EDT.TO/ Spectral medical

[Bozzie]

You too CB hope florida is treating you well buddy!

 

[CoachCB]

You too CB hope florida is treating you well buddy!

Hope all's well up your way! I'm in Chicago working as a consultant on an emergency management gig. Hoping to be done by mid-Dec. Didn't really expect to spend the fall up here. lol

 

[Bozzie]

Hope all's well up your way! I'm in Chicago working as a consultant on an emergency management gig. Hoping to be done by mid-Dec. Didn't really expect to spend the fall up here. lol

ha..good man..you are crushing it no doubt.
Stay warm, good hearing from you dude.

 

[beeker]

And there is now proof...in the SEDAR filings, that Baxter has taken an, in effect, equity interest in Spectral - by taking one of the two $ 2.5M Convertible Debentures in the latest financing that will close any day now. This is the same $ 30B (by Market Cap) company that signed a Distribution Agreement for PMX back in 2020, and that is helping to fund completion of the Tigris Trial. Given the "open label" nature of the Trial, and the degree to which Baxter is probably "tapped in" with hospitals, this would seem to be a VERY good sign.

 

[Bozzie]

And there is now proof...in the SEDAR filings, that Baxter has taken an, in effect, equity interest in Spectral - by taking one of the two $ 2.5M Convertible Debentures in the latest financing that will close any day now. This is the same $ 30B (by Market Cap) company that signed a Distribution Agreement for PMX back in 2020, and that is helping to fund completion of the Tigris Trial. Given the "open label" nature of the Trial, and the degree to which Baxter is probably "tapped in" with hospitals, this would seem to be a VERY good sign.

Why hide the deal in the phrase "Strategic Partner"...Just waiting on the Dialco part to drop.
Not much you can say here every possible line from "Newco" has been drawn to Spectral.
I've felt this would be the situation with DaVita for a few years..
Massive market presents ,clinics just about everywhere.

Find a Dialysis Center

Use Our Find a Dialysis Center Tool to find the DaVita Kidney Care dialysis center that best fits your needs or speak with a placement specialist: (800)424-6589

www.davita.com

Interesting for sure...

 

[beeker]

Why hide the deal in the phrase "Strategic Partner"...Just waiting on the Dialco part to drop.
Not much you can say here every possible line from "Newco" has been drawn to Spectral.
I've felt this would be the situation with DaVita for a few years..
Massive market presents ,clinics just about everywhere.

Find a Dialysis Center

Use Our Find a Dialysis Center Tool to find the DaVita Kidney Care dialysis center that best fits your needs or speak with a placement specialist: (800)424-6589

www.davita.com

Interesting for sure...

Hopefully their massive market presence will yield massive market presents for Spectral shareholders (this Xmas please).

I agree (and hope) it's most likely DaVita/Medtronics via Newco. I'll give that a 90% probability. Further announcements in 2023 on that.
Here's a list of the largest players.

List of US dialysis providers - Wikipedia

en.wikipedia.org

In some ways I could see Braun, Baxter, CVS wanting to play a role - esp. on the equipment side. Fresenius - doubtful - too much of a monopoly already.

 

[Bozzie]

Hopefully their massive market presence will yield massive market presents for Spectral shareholders (this Xmas please).

I agree (and hope) it's most likely DaVita/Medtronics via Newco. I'll give that a 90% probability. Further announcements in 2023 on that.
Here's a list of the largest players.

List of US dialysis providers - Wikipedia

en.wikipedia.org

In some ways I could see Braun, Baxter, CVS wanting to play a role - esp. on the equipment side. Fresenius - doubtful - too much of a monopoly already.

hahah...missed that...:0
The CVS DAKA thing is still rolling...the connection to Sam/ Braun is noted.
For Anyone following loosely Sam Amory as of (around 10 months? or so ) is heading Spectral's pump division, it's a big job to leave for a unknown company running out of an office park near Toronto. I'd add Blair McInnis CFO left a company doing revenues of + 450 million annually.
It's a good team, something not known yet to investors attracted this talent is my guess...If either were to leave.. I'd be frightened.

