EDT.TO/ Spectral medical

[Bozzie]

I'm in this one deep and have been for many years.
I finally think their time is coming.
Worth a look trading on the Toronto exchange, super cheap but they have a decent HDP coming to market.
Company info link

Stockhouse privacy policy (version 1)

 

[brucefan]

EDTXF for those that want to follow

 

[Bozzie]

More info.. I'm in pretty deep on this one if it hits I'd be set for life.
Holding 400k


https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-019-0386-0

 

[smartmoneyfollower]

What did you buy in and when, so we can look at the volume, a 400 K investment would spike volume between of course between 400 and 800 K ... "I'm in this one deep and have been for many years." , or did you buy in dark pools ?

 

[Bozzie]

What did you buy in and when, so we can look at the volume, a 400 K investment would spike volume between of course between 400 and 800 K ... "I'm in this one deep and have been for many years." , or did you buy in dark pools ?

I've been buying a little at a time for years.. It's been brutal journey at one point in Oct 2016 i sold it all and got back in early in 2017.
The home Dialysis pump is the key reason I'm still invested ..I feel someone big is going to step up and take these guy out at some point.
Right now the pump is approved for CRTT and the paper work has be filed with the FDA for HD.
Nextstage has the only HD pump approved by the FDA and they were sold for 2 Billion recently.. This is the cheapest pump on the market and is the only one that uses a piston and clamp system instead of a roller system.. One of the thing I like is the piston system Spectral medical owns the rights to the system for the next 15 years and it is licensable.. DaVita, CVS,Baxter and Medtronic all need HD pumps, developing one has been a bad trip for Baxter in particular.

The HD is a market set to take off and I think these guys are on the launching pad.

Baxter has done two rounds with DEKA trying to get a HD pump together and now for some reason CVS is trying with DEKA where Baxter failed twice.

https://homedialysis.org/news-and-research/blog/168-an-obituary-for-baxter-s-vivia-home-hd-machine

 

[smartmoneyfollower]

Baxter International Inc is a company i would invents in below 65 at its current debt levels, the quarterly cash dividend, to a rate of $0.22 per share of common stock is just too low for me to be a buyer.

 

[Bozzie]

Baxter being a legacy technology company needs new product in the pipeline to achieve the 11% growth a year they look for.

But I get ya, it's been a very frustrating investment for me..no doubt

Good luck smart

 

[Bozzie]

Baxter should have never split the company in two..Baxalta had emerging markets and new tech before being sold in 2016.
No telling what baxter would be worth now... witch is the reason Baxter needs new tech bad.
The CEO said recently that they have 750 million for accusations this year.
CVS is is interesting.. I like what they plan on doing in the field of DH.. risky but they need to get into individual care because of the Express Scrips of the world eating into walk in script sales

 

[Bozzie]

Baxter needs EDT's home dialysis machine in a bad way.


https://www.medtechdive.com/news/ba...s-on-heels-of-trump-kidney-initiative/558542/

 

[smartmoneyfollower]

Thank you Bozzie, Good information

 

[TheFalls]

No debt. But financials are pretty terrible here

 

[Bozzie]

No debt. But financials are pretty terrible here

I'd call them a research and development Co. so..yeah the finances are pretty bad.
IMO they are set to sell the whole company and I think it will happen within 3 to 6 months.
If the HFT (Human fault testing) numbers are good it's a slam dunk someone will step up and take them out. (HFT # due this quarter)..HFT numbers are like top line numbers in a trial only they are testing too see if the system is easy enough for someone to use at home for dialysis without a professional.
I'd think if there are multiple bidders you could see above 5 bucks.

Timing is everything and it's this products time.. thanks to Trump and the 114 billion spent on in clinic dialysis by the government.
1 in 5 Medicare dollars goes towards kidney care...that is a staggering number and these guys have a solution.

 

[TheFalls]

very nice....a $1B company?^^^ declining/stagnant sales were the biggest issue...they are pretty much the same as they were 5 years ago

so there is a 7ish year timeline to move 80% (from the current 12%) of dialysis treatments to the home, and there are currently only a couple of other companies doing this now?

if their testing numbers are good, they become an immediate takeover target? and their new CFO is versed in M&As?

anything else we are missing here?

