US FDA Approves an Investigational Device Exemption for Spectral Medical PMX to Treat COVID-19 Patients Suffering from Septic Shock

   TORONTO, April 14, 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, is pleased to announce that the United States Federal Food and Drug Agency (“FDA”) has approved a supplemental Investigational Device Exemption (“IDE”) for the use of Spectral’s PMX cartridge (“PMX”) in the treatment of patients with COVID-19.

This IDE approval provides the opportunity for the use of PMX in COVID-19 patients suffering from septic shock, and is a supplement to the Company’s current Tigris trial, which is an FDA approved Phase III clinical trial in the U.S. for the use of PMX for septic shock.

As opposed to Emergency Use Authorization (“EUA”), Spectral’s IDE supplement approved by the FDA recognizes that there is sufficient safety and effectiveness data to allow clinicians to use PMX to treat patients that are similar to patients in the Tigris trial, plus are COVID-19 positive. Spectral will provide these therapeutic cartridges free of charge.

“This immediately green lights our Tigris study centers which are already prepared and trained on PMX use, and our resources can be used to quickly bring on more hospitals,” said Debra Foster VP of Clinical Development at Spectral. “We have been fielding unsolicited inbound inquiries from hospitals in North America concerning our therapy for the COVID-19 pandemic as it relates to septic shock, asking how we can help.”

There is a very strong scientific case for the use of PMX in COVID-19 patients. 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 Spectral’s FDA approved Endotoxin Activity Assay (EAA) has been identified in COVID-19 patients in Japan, Italy and the U.S. Several COVID-19 patients have been treated with PMX in the U.S. under compassionate use but the IDE approval will allow greater and faster access to PMX and will result in further data collection on safety and efficacy.

PMX has been used to treat patients outside the U.S. during other viral pandemics including the avian flu (H5N1) and the swine flu pandemic (H1N1) which also resulted in acute respiratory distress.  In previous publications, the use of PMX in septic shock patients has resulted in decreased dependency on ventilators, which is a serious issue during this COVID-19 pandemic. The publications data showed improvement on chest x-ray results, improved lung function and successful wean from the ventilator.

“This IDE approval will allow us to significantly help COVID-19 patients who experience septic shock resulting in multiple organ failure, and could ultimately help save lives,” said Dr. Paul Walker, President and CEO of Spectral Medical. “We have been conducting septic shock trials with the combination of our FDA approved diagnostic EAA, and a specific endotoxin removal therapeutic cartridge (PMX) in the U.S. for many years, and continue to work with many institutions focused on reducing the mortality of septic shock. We are encouraged by the results of PMX in treating COVID-19 patients in Japan, Italy, and the U.S., and are collecting data regarding the increase in endotoxin activity in patients with COVID-19 in collaboration with our EAA distribution partners mainly in Italy and Japan. Spectral now hopes to contribute more to the treatment of septic shock patients during this pandemic.”

Spectral has also been actively working with Health Canada to expedite required approvals for use in COVID-19 patients, and anticipates being in a position to provide an update in the very near future.

About Spectral

Spectral is a Phase III 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 has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market.  Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com.

Forward-looking statement

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

For further information, please contact:

Dr. Paul Walker President and CEO Spectral Medical Inc. 416-626-3233 ext. 2100 pwalker@spectraldx.com

Mr. Chris Seto CFO Spectral Medical Inc. 416-626-3233 ext. 2004 cseto@spectraldx.com

Ali Mahdavi Capital Markets & Investor Relations 416-962-3300 am@spinnakercmi.com