Spectral Medical Announces U.S. FDA Approval of DIMI Trial Protocol Amendment

Amendment expected to overcome key pandemic challenges and improve both site and patient enrollment

TORONTO, Jan. 31, 2022 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical Inc. (“Dialco”) has received approval of a protocol amendment to its DIMI usability trial from the United States Federal Food and Drug Agency (“FDA”). This protocol amendment allows for both improved patient and clinical logistics flow in conducting the DIMI trial.

The DIMI usability trial is designed to evaluate the safety and efficacy of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients. The Company is progressing with contracting clinical trial sites and the trial will include 35 patients in the United States.

Dr. John Kellum, Chief Medical Officer of Spectral, commented, “This protocol amendment addresses both patient and clinical logistics flow issues currently experienced throughout the dialysis clinic industry. We worked closely with our clinical trial partners and vetted the modifications to our DIMI protocol with potential clinical trial sites. We now believe we have an exceptional approved protocol for the DIMI trial and look forward to onboarding the clinical sites.”

Chris Seto, CEO of Spectral, commented, “We remain focused on the start of our DIMI usability trial for home use of this well designed device. We appreciate the support of our potential clinical site trial partners who have been working hard to address labor shortages and attrition within dialysis clinics. They provided us valuable feedback on our amendments to the trial. Based on the approved protocol amendment, we are now progressing to the site contracting phase, which we expect will provide greater visibility on the revised DIMI trial timeline.”

Mr. Seto continued, “We believe this trial will showcase DIMI as a disruptive technology that is at the forefront of addressing the most significant barriers to adoption for home hemodialysis. Specifically, the use of pre-filled dialysate bags aims to simplify home dialysis for patients and overcome the challenge of water quality, which is a common issue throughout many regions across the U.S. We also believe this trial represents an incredible commercial opportunity to demonstrate positive real world experience of the versatility of DIMI amongst our clinical trial partners, who are also our potential customers. Dialco is committed to bringing this innovative device to empower more patients and their care partners to transfer from in-center dialysis to their homes.”

About Spectral

Spectral is a Phase 3 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 300,000 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 set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

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 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 as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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