 

[Bozzie]

very nice....a $1B company?^^^ declining/stagnant sales were the biggest issue...they are pretty much the same as they were 5 years ago

so there is a 7ish year timeline to move 80% (from the current 12%) of dialysis treatments to the home, and there are currently only a couple of other companies doing this now?

if their testing numbers are good, they become an immediate takeover target? and their new CFO is versed in M&As?

anything else we are missing here?

Yes, I think around billion

This is a post from another board in reference to this article.

CVS Article
https://www.bloomberg.com/news/arti...idney-dialysis-with-help-from-segway-inventor


Post dated 07/19/19
Two dudes chat / Stockhouse

Dude A

Hey Dude BI was looking at the CVS article and it got me thinking... they look to be 4-5 years away from approval if all goes well. It seems like there are a couple other pumps looking at similar timeframes.

Do you think Spectral is being low balled or not being fully considered until we get the home use approval?

Which made me also ask- do we know we are fully engaged in that final approval? And how tough it is- knowing we already have CRRT approval?

I keep thinking we should be getting a lot more attention as the only other pump in town- but maybe I’ve oversimplified the next step and it’s timetable?

All the best,

Dude A


Dude B

I can't figure out why CVS doesn't seem to care that their DEKA pump is so far behind spectral and even Quanta's machine. They own Aetna insurance so they already have 22 million people that they will eventually be able to funnel into their DEKA machine. I'm also wondering if it's going to take a year or two for this whole Trump kidney initiative and push towards home dialysis to really gain momentum. I really feel like we are going to be the second home pump available in the USA but it doesn't seem like this is enough of a driving force to get paid a huge buyout premium. I guess timeline isn't as important and the main driving force behind a pumps value is price and performance. The machines that will eventually win market share are going to be the ones that perform well and have the lowest manufacturing cost. Unfortunately we know very little about either of these things and we know almost nothing about how our pump compares performance/price-wise to Quanta, Nxstage, and Outsets.

As far a home approval goes I'm basically waiting for that announcement that our application has been submitted. Their presentations say that it's expected to be submitted in the 3rd quarter which we are now in and it also said that all key elements of the application were ready. I think we are waiting for the final HFT trial results from the clinicians at U of Michigan. The home application getting submitted will definitely be a milestone in my mind but then you have the FDA taking a couple months to officially accept it and/or respond with questions etc. Then they'll take a few months to make a final decision. I accept all this fda timeline stuff and all I really want to know is how does our machine stack up against the others?

Here's a really good look at the Quanta pump. Look at how big their disposable cartridge is compared to ours. I still have that sneaky feeling that our piston drive is gonna be the thing that puts us on top.


https://www.youtube.com/watch?v=johaS_MHVqo



Dude A



That is interesting to see. I hope we are doing as much as Quanta is... From the little bits we’ve heard the piston is a breakthrough- let’s hope they’re right.

I do think you’re right- the big money sees that this market and the insurance cos. transitioning to approving the costs of buying home machines, training etc. is still a couple/ few years off. I know it will save insurance cos. in time- but up front they’ll be writing a lot of big checks.
So does that make potential buyer say- let’s sit back and see what is the best bet once the 3- 4 new pumps come online- and then pay a premium for the best. (It still probably won’t be a 2Bill/ NexStage premium).
I'd also imagine they’d be dangling a low offer to this small co.- with a pump that’s not fully approved.

So maybe it’ll take final approval and a few buyers doing some head to head testing before we get paid what it’s worth... Which again goes back to how good is it? And how long is the FDA path.

Hope we hear it’s started soon.
All the best Dude A

Dude B


Yeah it's sorta like a brand new drug waiting to see if it gets approval. It's pretty rare to see a drug company get bought out before fda approval though it did happen with Celator. Our pump is a little different in that it has CRRT approval already so we know it works. That CRRT approval is our big edge over the other pumps. The home approval is basically approval that our machine is simple enough to be used by a layman. If the HFT trial results come back glowing and with very few user errors then our odds of home approval go even higher and our odds of an early buy out greatly increase. I'd imagine Spectral has come up with a price they want upon home approval, call it X. Then everything works backwards from there, so their asking price two months ago was 70% of X, and their asking price after the HFT/application is submitted would be 80% of X, and their asking price upon home approval is 100% of X. But this is all just me thinking out loud.
The other thing that's important to remember is that CVS has probably never even heard of us. Same goes for Medtronic probably too. Spectral basically just started their coming out party with the launch of the Dialco website. That's why I think the home application being submitted is such an important milestone because when that gets submitted to the FDA every major player in the kidney field will hear about it and come sniffing around. If our pump wipes the floor with the DEKA pump then CVS will have no choice but to try to get us. That's when performance will really come to a head and the top performer will be the first one to get signed in the draft. Well technically Nxstage already went number one but number two usually gets a pretty decent signing bonus too!

