MARKET)
  3. GROUP OF HIGHLY PUBLISHED AND ACCOMPLISHED PROFESSIONALS (TEAM IS TOP SHELF)
  4. LAST YEAR THE COMPANY SIGNED A DISTRIBUTION AGREEMENT AND RECEIVED UPFRONT PAYMENT WITH ONE OF LARGEST MEDICAL HEALTHCARE COMPANIES LISTED ON NYSE (BUY IN FROM MAJOR - SALES STRATEGY)
  5. TRIAL IS REASONABLY CLOSE TO COMPLETION (1 YEAR TIME HORIZON)
  6. COMPANY IS WELL FUNDED FOR PMX TRIAL (NO DILUTION EXPECTED)
BONUS POINTS:
  1. ALREADY APPROVED IN EUROPE AND JAPAN WHERE IT HAS TREATED 300 000+ PATIENTS
  2. SPECULATION AS TRIAL(S) NEAR(S) COMPLETION COULD CAUSE UPWARDS PRICE PRESSURE AS IT HAS DONE IN THE PAST
  3. IF THE COMPANY LIVES UP TO ITS US LISTING PROMISE IN THE SHORT TERM WE SEE A MUCH LARGER INVESTING AUDIENCE
  4. NEW CMO HIRE OPENS WORLD OF POTENTIAL OPPORTUNITIES
  5. ADDITIONAL PRODUCT PIPELINE IN HOME DIALYSIS PARTIALLY FDA APPROVED AND PROVIDES BACKSTOP
GENERAL OVERVIEW
Spectral Medical is a small cap (~$50M CAD) medical device company that is on the cusp of commercializing multiple products that they either already have or are nearing the corner for FDA approvals. Its flagship project is a treatment for severe sepsis that is currently in an FDA Stage 3b confirmatory trial with an expectation for completion in late 2021. This product is known as “PMX” and has NO COMPETITORS as there are NO FDA approved solutions for sepsis in the market and none coming any time soon. PMX has been licensed to Spectral ($EDT) with exclusivity to the North American market. The product has already been in use in real clinical settings as it has already been approved for use in Japan and Europe by the licensor (Toray Industries) and has thus far treated 300 000+ patients to date and counting. Spectrals nearest competitor, Cytosorbent has a market cap that is multiples of where Spectral currently sits even though they are only in phase 2 and as such years behind in North America. Cytosorbents does have approval for its product in Germany with about 8.2M in revenue per quarter and growing. Having said that, North America is where we think the real opportunity lies. Noteworthy is that Spectrals ability to get the product to market is highly de-risked through an exclusive distribution agreement with Baxter, one of the largest multinational health care companies listed on NYSE. The company also has a stacked board and C suite of top notch professionals. We paid particular attention to a recent CMO hire that happens to be “the world authority in Blood Purification and Renal Replacement Therapy”. A simple google search of his name will detail numerous industry connections that we think could spell a roadmap to success at a later time. A major reason that the writers can see for the market cap to be sitting where it is, is that it has not been cross listed in the US, yet. Biotech stocks do not get a lot of love in Canada.
For Spectral, the focus on a Canadian-only listing could change in the near term. This is where we think the opportunity lies in the short term. For the long term, aside from hitting FDA milestones, we believe that there is some information asymmetry that sits with their newest CMO hire. In the latest investor deck the company states an intention to possibly list on a senior US exchange. In fact, they have already taken steps in this direction having received shareholder approval for a share consolidation in 2021 to meet listing requirements. Why would they if that’s not something they were actively pursuing? As such, we propose that they could see a significant re-rating of share price for this reason alone. There are others that we will outline below. This paper will not get into the specifics of the science and will give a general overview of the company as we see it. There is no amount of due diligence that the writers here can do regarding the science that Baxter hasn’t already done. Armed with the knowledge that Baxter has given Spectral a $6.5M CAD upfront payment for which they presumably did the most thorough due diligence, one can reasonably conclude that the science has merit. For those who want to read more about it or the company and its milestones in general, we encourage you to check out FDA filings, the company’s own presentation, or contact them directly to answer technical questions. This paper will also not get into modelling or sales predictions and will assume there is a market, the market is large, there is a credible partner in place to make sure said product is sold and revenues come in if approvals are granted. Rather, we will focus on a general overview of the company, where the information asymmetry could potentially sit, namely the lack of awareness by both retail and institutional investors in the US, as well as, their newest CMO hire.
PRODUCT PIPELINE SNAPSHOT
They have two separate product pipelines that could be/are being commercialized in the near future. PMX and DIMI. The combined addressable market size for both of the company products is $6.5B USD. There are other FDA/Health Canada fully approved products that the company currently has but they will not be discussed in any detail here as they are compliments to the grand finale.
Screenshot taken from company presentation
Product 1: PMX
PMX is intended for the treatment of patients in septic shock and has been licensed for distribution and commercialization in North America from Toray Industries in Japan where it has already been approved since 2002 and has treated over 300 000+ patients and counting. It has also been approved in Europe since 1994.
PMX has already been through 3 phases with the FDA and failed to gain approval in 2016 at the conclusion of the trial. However, they did find a subset of patients with significant relative risk reduction in mortality. A phase 3b open label trial dubbed “Tigris” has been approved since September 2019 and is currently well underway with an estimated completion at the end of 2021. Commercialization could begin as early as 2022. As the trial nears completion we see it as highly likely that the price will continue to rise in anticipation of the results as speculators arrive. It is far enough out right now to get in at what we find to be attractive prices. Interim results are expected Q2 2021. The FDA has allowed them to use the favorable data of the benefit receiving subset of patients from their failed phase 3 for this phase 3b confirmatory trial. De-risking the Phase 3b study in the sense that they are already starting with statistically significant results. The likelihood of Spectral actually having decent market penetration for PMX, if it were to be approved, is high given the fact that they have an Exclusive Distribution Agreement with Baxter, one of the largest multinational health care companies in the world. Baxter is buying exclusivity rights to distribute PMX in North America via an already completed upfront rights payment and various non dilutive milestone payments moving forward. Should the company hit these targets moving forward there is a high possibility that the company will not need to dilute any further.
Screenshot taken from company presentation
A press release for the partnership can be found on both Baxter and Spectrals websites:
https://www.baxter.com/baxter-newsroom/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-blood-filter
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
Product 2: DIMI
DIMI is a device intended for easy portable hemodialysis. DIMI, a portable dialysis machine has already been recently approved by the FDA in 2020 for in hospital use and the company is currently in the process of trying to obtain approval for home dialysis. Home dialysis is a growing market trend as it cuts down cost and risk of transporting patients. It also increases patient autonomy and comfort. From what we understand there is also a government push towards home dialysis in the US. Read more in the corporate presentation.
Screenshot taken from company presentation
US LISTING. It is our belief that the company is relatively unknown to its neighbors south of the border. If it is introduced to a much larger US investing audience it is quite possible that shareholders may see immediate benefit. Moreover, it is our unprofessional opinion that even the narrower Canadian space is not aware that the company is in pursuit of a US listing.
CMO HIRE. We have found it to be of interest that the new CMO is an established collaborator with multiple successful companies in both the dialysis and sepsis space. {Screenshot at 19 Seconds https://youtu.be/jeGXkKBHo28 } Notable mentions include its much higher market cap direct comparables NxStage and Cytosorbents. Why would this accomplished researcher at the peak of his career, fully understanding the science and risks begin working with a company that he believes could fail? After all, this isn’t a major industry player that has a massive cash cushion in the event of a failure. We would hope that he sees something of value here. A similar company, producing similar products to Spectral, that he was on the scientific advisory board for, NxStage, was sold to Fresenius for $2 Billion for what we see as an arguably inferior, albeit fully FDA approved for home use, product. Note that Spectral is well on its way. Cytosorbents has a current market cap of $400M USD and is in behind Spectral in FDA trials. He has also published numerous research articles sponsored by Baxter. On the face of it, it would appear that this small community of leading scientists and the respective companies in the field of sepsis and blood purification have all done very well market cap wise, except Spectral. In addition to the thesis that the price could go up based on a US listing we find it possible that the new CMO hire is likely to provide new opportunity to the company through his network. If the charts of any of these other companies that the CMO has advised for foreshadow what’s to come for Spectral we see this as a compelling investment.
https://spectraldx.com/spectral-medical-appoints-dr-john-kellum-as-chief-medical-office
https://www.fresenius.com/7461
https://www.modernhealthcare.com/article/20190226/NEWS/190229935/fresenius-medical-care-closes-2-billion-nxstage-acquisition
UPDATE:
We waited with this update until we were fairly confident that the company was very near term in its US listing ambitions, had a number of catalysts met and within close reach, and most importantly would not suprise us with further dilutive events.
Promises made, promises kept. The positive developments regarding the TIGRIS trial and corporate progress overall:
A US listing on a senior exchange announcement should be coming any day now as the company had stated they were aiming for early 2022 according to a December company presentation. The company stated that it was important for major milestones to line up in order for the listing to make sense and are of the belief that timing is now right. A link to the update regarding US listing can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72
It turns out their new CEO and CMO have been delivering results as there are rumors circling various chat forums about a potential partnership with DaVita, one of two largeset nursing home operators in the US ($10.69B Market Cap). The company, after the rumors began circulating, mentioned DaVita multiple times during an investor conference call (a recording of the conference call can be found here: https://www.webcaster4.com/Webcast/Page/2813/43726 ). Additionally DaVita put out a press release regarding a new hire for a division that will specificially focus on Kidney care and more importantly home dialysis, for which Spectral is trying to provide a solution. The press release potentially had a large impact on the volume of Spectral shares traded that afternoon. (DaVita Press Release: https://finance.yahoo.com/news/davita-integrated-kidney-care-expands-110200664.html )
Spectral has gotten an additional 5 sites up and running potentially increasing enrolement by 50% over last years 10 sites. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The FDA has allowed the company to include SOFA scores for patient selection which should increase enrolement by roughly 25-50%. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The math behind the price fall
The company had failed to materialize an attempted direct investment and spin out of its medical device division Dialco. It has been in the dog house since and was forced to exercise $3M in 40 cent warrants and take a $10M financing completed in June 2021 for business continuity. The authors did not see this coming but saw and used the opportunity to average down (have not sold a single share). The current price is at a 50% discount to what accredited and institutional investors paid just months ago. Since the hiccup, the company has been executing milestones according to plan and seems to be finally rounding the corner. https://ca.finance.yahoo.com/news/spectral-medical-inc-closes-10-130500091.html
Seasonal Tax Loss selling seems to have finally ended and double bottom appears to have passed the smell test. Hence the update at this time once we were fairly sure the financing and weak hands had blown their paper out. Volume over the last two days has increased 10 fold and we suspect that we are in the midsts of a reversal.
Trades made
Various buys with .35 cent average
Research
https://www.globenewswire.com/news-release/2019/09/24/1919871/0/en/Spectral-Medical-Launches-the-Tigris-Trial.html
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
https://spectraldx.com/spectral-medical-provides-corporate-update-3/
“Early Tigris trial observations in-line with Euphrates post-hoc results”
https://spectraldx.com/u-s-fda-grants-510k-clearance-for-spectrals-dimi/
· Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
· U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
· Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
· Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
· Spectral to receive upfront exclusive rights payment
https://spectraldx.com/spectral-medical-provides-corporate-update-2/
Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players.
ANALYST COVERAGE
https://www.cantechletter.com/2019/11/paradigm-capital-launches-coverage-of-spectral-medical-with-a-buy/
Disclaimer contd.: We own Spectral Medical shares and as such, in that regard, are biased. We are not affiliated in any way with the company or their contractors nor do we even know anyone that knows someone that works or contracts for at the company. Also, we are not financial advisors nor are we qualified to give financial advice. This is not an endorsement to buy or sell shares of the company. If you plan on investing in this stock or any other you should first speak to a qualified investment advisor. Our risk tolerances may also drastically differ from yours. This may be a given, but we also wanted to highlight that there is a risk that the company does not obtain the approvals they seek or that they run out of cash. The intent of this write-up is to shed light on a company that we perceive to be severely under undervalued and puzzlingly unknown. A fair warning that at any time and without warning we may buy or sell shares.
We did our absolute best to try and not be misleading in any way and will include references to most of what was written here using hyperlinks to credible sources and the company’s own documents. Having said that, we too, are human and it is possible that in this write-up we have made mistakes. It is not out of malice, we encourage everyone that reads this thread to do their own due diligence.
We welcome all opposing views and hope that if we have made mistakes, shortcomings, flaws, gaps in our research you will point them out. It will only help us save money if we have overlooked something of importance. This is an ongoing conversation.
submitted by GoldBug236 to biotech_stocks [link] [comments]


