Spectral Medical Provides Corporate Update
Toronto, Ontario | August 8, 2019
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, is providing a corporate update on its activities both for the start-up of the Tigris trial and developments in Dialco, a wholly-owned subsidiary of Spectral.
The enthusiasm for the Tigris trial among our hospital sites remains very high, as all these sites were part of the EUPHRATES trial and had a good experience with the targeted therapy of PMX hemoperfusion. Spectral is actively working with the ten sites that will be starting the Tigris trial, and the Company anticipates some sites opening for enrolment beginning in Q3 2019.
Initiating a regulatory trial in multiple sites in the U.S. requires a number of steps, however our experienced clinical team is moving forward according to schedule. In terms of the trial process, once a site has agreed to participate in a trial based on their review of the FDA approved protocol there are three major hurdles involved in getting the trial initiated: i) obtaining Institutional Review Board (IRB) approval; ii) concluding the Contract Trial Agreement (CTA); and iii) finally agreeing on the per patient costs and start up budget. Once all of these are agreed to, onsite training and site initiation follows. The unique study design, developed with guidance from the FDA, encourages investigators to participate, not only due to the “open label” approach which allows “hands on” experience for the investigators but also in the logical use of Bayesian statistical analyses, making use of the important data from the EUPHRATES trial.
Dialco continues to roll out the SAMI promotion both in the U.S. and Canada. In the U.S., directly and through our partner SeaStar, three centers have been trained and are currently using SAMI, while in Canada, Dialco recently entered in a technology evaluation agreement with a major hospital in the Toronto area. The regulatory submission to the FDA for DIMI, a home dialysis instrument continues on track for Q4 2019 submission to the FDA.
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.
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.
For further information, please contact:
Dr. Paul Walker
President & CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
Spectral Medical Inc.
416-626-3233 ext. 2004
Capital Markets & Investor Relations