Spectral Announces Successful Manufacturing Audit of Toray by the US FDA

Spectral Medical (TSX:EDT) has announced that Toray Industries has successfully passed a GMP Audit with the US FDA.

As quoted in the press release:

The audit was performed as part of the pre-approval process for Spectral’s ongoing PMA application for the PMX cartridge. A successful GMP audit for Toray means that the methods, the facilities and the controls used for the manufacture, processing, packing, and testing of the device were found adequate to ensure and preserve its identity, strength, quality, and purity.

https://www.accessdata.fda.gov/scripts/inspsearch/results.cfm

Dr. Paul Walker, President and CEO of Spectral states that, “while we have been confident in Toray’s manufacturing expertise, this endorsement from FDA, ensures Toray’s readiness for commercial manufacturing for the United States market. This GMP audit along with positive FDA audits of the CRO and study sites, that have recently been completed, confirms the quality and integrity of the EUPHRATES clinical trial data submitted to the FDA.”

Tory built a new manufacturing plant in Okasaki Japan, which has been producing the PMX cartridge since 2014 and was the subject of this recent audit. This plant is capable of meeting the demands of the North American market for PMX required with the potential of FDA approval.

The PMX cartridge is the world’s first device for sepsis that works by selective adsorption of endotoxin from the bloodstream. While the product has received CE Mark approval in Europe and Canada as well as many other countries, the PMA process in the US consists of a compilation of sections or “modules,” such as preclinical, clinical, and manufacturing, that together are a complete application.

Click here to read the full press release.