TORONTO, July 11 2022 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:EDT), a late-stage theranostics company providing treatment options for sepsis and septic shock, today announced that the U.S. Food & Drug Administration (“FDA”) has granted Breakthrough Device Designation to the Toraymyxin™ device the Company’s (“PMX”), a therapeutic hemoperfusion device that removes endotoxin, which can cause septic shock.
The goal of the Breakthrough Devices program is to provide patients and healthcare providers with rapid access to medical devices by accelerating their development, evaluation and review, while preserving legal standards for pre-market approval, 510(k) authorization and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.
Dr John Kellum, Spectral’s Chief Medical Officer, said: “For more than 50 years the medical scientific community has sought a treatment for sepsis, but today no specific therapy is available. A new therapy showing survival benefit for the most severely affected patients would indeed be breakthrough technology and we’re glad to see the FDA agreeing.
“We are entering an era of personalized medicine for serious illnesses,” Dr. Kellum continued. “By dividing sepsis into subsets that have specific molecular pathogenesis, we believe that our strategy targeting endotoxemic septic shock, characterized by elevated levels of endotoxin in the blood, is much more likely to succeed, where d Other non-specific therapies have failed time and time again. Our aim is to show a large difference in mortality when anti-endotoxin therapy is applied to carefully selected patients with high endotoxin activity in their bloodstream. “Plus, we have a diagnostic test already in clinical use to identify these patients. We believe this combination of advanced diagnosis with specific therapy represents the future of sepsis care.”
Chris Seto, CEO of Spectral, said, “We are honored and grateful to the FDA for granting PMX breakthrough device status. Although our clinical trial is still ongoing, the clinical data both inside and outside the trial are very encouraging and we believe that PMX has the potential to bring hope to patients suffering from of this devastating disease, as the endotoxin often leads to multiple organ failure and death. In fact, approximately 120,000 patients suffer from endotoxemic septic shock each year, with an estimated mortality rate of 50%. In turn, we estimate this translates to a $1.6 billion annual market for PMX in the United States alone. Our ongoing TIGRIS Phase 3 confirmatory trial continues to progress, with more than a quarter of the planned 150 patients randomized to date. We also believe that this trial is significantly reduced given previous clinical data from our EUPHRATES trial. Importantly, we believe this breakthrough device designation will help expedite review by regulators upon completion of the TIGRIS trial. In addition, we continue to work closely with Baxter, our exclusive commercial partner in the United States and Canada, to prepare for commercialization, assuming the trial is successful, and we receive regulatory approval.
About the FDA Breakthrough Devices Program and Breakthrough Designation
The Breakthrough Devices program was created to accelerate the development and prioritize the review of certain medical devices that enable more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program aims to help patients gain faster access to these medical devices by accelerating their development, evaluation and review, while preserving the legal standards of premarket approval, 510(k) clearance and De Novo marketing authorization, in accordance with FDA guidelines. protection and promotion of public health.
Spectral is a Phase 3 company seeking US FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). The 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 Test (EAA™), the only diagnostic authorized by the FDA for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively in over 340,000 patients to date. In March 2009, Spectral obtained exclusive development and commercialization rights in the United States 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 each year in North America.
Spectral, through its wholly-owned subsidiary, Dialco Medical Inc., also markets a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI targets the acute RRT market, while DIMI targets the chronic RRT market. Dialco is currently seeking regulatory approval for home use in the United States of DIMI, which is based on the same RRT platform as SAMI, but will be intended for use in home hemodialysis. DIMI recently received its FDA 510k clearance for hospital and clinical use, and obtained its license from Health Canada for use in Canadian hospitals, clinics and at home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, visit www.spectraldx.com.
InformationinthisnewReleasethisisnotrunningWherehistoricalfactualinformationmayconstituteforward-looking information within the meaning of securities laws. Such information, including with respect to Spectral’s future prospects and anticipated events or results, implicitly contains assumptions based on the beliefs of Spectral’s senior management.asgoodasinformationcurrentlyavailableatthis.Whereasthesehypotheseswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results arematterataNumberofrisksanduncertainties,includingtheavailablityoffundsandResourcesatto chaseR&D projects, the successful and timely completion of clinical studies, Spectral’s ability to take advantage of commercial opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as the terms and conditions of the economy, market and business, and could differ materially from what is currently expected.
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