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Spectral Announces Distribution Agreement for its Proprietary CRRT Machine
TORONTO, Jan. 22, 2019 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock guided by a companion diagnostic, today announces the completion of a distribution agreement for its proprietary continuous renal replacement therapy (CRRT) machine with a private U.S. company. The agreement is for Spectral to provide CRRT machines for their use in a specific therapeutic niche where an open platform CRRT machine is preferred. In addition, the CRRT machine is being launched in Canada and the United States for use as a renal replacement therapy machine giving priority to customers that have followed its development and have expressed an interest in the technology.
“The Spectral CRRT machine can deliver support for patients with acute renal injury requiring extracorporeal treatments in the ICU. Its unique open platform design provides doctors with flexibility when tailoring renal support for the patient’s specific needs,” said Dr. Gualtiero Guadagni, Vice President of Sales & Marketing at Spectral.
About Spectral’s CRRT Machine
The Spectral CRRT machine (previously known as the “SAM” PUMP) is an innovative instrument based on a patented cassette technology that can be used for CRRT and therapeutic plasma exchange (TPE) modalities. This CRRT Machine is user friendly, built on a small footprint, and allows for use of any dialyzer and/or dialysis membrane available on the market. The Company has exclusive license rights for the CRRT machine in North America for all hospital applications and has worldwide exclusivity for hemoperfusion application.
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 150,000 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 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 and the TIGRIS Trial, 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 28, 2018, and in other filings of Spectral with securities and regulatory authorities which are available at www.sedar.com. 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.
For further information please contact:
President and CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
Capital Markets & Investor Relations