 

[Bozzie]

https://www.linkedin.com/in/samuel-amory-27360b16/

 

[Bozzie]

Latest profile....33 years at Braun.

https://www.linkedin.com/in/samuel-amory/

Medtronic and DaVita announce new kidney health technology company

/PRNewswire/ -- Medtronic plc (NYSE:MDT) and DaVita Inc. (NYSE:DVA) today announced the intent to form a new, independent kidney care-focused medical device...

www.prnewswire.com

Medtronic’s planned spinoff ‘doesn’t move the needle’ in growth strategy: analysts

Combining patient monitoring and respiratory intervention businesses into a separate company may not be enough to address investor concerns.

www.medtechdive.com

 

[beeker]

You're correct. It's highly unlikely that Sam would throw away a 33 year career to join a small fledgling Cdn Company. Unless said Company is NOT fledgling at all, but instead is busy creating a "ground floor" opportunity with lots of potential upside, for whomever might run it.
It's a little disappointing that from the second article, Medtronics does not see Home Dialysis as growth market (hence the spin-out). Maybe shareholders are just too short-term focused, as is often the case.

 

[Bozzie]

Insiders taking part.....

 

[beeker]

Insiders taking part.....

Yep ! It never hurts to pay attention to what the smart money is doing. I'm thinking news on Dialco - anytime now.

 

[Steiner69eR]

Insiders taking part.....

nasty Dialco news. Can’t trust this management team/BoD…

thoughts? Hope all is well, my friend.

 

[Bozzie]

nasty Dialco news. Can’t trust this management team/BoD…

thoughts? Hope all is well, my friend.

I'm have a hard time figuring out the deal...Consolidation of some sort ..I'm baffled given the extension they signed awhile back..
I'm more baffled by insiders buying large amounts over the last few months....think I'm going to give this a beat or two before I jump either way....The analyst report is full of holes, he's not getting the full story IMO

Hope you're doing well too

 

[Bozzie]

Good or bad..I'm not sure? The company is making moves, I feel something will be disclosed in the next IR at the end of March
I'd either sell or get ready for the potential of a lump of coal. A bit of a fight is under way with shareholders and the company..Seems something is being withheld ..something potentially material in scope.

All I can hope is the reason news is being pushed back on is this quote from the Canadian securities website.

Confidentiality3

(1) Securities legislation permits a company to delay disclosure of a material change and to keep it confidential temporarily where immediate release of the information would be unduly detrimental to the company’s interests. For example, immediate disclosure might interfere with a company’s achievement of a specific objective, with ongoing negotiations, or with its ability to complete a transaction. If the harm to a company’s business from disclosing outweighs the general benefit to the market of immediate disclosure, withholding disclosure is justified. In such cases a company may withhold public disclosure, but it must make a confidential filing with the securities commission.4 Certain jurisdictions also require companies to renew the confidential filing every 10 days should they want to continue to keep the information confidential.

(2) We discourage companies from delaying disclosure for a lengthy period of time as it becomes less likely that confidentiality can be maintained beyond the short term. 2.3

Maintaining Confidentiality5
(1) Where disclosure of a material change is delayed, a company must maintain complete confidentiality. During the period before a material change is disclosed, market activity in the company’s securities should be carefully monitored. Any unusual market activity may mean that news of the matter has been leaked and that certain persons are taking advantage of it. If the confidential material change, or rumours about it, have leaked or appear to be impacting the market, a company should take immediate steps to ensure that a full public announcement is made. This would include contacting the relevant exchange and asking that trading be halted pending the issuance of a news release.6

(2) Where a material change is being kept confidential, the company is under a duty to make sure that persons with knowledge of the material change have not made use of such information in purchasing or selling its securities. Such information should not be disclosed to any person or company, except in the necessary course of business.

I'm holding but I have a high pain tolerance.
Stay tuned....

 

[valium]

i didn't see any news this week on Spectral yet the largest volume day in six months happens on a big down day. Bozzie, what did you do? Unload your position?

 

[Bozzie]

i didn't see any news this week on Spectral yet the largest volume day in six months happens on a big down day. Bozzie, what did you do? Unload your position?