Dude A

I hate the wait, but as this home market heats up and becomes more obvious and valuable to the big players it might benefit us… I still think Walmart is going to come in heavy- not sure they are going to want to own their own pump- but as their clinics open up it’s going to be a huge deal for someone- and cost has always been their focus. (We should be talking to them)
I’d guess there will end up being around 4 pumps that make a big push for the market in the next 4 or 5 years? What do you think?

So, as long as we are ahead/ early on the approval process (hopefully second), and the machine is really good- then this time is really the market catching up with (hopefully) a very bullish evaluation that Spectral has on it.

So the HFT application submission is next. Is that us submitting outside testing/ data? Or is that when we send the pump out for it to be real world tested?

all the best,
Dude A


Dude B


Nxstage, Spectral, Quanta, Outset, DEKA. So 5 pumps in the race to start but I could see DEKA being dropped for a second time. That list is how I would rank them. Spectral has a good lead in the USA on Quanta but they are no joke and have deep pockets backing them.

So HFT stands for Human Factors Testing and it's the last piece we need to submit our FDA application for home use. Spectrals HFT testing has been going on for months and the latest investors presentation from April says, "Beta testers from major academic centers in US and Canada are beginning a product evaluation, with enthusiastic feedback from the training sessions," and also, "Regulatory Path for Home Dialysis 510k and Health Canada submissions will be based on the already cleared CRRT version. CE mark already obtained. More than 100 dialysis sessions already performed." Slides 18 & 20.

If you want a good idea what HFT is go to Quanta's press release about their results. It's very informative on how the process works. Here's the two link:

http://www.quantadt.com/wp-content/...-Hemodialysis-International-Press-Release.pdf

[FONT=wf_segoe-ui_light]Results from SC+ Human Factors Testing Published in Hemodialysis International Alcester, Warwickshire, UK, 15 April 2019: Quanta Dialysis Technologies Ltd (“Quanta” or

[FONT=wf_segoe-ui_normal]SC+ is a small, simple and powerful haemodialysis system designed to provide greater flexibility around where, when and how patients manage and receive their dialysis therapy.[/FONT] [FONT=wf_segoe-ui_normal]www.quantadt.com[/FONT]

https://onlinelibrary.wiley.com/doi/full/10.1111/hdi.12757

image: https://onlinelibrary.wiley.com/cover/15424758

[FONT=wf_segoe-ui_light]Human factors testing of the Quanta SC+ hemodialysis system: An innovative system for home and clinic use - Harasemiw - - Hemodialysis International - Wiley Online Library[/FONT] [FONT=wf_segoe-ui_normal]Introduction: Uptake rates of home hemodialysis are the lowest among all modality types, despite providing patients with clinical and quality of life benefits at a lower cost to providers. Currently, there is a need to develop dialysis systems that are appealing to patients while also being suitable for use across the continuum of care.[/FONT] [FONT=wf_segoe-ui_normal]onlinelibrary.wiley.com[/FONT]

[/FONT]

 

[smartmoneyfollower]

Baxter needs EDT's home dialysis machine in a bad way.


https://www.medtechdive.com/news/ba...s-on-heels-of-trump-kidney-initiative/558542/

Baxter stock jumped higher into a buy zone Thursday after the medical technology company topped the Street's second-quarter expectations and raised its profit guidance.

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On today's stock market, shares of Baxter(BAX) lifted 1.5%, to 85.16. Baxter stockbroke out of a cup formation with a buy pointat 82.35 in mid-June. Baxter ranks in the top 6% of all stocks, with a Composite Rating of 94, a measure of key growth metrics.
For the second quarter, Baxter earningsincreased 16% to 89 cents per share, minus certain items. That topped the average estimate of analysts polled by Zacks Investment Research for Baxter earnings of 81 cents a share.
Sales were flat on a strict as-reported basis at $2.84 billion. Operationally, sales grew 4%.

