Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical has been Granted FDA IDE Authorization to Conduct a Trial of DIMI for Home Hemodialysis Use
TORONTO, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical Inc. (“Dialco”), has been granted Investigational Device Exemption (IDE) authorization by the United States Food and Drug Administration (FDA) to conduct a usability trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment.
DIMI is an innovative renal replacement system based on a fully integrated cassette technology, which simplifies set-up, operation, and management of a dialysis session when compared to other instruments currently available on the market. DIMI was recently cleared by the FDA to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis, hemodiafiltration, hemofiltration and/or ultrafiltration in hospital or clinical settings.
The approved IDE usability trial is expected to enroll 35 patients and is designed to evaluate the safety and efficacy of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events happening during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients.
Dialco is in the process of selecting its contract research organization (“CRO”) partner to run the trial, as well as identifying and evaluating clinical sites that will participate in the trial.
“We look forward to working with our early adopters and other clinical teams to evaluate DIMI and run the usability trial to pursue the home market designation,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “The trial design is similar to the ones run recently by Outset Medical and previously by NxStage. The key measure of success will be demonstrating that DIMI can deliver the prescribed dialysis needs per session, both in hospital and in the home environment, while maintaining safeguards for the mitigation of safety risk.”
“We are very excited to announce that the FDA has granted IDE authorization to commence this landmark trial of DIMI for at home use,” said Chris Seto, COO and CFO of Spectral. “This latest authorization follows our recent FDA 510(k) Clearance of DIMI for use within hospitals, clinics and skilled nursing facilities. Assuming this trial is successful, we believe Dialco’s addressable home hemodialysis market alone will approach $3 billion by 2025, due to increasing pressure to transition hemodialysis to an at-home setting in the U.S. We are more excited than ever by the outlook for the business and look forward to announcing a number of important upcoming milestones.”
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., 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.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
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