2021.12.21 17:44 GoldBug236 SPECTRAL MEDICAL $EDT.TO $EDTFX

$EDT.TO $EDTXF
Market cap ~$50M CAD
Share price ~.27 CAD @ DEC 20, 2021
Shares out 228M
Ideal time horizon for our investment: 1 Year
Spectral Medical (EDT.TO or EDTXF USA) is a small cap (~$50M CAD) medical device company listed on the TSX in Canada that is on the cusp of commercializing multiple products that they either already have FDA approval or are just at the cusp of requesting approvals for. Its flagship project is a treatment for severe sepsis that is in an FDA stage 3b confirmatory trial. As far as the writers know this is the only company with a Phase 3 trial for sepsis in North America.
Corporate Presentation
PowerPoint Presentation (spectraldx.com)
UPDATE AT THE BOTTOM OF WRITEUP
BACKGROUND & WRITE UP
Here is an investment thesis for Spectral Medical ($EDT.TO) written by a couple of retail investors; one with a degree in commerce and the other with a PhD in science. Disclaimer: A warning to the reader that we are by no means experts on biotech stocks or very knowledgeable about FDA trials. This is not an endorsement to buy or sell shares of the company. A more detailed disclaimer can be found at the bottom. We had spent a significant amount of time doing research and reading to get to where we are with this investment. How well we did is up for debate. In this paper we attempt to address as much as we could. There is an abundance of information rendering it impossible for us to comprehensively discuss all of the strengths and weaknesses that we saw, however, after many iterations we have boiled it down to the following points that we wanted to highlight. The first 6 points establish the basis and essence of our high conviction trade and things we, and probably any investor, would like to see in any company.
WHY WE LIKE IT?
  1. IF APPROVED, NO COMPETITORS IN THE SEPSIS SPACE FOR AT LEAST 5 YEARS (HUGE MOAT)
  2. SOLVING HOLY GRAIL OF MEDICAL PROBLEMS, SEPSIS (LARGE MARKET)
  3. GROUP OF HIGHLY PUBLISHED AND ACCOMPLISHED PROFESSIONALS (TEAM IS TOP SHELF)
  4. LAST YEAR THE COMPANY SIGNED A DISTRIBUTION AGREEMENT AND RECEIVED UPFRONT PAYMENT WITH ONE OF LARGEST MEDICAL HEALTHCARE COMPANIES LISTED ON NYSE (BUY IN FROM MAJOR - SALES STRATEGY)
  5. TRIAL IS REASONABLY CLOSE TO COMPLETION (1 YEAR TIME HORIZON)
  6. COMPANY IS WELL FUNDED FOR PMX TRIAL (NO DILUTION EXPECTED)
BONUS POINTS:
  1. ALREADY APPROVED IN EUROPE AND JAPAN WHERE IT HAS TREATED 300 000+ PATIENTS
  2. SPECULATION AS TRIAL(S) NEAR(S) COMPLETION COULD CAUSE UPWARDS PRICE PRESSURE AS IT HAS DONE IN THE PAST
  3. IF THE COMPANY LIVES UP TO ITS US LISTING PROMISE IN THE SHORT TERM WE SEE A MUCH LARGER INVESTING AUDIENCE
  4. NEW CMO HIRE OPENS WORLD OF POTENTIAL OPPORTUNITIES
  5. ADDITIONAL PRODUCT PIPELINE IN HOME DIALYSIS PARTIALLY FDA APPROVED AND PROVIDES BACKSTOP
GENERAL OVERVIEW
Spectral Medical is a small cap (~$50M CAD) medical device company that is on the cusp of commercializing multiple products that they either already have or are nearing the corner for FDA approvals. Its flagship project is a treatment for severe sepsis that is currently in an FDA Stage 3b confirmatory trial with an expectation for completion in late 2021. This product is known as “PMX” and has NO COMPETITORS as there are NO FDA approved solutions for sepsis in the market and none coming any time soon. PMX has been licensed to Spectral ($EDT) with exclusivity to the North American market. The product has already been in use in real clinical settings as it has already been approved for use in Japan and Europe by the licensor (Toray Industries) and has thus far treated 300 000+ patients to date and counting. Spectrals nearest competitor, Cytosorbent has a market cap that is multiples of where Spectral currently sits even though they are only in phase 2 and as such years behind in North America. Cytosorbents does have approval for its product in Germany with about 8.2M in revenue per quarter and growing. Having said that, North America is where we think the real opportunity lies. Noteworthy is that Spectrals ability to get the product to market is highly de-risked through an exclusive distribution agreement with Baxter, one of the largest multinational health care companies listed on NYSE. The company also has a stacked board and C suite of top notch professionals. We paid particular attention to a recent CMO hire that happens to be “the world authority in Blood Purification and Renal Replacement Therapy”. A simple google search of his name will detail numerous industry connections that we think could spell a roadmap to success at a later time. A major reason that the writers can see for the market cap to be sitting where it is, is that it has not been cross listed in the US, yet. Biotech stocks do not get a lot of love in Canada.
For Spectral, the focus on a Canadian-only listing could change in the near term. This is where we think the opportunity lies in the short term. For the long term, aside from hitting FDA milestones, we believe that there is some information asymmetry that sits with their newest CMO hire. In the latest investor deck the company states an intention to possibly list on a senior US exchange. In fact, they have already taken steps in this direction having received shareholder approval for a share consolidation in 2021 to meet listing requirements. Why would they if that’s not something they were actively pursuing? As such, we propose that they could see a significant re-rating of share price for this reason alone. There are others that we will outline below. This paper will not get into the specifics of the science and will give a general overview of the company as we see it. There is no amount of due diligence that the writers here can do regarding the science that Baxter hasn’t already done. Armed with the knowledge that Baxter has given Spectral a $6.5M CAD upfront payment for which they presumably did the most thorough due diligence, one can reasonably conclude that the science has merit. For those who want to read more about it or the company and its milestones in general, we encourage you to check out FDA filings, the company’s own presentation, or contact them directly to answer technical questions. This paper will also not get into modelling or sales predictions and will assume there is a market, the market is large, there is a credible partner in place to make sure said product is sold and revenues come in if approvals are granted. Rather, we will focus on a general overview of the company, where the information asymmetry could potentially sit, namely the lack of awareness by both retail and institutional investors in the US, as well as, their newest CMO hire.
PRODUCT PIPELINE SNAPSHOT
They have two separate product pipelines that could be/are being commercialized in the near future. PMX and DIMI. The combined addressable market size for both of the company products is $6.5B USD. There are other FDA/Health Canada fully approved products that the company currently has but they will not be discussed in any detail here as they are compliments to the grand finale.
Screenshot taken from company presentation
Product 1: PMX
PMX is intended for the treatment of patients in septic shock and has been licensed for distribution and commercialization in North America from Toray Industries in Japan where it has already been approved since 2002 and has treated over 300 000+ patients and counting. It has also been approved in Europe since 1994.
PMX has already been through 3 phases with the FDA and failed to gain approval in 2016 at the conclusion of the trial. However, they did find a subset of patients with significant relative risk reduction in mortality. A phase 3b open label trial dubbed “Tigris” has been approved since September 2019 and is currently well underway with an estimated completion at the end of 2021. Commercialization could begin as early as 2022. As the trial nears completion we see it as highly likely that the price will continue to rise in anticipation of the results as speculators arrive. It is far enough out right now to get in at what we find to be attractive prices. Interim results are expected Q2 2021. The FDA has allowed them to use the favorable data of the benefit receiving subset of patients from their failed phase 3 for this phase 3b confirmatory trial. De-risking the Phase 3b study in the sense that they are already starting with statistically significant results. The likelihood of Spectral actually having decent market penetration for PMX, if it were to be approved, is high given the fact that they have an Exclusive Distribution Agreement with Baxter, one of the largest multinational health care companies in the world. Baxter is buying exclusivity rights to distribute PMX in North America via an already completed upfront rights payment and various non dilutive milestone payments moving forward. Should the company hit these targets moving forward there is a high possibility that the company will not need to dilute any further.
Screenshot taken from company presentation
A press release for the partnership can be found on both Baxter and Spectrals websites:
https://www.baxter.com/baxter-newsroom/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-blood-filter
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
Product 2: DIMI
DIMI is a device intended for easy portable hemodialysis. DIMI, a portable dialysis machine has already been recently approved by the FDA in 2020 for in hospital use and the company is currently in the process of trying to obtain approval for home dialysis. Home dialysis is a growing market trend as it cuts down cost and risk of transporting patients. It also increases patient autonomy and comfort. From what we understand there is also a government push towards home dialysis in the US. Read more in the corporate presentation.
Screenshot taken from company presentation
US LISTING. It is our belief that the company is relatively unknown to its neighbors south of the border. If it is introduced to a much larger US investing audience it is quite possible that shareholders may see immediate benefit. Moreover, it is our unprofessional opinion that even the narrower Canadian space is not aware that the company is in pursuit of a US listing.
CMO HIRE. We have found it to be of interest that the new CMO is an established collaborator with multiple successful companies in both the dialysis and sepsis space. {Screenshot at 19 Seconds https://youtu.be/jeGXkKBHo28 } Notable mentions include its much higher market cap direct comparables NxStage and Cytosorbents. Why would this accomplished researcher at the peak of his career, fully understanding the science and risks begin working with a company that he believes could fail? After all, this isn’t a major industry player that has a massive cash cushion in the event of a failure. We would hope that he sees something of value here. A similar company, producing similar products to Spectral, that he was on the scientific advisory board for, NxStage, was sold to Fresenius for $2 Billion for what we see as an arguably inferior, albeit fully FDA approved for home use, product. Note that Spectral is well on its way. Cytosorbents has a current market cap of $400M USD and is in behind Spectral in FDA trials. He has also published numerous research articles sponsored by Baxter. On the face of it, it would appear that this small community of leading scientists and the respective companies in the field of sepsis and blood purification have all done very well market cap wise, except Spectral. In addition to the thesis that the price could go up based on a US listing we find it possible that the new CMO hire is likely to provide new opportunity to the company through his network. If the charts of any of these other companies that the CMO has advised for foreshadow what’s to come for Spectral we see this as a compelling investment.
https://spectraldx.com/spectral-medical-appoints-dr-john-kellum-as-chief-medical-office
https://www.fresenius.com/7461
https://www.modernhealthcare.com/article/20190226/NEWS/190229935/fresenius-medical-care-closes-2-billion-nxstage-acquisition
UPDATE:
We waited with this update until we were fairly confident that the company was very near term in its US listing ambitions, had a number of catalysts met and within close reach, and most importantly would not suprise us with further dilutive events.
Promises made, promises kept. The positive developments regarding the TIGRIS trial and corporate progress overall:
A US listing on a senior exchange announcement should be coming any day now as the company had stated they were aiming for early 2022 according to a December company presentation. The company stated that it was important for major milestones to line up in order for the listing to make sense and are of the belief that timing is now right. A link to the update regarding US listing can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72
It turns out their new CEO and CMO have been delivering results as there are rumors circling various chat forums about a potential partnership with DaVita, one of two largeset nursing home operators in the US ($10.69B Market Cap). The company, after the rumors began circulating, mentioned DaVita multiple times during an investor conference call (a recording of the conference call can be found here: https://www.webcaster4.com/Webcast/Page/2813/43726 ). Additionally DaVita put out a press release regarding a new hire for a division that will specificially focus on Kidney care and more importantly home dialysis, for which Spectral is trying to provide a solution. The press release potentially had a large impact on the volume of Spectral shares traded that afternoon. (DaVita Press Release: https://finance.yahoo.com/news/davita-integrated-kidney-care-expands-110200664.html )
Spectral has gotten an additional 5 sites up and running potentially increasing enrolement by 50% over last years 10 sites. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The FDA has allowed the company to include SOFA scores for patient selection which should increase enrolement by roughly 25-50%. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The math behind the price fall
The company had failed to materialize an attempted direct investment and spin out of its medical device division Dialco. It has been in the dog house since and was forced to exercise $3M in 40 cent warrants and take a $10M financing completed in June 2021 for business continuity. The authors did not see this coming but saw and used the opportunity to average down (have not sold a single share). The current price is at a 50% discount to what accredited and institutional investors paid just months ago. Since the hiccup, the company has been executing milestones according to plan and seems to be finally rounding the corner. https://ca.finance.yahoo.com/news/spectral-medical-inc-closes-10-130500091.html
Seasonal Tax Loss selling seems to have finally ended and double bottom appears to have passed the smell test. Hence the update at this time once we were fairly sure the financing and weak hands had blown their paper out. Volume over the last two days has increased 10 fold and we suspect that we are in the midsts of a reversal.
Trades made
Various buys with .35 cent average
Research
https://www.globenewswire.com/news-release/2019/09/24/1919871/0/en/Spectral-Medical-Launches-the-Tigris-Trial.html
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
https://spectraldx.com/spectral-medical-provides-corporate-update-3/
“Early Tigris trial observations in-line with Euphrates post-hoc results”
https://spectraldx.com/u-s-fda-grants-510k-clearance-for-spectrals-dimi/
· Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
· U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
· Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
· Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
· Spectral to receive upfront exclusive rights payment
https://spectraldx.com/spectral-medical-provides-corporate-update-2/
Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players.
ANALYST COVERAGE
https://www.cantechletter.com/2019/11/paradigm-capital-launches-coverage-of-spectral-medical-with-a-buy/
Disclaimer contd.: We own Spectral Medical shares and as such, in that regard, are biased. We are not affiliated in any way with the company or their contractors nor do we even know anyone that knows someone that works or contracts for at the company. Also, we are not financial advisors nor are we qualified to give financial advice. This is not an endorsement to buy or sell shares of the company. If you plan on investing in this stock or any other you should first speak to a qualified investment advisor. Our risk tolerances may also drastically differ from yours. This may be a given, but we also wanted to highlight that there is a risk that the company does not obtain the approvals they seek or that they run out of cash. The intent of this write-up is to shed light on a company that we perceive to be severely under undervalued and puzzlingly unknown. A fair warning that at any time and without warning we may buy or sell shares.
We did our absolute best to try and not be misleading in any way and will include references to most of what was written here using hyperlinks to credible sources and the company’s own documents. Having said that, we too, are human and it is possible that in this write-up we have made mistakes. It is not out of malice, we encourage everyone that reads this thread to do their own due diligence.
We welcome all opposing views and hope that if we have made mistakes, shortcomings, flaws, gaps in our research you will point them out. It will only help us save money if we have overlooked something of importance. This is an ongoing conversation.
submitted by GoldBug236 to Biotechplays [link] [comments]


