Spectral Medical Announces Internal Reorganization of its Wholly Owned Subsidiary Dialco Medical to Enhance Operations and Accelerate Commercialization
TORONTO, Aug. 09, 2021 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced an internal reorganization to strengthen the core competencies and management of its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”). In connection with the reorganization, there will be four department directors, responsible for the following areas: sales & marketing; quality assurance and regulatory affairs (QA/RA), clinical; and technical. The QA/RA and clinical departments will share responsibilities across Spectral’s operations, including PMX, while the technical and sales & marketing departments will be exclusively focused on advancing Dialco’s operations. Each of the department directors will report directly to Chis Seto, the Company’s CEO, on an interim basis. In connection with the reorganization, the Company announces that Gualtiero Guadagni has resigned as President of Dialco to pursue other opportunities.
Chris Seto, CEO of Spectral, stated, “We are making tremendous progress advancing our Dialco subsidiary, and believe this internal reorganization will help strengthen the organization in advance of key upcoming milestones. Specifically, we are progressing our DIMI usability trial, which is the final regulatory step required before seeking FDA clearance for in-home hemodialysis use. We are on track to commence site initiation and patient enrollment for the DIMI usability trial during the third quarter of 2021 with the completion of the study expected in the first half of 2022 and FDA submission anticipated in the third quarter of 2022. Regarding DIMI product development, we look forward to submitting the 510(k) application for our DIMI peritoneal dialysis software in the fourth quarter of 2021 and we are rapidly advancing development of prepackaged sterile dialysate, which we expect to complete by the end of third quarter of 2022. Finally, in terms of our SAMI device, which already has both FDA and Health Canada regulatory approvals, we are building our commercial infrastructure and salesforce with plans to hire field reps at a rate of 3 per quarter. In addition, a number of premier healthcare institutions in both Canada and the U.S. have agreed to conduct clinical evaluations of SAMI later this year. At the same time, we are in active discussions with potential distribution partners, and look forward to providing additional updates in the near future.”
“I would also like to thank Dr. Gualtiero Guadagni for his contributions to the organization, which helped us establish a solid foundation for future growth. We look forward to building upon our significant accomplishments to-date, and believe these latest initiatives will help accelerate the clinical activities and commercial roll-out of our SAMI and DIMI devices. Importantly, these devices have the potential to directly address the operational complexity of current RRT devices, which we believe positions us to capture a significant share of the $10 billion dialysis market.”
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.
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.
For further information, please contact:
|Mr. Chris Seto||Mr. Ali Mahdavi||David Waldman/Natalya Rudman|
|CEO||Capital Markets & Investor Relations||US Investor Relations|
|Spectral Medical Inc.||Spinnaker Capital Markets Inc.||Crescendo Communications, LLC|
|416-626-3233 ext. 2004||416-962-3300||212-671-1020|