Health Canada Issues an Interim Order for Spectral Medical’s PMX to Treat COVID-19 Patients

• PMX has successfully been used for treatment in COVID-19 patients in the U.S., Japan and Italy
   
• Interim Order expands already approved PMX Health Canada indications for use to include treatment of COVID-19 patients

TORONTO, April 20, 2020 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that Health Canada has issued an Interim Order expanding the already approved indications for use of Spectral’s Toraymyxin (“PMX”) hemoperfusion cartridge specifically for patients with COVID-19. 

As part of the Interim Order process, the Health Minister determined that there is an urgent public health need for the importation or sale of PMX. Spectral and its manufacturing partner, collectively applied for the authorization for the Interim Order.

The Interim Order allows for the use of PMX to treat COVID-19 patients, particularly those with acute respiratory failure, diffuse alveolar damage or difficulty with maintaining oxygenation, in the presence of hypotensive shock. Health Canada’s Interim Order related to PMX, and the new indication information will be published on the Government of Canada’s website under the ‘List of Medical Devices for Expanded Use in Relation to COVID-19 Pandemic’. As in the recently announced U.S. FDA supplemental IDE approval, Spectral will provide these therapeutic cartridges free of charge.

There is a very strong scientific case for the use of PMX in COVID-19 patients. PMX has been used to treat patients during other analogous viral pandemics including the avian flu (H5N1) and swine flu (H1N1) pandemics, which also resulted in acute respiratory distress syndrome (ARDS).  In previous publications, the use of PMX during these similar viral pandemics showed improvement in chest x-ray results and lung function, and successful wean from mechanical ventilation.

“Improvements in the clinical outcome of these patients may be the direct effect of removing endotoxin,” said Debra Foster, VP of Clinical Development at Spectral.  “Endotoxin is the primary driver of the cytokine storm and there is reliable evidence that removing endotoxin by the PMX cartridge reduces circulating levels of cytokines. Increased levels of endotoxin activity as measured by our FDA approved Endotoxin Activity Assay (EAA) has been identified in COVID-19 patients in Japan, Italy and the U.S.”