2021.12.21 17:43 GoldBug236 SPECTRAL MEDICAL $EDT.TO $EDTFX

$EDT.TO $EDTXF
Market cap ~$50M CAD
Share price ~.27 CAD @ DEC 20, 2021
Shares out 228M
Ideal time horizon for our investment: 1 Year
Spectral Medical (EDT.TO or EDTXF USA) is a small cap (~$50M CAD) medical device company listed on the TSX in Canada that is on the cusp of commercializing multiple products that they either already have FDA approval or are just at the cusp of requesting approvals for. Its flagship project is a treatment for severe sepsis that is in an FDA stage 3b confirmatory trial. As far as the writers know this is the only company with a Phase 3 trial for sepsis in North America.
Corporate Presentation
PowerPoint Presentation (spectraldx.com)
UPDATE AT THE BOTTOM OF WRITEUP
BACKGROUND & WRITE UP
Here is an investment thesis for Spectral Medical ($EDT.TO) written by a couple of retail investors; one with a degree in commerce and the other with a PhD in science. Disclaimer: A warning to the reader that we are by no means experts on biotech stocks or very knowledgeable about FDA trials. This is not an endorsement to buy or sell shares of the company. A more detailed disclaimer can be found at the bottom. We had spent a significant amount of time doing research and reading to get to where we are with this investment. How well we did is up for debate. In this paper we attempt to address as much as we could. There is an abundance of information rendering it impossible for us to comprehensively discuss all of the strengths and weaknesses that we saw, however, after many iterations we have boiled it down to the following points that we wanted to highlight. The first 6 points establish the basis and essence of our high conviction trade and things we, and probably any investor, would like to see in any company.
WHY WE LIKE IT?
  1. IF APPROVED, NO COMPETITORS IN THE SEPSIS SPACE FOR AT LEAST 5 YEARS (HUGE MOAT)
  2. SOLVING HOLY GRAIL OF MEDICAL PROBLEMS, SEPSIS (LARGE MARKET)
  3. GROUP OF HIGHLY PUBLISHED AND ACCOMPLISHED PROFESSIONALS (TEAM IS TOP SHELF)
  4. LAST YEAR THE COMPANY SIGNED A DISTRIBUTION AGREEMENT AND RECEIVED UPFRONT PAYMENT WITH ONE OF LARGEST MEDICAL HEALTHCARE COMPANIES LISTED ON NYSE (BUY IN FROM MAJOR - SALES STRATEGY)
  5. TRIAL IS REASONABLY CLOSE TO COMPLETION (1 YEAR TIME HORIZON)
  6. COMPANY IS WELL FUNDED FOR PMX TRIAL (NO DILUTION EXPECTED)
BONUS POINTS:
  1. ALREADY APPROVED IN EUROPE AND JAPAN WHERE IT HAS TREATED 300 000+ PATIENTS
  2. SPECULATION AS TRIAL(S) NEAR(S) COMPLETION COULD CAUSE UPWARDS PRICE PRESSURE AS IT HAS DONE IN THE PAST
  3. IF THE COMPANY LIVES UP TO ITS US LISTING PROMISE IN THE SHORT TERM WE SEE A MUCH LARGER INVESTING AUDIENCE
  4. NEW CMO HIRE OPENS WORLD OF POTENTIAL OPPORTUNITIES
  5. ADDITIONAL PRODUCT PIPELINE IN HOME DIALYSIS PARTIALLY FDA APPROVED AND PROVIDES BACKSTOP
GENERAL OVERVIEW
Spectral Medical is a small cap (~$50M CAD) medical device company that is on the cusp of commercializing multiple products that they either already have or are nearing the corner for FDA approvals. Its flagship project is a treatment for severe sepsis that is currently in an FDA Stage 3b confirmatory trial with an expectation for completion in late 2021. This product is known as “PMX” and has NO COMPETITORS as there are NO FDA approved solutions for sepsis in the market and none coming any time soon. PMX has been licensed to Spectral ($EDT) with exclusivity to the North American market. The product has already been in use in real clinical settings as it has already been approved for use in Japan and Europe by the licensor (Toray Industries) and has thus far treated 300 000+ patients to date and counting. Spectrals nearest competitor, Cytosorbent has a market cap that is multiples of where Spectral currently sits even though they are only in phase 2 and as such years behind in North America. Cytosorbents does have approval for its product in Germany with about 8.2M in revenue per quarter and growing. Having said that, North America is where we think the real opportunity lies. Noteworthy is that Spectrals ability to get the product to market is highly de-risked through an exclusive distribution agreement with Baxter, one of the largest multinational health care companies listed on NYSE. The company also has a stacked board and C suite of top notch professionals. We paid particular attention to a recent CMO hire that happens to be “the world authority in Blood Purification and Renal Replacement Therapy”. A simple google search of his name will detail numerous industry connections that we think could spell a roadmap to success at a later time. A major reason that the writers can see for the market cap to be sitting where it is, is that it has not been cross listed in the US, yet. Biotech stocks do not get a lot of love in Canada.
For Spectral, the focus on a Canadian-only listing could change in the near term. This is where we think the opportunity lies in the short term. For the long term, aside from hitting FDA milestones, we believe that there is some information asymmetry that sits with their newest CMO hire. In the latest investor deck the company states an intention to possibly list on a senior US exchange. In fact, they have already taken steps in this direction having received shareholder approval for a share consolidation in 2021 to meet listing requirements. Why would they if that’s not something they were actively pursuing? As such, we propose that they could see a significant re-rating of share price for this reason alone. There are others that we will outline below. This paper will not get into the specifics of the science and will give a general overview of the company as we see it. There is no amount of due diligence that the writers here can do regarding the science that Baxter hasn’t already done. Armed with the knowledge that Baxter has given Spectral a $6.5M CAD upfront payment for which they presumably did the most thorough due diligence, one can reasonably conclude that the science has merit. For those who want to read more about it or the company and its milestones in general, we encourage you to check out FDA filings, the company’s own presentation, or contact them directly to answer technical questions. This paper will also not get into modelling or sales predictions and will assume there is a market, the market is large, there is a credible partner in place to make sure said product is sold and revenues come in if approvals are granted. Rather, we will focus on a general overview of the company, where the information asymmetry could potentially sit, namely the lack of awareness by both retail and institutional investors in the US, as well as, their newest CMO hire.
PRODUCT PIPELINE SNAPSHOT
They have two separate product pipelines that could be/are being commercialized in the near future. PMX and DIMI. The combined addressable market size for both of the company products is $6.5B USD. There are other FDA/Health Canada fully approved products that the company currently has but they will not be discussed in any detail here as they are compliments to the grand finale.
Screenshot taken from company presentation
Product 1: PMX
PMX is intended for the treatment of patients in septic shock and has been licensed for distribution and commercialization in North America from Toray Industries in Japan where it has already been approved since 2002 and has treated over 300 000+ patients and counting. It has also been approved in Europe since 1994.
PMX has already been through 3 phases with the FDA and failed to gain approval in 2016 at the conclusion of the trial. However, they did find a subset of patients with significant relative risk reduction in mortality. A phase 3b open label trial dubbed “Tigris” has been approved since September 2019 and is currently well underway with an estimated completion at the end of 2021. Commercialization could begin as early as 2022. As the trial nears completion we see it as highly likely that the price will continue to rise in anticipation of the results as speculators arrive. It is far enough out right now to get in at what we find to be attractive prices. Interim results are expected Q2 2021. The FDA has allowed them to use the favorable data of the benefit receiving subset of patients from their failed phase 3 for this phase 3b confirmatory trial. De-risking the Phase 3b study in the sense that they are already starting with statistically significant results. The likelihood of Spectral actually having decent market penetration for PMX, if it were to be approved, is high given the fact that they have an Exclusive Distribution Agreement with Baxter, one of the largest multinational health care companies in the world. Baxter is buying exclusivity rights to distribute PMX in North America via an already completed upfront rights payment and various non dilutive milestone payments moving forward. Should the company hit these targets moving forward there is a high possibility that the company will not need to dilute any further.
Screenshot taken from company presentation
A press release for the partnership can be found on both Baxter and Spectrals websites:
https://www.baxter.com/baxter-newsroom/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-blood-filter
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
Product 2: DIMI
DIMI is a device intended for easy portable hemodialysis. DIMI, a portable dialysis machine has already been recently approved by the FDA in 2020 for in hospital use and the company is currently in the process of trying to obtain approval for home dialysis. Home dialysis is a growing market trend as it cuts down cost and risk of transporting patients. It also increases patient autonomy and comfort. From what we understand there is also a government push towards home dialysis in the US. Read more in the corporate presentation.
Screenshot taken from company presentation
US LISTING. It is our belief that the company is relatively unknown to its neighbors south of the border. If it is introduced to a much larger US investing audience it is quite possible that shareholders may see immediate benefit. Moreover, it is our unprofessional opinion that even the narrower Canadian space is not aware that the company is in pursuit of a US listing.
CMO HIRE. We have found it to be of interest that the new CMO is an established collaborator with multiple successful companies in both the dialysis and sepsis space. {Screenshot at 19 Seconds https://youtu.be/jeGXkKBHo28 } Notable mentions include its much higher market cap direct comparables NxStage and Cytosorbents. Why would this accomplished researcher at the peak of his career, fully understanding the science and risks begin working with a company that he believes could fail? After all, this isn’t a major industry player that has a massive cash cushion in the event of a failure. We would hope that he sees something of value here. A similar company, producing similar products to Spectral, that he was on the scientific advisory board for, NxStage, was sold to Fresenius for $2 Billion for what we see as an arguably inferior, albeit fully FDA approved for home use, product. Note that Spectral is well on its way. Cytosorbents has a current market cap of $400M USD and is in behind Spectral in FDA trials. He has also published numerous research articles sponsored by Baxter. On the face of it, it would appear that this small community of leading scientists and the respective companies in the field of sepsis and blood purification have all done very well market cap wise, except Spectral. In addition to the thesis that the price could go up based on a US listing we find it possible that the new CMO hire is likely to provide new opportunity to the company through his network. If the charts of any of these other companies that the CMO has advised for foreshadow what’s to come for Spectral we see this as a compelling investment.
https://spectraldx.com/spectral-medical-appoints-dr-john-kellum-as-chief-medical-office
https://www.fresenius.com/7461
https://www.modernhealthcare.com/article/20190226/NEWS/190229935/fresenius-medical-care-closes-2-billion-nxstage-acquisition
UPDATE:
We waited with this update until we were fairly confident that the company was very near term in its US listing ambitions, had a number of catalysts met and within close reach, and most importantly would not suprise us with further dilutive events.
Promises made, promises kept. The positive developments regarding the TIGRIS trial and corporate progress overall:
A US listing on a senior exchange announcement should be coming any day now as the company had stated they were aiming for early 2022 according to a December company presentation. The company stated that it was important for major milestones to line up in order for the listing to make sense and are of the belief that timing is now right. A link to the update regarding US listing can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72
It turns out their new CEO and CMO have been delivering results as there are rumors circling various chat forums about a potential partnership with DaVita, one of two largeset nursing home operators in the US ($10.69B Market Cap). The company, after the rumors began circulating, mentioned DaVita multiple times during an investor conference call (a recording of the conference call can be found here: https://www.webcaster4.com/Webcast/Page/2813/43726 ). Additionally DaVita put out a press release regarding a new hire for a division that will specificially focus on Kidney care and more importantly home dialysis, for which Spectral is trying to provide a solution. The press release potentially had a large impact on the volume of Spectral shares traded that afternoon. (DaVita Press Release: https://finance.yahoo.com/news/davita-integrated-kidney-care-expands-110200664.html )
Spectral has gotten an additional 5 sites up and running potentially increasing enrolement by 50% over last years 10 sites. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The FDA has allowed the company to include SOFA scores for patient selection which should increase enrolement by roughly 25-50%. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The math behind the price fall
The company had failed to materialize an attempted direct investment and spin out of its medical device division Dialco. It has been in the dog house since and was forced to exercise $3M in 40 cent warrants and take a $10M financing completed in June 2021 for business continuity. The authors did not see this coming but saw and used the opportunity to average down (have not sold a single share). The current price is at a 50% discount to what accredited and institutional investors paid just months ago. Since the hiccup, the company has been executing milestones according to plan and seems to be finally rounding the corner. https://ca.finance.yahoo.com/news/spectral-medical-inc-closes-10-130500091.html
Seasonal Tax Loss selling seems to have finally ended and double bottom appears to have passed the smell test. Hence the update at this time once we were fairly sure the financing and weak hands had blown their paper out. Volume over the last two days has increased 10 fold and we suspect that we are in the midsts of a reversal.
Trades made
Various buys with .35 cent average
Research
https://www.globenewswire.com/news-release/2019/09/24/1919871/0/en/Spectral-Medical-Launches-the-Tigris-Trial.html
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
https://spectraldx.com/spectral-medical-provides-corporate-update-3/
“Early Tigris trial observations in-line with Euphrates post-hoc results”
https://spectraldx.com/u-s-fda-grants-510k-clearance-for-spectrals-dimi/
· Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
· U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
· Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
· Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
· Spectral to receive upfront exclusive rights payment
https://spectraldx.com/spectral-medical-provides-corporate-update-2/
Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players.
ANALYST COVERAGE
https://www.cantechletter.com/2019/11/paradigm-capital-launches-coverage-of-spectral-medical-with-a-buy/
Disclaimer contd.: We own Spectral Medical shares and as such, in that regard, are biased. We are not affiliated in any way with the company or their contractors nor do we even know anyone that knows someone that works or contracts for at the company. Also, we are not financial advisors nor are we qualified to give financial advice. This is not an endorsement to buy or sell shares of the company. If you plan on investing in this stock or any other you should first speak to a qualified investment advisor. Our risk tolerances may also drastically differ from yours. This may be a given, but we also wanted to highlight that there is a risk that the company does not obtain the approvals they seek or that they run out of cash. The intent of this write-up is to shed light on a company that we perceive to be severely under undervalued and puzzlingly unknown. A fair warning that at any time and without warning we may buy or sell shares.
We did our absolute best to try and not be misleading in any way and will include references to most of what was written here using hyperlinks to credible sources and the company’s own documents. Having said that, we too, are human and it is possible that in this write-up we have made mistakes. It is not out of malice, we encourage everyone that reads this thread to do their own due diligence.
We welcome all opposing views and hope that if we have made mistakes, shortcomings, flaws, gaps in our research you will point them out. It will only help us save money if we have overlooked something of importance. This is an ongoing conversation.
submitted by GoldBug236 to biotech_stocks [link] [comments]


