TORONTO, Canada – June 27, 2023- 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 it has appointed Dr. David W. Feigal, Jr., M.D., M.P.H., to its Board of Directors.
Dr. Feigal brings over four decades of experience in regulatory affairs and clinical research of medical devices, biologics, and products in multiple therapeutic areas. Currently, Dr. Feigal is a Partner at NDA Partners LLC, a ProPharma Company, which is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. He has also worked for major U.S. and international life science corporations such as Amgen, Inc. serving as Vice President of Global Requlatory Affairs, and Elan Pharmaceuticals, Inc., serving as Senior Vice President of Global Regulatory Affairs and Global Safety Surveillance and Biostatistics. He has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas.
Dr. Feigal also has extensive experience as a regulator and spent 12 years at the Food and Drug Administration (FDA), holding senior roles within the Center for Drug Evaluation and Research (CDER), including Director, Division of Anti-Viral Drug Products; Acting Director, Division of Anti-Infective Drug Products; Director, Office of Drug Evaluation-IV; as well as Medical Deputy Center Director and ultimately Center Director within the Center for Devices and Radiological Health (CDRH).
Prior to joining the FDA, he worked for a decade within the academic and hospital settings of the University of California, San Diego, San Francisco, and Davis. Dr. Feigal has contributed to global government programs conducted by the World Health Organization, the European Medicines Evaluation Agency (EMEA), the National Institutes of Health, and others. He has served on numerous committees within the U.S. Department of Health and Human Services, has served on boards of both companies and funds, is a renowned speaker, and has published over 50 papers. He holds a BA from the University of Minnesota, an MD from Stanford University and a Master of Public Health from the University of California, Berkeley.
“We are extremely proud to have Dr. Feigal join our Board of Directors,” commented, Anthony Bihl, Chairman of the Board at Spectral Medical. “Dr. Feigal brings decades of experience in the medical field and extensive knowledge regarding clinical development and regulatory processes. Given the status of our Phase 3 trial of PMX and our continued progression toward completion and potential FDA submission, we believe Dr. Feigal will provide valuable insights and assist with meeting the complex requirements of the FDA. With the combined knowledge and expertise of Dr. Feigal, along with the current leadership team, we are well positioned to advance Spectral to meaningful milestones and potential FDA approval of PMX, bringing a personalized therapy to those suffering from endotoxemic septic shock.”
Chris Seto, Chief Executive Officer of Spectral Medical, added, “We are approaching an inflection point for Spectral with respect to clinical development. We have undertaken efforts to enhance enrollment of Tigris, and continue to witness data that exceeds our expectations. As we expect to hit significant milestones relating to PMX, we are excited to have Dr. Feigal on our Board to provide his expertise and valuable knowledge to assist our efforts of obtaining FDA approval. We look forward to his contributions to Spectral and aiding in the advancement of PMX to market.”
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. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com.
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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David Waldman/ Natalya Rudman
Spectral Medical Inc.