EDT.TO/ Spectral medical

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Baxter to announce something about spectral at 90 participants , I have the feeling short term this will be a selling opportunity..Long term the numbers will be un vailed on the study , this number should give an idea of the value for Spectrals filter and diagnoses tools

Some are speculating Baxter pulls the trigger on an option to buy Spectral..Personally i think they take the trial over and bring it to completion in a timely manner.
still have a few months on this as Spectral is at 81 subjects with 90 needed for the interim numbers..add the 28 mortality and you might be looking at late Feb to March for a Baxter announcement.

Below is a link to Baxters spin off and the likely spot the spectral products would be sold.

My plan is buying a bit more to sell on the baxter announcement news.

I own around 600k shares at this point.


 

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TIGRIS TRIAL UPDATE

79 patients enrolled


TORONTO, Canada – December 4, 2023 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update for the month of November on 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 treated for endotoxemia and septic shock.
79 patients enrolled to date and continuing to close in on the interim target of 90 patients, an important milestone as the Company’s strategic commercial partner, Baxter (NYSE:BAX), will have the opportunity to view the data as well as provide a second milestone payment to Spectral.

Currently 20 Tigris trial sites, with near term onboarding of new, high quality clinical sites.

Crude mortality results at both 28-day (primary endpoint) and at 1-year, thus far, continue to exceed efficacy targets.
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “In November we experienced strong enrollment into Tigris despite the U.S. Thanksgiving holiday, with five patient enrollments in the last six weeks. We continue to make progress opening additional sites, which should positively impact the pace of enrollment. Additionally, the high rates of influenza that we are witnessing across the southern U.S. and California could have a positive impact on our enrollment, as influenza is often a trigger for bacterial sepsis. Overall, we are rapidly advancing our Tigris trial and remain highly encouraged by the outlook, given the fact preliminary mortality data continues to exceed our expectations.”

“We continue to be very bullish on the outcome of the Tigris trial. We recently published a Bayesian methodology paper in a major scientific journal. The analysis clearly indicates that our trial strategy is highly likely to succeed in our goal of FDA approval for PMX. 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,” said Chris Seto, Chief Executive Officer of Spectral. “Additionally, we are making steady headway towards reaching out our interim count of 90 patients, which is expected to play as a major catalyst for the Company.”

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
 

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AM IR

SPECTRAL MEDICAL PROVIDES TIGRIS TRIAL UPDATE

81 patients enrolled

TORONTO, Canada – December 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 provided an update on 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 treated for endotoxemia and septic shock.

Enrollment:
  • Robust enrollment activity since the end of October, with 81 patients enrolled to date,
    • Seven patients enrolled over the last eight weeks
    • Screening activity at current sites remains strong with 100+ patients screened per week
  • Closing in on the interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment, Baxter has the option to make the second milestone payment to Spectral to maintain its PMX exclusive distribution rights.
  • Crude mortality results at both 28-day (primary endpoint) and at one year, thus far, continue to exceed efficacy targets.
Trial Sites:
  • Currently 20 Tigris trial sites, with near term onboarding of new, high quality clinical sites.
    • Clinical Trial Agreements (“CTA”) either executed or in final revision phase at six new clinical sites.
EDEN Study:
  • Completed the EDEN study, a parallel observational study, in which data is collected on patients with septic shock even if ineligible for Tigris. The EDEN study is among the largest ever to examine the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX, and provide important data on potential expanded indications for PMX.
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “Since the end of October, we experienced strong enrollment into Tigris despite the U.S. Thanksgiving holiday, with seven patient enrollments in the last eight weeks. We continue to make progress opening additional sites, which should positively impact the pace of enrollment. Additionally, the high rates of influenza that we are witnessing across the southern U.S. and California could have a positive impact on our enrollment, as influenza is often a trigger for bacterial sepsis. Overall, we are rapidly advancing our Tigris trial and remain highly encouraged by the outlook, given the fact preliminary mortality data continues to exceed our expectations.”

“We are pleased with the pace of enrollment activity since holding our Investigator Meeting this past May. The sustained enrollment activity over these past seven months has put Spectral within striking distance of our interim enrollment milestone of 90 patients, which is expected to play as a major catalyst for the Company,” said Chris Seto, Chief Executive Officer of Spectral Medical.

As a reminder, under the exclusive distribution agreement between Spectral and Baxter International (NYSE.BAX), following the enrollment of 90 patients, Baxter has the option to provide a second milestone payment to Spectral in order to affirm and maintain its exclusive distribution rights to PMX.

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.

The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.

The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.

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.

 

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Nice 25% bump this month..I'd expect a further run up to the data....

Then Baxter has some sorta announcement is what has been said by Spectral management.

.41 today.
 

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Up another 6% early..decent volume.

Money watching FOMO setting in.

Should continue matching up to the data release...

.51 would be 20% this week.

