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

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Spectral Medical Inc > What exactly is a breakthrough designation?

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Post by Gorf79 on Jul 18, 2022 4:34pm

What exactly is a breakthrough designation?

Well most importantly there are 4 criteria, and at least 1 must be met;

Breakthrough Technology
No approved alternative exists
Offers significant advantages over current treatment
Devoce availability is in the best interests of patients

Well folks, they hit grand slams on all 4, even though only 1 has to be met.

Everybody getting the program now?!!!!

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Comment by JohnnyCashMoney on Jul 18, 2022 5:03pm

I'll give you one point. Never heard the word Devoce in my life. You are SMATR I'll look it up when I get on my jet and connect to wifi, via Elon Must

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