TORONTO, Sept. 18, 2019 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced that members of the Board of Directors and Management will ring the opening bell of the Toronto Stock Exchange on September 18, 2019. The event is in honor of the Company being successfully listed on the exchange for 25 years.
“We are very pleased to mark this important milestone. Spectral has continued to focus on large unmet needs in order to bring therapeutic medical devices improving care to large numbers of patients where no other therapy exists,” said Dr. Paul Walker, President and CEO of Spectral Medical. “Our lead product, the Endotoxin Activity Assay (the EAA), is the only diagnostic tool to timely identify endotoxemia in whole blood. Once identified, we can then offer the PMX cartridge for endotoxin removal. In the U.S., Spectral will soon start patient enrollment into the Tigris trial. Tigris is the follow-on FDA Phase III trial to the previous EUPHRATES trial, where the Company identified a subgroup that had a clinically meaningful mortality benefit. As a result, Spectral has designed the Tigris trial as a focused, open label trial with guidance from the FDA. In addition, to our focus on endotoxin, Spectral has chosen the acute and chronic kidney failure population as a focus for our product development team. Recently, the FDA cleared the SAMI instrument for acute dialysis, and we plan to submit a claim expansion for its use as a hemoperfusion delivery system once the sepsis therapy is approved. In order to maximize this opportunity, we recently created Dialco Medical to focus on unmet needs for acute and chronic dialysis, and a second product offering, DIMI, is poised for submission to the FDA.”
“At Dialco, leveraging the 25 years of experience that Spectral has gained in successful product development and regulatory affairs, we are committed to bringing new products to the dialysis market in the hospital and home setting. Our simplified dialysis technology will help a broad number of dialysis patients to embrace the option of home hemodialysis and therefore improve their quality of life,” said Gualtiero Guadagni, President of Dialco.
About Spectral Medical Inc.
Spectral is a Phase III company seeking U.S. Food and Drug Administration (“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 170,000 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 350,000 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.
Forward-looking statements
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, general economic, market and business conditions, as well as other risks and uncertainties which are more fully described in Spectral’s Annual Information Form dated March 27, 2019, and in other filings of Spectral with securities and regulatory authorities which are available at www.sedar.com. There is no guarantee that Spectral will obtain the FDA approval of PMX in the United States. Spectral does not undertake any obligation to update forward-looking statements should these assumptions change. Nothing in this document should be construed as either an offer to sell or a solicitation to buy or sell Spectral securities.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
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