The company says the data is exceeding previously released data that is a target for FDA approval..

I'm always suspicious of the CEO spouting BS.. hopefully hes not blowing smoke.
 

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.51 another 20%
.62 next stop for another 20%

come on Spectral....

 

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.65..i expect the next leg up to be significant on a Baxter announcement. That RI/PR should give a clear direction where this is heading in the next year or so.

.78 would be another 20%
 

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SPECTRAL MEDICAL ANNOUNCES MAJOR MILESTONE BY REACHING ITS INTERIM ENROLLMENT TARGET OF 90 PATIENTS


TORONTO, Canada – February 15, 2024 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced a major milestone by reaching its Interim Enrollment target of patient 90 in its TIGRIS trial.

Under the terms of the Company’s Exclusive Distribution Agreement with Baxter International (“Baxter”) (NYSE:BAX), at Interim Enrollment, Baxter has the option to make a second milestone payment to Spectral to maintain its PMX exclusive distribution rights. As such, Spectral has formally notified Baxter of reaching its Interim Enrollment target of 90 patients.

“Enrolling patient 90 represents a major milestone in many ways for Spectral as we continue to see acceleration across our Tigris trial sites and building confidence and momentum towards completing the trial,” said Chris Seto, CEO of Spectral Medical. “We remain confident in the outcome of Tigris and our potential for FDA approval and look forward to our continued partnership with Baxter to commercialize PMX and bring a new standard of care across ICUs in the United States.”

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.

The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis
.

The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
 

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First step in the eventual deal for full rights.

IDK what effect this will have on the short term price



SPECTRAL MEDICAL ANNOUNCES AMENDMENT AND EXTENSION OF EXCLUSIVE SUPPLY AND DISTRIBUTION AGREEMENT WITH BAXTER HEALTHCARE CORPORATION

Baxter to act as exclusive partner to Spectral for 10 years following PMX approval by U.S. FDA


TORONTO, Canada – February 21, 2024 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, is pleased to announce an extension to its supply and distribution agreement (the “Amended Agreement”) with Baxter Healthcare Corporation, a subsidiary of Baxter International Inc. (“Baxter”) (NYSE:BAX), originally entered into in February 2020.

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 Spectral’s Endotoxin Activity Assay (EAA™), the only diagnostic currently cleared by U.S. FDA for the risk of developing sepsis.

Under the terms of the Amended Agreement, Baxter’s exclusive rights to supply and distribute PMX products will be in effect for ten (10) years following the date that the U.S. FDA marketing authorization for PMX products in the United States is obtained. Upon Baxter International Inc.’s previously announced planned separation of its Kidney Care business (or any other separation of all or part of such Kidney Care business) into an independent company, the rights and obligations under the Amended Agreement will be assigned or otherwise transferred by Baxter to the new Kidney Care company.

“Baxter’s continued commitment to Spectral as our exclusive supply and distribution partner being extended for a ten-year period upon U.S. FDA approval provides us with great confidence in our commercialization path,” said Chris Seto, CEO of Spectral Medical. “We are grateful and appreciative to the Baxter Acute Therapies team for the partnership through their investments in Spectral and their continued level of enthusiasm and hands-on involvement in planning for a successful launch of our PMX products into ICUs across the United States.”

“We are encouraged by Spectral’s evidence generation strategy for PMX, and our teams are fully engaged in support of our shared goal: reaching more critically ill patients with clinically effective and differentiated therapies,” said Gavin Campbell, President, Acute Therapies - Baxter. He added: “The commercialization of advanced blood filtration therapies like PMX is a strategic priority for Baxter Acute Therapies.”

Baxter Milestone Payment to Spectral

Under the terms of the Amended Agreement, once 90 patients were enrolled in Spectral’s PMX-focused Tigris Trial, Baxter had the option to make a milestone payment to Spectral to maintain its exclusive distribution rights for PMX products in the United States and Canada.

On February 15, 2024, Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification to Baxter of this achievement. Subsequently, Baxter exercised its option to maintain exclusive distribution rights.

Spectral Medical Tigris Trial and Corporate Update Call

Chris Seto, Chief Executive Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.

CONFERENCE CALL DETAILS:

Date: Thursday, February 22, 2024

Time: 10:00 a.m. (ET)

Dial in Numbers: 1-877-407-0792 or 1-201-689-8263

Replay Dial-In: 1-844-512-2921 or 1-412-317-6671 (available after 3:00 p.m. ET, February 22, 2024)

Replay Expiration: Thursday, March 7, 2024 at 11:59 p.m. ET

Access ID: 13744665

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 U.S. 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.

The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a severe form of sepsis with significant impact on patient outcomes and healthcare costs.
.

The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.

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 (and the receipt of any required regulatory approvals or clearances), 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.
 

