TORONTO, Canada –
March 16, 2022 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT),
today announced that its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) has formed a Medical Advisory Board to support in guiding the DIMI usability trial and continued development of the DIMI device.
Medical Advisory Board members: • Christopher T. Chan, MD, serves as Chief of Nephrology at Toronto General Hospital, as well as Professor of Medicine at the University of Toronto and R. Fraser Elliott Chair in Home Dialysis at the University Health Network. Dr. Chan is also Associate Editor for the Clinical Journal of the American Society of Nephrology.
• Jenny I. Shen, MD, MS, is an Assistant Professor of Medicine and Physician Specialist within the Division of Nephrology and Hypertension at Harbor-UCLA Medical Center. Dr. Shen is an expert in home dialysis and health disparities.
• Lisa Koester-Wiedemann, MSN, CS, CNN-NP, is a Renal Nurse Practitioner in the Division of Nephrology at Washington University and an expert in home hemodialysis and patient experience.
• Fredric Finkelstein, MD, is Clinical Professor of Medicine at the Yale University Medical School, as well as a Nephrology Specialist and key proponent of patient-centered care. He also served as a principal investigator for the FREEDOM hemodialysis study.
John Kellum, MD, CMO of Spectral observed “We are extremely pleased to announce our partnership with such a distinguished group of clinicians and scientists. They not only represent the top opinion leaders in the home hemodialysis space but collectively they have expertise in clinical research, patient care, and patient-centered outcomes related to dialysis in the home. We could not have a better team advising us.”
Chris Seto, CEO of Spectral, commented, "The establishment of our Medical Advisory Board is an important resource as we prepare to commence our upcoming DIMI usability trial in 2022. This trial is expected to be the final regulatory step required before seeking FDA clearance for in-home hemodialysis use. We are thrilled to have attracted some of the world’s leading experts in home hemodialysis. We believe their clinical expertise in home hemodialysis will add invaluable feedback to help accelerate the clinical activities and commercial roll-out of our DIMI device.”
DIMI is an easy-to-use home hemodialysis machine, built on the same platform as the Company’s SAMI device. The Company received FDA 510(k) clearance for DIMI to treat patients in the hospital or clinical settings and is seeking to obtain regulatory approval for DIMI in the United States for in-home use. The Company is planning a usability trial for the DIMI device, which is designed to evaluate the safety and efficacy of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients.
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 300,000 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 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.
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