Spectral Medical (TSX: EDT) 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.
View Top Employees from Spectral Medical Inc.Website | http://www.spectraldx.com |
Ticker | EDT |
Revenue | $2 million |
Funding | $24.3 million |
Employees | 37 (34 on RocketReach) |
Founded | 1991 |
Address | 135 The West Mall, Unit 2, Toronto, Ontario M9C 1C2, CA |
Phone | (416) 626-3233 |
Fax | (416) 626-7383 |
Technologies |
JavaScript,
HTML,
PHP
+12 more
(view full list)
|
Industry | Biotechnology Research, Medical Devices & Equipment, Biotechnology, Diagnostic Equipment, Manufacturing, Science and Engineering, Monitoring Equipment, Health Diagnostics, Health Care, Therapeutics |
Web Rank | 17 Million |
Keywords | Spectral Diagnostics, Spectral Medical, Spectral Medical Inc. - Etobicoke, On |
Competitors | Advanced Animal Diagnostics, Konan Medical USA, Inc., Kypha, LBT Innovations Ltd, Provista Diagnostics |
SIC | SIC Code 38 Companies, SIC Code 37 Companies |
NAICS | NAICS Code 54171 Companies, NAICS Code 541712 Companies, NAICS Code 5417 Companies, NAICS Code 541711 Companies, NAICS Code 541 Companies, NAICS Code 54 Companies |
Looking for a particular Spectral Medical Inc. employee's phone or email?
The Spectral Medical Inc. annual revenue was $2 million in 2024.
Chris Seto is the CEO of Spectral Medical Inc..
34 people are employed at Spectral Medical Inc..
Spectral Medical Inc. is based in Toronto, Ontario.
The NAICS codes for Spectral Medical Inc. are [54171, 541712, 5417, 541711, 541, 54].
The SIC codes for Spectral Medical Inc. are [38, 37].