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Tomorrow's call...should be telling

CONFERENCE CALL DETAILS:

Date: Thursday, February 22, 2024

Time: 10:00 a.m. (ET)

Dial in Numbers: 1-877-407-0792 or 1-201-689-8263

Replay Dial-In: 1-844-512-2921 or 1-412-317-6671(available after 3:00 p.m. ET, February 22, 2024)

Replay Expiration: Thursday, March 7, 2024 at 11:59 p.m. ET

Access ID: 13744665
 

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Boz’ - hope all is well my friend.

Initial sense is that was not a great update. More cash burn and dilution likely incoming(?)

Sounds like we will have to wait for the full 150?
What do you realistically put the market cap ceiling at post-approval? Share price remains low but the market cap has crept up significantly over the years. $140M CAD market cap today. Ceiling of $1B? 7x return is nice but there is certainly risk here and I’ve swallowed several losses along the way…hopefully I’m significantly understating potential. 2B? I know there is a profit split with Baxter…tying to extrapolate the EBITDA to EDT.

Holding 170,000 so I have confidence (and continued patience, albeit it’s been several years and there’s an opportunity cost seeing billion dollar companies move like micro caps like Spectral, with much less risk), just trying to play devil’s advocate a bit here.

Best,
Steiner
 

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Boz’ - hope all is well my friend.

Initial sense is that was not a great update. More cash burn and dilution likely incoming(?)

Sounds like we will have to wait for the full 150?
What do you realistically put the market cap ceiling at post-approval? Share price remains low but the market cap has crept up significantly over the years. $140M CAD market cap today. Ceiling of $1B? 7x return is nice but there is certainly risk here and I’ve swallowed several losses along the way…hopefully I’m significantly understating potential. 2B? I know there is a profit split with Baxter…tying to extrapolate the EBITDA to EDT.

Holding 170,000 so I have confidence (and continued patience, albeit it’s been several years and there’s an opportunity cost seeing billion dollar companies move like micro caps like Spectral, with much less risk), just trying to play devil’s advocate a bit here.

Best,
Steiner


I totally get your view mine is basically the same.
The risk is significant. Still.
The next raise is some sorta bridge i hope and we avoid dilution ,the way this is financed will be telling.

I'm holding..Baxters payment was in line with the original agreement, i think people expected more and the price reflects that fact. If you're Baxter IDK why you'd give spectral any more cash than the agreement states.

Baxter has 10 billion in debt and a B- rating from fitch..one stop from a junk rating...shocking actually.
Baxters Hill Rom deal was a flop and comprised moves the company can make.

The spin off Ventive is a vehicle for paying down that debt and Spectral is the centerpiece of Ventive...one thing I'd say is Baxter has more science-based advisors and they did make the agreed payment...

The 1.60 target from paradigm is a head scratcher..its not in line with the spectral numbers

I'm trying to put all the noise behind me. I know if the trail is successful we win big..if its not we lose, although the diagnostic has some value without the filter.

Binary all the way.

I'll be in touch over PM in the next few weeks.

Hope all is well.













.
 

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SPECTRAL MEDICAL PROVIDES FEBRUARY TIGRIS TRIAL UPDATE

93 patients enrolled

February represents a second record breaking consecutive month for patient enrollment


TORONTO, Canada – February 28, 2024 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on 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 treated for endotoxemia and septic shock.

Enrollment:
Robust enrollment activity continues throughout 2024:
93 patients enrolled to-date
Six patients enrolled in the month of February – follows the six patients enrolled in January
Twelve patients enrolled in the first two months of 2024 – represents the most robust enrollment rates since the start of the Tigris study
With 57 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
To support sustained enrollment, Spectral to host an in-person Investigator Meeting March 12th & 13th in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego
Trial Sites:
Currently 21 Tigris trial sites, with continued progress opening an additional four new, high quality clinical sites
The Institute for Extracorporeal Life Support (San Antonio, TX) finalized and executed the Tigris clinical trial agreement
Expect significant site onboarding activity throughout Q1/24, with final training scheduled at three of the remaining four sites
 

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Intersting addition here.

Spectral just put Baxters ex president on the spectral board.
He also headed the Vantive baxter spin off who's has spectral products in their investor presentation.

Good sign...650K and holding
 

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insiders exercising options ...large chunks.

great look

  • May 29, 2024 (filed on Jun 04, 2024)
    Insider Name:
    Seto, Chris
    Ownership Type:
    Direct Ownership
    Securities:
    Common Shares
    Nature of Transaction:
    51 - Exercise of options
    # or value acquired/disposed of:
    565,000
    Price:
    $0.36
Jun 03, 2024 (filed on Jun 04, 2024)
Insider Name:
Walker, Paul M.
Ownership Type:
Direct Ownership
Securities:
Common Shares
Nature of Transaction:
51 - Exercise of options
# or value acquired/disposed of:
200,000
Price:
$0.38
 

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