 

[Bozzie]

Hoping that whale (Baxter) swims close... Baxter,CVS,DaVita and Medtronic all are looking for machines.
CVS is in bed with the wrong developers (DEKA), Baxter did three separate rounds with DEKA trying to get a home machine off the ground and nothing came of it.
DaVita at this point has no choice but buy home machines from their biggest competitor( Fresenius ) DaVita is the the process of buying back 1 billion dollars is stock witch is interesting.
Medtronic bought Bellco an Italian device maker in 2016 and basically entered the renal market for the first time, all of the Bellco pumps are made for a clinical setting not home. Medtronic is 100 billion dollar company.

I won't say much more for the time being but you can see how the market is lining up for some sort of consolidation where it comes to Home Renal care.

Good luck fellas

 

[Bozzie]

Year high hit today... hopefully news of a deal is coming soon

 

[Bozzie]

Paradigm initiated coverage this week with a 2.00 $... 2019 YE price witch is a bit of a head scratcher.

A few highlights.


Spectral Reaches Finish Line in New Septic Shock Therapy
Investment Thesis
Spectral Medical is a clinical-stage medical device company focused on addressing significant needs in critical care. While EDT has traded on the TSX for 25 years, in 2010 the company transformed its focus toward its current pipeline of septic shock and dialysis products. Its ToraymyxinTM(PMXTM) device filters septic shock-inducing endotoxin from the blood of patients who are in critical condition. If successful in its ongoing Phase 3b trial, EDT could launch the only FDA-approved treatment for septic shock patients in 2022. The company is also entering the dialysis market through a wholly owned subsidiary, Dialco Medical Inc. This subsidiary is launching dialysis machines for both acute and chronic dialysis — SAMI and DIMI. SAMI is cleared by the FDA and Health Canada for acute dialysis in the intensive care unit (ICU), while DIMI is being developed for in-centre and at-home use and is expecting near-term FDA clearance to enable an initial 2020 launch. By commercializing products focused on treating septic shock and simplifying dialysis treatment, EDT could redefine treatment and improve outcomes for critical care patients in the near future. Considering these key differentiators, we see EDT as a compelling investment opportunity.
Highlights

•  A New Therapy for a Huge Unmet Medical Need | Sepsis is one of the largest global unmet medical needs. Septic shock, a severe form of sepsis, impacts 330,000 U.S. patients each year and has a mortality rate of over 40%. Beyond managing symptoms, there are no effective therapies for the treatment of septic shock. EDT has initiated a registrational U.S.-based Phase 3b clinical trial on ToraymyxinTM (PMXTM), its therapeutic toxin-removal device that removes septic shock-causing endotoxin from the blood, to provide new options for these patients and access this C$1.6-billion market.
•  A Unique Companion Diagnostic | EDT’s 450 patient Phase 3 clinical trial demonstrated that its Endotoxin Activity Assay (EAATM), the only FDA-approved approach for determining endotoxin activity levels, could be used to identify patients most likely to benefit from PMXTM treatment.
•  Simplifying Dialysis | With 750,000 Americans suffering from end-stage renal disease (ESRD) and transplant availability not growing to meet demand, dialysis is a growing component of both acute and continual renal care. Providing new products focused on ease of use, portability and unmet patient needs should position EDT into this important market.
•  Increasing Focus on Home Dialysis Treatment | Dialysis treatment costs take up over 7% of the total U.S. Medicare budget. In a bid to reduce costs and improve patient quality of life, recent policy changes set a goal to increase home dialysis rates from 12% to 80%. This drastic shift provides a unique opportunity for EDT to enter this changing market with its DIMI home dialysis product.
  
