Spectral Medical Announces that its wholly owned subsidiary Dialco Medical has received MDSAP certification
- MDSAP is the highest quality and regulatory standard in the medical device industry
TORONTO, Canada – November 24, 2020 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market, today announced that its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) received its Medical Device Single Audit Program (“MDSAP”) certification for “the design, manufacture, installation and service of equipment for extracorporeal blood purification and its related disposable” under ISO 13485 for Canada (Medical Devices Regulations – Part 1- SOR 98/282) and United States (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D), 21 CFR 821).
MDSAP allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory jurisdictions or authorities to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on the industry. The program was developed by the International Medical Device Regulators Forum and currently representatives from The Therapeutic Goods Administration in Australia; Brazil’s Agência Nacional de Vigilância Sanitária; Health Canada Canadian Medical Device Regulations; Japan’s Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency, and the U.S. Food and Drug Administration, Center for Devices and Radiological Health participate in the program.
“On Dialco’s continued commercialization path, MDSAP and ISO 13485 certifications represent important milestones. Not only does certification through these programs validate our ongoing commitment to maintaining the highest quality assurance standards within the medical device industry, but MDSAP certification is also a Health Canada mandated requirement to sell medical devices in Canada,” said Dr. Gualtiero Guadagni, President of Dialco. “Additionally, Dialco’s receipt of its own MDSAP certification supports Dialco’s continuous pathway of achieving a fully independent operating structure."
About Spectral and Dialco
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 is 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 in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.
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 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 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.
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