2021.12.21 17:34 GoldBug236 SPECTRAL MEDICAL $EDT.TO $EDTFX

$EDT.TO $EDTXF
Market cap ~$50M CAD
Share price ~.27 CAD @ DEC 20, 2021
Shares out 228M
Ideal time horizon for our investment: 1 Year
Spectral Medical (EDT.TO or EDTXF USA) is a small cap (~$50M CAD) medical device company listed on the TSX in Canada that is on the cusp of commercializing multiple products that they either already have FDA approval or are just at the cusp of requesting approvals for. Its flagship project is a treatment for severe sepsis that is in an FDA stage 3b confirmatory trial. As far as the writers know this is the only company with a Phase 3 trial for sepsis in North America.
Corporate Presentation
PowerPoint Presentation (spectraldx.com)
UPDATE AT THE BOTTOM OF WRITEUP
BACKGROUND & WRITE UP
Here is an investment thesis for Spectral Medical ($EDT.TO) written by a couple of retail investors; one with a degree in commerce and the other with a PhD in science. Disclaimer: A warning to the reader that we are by no means experts on biotech stocks or very knowledgeable about FDA trials. This is not an endorsement to buy or sell shares of the company. A more detailed disclaimer can be found at the bottom. We had spent a significant amount of time doing research and reading to get to where we are with this investment. How well we did is up for debate. In this paper we attempt to address as much as we could. There is an abundance of information rendering it impossible for us to comprehensively discuss all of the strengths and weaknesses that we saw, however, after many iterations we have boiled it down to the following points that we wanted to highlight. The first 6 points establish the basis and essence of our high conviction trade and things we, and probably any investor, would like to see in any company.
WHY WE LIKE IT?
  1. IF APPROVED, NO COMPETITORS IN THE SEPSIS SPACE FOR AT LEAST 5 YEARS (HUGE MOAT)
  2. SOLVING HOLY GRAIL OF MEDICAL PROBLEMS, SEPSIS (LARGE MARKET)
  3. GROUP OF HIGHLY PUBLISHED AND ACCOMPLISHED PROFESSIONALS (TEAM IS TOP SHELF)
  4. LAST YEAR THE COMPANY SIGNED A DISTRIBUTION AGREEMENT AND RECEIVED UPFRONT PAYMENT WITH ONE OF LARGEST MEDICAL HEALTHCARE COMPANIES LISTED ON NYSE (BUY IN FROM MAJOR - SALES STRATEGY)
  5. TRIAL IS REASONABLY CLOSE TO COMPLETION (1 YEAR TIME HORIZON)
  6. COMPANY IS WELL FUNDED FOR PMX TRIAL (NO DILUTION EXPECTED)
BONUS POINTS:
  1. ALREADY APPROVED IN EUROPE AND JAPAN WHERE IT HAS TREATED 300 000+ PATIENTS
  2. SPECULATION AS TRIAL(S) NEAR(S) COMPLETION COULD CAUSE UPWARDS PRICE PRESSURE AS IT HAS DONE IN THE PAST
  3. IF THE COMPANY LIVES UP TO ITS US LISTING PROMISE IN THE SHORT TERM WE SEE A MUCH LARGER INVESTING AUDIENCE
  4. NEW CMO HIRE OPENS WORLD OF POTENTIAL OPPORTUNITIES
  5. ADDITIONAL PRODUCT PIPELINE IN HOME DIALYSIS PARTIALLY FDA APPROVED AND PROVIDES BACKSTOP
GENERAL OVERVIEW
Spectral Medical is a small cap (~$80M USD) medical device company that is on the cusp of commercializing multiple products that they either already have or are nearing the corner for FDA approvals. Its flagship project is a treatment for severe sepsis that is currently in an FDA Stage 3b confirmatory trial with an expectation for completion in late 2021. This product is known as “PMX” and has NO COMPETITORS as there are NO FDA approved solutions for sepsis in the market and none coming any time soon. PMX has been licensed to Spectral ($EDT) with exclusivity to the North American market. The product has already been in use in real clinical settings as it has already been approved for use in Japan and Europe by the licensor (Toray Industries) and has thus far treated 300 000+ patients to date and counting. Spectrals nearest competitor, Cytosorbent has a market cap that is multiples of where Spectral currently sits even though they are only in phase 2 and as such years behind in North America. Cytosorbents does have approval for its product in Germany with about 8.2M in revenue per quarter and growing. Having said that, North America is where we think the real opportunity lies. Noteworthy is that Spectrals ability to get the product to market is highly de-risked through an exclusive distribution agreement with Baxter, one of the largest multinational health care companies listed on NYSE. The company also has a stacked board and C suite of top notch professionals. We paid particular attention to a recent CMO hire that happens to be “the world authority in Blood Purification and Renal Replacement Therapy”. A simple google search of his name will detail numerous industry connections that we think could spell a roadmap to success at a later time. A major reason that the writers can see for the market cap to be sitting where it is, is that it has not been cross listed in the US, yet. Biotech stocks do not get a lot of love in Canada.
For Spectral, the focus on a Canadian-only listing could change in the near term. This is where we think the opportunity lies in the short term. For the long term, aside from hitting FDA milestones, we believe that there is some information asymmetry that sits with their newest CMO hire. In the latest investor deck the company states an intention to possibly list on a senior US exchange. In fact, they have already taken steps in this direction having received shareholder approval for a share consolidation in 2021 to meet listing requirements. Why would they if that’s not something they were actively pursuing? As such, we propose that they could see a significant re-rating of share price for this reason alone. There are others that we will outline below. This paper will not get into the specifics of the science and will give a general overview of the company as we see it. There is no amount of due diligence that the writers here can do regarding the science that Baxter hasn’t already done. Armed with the knowledge that Baxter has given Spectral a $6.5M CAD upfront payment for which they presumably did the most thorough due diligence, one can reasonably conclude that the science has merit. For those who want to read more about it or the company and its milestones in general, we encourage you to check out FDA filings, the company’s own presentation, or contact them directly to answer technical questions. This paper will also not get into modelling or sales predictions and will assume there is a market, the market is large, there is a credible partner in place to make sure said product is sold and revenues come in if approvals are granted. Rather, we will focus on a general overview of the company, where the information asymmetry could potentially sit, namely the lack of awareness by both retail and institutional investors in the US, as well as, their newest CMO hire.
PRODUCT PIPELINE SNAPSHOT
They have two separate product pipelines that could be/are being commercialized in the near future. PMX and DIMI. The combined addressable market size for both of the company products is $6.5B USD. There are other FDA/Health Canada fully approved products that the company currently has but they will not be discussed in any detail here as they are compliments to the grand finale.
Screenshot taken from company presentation
Product 1: PMX
PMX is intended for the treatment of patients in septic shock and has been licensed for distribution and commercialization in North America from Toray Industries in Japan where it has already been approved since 2002 and has treated over 300 000+ patients and counting. It has also been approved in Europe since 1994.
PMX has already been through 3 phases with the FDA and failed to gain approval in 2016 at the conclusion of the trial. However, they did find a subset of patients with significant relative risk reduction in mortality. A phase 3b open label trial dubbed “Tigris” has been approved since September 2019 and is currently well underway with an estimated completion at the end of 2021. Commercialization could begin as early as 2022. As the trial nears completion we see it as highly likely that the price will continue to rise in anticipation of the results as speculators arrive. It is far enough out right now to get in at what we find to be attractive prices. Interim results are expected Q2 2021. The FDA has allowed them to use the favorable data of the benefit receiving subset of patients from their failed phase 3 for this phase 3b confirmatory trial. De-risking the Phase 3b study in the sense that they are already starting with statistically significant results. The likelihood of Spectral actually having decent market penetration for PMX, if it were to be approved, is high given the fact that they have an Exclusive Distribution Agreement with Baxter, one of the largest multinational health care companies in the world. Baxter is buying exclusivity rights to distribute PMX in North America via an already completed upfront rights payment and various non dilutive milestone payments moving forward. Should the company hit these targets moving forward there is a high possibility that the company will not need to dilute any further.
Screenshot taken from company presentation
A press release for the partnership can be found on both Baxter and Spectrals websites:
https://www.baxter.com/baxter-newsroom/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-blood-filter
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