  
  
  Dialysis Competitive Analysis
  
  
  Unlike the treatment of sepsis, there are a wide array of existing dialysis products for use within clinics and at home. Recent advancements in both technology and policy are driving these markets to reduce cost and complexity by increasing the use of at-home treatment.
  The dialysis equipment market is dominated by two large-cap players, Baxter and Fresenius Medical. Baxter is a U.S. company that has a broad portfolio of renal and hospital products, includingFresenius Medical not only manufactures its own line of dialysis machines; but it is also one of the largest operators ofdialysis clinics across the U.S. For home dialysis, the company has marketed its 2008K machine since 2011 and has its stay•safe and sleep•safe harmony\devices for home-based PD treatments. However, in 2017, the company acquired medical technology and services company NxStage Medical Inc. for $2 billion. NxStage, which markets the SystemOnhemodialysis machine for home and in-centre use, had 9,000 patients using the SystemOne and revenue of$336 million in 2016. This acquisition combines Fresenius’ existing line of PD devices with a leading hemodialysis device for home-based care.
  In addition to the large-cap companies, the smaller U.K.-based Quanta Dialysis Technologies is developing a new home hemodialysis machine. The company’s SC+ is a portable and easy-to-use home hemodialysis system; however, it requires home renovations to install a permanent water source. The company recently launched its human factors testing study in preparation for submitting its 510(k) FDA filing by year-end. We summarize these existing and new home hemodialysis machines in Appendix IV.
  Changing technologies and policy are transforming the dialysis market, especially around home-based care. While existing large-cap and newer players are repositioning themselves to capture this changing market, there is opportunity for EDT, through Dialco, to create significant value and new options for patients. Dialco’s SAMI and DIMI products focus on ease of use, portability, digital connectivity with clinicians and lack of required infrastructure modifications, which we believe will position it well within this changing landscape.acute and chronic dialysis, sterile IV solutions, infusion systems and devices, and many others. Despite this portfolio of products, renal care is the largest source of Baxter’s revenue. The company’s dialysisproducts span equipment for at-home peritoneal dialysis (PD) and a range of hemodialysis products foruse in the clinic. Since PD makes up ~78% of home dialysis, they have a strong presence in home-based treatment. However, the company does not currently have a home hemodialysis product on themarket. Also, following President Trump’s Executive Order aiming to incentivize home dialysis, thecompany announced a significant investment into its at-home PD business.
  
  
  EDT Market Opportunity and Drivers
  
  
  Clear Clinical and Regulatory Pathways: EDT has been investigating PMXTM for septic shock treatment since 2010. The EUPHRATES trial was a significant six-year, $60-million investment that provided a solid foundation for launching the company’s registrational Tigris trial. These benefits include promising results in an identifiable group of patients, clinicians who are knowledgeable about the device, trial sites that can effectively enroll patients in the new trial and strong engagement with regulators who have clearly defined the requirements for PMXTM approval. For DIMI, the dialysis machine is built on the already approved SAMI system and an FDA 510(k) equivalency application is currently being prepared.
  79,000 U.S. Septic Shock Patients Could Benefit from PMXTM: Across the U.S., 1.7-million patients will be diagnosed with sepsis each year without any effective treatment options. Of these patients, ~330,000 will develop septic shock. Based on the results of the EUPHRATES trial, an ~79,000 of these patients have endotoxin levels and multiple organ failures that would benefit from PMXTM treatment. With a lack of existing effective therapies and an anticipated cost of ~C$20,000 per treatment, the company sees this as at least a C$1.6-billion market opportunity.
  A Growing Need for Dialysis Treatments: In 2018, nearly 750,000 adults in the U.S. were suffering from end-stage renal disease (ESRD). While incidence is increasing, availability of kidney transplants has not been able to keep up with demand. This has resulted in an increasing reliance on dialysis for treatment.
  Move toward Home Dialysis: Dialysis costs Medicare an average of $90,000 per patient. To reduce these costs, there is a significant push toward less expensive home dialysis, which in 2016 only made up 12% of dialysis care. To incentivize this transition, CMS is proposing a new funding model that increases the payments made to treatment facilities and clinicians for home dialysis services. Implementation is expected in the early part of 2020, and the proposal has already led to increased investment in home dialysis, including Baxter announcing
  increased focus on home care and Fresenius touting the acquisition of home hemodialysis machine maker NxStage as key to its efforts in home care going forward.
  
  
  Dialysis Reimbursement and Commercialization
  
  
  INITIATION REPORT | November 1, 2019
  
  
  Spectral Medical Inc.
  
