Join today and have your say! It’s FREE!

Become a member today, It's free!

We will not release or resell your information to third parties without your permission.
Please Try Again
{{ error }}
By providing my email, I consent to receiving investment related electronic messages from Stockhouse.

or

Sign In

Please Try Again
{{ error }}
Password Hint : {{passwordHint}}
Forgot Password?

or

Please Try Again {{ error }}

Send my password

SUCCESS
An email was sent with password retrieval instructions. Please go to the link in the email message to retrieve your password.

Become a member today, It's free!

We will not release or resell your information to third parties without your permission.
Quote  |  Bullboard  |  News  |  Opinion  |  Profile  |  Peers  |  Filings  |  Financials  |  Options  |  Price History  |  Ratios  |  Ownership  |  Insiders  |  Valuation

Bullboard - Stock Discussion Forum Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis... see more

TSX:EDT - Post Discussion

Spectral Medical Inc > WOW! - The TIGRIS "EXCEEDING EXPECTATION" commentary....
View:
Post by SouthernTierTom on Apr 27, 2022 10:07am

WOW! - The TIGRIS "EXCEEDING EXPECTATION" commentary....

from multiple high level EDT insider / executive types must be as "good as advertised" ..Hmmm??

I guess if the phase 2 Euphas could be stopped at patient 64 ( 34 = PMX. 30= SOC ) we could perhaps expect similar given the 179 patient ( taken from the phase 3 trial ) head start and the "Bayseian trial design"

I must say I am impressed buy the bullish suggestion.  Bear in mind when ~ 350,000 patients have safely used the filter it should not come as a big surprise.  The area is a complete UNmet need and the wholly-owned and FDA approved EAA diagnostic's ability to screen, guide and confirm efficacy is icing on the $eptic Cake.

None-the-less and Ear-regardless....this summary being presented to New Yorkers next week is indeed a welcome suprise to the 28 year time-line for Toray and the PMX filter...ENJOY!!

Spectral Medical Inc.

  Company Info

 Company Website: https://spectraldx.com/
 Why investors should take notice:
1) Spectral Medical is a clinical stage medical device company developing products for the treatment of significant critical care needs – specifically in the areas of septic shock and renal disease
2) Addressing Unmet Need in Treatment of Endotoxemic Septic Shock
3) Anticipated FDA Approval and PMX Launch in Q4 2022 - $1.5 Billion USD market opportunity
4) There aren't any competing therapeutic devices expected for the next 7 years
5) 8.9 million of cash on hand as of Dec 31, 2021- No debt

  Company Description

 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 has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 300,000 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 set of proprietary platforms addressing renal replacement therapy (“RRT”) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Comment by SouthernTierTom on Apr 28, 2022 9:17am
WOW! ....where is all this confidence suddenly coming from.  Strong statement.  Perhaps it is the fact that the current FDA phase 3B TIGRIS trial being run solely here within our borders is an OPEN LABEL trial that allows for ALL participating to have FULL access to the "data" .... Indeed exciting times, my personal crystal ball doesn't produce meaningful interest until the ...more  
The Market Update
{{currentVideo.title}} {{currentVideo.relativeTime}}
< Previous bulletin
Next bulletin >

At the Bell logo
A daily snapshot of everything
from market open to close.

{{currentVideo.companyName}}
{{currentVideo.intervieweeName}}{{currentVideo.intervieweeTitle}}
< Previous
Next >
Dealroom for high-potential pre-IPO opportunities