Product 2: DIMI
DIMI is a device intended for easy portable hemodialysis. DIMI, a portable dialysis machine has already been recently approved by the FDA in 2020 for in hospital use and the company is currently in the process of trying to obtain approval for home dialysis. Home dialysis is a growing market trend as it cuts down cost and risk of transporting patients. It also increases patient autonomy and comfort. From what we understand there is also a government push towards home dialysis in the US. Read more in the corporate presentation.
Screenshot taken from company presentation
US LISTING. It is our belief that the company is relatively unknown to its neighbors south of the border. If it is introduced to a much larger US investing audience it is quite possible that shareholders may see immediate benefit. Moreover, it is our unprofessional opinion that even the narrower Canadian space is not aware that the company is in pursuit of a US listing.
CMO HIRE. We have found it to be of interest that the new CMO is an established collaborator with multiple successful companies in both the dialysis and sepsis space. {Screenshot at 19 Seconds https://youtu.be/jeGXkKBHo28 } Notable mentions include its much higher market cap direct comparables NxStage and Cytosorbents. Why would this accomplished researcher at the peak of his career, fully understanding the science and risks begin working with a company that he believes could fail? After all, this isn’t a major industry player that has a massive cash cushion in the event of a failure. We would hope that he sees something of value here. A similar company, producing similar products to Spectral, that he was on the scientific advisory board for, NxStage, was sold to Fresenius for $2 Billion for what we see as an arguably inferior, albeit fully FDA approved for home use, product. Note that Spectral is well on its way. Cytosorbents has a current market cap of $400M USD and is in behind Spectral in FDA trials. He has also published numerous research articles sponsored by Baxter. On the face of it, it would appear that this small community of leading scientists and the respective companies in the field of sepsis and blood purification have all done very well market cap wise, except Spectral. In addition to the thesis that the price could go up based on a US listing we find it possible that the new CMO hire is likely to provide new opportunity to the company through his network. If the charts of any of these other companies that the CMO has advised for foreshadow what’s to come for Spectral we see this as a compelling investment.
https://spectraldx.com/spectral-medical-appoints-dr-john-kellum-as-chief-medical-office
https://www.fresenius.com/7461
https://www.modernhealthcare.com/article/20190226/NEWS/190229935/fresenius-medical-care-closes-2-billion-nxstage-acquisition
UPDATE:
We waited with this update until we were fairly confident that the company was very near term in its US listing ambitions, had a number of catalysts met and within close reach, and most importantly would not suprise us with further dilutive events.
Promises made, promises kept. The positive developments regarding the TIGRIS trial and corporate progress overall:
A US listing on a senior exchange announcement should be coming any day now as the company had stated they were aiming for early 2022 according to a December company presentation. The company stated that it was important for major milestones to line up in order for the listing to make sense and are of the belief that timing is now right. A link to the update regarding US listing can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72
It turns out their new CEO and CMO have been delivering results as there are rumors circling various chat forums about a potential partnership with DaVita, one of two largeset nursing home operators in the US ($10.69B Market Cap). The company, after the rumors began circulating, mentioned DaVita multiple times during an investor conference call (a recording of the conference call can be found here: https://www.webcaster4.com/Webcast/Page/2813/43726 ). Additionally DaVita put out a press release regarding a new hire for a division that will specificially focus on Kidney care and more importantly home dialysis, for which Spectral is trying to provide a solution. The press release potentially had a large impact on the volume of Spectral shares traded that afternoon. (DaVita Press Release: https://finance.yahoo.com/news/davita-integrated-kidney-care-expands-110200664.html )
Spectral has gotten an additional 5 sites up and running potentially increasing enrolement by 50% over last years 10 sites. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The FDA has allowed the company to include SOFA scores for patient selection which should increase enrolement by roughly 25-50%. https://ca.finance.yahoo.com/news/spectral-medical-announces-u-fda-130000488.html
The math behind the price fall
The company had failed to materialize an attempted direct investment and spin out of its medical device division Dialco. It has been in the dog house since and was forced to exercise $3M in 40 cent warrants and take a $10M financing completed in June 2021 for business continuity. The authors did not see this coming but saw and used the opportunity to average down (have not sold a single share). The current price is at a 50% discount to what accredited and institutional investors paid just months ago. Since the hiccup, the company has been executing milestones according to plan and seems to be finally rounding the corner. https://ca.finance.yahoo.com/news/spectral-medical-inc-closes-10-130500091.html
Seasonal Tax Loss selling seems to have finally ended and double bottom appears to have passed the smell test. Hence the update at this time once we were fairly sure the financing and weak hands had blown their paper out. Volume over the last two days has increased 10 fold and we suspect that we are in the midsts of a reversal.
Trades made
Various buys with .35 cent average
Research
https://www.globenewswire.com/news-release/2019/09/24/1919871/0/en/Spectral-Medical-Launches-the-Tigris-Trial.html
“The Tigris trial, designed with input from the FDA, will provide additional data to the EUPHRATES sub population who responded positively to treatment with the PMX cartridge and had a clinically meaningful 10% reduction in 28-day mortality. This group also showed improvement in organ function and reduction in the need for vasopressors. Spectral continues to be at the forefront of innovative clinical trials as the Tigris study analysis plan includes the use of Bayesian statistics which will leverage data already obtained in the EUPHRATES trial,” said Dr. Paul Walker, President and CEO of Spectral Medical.
https://spectraldx.com/spectral-medical-provides-corporate-update-3/
“Early Tigris trial observations in-line with Euphrates post-hoc results”
https://spectraldx.com/u-s-fda-grants-510k-clearance-for-spectrals-dimi/
· Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
· U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
https://spectraldx.com/baxter-and-spectral-medical-announce-exclusive-distribution-agreement-for-blood-filter-in-u-s-and-canada/
· Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
· Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
· Spectral to receive upfront exclusive rights payment
https://spectraldx.com/spectral-medical-provides-corporate-update-2/
Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players.
ANALYST COVERAGE
https://www.cantechletter.com/2019/11/paradigm-capital-launches-coverage-of-spectral-medical-with-a-buy/
Disclaimer contd.: We own Spectral Medical shares and as such, in that regard, are biased. We are not affiliated in any way with the company or their contractors nor do we even know anyone that knows someone that works or contracts for at the company. Also, we are not financial advisors nor are we qualified to give financial advice. This is not an endorsement to buy or sell shares of the company. If you plan on investing in this stock or any other you should first speak to a qualified investment advisor. Our risk tolerances may also drastically differ from yours. This may be a given, but we also wanted to highlight that there is a risk that the company does not obtain the approvals they seek or that they run out of cash. The intent of this write-up is to shed light on a company that we perceive to be severely under undervalued and puzzlingly unknown. A fair warning that at any time and without warning we may buy or sell shares.
We did our absolute best to try and not be misleading in any way and will include references to most of what was written here using hyperlinks to credible sources and the company’s own documents. Having said that, we too, are human and it is possible that in this write-up we have made mistakes. It is not out of malice, we encourage everyone that reads this thread to do their own due diligence.
We welcome all opposing views and hope that if we have made mistakes, shortcomings, flaws, gaps in our research you will point them out. It will only help us save money if we have overlooked something of importance. This is an ongoing conversation.
submitted by GoldBug236 to pennystocks [link] [comments]


