US FDA Grants Spectral Medical Breakthrough Device Designation for Toraymyxin(TM) ("PMX") for the Treatment of Endotoxemic Septic Shock

Breakthrough designation expected to help accelerate regulatory review

TORONTO, July 11, 2022 (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 the US Food & Drug Administration (“FDA”) has granted Breakthrough Device designation for the Company’s Toraymyxin™ (“PMX”) device, a therapeutic hemoperfusion device that removes endotoxin, which can cause septic shock.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

Dr. John Kellum, Chief Medical Officer of Spectral, commented, “For over 50 years the medical scientific community has sought a treatment for sepsis, yet today, no specific therapies are available. A new therapy showing survival benefit for the most severely affected patients would indeed be a breakthrough technology and we are pleased to see that the FDA agrees.”

“We are entering an era of personalized medicine for critical illnesses,” continued Dr. Kellum. “By breaking up sepsis into subsets that have specific molecular pathogenesis, we believe our strategy targeting endotoxemic septic shock, characterized by high levels of endotoxin in the bloodstream, is far more likely to succeed, where other non-specific therapies have failed time and again. Our goal is to show a large difference in mortality when an anti-endotoxin therapy is applied to carefully selected patients with high endotoxin activity in their bloodstream. Moreover, we have a diagnostic test already in clinical use to identify these patients. We believe this combination of an advanced diagnostic with a specific therapy represents the future of sepsis care.”

Chris Seto, CEO of Spectral, stated, “We are honored and grateful to the FDA for granting Breakthrough Device status for PMX. While our clinical trial is still underway, clinical data both within and outside the trial are highly encouraging and we believe PMX has the potential to provide hope for patients suffering from this devastating illness, as endotoxin often leads to multiple organ failure and death. In fact, approximately 120,000 patients each year suffer from endotoxemic septic shock, with an estimated 50% mortality rate. In turn, we estimate this translates to a $1.6 billion annual market for PMX in the U.S. alone. Our current TIGRIS Phase 3 confirmatory trial is continuing to progress, with over a quarter patients out of a planned 150 patients randomized to date. We also believe this trial is significantly de-risked given the prior clinical data from our EUPHRATES trial. Importantly, we believe this Breakthrough Device designation will help accelerate review by the regulators upon completion of the TIGRIS trial. Moreover, we continue to work closely with Baxter, our exclusive commercial partner in the U.S. and Canada, in order to prepare for commercialization, assuming the trial is successful, and we receive regulatory approval.”

About FDA Breakthrough Devices Program and Breakthrough Designation

The Breakthrough Devices Program was established to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

About Spectral

Spectral 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. 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., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

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

Forward-looking statement

Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-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 managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&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.

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