  
  
  
  
  
  
  
  EDT is making a push into the hemodialysis market through a wholly owned subsidiary Dialco Medical Inc. with two products, SAMI and DIMI. SAMI is a dialysis device for use in hospitals that obtained FDA approval in late 2017. It is designed around an open platform focused on simple operation and compact design. DIMI, which is based on the same design as SAMI, was developed for in-centre and home use, and is being prepared for FDA 510(k) submission to demonstrate its equivalent performance to that of the previously approved SAMI system. The company holds the North American license rights to these products from Infomed S.A., a Swiss-based medical device company. The SAMI license is a perpetual license with an eight-year manufacturing agreement, while DIMI is currently under an initial two-year license term which is automatically renewable following FDA approval.
  In the U.S., Medicare covers expenses for patients of any age requiring either dialysis or kidney transplants. This cost Medicare $35 billion in 2016, representing 7% of the entire Medicare budget. Per patient, dialysis costs Medicare an average of $90,000 per year. Owing to these high costs, there is a significant push from more expensive in-centre care to home-based care. In 2016, only 12% of dialysis was performed at home, despite the lower costs and increased quality of life associated with this approach. However, current home dialysis technology can still be costly. Since many machines require large volumes of highly pure water to produce the dialysate, the patient’s home must undergo significant renovations costing up to $35,000 to install the large and stationary dialysis machine. New technologies and dialysate delivery models are creating new opportunities to reduce costs and improve the patient’s experience while undergoing treatment.
  
  On July 10, 2019, President Trump signed an executive order titled Executive Order on Advancing American Kidney Health which included a focus on encouraging in-home dialysis. As a result of this order, the U.S. CMS has proposed a number of new funding models to increase home dialysis use from 12% to 80% by 2025. This includes increasing Medicare payments to ESRD facilities and clinicians for home dialysis and dialysis-related services, under the Home Dialysis Adjustment Program set to be implemented in early 2020. This proposal has already led to increased investment in home dialysis by key players, including Baxter (BAX-N) announcing an increased focus on home care and Fresenius (FRE-ETR) touting the acquisition of home hemodialysis machine maker NxStage as key to its efforts in home care going forward.
  The dialysis line of products has numerous value drivers for EDT. At this stage, EDT’s FDA-approved dialysis machine (i.e., SAMI) helps mitigate the risk that current dialysis machine manufacturers will change their designs to prevent the use of PMXTM cartridges once it is approved. In addition to future uses in PMX-based sepsis treatment which are expected to drive sales of this acute dialysis machine, SAMI has already achieved $500,000 in sales as a stand-alone device following the early 2019 commercial launch. However, given the existence of multiple well-entrenched players in the acute dialysis space, we believe the principle opportunity for EDT in the dialysis space is the use of DIMI for chronic dialysis, specifically for at-home treatment.
  The company expects to submit Health Canada and FDA applications for home-use of DIMI in 2020 and launching in 2021. The company will file 510(k) applications for home-use in two steps, with a first 510(k) filing demonstrating equivalency to the already approved SAMI being submitted this quarter for in-centre use, and the second 510(k) filing specifically for home-use being submitted at end of 2020.
  EDT expects SAMI and DIMI revenue to be driven by sales of the dialysis machines, coupled with disposables and dialysate solutions. Both SAMI and DIMI will be priced at $40,000 each, with disposables totalling up to about $25,000 per year. The disposable is a cartridge, used by both SAMI and DIMI, that is inserted into the pump and includes the tubing that connects to the patient’s catheter port. These are used with each treatment, which on average is three times per week. The machines also require highly pure dialysis solution, which the company will also sell to institutions and home users. Regular dialysis requires 100 litres of dialysis solution per week. While many existing home dialysis machines require large reverse osmosis systems to provide this highly pure water, DIMI is designed to use bagged dialysate which would be delivered to the patient’s home or distributed through local
  
  
  
  Bottom up valuation
  
  2019 YE. 2020 YE. 2021 YE. 2022 YE
  $2.00 $2.40 $3.62. $5.46

 

[Bozzie]

If anyone is interested ...the full report was just posted on the Spectral web site.

 

[smartmoneyfollower]

Just a observation, 50% of the people alive today in the united states will live to 100 years old. They will only earn an income untill 60. I think you were spot on with your 07-26-2019 post.