2021.12.15 14:28 WilsonTeresa223 [HIRING] 25 Jobs in SC Hiring Now!

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Hey guys, here are some recent job openings in sc. Feel free to comment here or send me a private message if you have any questions, I'm at the community's disposal! If you encounter any problems with any of these job openings please let me know that I will modify the table accordingly. Thanks!
submitted by WilsonTeresa223 to SCJobsforAll [link] [comments]


2021.04.21 21:35 Buck_Joffrey Wealth Formula Episode: 260: Does Crypto Have a Role in Real Estate?

Catch the full episode: https://www.wealthformula.com/podcast/260-does-crypto-have-a-role-in-real-estate
Buck: Welcome back to the show everyone today my guest on Wealth Formula Podcast is Jason Ricks Jason is CEO and co-founder of liberty real estate fund which is an interesting fund that revolves around the single-tenant net lease market which we’ll talk about specifically in addition to that it is I guess the first security token offering type fund out there in this space as well. Anyway, welcome to the show Jason.
Jason: Yeah thanks for having me on Buck. Long-term listener so thanks again for giving me the opportunity to speak today.
Buck: Yeah of course and did I get that right about it being the first of its kind in terms of the security token?
Jason: That’s correct. It’s the world’s first. There’s been other funds or let’s say individual assets that have been tokenized but nothing as advanced as acquiring single-tenant properties across the United States like we have today.
Buck: Got it all right well why don’t we start out the usual way which is to kind of just start out with who you are what’s your background you’ve been in commercial real estate for a while it looks like.
Jason: Yeah so I grew up in Austin. I thought I was going to be a professional football player that ended up not going according to planned and I was a field goal kicker at Oklahoma state. In 2004–08 got out of college and said okay what the hell am I going to do with my life and fell into commercial real estate after about 19 interviews it was 2008. So it was kind of a difficult time to get into the space but cut my teeth on leasing a lot of early on brokerage and then over the course of my career, I got kind of shifted into asset management I worked for a large value-add portfolio out of a wealthy individual out of California and then decided I wanted to kind of get more institutional and work for a private REIT where I oversaw a portfolio of about 500 million.
Buck: Got it so let’s see your you know your fund focuses on the single-tenant net lease market talk about exactly what that is.
Jason: Sure so for your listeners quite simply it’s a single-tenant occupant now the easiest way I can kind of use an example think of a McDonald’s or a drive-through Starbucks you have one tenant on an out parcel usually with extremely high visibility and they control their individual space and the space around their building.
Buck: Got it. And so that would that include that wouldn’t include malls or anything like that. It’s basically just like single-standing buildings with one business for the most part right?
Jason: Absolutely think of like a gas station’s a perfect example. Sometimes these are on what I would call the parcels or the outside of the parking lot behind like a let’s say a grocery store like a Walmart or something like that.
Buck: So when you hear that you gotta wonder well what would the benefit of a single-tenant property within an investment portfolio be? Wouldn’t that be creating a lot more risk how do you deal with that?
Jason: Sure so surprisingly and we’ve done back data information on this single-tenant net lease for the last 30 years have been the highest occupied asset class when you compare to any other type of commercial real estate class so above a multi-family above industrial office and traditional retail and there’s a lot of reasons and advantages for single-tenant net leases that I can get into and they’re always in ultimate high demand from investors and from tenants.
Buck: And why is that? Why are they in such demand?
Jason: Sure it’s unfeathered access and visibility Buck is one of the big ones it’s literally a walking talking billboard so you imagine the best located real estate within a market. Tons of vehicles traveling to and from every day past that building it has control of its parking lot and the space itself and so becomes extremely highly desirable.
Buck: One of the other things to mention I guess would be the fact that they’re net leases. You want to talk a little bit about net leases as opposed to what we may be used to in the other types of real estate?
Jason: Absolutely. So this is the thing that this is ultimately why we call these bonds wrapped in real estate. So imagine an essential business like a convenience store with great credit behind it like a Shell or 7-eleven and they’re on the hard corner, they’ve got great visibility and access to their space and they’re structured on a long-term lease. And here’s the beauty: the taxes the insurance and the maintenance on the building is all passed through to the tenant and that’s structured in their lease. So I’m not getting a phone call in the middle of the night to change a toilet I’m not getting calls to say hey my roof needs repair or my air conditioning unit needs to be replaced so all those things are structured that way so we call these essentially just bonds wrapped in real estate.
Buck: Yep and I think that’s a good way to describe it because I think again going back to the idea of why you know somebody might look at this and say it’s a single-tenant is it riskier how do you look at individual tenants I mean obviously you mentioned you know bonds wrapped up in real estate well a lot of times that’s what bonds are right so tell me how do you determine or how do you classify or categorize potential tenants?
Jason: Well I’ll kind of give you some examples right so we’d look at like a Goodyear a Firestone for the market cap on some of these buildings or some of these tenants you know Goodyear’s close to 2 billion market cap, firestone’s 21 billion in market cap so you look at their credit and you can do a lot of interesting searches online and a lot of their financials again these are publicly traded companies and we can evaluate the risk profile from that standpoint.
Buck: Got it. So you can essentially kind of you know you’re basically basing your lease the risk of your lease on the financials of the company that you’re looking at and so I suspect and correct me if I’m wrong just like in bonds where you’re going to have high yield bonds low you know lower-yielding bonds a lot of you know junk bonds are the ones that yield the highest so you know you’re going to generally get the higher cap rate at the higher yield for you know businesses with that are not as creditworthy.
Jason: 100% that’s exactly right and it’s interesting that you brought up junk bonds because you know we’re closely tied to fixed income given the asset class type so you know junk bonds are yielding under four percent the ten years at one six one seven today floating these are real yields that are nothing I can go out and buy a 7-eleven backed by that credit and that market cap at five cap and then I could put debt on it at 70 percent and so I can get a premium coupon to investors which I would argue is better than what you could get on a corporate bond yield right corporate bond yields are around three percent right now so it just for me it’s a no-brainer for folks that are looking for fixed income.
Buck: You know and that’s right so you brought up five cap on a 7-eleven obviously this depends regionally as well right I mean correct cap in LA probably not you know or New York City how does that vary. I mean tell me a little bit about this market it’s good I think this group that you know my listeners are pretty familiar with multi-family real estate because we do a ton of it and you know in my Investor Club we’re doing a lot in Dallas Fort Worth and Arizona and we’re doing that because the profile of those markets are that they’re extremely fast-growing markets and they’re not tertiary markets you stay away from tertiary markets because of the fluctuations and the lack of fundamentals how do you look at triple net property is it just the parallel markets to multifamily?
Jason: So it’s pretty comparable so we have this old adage in our business where retail follows rooftops and so we’re looking at net migration patterns we’re looking at cities that are on the come essentially and where these demographic trends are shifting and so we have this catchy phrase it’s corning from my partner but it’s essentially the smile states that are getting a lot of the growth and so we’re big fans of DFW and phoenix just like you are Buck we also like Florida we like things that are happening in Georgia the Carolinas Tennessee’s getting a ton of growth but you know there’s this devil between do you reach for a yield in a two sharing market and that’s just not who we are yes I can probably go buy a better cap rate somewhere but I take on a ton of risk because if that tenant goes out for whatever reason trying to backfill that in a smaller town is tough.
Buck: Yep exactly so it’s actually got a lot of similarities you know to anything else that we do all right well let me ask you this because I guess the next question is I know I’ve got listeners out here thinking well geez you know this sounds like maybe the kind of space where I should just go out and maybe buy some my own stuff, after all, it sounds like it’s not terribly you know management heavy you know a company comes in there and you know you’re basically saying hey here are the reins just pay me you know and I’m just gonna collect a check every month I mean that’s basically it so if that’s the case why would I choose to invest in a fund if I can just afford to go out and buy some triple net real estate?
Jason: Sure I’m a big believer in diversification sure and you know you go out and put all your eggs in one basket you’re making a large bet maybe not for some of your listeners but some of them maybe you go out and buy I don’t know let’s say you go buy a dollar for three million dollars in one market you have a lot of concentration risk and so with our fund you get industry diversification and geographic diversification and you don’t have to deal with all the headaches of putting these deals together meeting with brokers interacting trying to do all the legal work trying to get all this stuff done the due diligence all those things that go into it we basically handle that upfront and then we do you know institutional quality reporting on the back end so if you’re super analytical and want to understand details we’re going to take that level of expertise that we have today and implement that towards the fund.
Buck: Yeah that makes sense. So let’s talk specifically a little bit about your fund, you mentioned you’re focusing on Dallas Fort Worth, Arizona, Florida, what kinds of property are you specifically looking at I mean are you are there certain companies like dollar trees are you sort of across the board or what?
Jason: Sure so it’s essential businesses and we came up with this idea about two years ago back when we saw online sales crushing traditional retail and we wanted something stable we really like the medical space. I think we’re very bullish on medical for a lot of demographic reasons and then we’d like we like auto care in service we like gas stations and daily needs and we’ve kind of looked into some other sectors too whether it be telecommunications even pawn shops believe it or not sure because some of these are very defensive in nature right so like let’s say for example the economy takes a nosedive and I was just listening to your podcast the other day you had a really cool economist on by the way that was fun and they were talking about maybe we’re going to have a dip in S&P500 here in the next couple years and you know when the market tanks a little bit you know they’re going to be spending more on their cars they’re not going to be buying new vehicles as much they’re going to be spending more time traveling in their cars versus getting on an expensive flight. And so a lot of these things are defensive even like a dollar tree, for example, well they typically do well in recessionary periods and so it’s kind of counterintuitive when you think about it originally but it kind of weathers both sides of the storm. So we like the diversity that we’ve selected and we really really bullish on medical.
Buck: How do you do a single lease with medical is it usually like an emergency room or something from a big company or how does that work?
