EDT.TO/ Spectral medical

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Till recently the NEO.Alpha & Omega saw no action, anyone have a theory on why these markets have had an up-ticked in volume when you could buy on the TSX? I don't why volume shifted to these markets.

TSX shows 80K, real volume closer to 300K combining the markets..

https://www.stockwatch.com/Quote/Detail?C:EDT




T:EDT - SPECTRAL MEDICAL INC - http://www.spectraldx.com14:03:59 EST
Sym-XBid - AskLastChg%ChVol$Vol#TrOpen-Hi-LoYear Hi-LoLast TrNewsDelay
EDT - T ▲ATS28.50.65·0.660.50.66-0.04-5.7277.01771410.63 0.70 0.620.81 0.34513:19:4310:0115 min RT 2¢
TSX - T28.50.65·0.660.50.66-0.04-5.780.151470.63 0.67 0.620.81 0.34513:16:5615 min
NEO ATS - U0.66-0.04-5.745.029300.70 0.70 0.6213:16:5615 min
Alpha - A0.66-0.04-5.780.352150.65 0.66 0.6313:00:2015 min
Omega - O0.66-0.04-5.720.01360.64 0.66 0.6213:19:4315 min
CX2 - H0.65-0.05-7.148.531190.65 0.66 0.6212:58:3815 min
CXD - D0.700.302Dec 08 15:50:0115 min
TriAct - M0.702.9222Sep 11 14:53:4615 min


 

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Bozzie:

I am in......nothing as large as you in terms of $$$. Maybe we can score big and I can come out to Oregon for a round of golf and a nice bottle of wine!!

Good Luck to us.
 

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This next phase of FDA requirements is Human factors testing, basically people are trained to use the machine in clinic for 6 weeks and are scored on every interaction with the machine...then sent home for 6 weeks with the machine and someone to monitor and scored the interactions again. Vetting the machine basically vs Human interaction fault rates. Another thing the FDA is looking at separately is a newly installed remote monitoring system for home use.
It's finally coming together, some good young minds have been pulling the strings for the past year, it looks like they have a clear strategy (FDA home approval) to drive the price and another to scare the Bjeee'$ outa anyone looking to buy a HD pump company on the cheap...(FDA approval with an up-listing)
Consider yourself invited NS.. I think we'll win here.
 

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I have 29,500 EDTXF @ .40/avg per share. I added some today when it was down big. I've been buying the dips and will probably add some more if it gets below .50 again.
 

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I have 29,500 EDTXF @ .40/avg per share. I added some today when it was down big. I've been buying the dips and will probably add some more if it gets below .50 again.


Nice CB you been slowly buying seems like....This has at least another 6 months before Fault testing is done plus a bit of time for the FDA to do its thing with the data afterward.

Outset up-date..I haven't been following them that closely, they went public during the pandemic....
https://www.bizjournals.com/sanjose...edical-ceo-quite-happy-with-125-ipo-jump.html

Also Outset has a ER call on the march 9th I'll be listening , feels like EDT is mirroring Outsets moves in a smaller way plus I'm curious what the plan is to get that 4 billion they think can be had on a takeout..Valued at 2.0 billion today by the market...on 20 mIllion in sales.

https://www.tullahomanews.com/news/business/outset-medical-to-report-fourth-quarter-and-full-year-2020-financial-results-on-tuesday-march/article_36441f75-61c6-5792-b5b9-569d4d497179.html


Just background noise for EDT at this point, Money is flowing to this market segment, I'd just like to see it flow EDTs direction before Outset pulls a player outa the loop on a takeout.
 

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I have 29,500 EDTXF @ .40/avg per share. I added some today when it was down big. I've been buying the dips and will probably add some more if it gets below .50 again.

Dam it Coach.....you had to post that you had 29,500 shares......being competitive now I will have to buy more just to have bragging rights that I didnt make as much as Bozzie but I made more than Coach.....when we all become filthy rich. hahaha
 

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Dam it Coach.....you had to post that you had 29,500 shares......being competitive now I will have to buy more just to have bragging rights that I didnt make as much as Bozzie but I made more than Coach.....when we all become filthy rich. hahaha

Yes...but my dollar cost average will be lower! Unless of course it tanks.....
 

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It'll have some down days still but long..They have the assets, it's all dependent on FDA approvals now.
 

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Nice, it'll bounce around a bit..Health care Canada "Home approval" on the pump should come at any time.
It'll be viewed as good news.
 

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This will be a boost for both retail and institutional investors in the US
Good good.



Spectral Medical Engages Crescendo Communications to Provide
Investor Relations Services in the United States


TORONTO, CANADA — March 4, 2021 – Spectral Medical Inc.(“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), announces that it has retained Crescendo Communications, LLC ("Crescendo") as its investor relations firm to help broaden awareness of the Company in the US financial markets.

David Waldman, President and CEO of Crescendo, commented, “We are honored to work with Spectral and look forward to supporting them in their mission of combatting the devastating impacts of sepsis, a leading cause of death in ICUs across the US. Spectral’s Toraymyxin™ PMX endotoxin removal cartridge, combined with its EAA™ diagnostic, address a dramatically underserved $1.5 billion market opportunity with no competing FDA approved solutions. Additionally, we believe there is a significant market opportunity within the Dialco business, with two first-in-class hemodialysis machines, positioned to capture significant market share within the $5.3 billion acute and home dialysis markets. We look forward to helping increase awareness within the US investment community, as Spectral advances towards a number of key milestones.”

About Spectral
Spectral is a Phase III 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 200,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.

