Spectral Medical Inc T.EDT

Alternate Symbol(s): EDTXF

Spectral Medical Inc. is a Canada-based late-stage theragnostic company advancing therapeutic options for sepsis and septic shock. The Company develops and commercializes a treatment for septic shock utilizing its Endotoxin Activity Assay (EAA) diagnostic and the Toraymyxin therapeutic (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s EAA. 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. It has pioneered the development of biochemical markers for the clinical syndrome known as septic shock. It is continuing its legacy business of manufacturing and selling certain proprietary reagents. It develops, produces and markets recombinant proteins, antibodies and calibrators. These materials are sold for use in research and development, as well as in products manufactured by other diagnostic companies.

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Spectral Medical Inc

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Post by smartsobon Jul 11, 2022 3:53pm

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Post# 34816072

not a slam dunk

6 benefits of FDA Breakthrough Devices program - StarFish Medical

Kiefa

June 1, 2020 at 12:22 am

Comapnies that are granted a Breakthrough through this program, do they stand a better change at being approved by the fda or do they product go on to get fda approval and is there a percentage rate of approvals
Virginia Anastassova

June 5, 2020 at 9:28 pm

The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. The Breakthrough Devices Program does not offer a better chance for approval as approval is based on evidence of device safety and effectiveness and the same criteria applies as for the regular approval pathways. Approval rates for 2019 are 40% based on 5 designations and 2 approvals out of 5.

Virginia