Jason: Yeah we like Davita we like Forsynias we like some of the big dental players Baylor Scott and white I’m sure you’re probably familiar with them with your research in DFW and some urgent cares. I think Buck you would probably know I know with your background you probably know some of that space. I think there may be some regulatory issues with urgent centers so we don’t want to go too heavy into that space so we may pick the best player in that but we’re not going to go full steam ahead on that individual use.
Buck: Makes sense okay so obviously okay so there’s this one piece that’s different as you mentioned from any other fund that’s doing it and that’s a securitization so for those people who don’t know tell explain what exactly a security token offering is.
Jason: Sure. The easiest way I can describe it, it’s a digital security and we’re able to capitalize on this by using blockchain technology which is just a fancy word for a digital ledger that’s the best way I can describe it without getting too far into the weeds.
Buck: Okay so what’s the big deal?
Jason: Yeah no totally so you know you know look I mean at the end of the day we’re a fund that pays our investors monthly cash flow but the reason why we did all this and this is our big kind of why we wanted to solve two problems we literally wanted to solve two problems and you’re in this space too. The first one is the lack of liquidity when you invest in a private real estate offering and I’ll give you a fun example here in a second you are beholden married with no or little say on what that sponsor does and you’re tied to the US dollar typically. If you’re investing into a US syndication so if they want to hold it for 10 years you’re along for the ride. You can complain all you want but that’s what they’re going to do that’s what they’re going to do so you have no control if you have a major life event. I’ll give you one that I’m going through right now we’re having a second kid which is exciting and but we need a bigger house my wife’s working from home so I’m trying to buy a house in Austin right now and everything is 20 over ask and people are wanting all cash offers so it’d be really nice if I could hey can I use this money that I have and all these other real estate investments that I have and just pull it out put it in the house and then later I can back fund it again if I wanted to. So you know things happen 10 years is a long time so liquidity and then what else you said yeah the other one is look if you’re a fixed income investor right now where are you going I mean there’s you don’t really have any options or choices so what we’re trying to do is provide an alternative to the fixed income bond market world and give you that same level of stability with the highest occupied asset class historically and give you those monthly returns and so that those are the two big problems that we’re trying to solve for.
Buck: All right so functionally let’s talk about how the security token works because you can have tokens all you want unless but if you don’t have you know any liquidity to the market it’s pretty much worthless. So how that’s going to be dependent on in part you know the size of your fund and the activity in your fund so talk a little bit about that my point here just for everybody who’s listening let me give you an example during the last cryptocurrency bull run. I had invested in one initial coin offering that turned my 50 grand into a million bucks but the problem is I couldn’t sell the damn thing even though there was this you know so-called token there was no liquidity to that market in the sense that yes there was tokens but there’s no activity on the buy and sell side so I’m playing devil’s advocate here not trying to you know call you out or something but I’m asking you how do you address that issue or you know is it you know the most people who are investing in real estate and these funds aren’t really looking to get out right so where’s the market? Who’s the market?
Jason: Yeah no great question. So yes we are in early innings we’re probably first or second inning right now of total market liquidity when you compare it to these other larger like you know for example the Nasdaq or dow or anything like that right so we’re not as robust on these exchanges as of yet but you have multiple different options. So the first option is I can go peer-to-peer right so that means I can call Buck. Buck’s got a lot of multi-family stuff security tokens and I want some I’m too allocated heavy towards industrial so I’m going to call Buck I’m saying hey Buck I want to buy some of your multi tokens I want some of that exposure in my portfolio you and I can make a peer-to-peer exchange so that’s the first way to do that the second way to do it is you have broker-dealers that can advertise and list these on exchanges for you or sell them in blocks to large institutions and then one of the other fun options is what we call these secondary markets that are very much up and coming but they’re getting more robust as people come around more to tokenization which is what we’ve seen accelerated over the last I would say last six months last three months in particular with the rise of all you know cryptocurrencies NFTs the interest in the fund and tokens in general has exploded so these secondary exchanges become really neat because on your dashboard. So if you’re an investor in our fund you can literally go to our dashboard and select on a secondary exchange and you can put it out on the exchange and see what the market would yield.
Buck: So if I’m looking for liquidity and I’m looking for exposure to real estate and triple net real estate and we’re multifamily again let me just ask you again from the perspective of somebody who’s looking for liquidity why would I go this route as opposed to finding a REIT that’s publicly traded and has a lot of liquidity?
Jason: Yeah no absolutely I’ll tell you why. Did you own any REITs?
Buck: Me? Hell no I don’t own REITs.
Jason: I know you don’t but you know in March of last year how much did those REITs go down?
Buck: Yeah I’m sure they went down a lot.
Jason: Sure now ask me how much did that cap rate suppress for 7-elevens did it lose did it go from did it go in California did it go from a four cap to a six cap no yeah actually you dropped yeah it dropped in value okay and I work for a REIT so I know all the fun in and outs of reporting the overhead the weighing down of the returns for investors and it’s an operational company it’s not like you’re investing in the real estate.
Buck: No I get it but I guess what I’m trying to do and again I understand I’m playing devil’s advocate because that’s my job here is if you start talking about the liquidity and exchanging securitized tokens in the same environment. You may have the same problem right I mean who’s you may have the same buyer fears with a security a securitized token as you would a stock I mean the reason why that stock price on the REIT went down is because people get worried and they start selling and they don’t want to buy stuff right so why would it be any different?
Jason: Well I’m honestly if it’s yielding what it’s yielding and someone wants to sell it at a 30 discount I’d be tickled to death to buy it first of all because yeah it’s the underlying value in nav right which is what we’re trading on not necessarily if a new CEO comes into the to the realm of the great sure or if they’ve got way too much exposure to AMC theaters, for example, yeah or some other you know old-age retailer or particular scenario that’s not favorable to the REIT.
Buck: Got it. All right so where is the market? How’s the market? What platform are you using for the trading of these tokens?
Jason: Sure so our registered transfer agent and again I’m trying not to use these terms but it’s securitized as the one that’s going to be issuing the tokens on our behalf and we’re looking at a couple of different exchanges right now because we’re launching the fund in may we have kind of this 12-month lock-up period before people can start trading it. So we’ve got a few different groups that we really like fusing out of Hong Kong is one of the exchanges that we’re really excited about they’ve had a lot of interest and a lot more transactions in their marketplace and then we’re kind of evaluating three or four others some are based in the United States some are also foreign.
Buck: So right now you haven’t gotten to the security token part of this and so people who are currently invested in the fund they would you know if essentially they would their ownership would be converted to securities?
Jason: So the fund will launch in May and then once essentially we go live with the fund and funds are invested and we start buying properties there’s a one-year lock-up period for the investors before they can trade it.
Buck: Yep that makes sense typically with the accredited investor issues that’s what you see. One other technical question and this is more out of curiosity because I’m just you know my brain always goes towards taxes Jason and so let’s say so your typical right now and you know we’re buying all this multi-family and one of the tremendous benefits that people get when they’re investing in this type of stuff is we’re using cost segregation analysis and bonus depreciation and you know we’re getting situations where we’re literally sometimes writing off people are writing off as much money or more than they actually invested as depreciation in the first year which is huge obviously in different real estate you have different levels of depreciation but there is always that level of depreciation how does the tokenization of this stuff how does that all work in terms of taxes and depreciation obviously I mean in our case if I bought something and I took that depreciation in the first year and all of a sudden I’ve got this asset that the basis is way low and presumable if I sell and I’m paying recapture so how does that work or is that something that maybe isn’t as applicable in your your space
Jason: I’m yeah I’m so glad you reminded me of this because I forgot to bring this up answering your read question we are a traditional 506C RegD so just like every other private fund that most of your investors invest in and because of that they’re K1 investors and so we take advantage of cost sag and bonus depreciation just like you guys do and that’s one of the benefits is on the REIT side those dividends are taxable at ordinary income and then this income through the fund is tax-advantaged.
Buck: I guess the question I have is on the technical aspect of that is one of the reasons you can do that is because you’ve got the K1s but the K1s are showing depreciation and you have a new basis you know with the depreciation now if you’re securitizing these tokens how does that when that token is transferred to one person to another how does that work because now you’ve got a token or a security that somebody owns that you know you’ve taken you know 100 depreciation on I mean when it gets sold to somebody else. How does that work?
Jason: Yeah absolutely it’s all done via what’s called a smart contract and this is one of the benefits to the early investors into the fund so if you’re an early investor into the fund you know obviously as the length of the fund goes on we get rental increases which increases your cash on cash we plan to do cost sag early on in the fund to basically benefit the early on investors that are coming in so they get some of the initial tax advantages and then when they sell them let’s say in five years from now yeah that basis is going to go to that new investor which ultimately gives them a little bit of you’re not as an ideal tax position compared to the guy that originally got in.
Buck: Got it. Well listen, how do we learn more?
Jason: Yeah we’ve got so many things out there. So we do the Chicago Blockchain Collective you know you can hear Mike on his podcast nothing but all this is basically at our website. So we put out free content all the time. You can hear me and Michael on multiple different podcasts. We’ve got a youtube channel it’s at libertyfund.io so libertyfund.io and you can feel free to reach out to me anytime at Jason libertyfund.io.
Buck: Jason good to have you on the show and good luck to you.
Jason: Yeah thanks Buck I appreciate it.
Buck: Be right back
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2021.02.19 15:06 Warm_Initiative_914 $AKBA - AKEBIA THERAPEUTICS. Product development based on Nobel Prize-winning science. Is there something we do not know yet ? VANGUARD, BLACK ROCK, WELLINGTON and STATE STREET CORP stacking up 50M+ shares during last two weeks compared to 20 % of this number during the previous 5 years.