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



For further information, please contact:


Dr. Paul Walker
President and CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
pwalker@spectraldx.com
Mr. Chris Seto
COO and CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakerc

 

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I missed the 5.3 Billion dollar market in Home dialysis this AM when I posted this.
Man O man that's a lot of cheese ...$$$



This will be a boost for both retail and institutional investors in the US
Good good.


Spectral Medical Engages Crescendo Communications to Provide
Investor Relations Services in the United States


TORONTO, CANADA — March 4, 2021 – Spectral Medical Inc.(“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), announces that it has retained Crescendo Communications, LLC ("Crescendo") as its investor relations firm to help broaden awareness of the Company in the US financial markets.

David Waldman, President and CEO of Crescendo, commented, “We are honored to work with Spectral and look forward to supporting them in their mission of combatting the devastating impacts of sepsis, a leading cause of death in ICUs across the US. Spectral’s Toraymyxin™ PMX endotoxin removal cartridge, combined with its EAA™ diagnostic, address a dramatically underserved $1.5 billion market opportunity with no competing FDA approved solutions. Additionally, we believe there is a significant market opportunity within the Dialco business, with two first-in-class hemodialysis machines, positioned to capture significant market share within the $5.3 billion acute and home dialysis markets. We look forward to helping increase awareness within the US investment community, as Spectral advances towards a number of key milestones.”

About Spectral
Spectral is a Phase III 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 200,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.

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



For further information, please contact:


Dr. Paul Walker
President and CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
pwalker@spectraldx.com
Mr. Chris Seto
COO and CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakerc

 

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This is one I'm hanging onto.


Looking good and the drop in price isn't a big deal.
I'd bet on Canadian home approval soon, I'd doubt it moves the price much but will be viewed as one step closer to the US market home approval.
Anyone wanting to make a move on these guys won't be happy as this steps up the approval ladder.
 

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Kellum is a big deal in the world of Hemo..Maybe the biggest next to one Italian guy "Ronco" who's also been pro Spectral
He's a catch and I'd bet more changes at the top structure of the company will be coming soon...All very good signs

Changes at the top of the company...
Seto is the guy who has the skills to drive this across the line.
Very good news..I have no idea if this has any effect on the price today.

fed0372a-a1bf-4e28-ad49-8534c1204b3c.jpg

Spectral Medical Announces the Appointment of Chris Seto to CEO

Dr. Paul Walker will remain on the Board of Directors focusing on the seamless transition of management and on ensuring continuity of the Tigris Trial


TORONTO, Canada – March 8, 2021 – Spectral Medical Inc.(“Spectral” or the “Company”) (TSX: EDT), today announced the appointment of Chris Seto to Chief Executive Officer (“CEO”), effective April 1, 2021. In his new role, Mr. Seto will continue to serve as the Company’s Chief Financial Officer (“CFO”). Dr. Paul Walker, current CEO, will remain committed to the Company as a member of the Board of Directors, where he will be responsible for a seamless transition of leadership, and focus his efforts on the Tigris Trial supporting Dr. John Kellum, Spectral’s recently announced Chief Medical Officer.

Previously, Mr. Seto was responsible for overseeing the financial and operational management of the Company including, finance, accounting, treasury and capital markets, as well as corporate planning and development, and investor relations. Prior to joining Spectral Medical, Mr. Seto was the CFO of MJardin Group Inc. (CSE:MJAR) and GrowForce Holdings Inc. Mr. Seto has over 25 years of capital markets and financial management experience, including senior investment banking positions with Paradigm Capital, UBS Securities and CIBC World Markets; and financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell. Mr. Seto holds a B. Comm. from McMaster University, an MBA from the Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).

“I would like to thank Dr. Walker and the Board of Directors for their confidence in my ability to lead Spectral to achieve growth in product commercialization, revenues and earnings in due course. I look forward to working with the Spectral team to continue on the exciting path we have developed for our Company under the leadership of Dr. Walker,” said Chris Seto, COO and CFO of Spectral Medical. “Over the last year we refined our corporate structure, including the recent appointment of Dr. John Kellum as Chief Medical Officer, which will make this transition seamless while maintaining our team’s focus on achieving our key corporate priorities.”

Dr. Walker commented, “I am very pleased that Chris is transitioning to the Chief Executive Officer position. Since joining the Company, Chris has demonstrated outstanding operational and financial leadership, and has played a key role in defining our strategy for the Dialco subsidiary. With the recent addition of Dr. John Kellum to our organization, I am confident that we are well positioned to successfully complete the Tigris Trial and to advance our scientific and product development agenda for Spectral.”

Anthony Bihl, Chairman of Spectral, further noted, “Chris’ transition to CEO is a reflection of his unwavering commitment and outstanding leadership. Moreover, I would like to personally express our sincere gratitude to Dr. Paul Walker, who has successfully led the organization over the last twenty years through a transition from a diagnostic focused company to a leading theranostics company focused on bringing unique commercial products to market—positioning us for long-term success. As one of the world’s leading experts on endotoxin and its role in sepsis, as well as the co-inventor of the Endotoxin Activity Assay (EAA™), we look forward to his continued contributions as we advance the Tigris Trial.”


About Spectral
Spectral is a Phase III 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 200,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.

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 or forward looking statements 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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at [url]www.sedar.com[/URL].

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.


For further information, please contact:


Mr. Chris Seto
COO and CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com
David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com

 

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Down 7% early....I added 500 shares when it was down 5%....and of course, it's down 2% more after I add. smh, fml!!
 

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Just think end game CB...
My feeling is the board is about to shift next, more changes coming.
Canadian HD approval will help and it should be coming soon enough
 

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