Sorry , I've had this thread on ignore because of my frustration with the company....Yes still, in haven't sold any despite it pissing me off somewhat.
The trial is actually enrolling normally after a change in the CRO... 16 participants till Baxters option @ (90) and payment are due given they are satisfied with the data.
Visually and PR wise it'll help the company if Baxter continues to commit long, hopefully an appreciation in price will follow.. It should, the next step sometime between the mid point (90) participants and the trial finish at 150 would be Baxter owning them in some way.

If Baxter passes...Not good.

Good luck if you're still in

 

[Bozzie]

nice 30% move last week if you're flipping in and out of this...I'm not.
I'm thinking it'll make another move shortly, big bids lurking last week that didn't execute.

 

[Bozzie]

SPECTRAL MEDICAL ANNOUNCES OPENING OF TIGRIS CLINICAL TRIAL SITE AT THE MAYO CLINIC TORONTO, Canada – October 16, 2023 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced the onboarding of the Mayo Clinic in Rochester, Minnesota, as its 19th clinical site for the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults being treated for endotoxemia and septic shock. The Mayo Clinic is a premier medical center in the U.S. and is top ranked in more specialties than any other hospital in the nation, according to U.S. News & World Report. Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are pleased to announce the addition of the Mayo Clinic to the premier roster of clinical trial sites participating in Tigris. Moreover, we are making continued progress enrolling additional sites, and are on track to add an additional six sites in the coming four to six weeks. We remain highly encouraged by the outlook for the trial, given both the current enrollment rates and preliminary mortality data.”

 

[Bozzie]

sounds good....$$$$$$$$$$$$$$$$$$$$

"Highly likely to succeed and not only will this support our FDA approval for PMX, but will also have a major impact on how trials in the ICU are conducted in the future."

SPECTRAL MEDICAL ANNOUNCES PUBLICATION OF TIGRIS TRIAL METHODS PAPER AND SIMULATION OF RESULTS Tomlinson et al. Bayesian methods: a potential path forward for sepsis trials. Critical Care (2023) 27:432 TORONTO, Canada – November 14, 2023 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced the publication of its Tigris trial methods paper in Critical Care, which discusses the use of Bayesian methods in clinical trial design. Simulation studies incorporating historical data from a 179-patient subgroup of Spectral’s EUPHRATES trial combined with data from the ongoing Tigris trial demonstrated an increase in power across a range of observed hypothetical results. Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “We are pleased to see the publication of this paper, in a major scientific journal. The analysis clearly indicates that our trial strategy is highly likely to succeed and not only will this support our FDA approval for PMX, but will also have a major impact on how trials in the ICU are conducted in the future. The simulations involving over 2,000 potential trial results show that using the planned 75% weight on the prior EUPHRATES data, an observed absolute risk reduction for mortality of 7% in Tigris is at approximately the 95% probability threshold for declaring PMX effective. Current results from Tigris are far in excess of this threshold.” Chris Seto, Chief Executive Officer of Spectral commented, “We are also pleased to see all of our study site investigators participating as authors on the study as we continue to work aggressively to complete the enrollment of our Tigris Trial. We are proud to be a part of this effort to help patients suffering from endotoxic septic shock and hope to bring a new standard of care to the market.” The Tigris Trial methods paper “Bayesian methods: a potential path forward for sepsis trials” can be accessed at: https://doi.org/10.1186/s13054-023-04717-x About Critical Care Critical Care is a high-quality, peer-reviewed, international clinical medical journal. Critical Care aims to improve the care of critically ill patients by acquiring, discussing, distributing, and promoting evidence-based information relevant to intensivists. Critical Care aims to provide a comprehensive overview of the intensive care field. About Spectral Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis. PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com. Forward-looking statement Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement. For further information, please contact: Blair McInnis Ali Mahdavi David Waldman/Natalya Rudman CFO Capital Markets & Investor Relations US Investor Relations Spectral Medical Inc. Spinnaker Capital Markets Crescendo Communications, LLC 416-626-3233 416-962-3300 212-671-1020 bmcinnis@spectraldx.com am@spinnakercmi.com edt@crescendo-ir.com