$AKBA - AKEBIA THERAPEUTICS. Product development based on Nobel Prize-winning science. Is there something we do not know yet ? VANGUARD, BLACK ROCK, WELLINGTON and STATE STREET CORP stacking up 50M+ shares during last two weeks compared to 20 % of this number during the previous 5 years.
https://preview.redd.it/nmdory5fyfi61.png?width=352&format=png&auto=webp&s=d273d3b1b3bd7563a0afd29fb2d1719e0ba86996

Company Profile
Akebia Therapeutics, Inc., a biopharmaceutical company, focuses on the development and commercialization of renal therapeutics for patients with kidney diseases. The company's lead product candidate includes Auryxia, a ferric citrate to control the serum phosphorus levels in adult patients with chronic kidney disease (CKD), on dialysis (DD)-CKD, or the hyperphosphatemia indication (HIF); and vadadustat, an oral therapy, which is in Phase III development for the treatment of anemia due to CKD in DD and non-dialysis patients. It has collaboration agreements with Otsuka Pharmaceutical Co. Ltd. for the development and commercialization of vadadustat in the United States, European Union, Russia, China, Australia, Canada, the Middle East, and other countries; and Mitsubishi Tanabe Pharma Corporation for the development and commercialization of vadadustat in Japan and other Asian countries, as well as research and license agreement with Janssen Pharmaceutica NV for the development and commercialization of HIF-prolyl hydroxylases-targeted compounds worldwide. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts.
Product Development based on Nobel Prize winning science
Akebias product candidate, vadadustat, is part of a new class of investigational agents called oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which are based on Nobel Prize-winning science. HIF-PHIs are designed to mimic the body’s response to lower levels of oxygen, such as when a person is at high altitude. The body naturally responds to lower oxygen levels by increasing the availability of HIF, which is a protein that coordinates the expression of the genes responsible for erythropoietin synthesis and the regulation of iron metabolism. Inhibition of hypoxia-inducible factor prolyl hydroxylase (HIF-PH) can lead to increased red blood cell production and improved oxygen delivery to tissues.
Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Within Japan, Vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
Akebia Therapeutics Appoints LeAnne M. Zumwalt, Dialysis Industry Leader, to Board of Directors
CAMBRIDGE, Mass., Feb. 18, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc., a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the appointment of LeAnne M. Zumwalt to its Board of Directors, effective February 16, 2021. Ms. Zumwalt was most recently Group Vice President, Government Affairs at DaVita Inc., one of the largest providers of dialysis and kidney care services in the United States.
"We're honored to have LeAnne Zumwalt join the Akebia Board of Directors," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "Her deep knowledge of and expertise in the U.S. dialysis market, in combination with the financial and public policy leadership roles she has held throughout her career, will be invaluable as we continue to advance our purpose and prepare for the launch of vadadustat, subject to approval."
"I'm excited to join Akebia during what I believe is a pivotal time for the Company and the kidney community," said Ms. Zumwalt. "Having spent the majority of my career working to advance the standard of care for kidney patients, I share Akebia's passion for bringing much-needed innovation to the kidney community. I look forward to helping Akebia deliver on the potential of vadadustat to help kidney patients."
Ms. Zumwalt has spent more than 20 years serving in a broad range of leadership positions at DaVita, which has grown over that time to a healthcare organization with more than 2,750 locations in the United States, caring for approximately 205,000 patients with chronic kidney disease.
Big movements in Akebia Therapeutics stock price on Thursday moving 10.07%
The stock lies in the middle of a very wide and strong rising trend in the short term and a further rise within the trend is signaled. Given the current short-term trend, the stock is expected to rise 39.61%during the next 3 months and, with a 90% probability hold a price between $4.97 and $7.31 at the end of this 3-month period.Since the short-term average is above the long-term average there is a general buy signal in the stock giving a positive forecast for the stock.
Several short-term signals, along with a general good trend, are positive the current levels may hold a buying opportunity as there is a fair chance for Akebia Therapeutics stock to perform well in the short-term.
Clinical Development
Vadadustat is an oral HIF-PHI in clinical development for the treatment of anemia due to CKD in dialysis dependent and non-dialysis dependent adult patients. We are evaluating the safety and efficacy of vadadustat in two global Phase 3 programs – INNO2VATE (dialysis) and PRO2TECT (non-dialysis).

https://preview.redd.it/w6shbt1gyfi61.png?width=2590&format=png&auto=webp&s=6128fd3cc408273dfe6381f994d325601486cb68
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In 2020, we announced results from the INNO2VATE program for vadadustat in adult patients on dialysis (incident and prevalent dialysis patients). Additional information is available here:https://ir.akebia.com/news-releases/news-release-details/akebia-presents-results-its-inno2vate-global-phase-3-program. We also announced results from the PRO2TECT program for vadadustat in adult patients not on dialysis. Additional information is available here:https://ir.akebia.com/news-releases/news-release-details/akebia-presents-results-its-pro2tect-global-phase-3-program. For the latest Akebia corporate presentation, please visit Akebia’s Investors page. In addition, Mitsubishi Tanabe Pharma Corporation (MTPC), our development and commercialization collaboration partner in Japan and certain other Asian countries for vadadustat, obtained approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020. Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO™. MTPC filed a Japanese New Drug Application for vadadustat in July 2019. The approval was based on data from the vadadustat development program, including MTPC’s two Phase 3 active-controlled pivotal studies, which support the efficacy and safety of vadadustat in treating both adult patients on dialysis and those not on dialysis with anemia due to CKD in Japan.
INSTITUTIONAL OWNERSHIP
Akebia Therapeutics, Inc. (US:AKBA) has 378 institutional owners and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 148,320,210 shares. Largest shareholders include State Street Corp, XBI - SPDR(R) S&P(R) Biotech ETF, Wellington Management Group Llp, BlackRock Inc., Vanguard Group Inc, Nantahala Capital Management, LLC, Satter Management Co., L.p., Goldman Sachs Group Inc, VTSMX - Vanguard Total Stock Market Index Fund Investor Shares, and IWM - iShares Russell 2000 ETF.
Akebia Therapeutics, Inc. (US:AKBA) institutional ownership structure shows current positions in the company by institutions and funds, as well as latest changes in position size. Major shareholders can include individual investors, mutual funds, hedge funds, or institutions. The Schedule 13D indicates that the investor holds (or held) more than 5% of the company and intends (or intended) to actively pursue a change in business strategy. Schedule 13G indicates a passive investment of over 5%.
The Company has not had that much of the institutional ownership movement, but throughout the last two weeks VANGUARD, BLACK ROCK,WELLINGTON ADN STATE STREET CORP filed for over 50M Shares alone, while over the previous four years the has not reached 25 % of that number.
📷
Gross Profit Margin15.92%
**Total Cash (MRQ)**269.25M
**Total Debt (MRQ)**105.42M
**Total Debt to Equity (MRQ)**33.15%
**Current Ratio (MRQ)**2.15
**Quick Ratio (MRQ)**1.62
Price Target 7-8
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2020.12.05 03:16 Locadoes Thoughts on IT and Biomed

I saw a post about how IT suppose to make Biomed disappeared. When I were a biomed student, people were saying that I were into IT because I were asking questions about it. As someone currently working as a biomed, I got some new perspective. I work for an ISO so I do doctor offices, dental, veterinary, etc. Here some thoughts:
I saw a first generation Midmark tabletop sterilizer today. That the reason why medical places contacted my company for repairs. All those old equipment are not connected to a network.
Here some medical equipment I see a lot:
- Tabletop's Sterilizer
- Otoscope
- Ophthalmoscope
- Manual Blood Pressure Unit
- Patient Lift
- Exam Light
- Exam Bed
- Centrifuge
- Fridges
- Old Infusion Pumps
- Wheelchair Scale
- Doctor's Office's Scale
- O2 Concentrator
- Therapeutic Ultrasound
Manufacturer could make them connected to the network but why would a doctor replaced the otoscope they been using for 20 years that work fine with a otoscope that is connected to the network. Many exam beds are electrical but people don't used the electrical functions.
A lot of the DaVita and doctor clinics could purchase infusion pumps that are connected to the network but the older infusion pumps can get the job done so they used those instead. Medical people don't like to spend money. A lot of the times the reason why they had their equipment check is due to legal requirements.
Some medical equipment will required configuring such as setting the date and time on a infusion pump to get ride of a error message. A lot of the times, medical equipment will required parts.
Update: Would like to emphasized this isn't "you shouldn't learned about networking" post. In imaging, telemetry, and newer infusion pumps, networking play a huge role. Please stop overselling the role IT play. As someone who taken four different networking classes for my degree, I wondered what the role IT play in the biomed world. What I needed than were accurate information, and what everyone looking into a biomed career need is accurate information about this topic.
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2020.09.03 15:50 Lead-Tight [HIRING] Charge Nurse - DaVita

Apply Here: https://fortworthjobbank.com/healthcare/charge-nurse-ce6f930/
JobsFortWorth
1000 Saint Louis Ave, Ste 101, Fort Worth, Texas, 76104, United States of America
As a DaVita Dialysis Charge Nurse (RN), you play a vital front-line role at an outpatient clinic, you will oversee all aspects of its operation. Including:
As a Charge Registered Nurse at DaVita you will constantly be on your toes working in a fast-paced, constantly evolving environment with new challenges to trouble-shoot and overcome. Make the most of your nursing and leadership skills to provide the highest level of care to our patients and ensure their safety, comfort, and well-being. In fact, we’re blowing away the competition with our clinical outcomes. Isn’t that why you went into nursing in the first place?
Patients – Help patients improve their quality of life by delivering outstanding clinical outcomes in a chronic setting.Relationships – Build long-term bonds with your patients and their families.Team – Your clinical team supports one another and creates a fun work environment.Clinical Leader- DaVita is the top performer with more 4 and 5 STAR dialysis centers according to CMS.
A Qualified Charge Nurse (RN) should bring:
Join us as we pursue our vision “To Build the Greatest Healthcare Community the World has Ever Seen.”
Why wait? Explore a career with DaVita today.
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