- Adds significant experience and strength to the Company’s commercialization focus
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Toronto, Ontario | August 4, 2020 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, announced today that it has appointed John E. Nosenzo as an independent director, effective immediately.
Mr. Nosenzo is currently the Chief Commercial Officer of Bioventus, a global leader in Orthobiologic solutions, and he brings to Spectral more than 25 years of extensive experience within multi-billion-dollar organizations in Healthcare Sales, Marketing, Service, Operations and General Management including Laboratory Diagnostic, Imaging Modalities, Brand and Generic Pharmaceuticals. He earned an MBA in marketing and management from Adelphi University and a Bachelor of Science in pharmacy from St. John’s University.
“We are very pleased that John has joined our board at this pivotal time in our Company’s development. His experience in the medical device sector in the U.S. will help guide Spectral’s commercial activities for our diagnostic and therapeutic approach to septic shock as well as Dialco’s commercialization in the area of renal replacement therapy,” said Dr Paul Walker, President and CEO of Spectral. The appointment of Mr. Nosenzo fills the vacancy arising from the retirement of Mr. Guillermo Herrera, who joined the Company as a director in 2006.
“On behalf of the board and management team, I would like to thank Guillermo for his commitment and contributions to Spectral during his tenure as director and wish him well in his future endeavors,” commented Mr. Tony Bihl, Chairman of Spectral’s Board of Directors.
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.
Information in this news release that is not current or historical factual information may constitute forward-looking information or forward-looking statements 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 and general economic, market and business conditions, including but not limited to the ongoing impact of COVID-19. Actual results could differ materially from what is currently expected, and readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation to update or revise any forward-looking statements. Reference is also made to the other risks and uncertainties that may affect the Company which are more fully described in Spectral’s Annual Information Form dated March 26, 2020 and other filings of Spectral with the securities regulatory authorities which are available at www.sedar.com.
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 & CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
COO & CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
Capital Markets & Investor Relations