Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI
TORONTO, March 31, 2021 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical Inc. (“Dialco”) has obtained its Health Canada license for the DIMI RRT system.
As per the Health Canada license, DIMI is a prescription only medical device, indicated for hemodialysis (“HD”), hemodiafiltration (“HDF”) and ultrafiltration (“UF”) for patients weighing 20 kgs or more, and can be used in hospitals, clinics and at home (by a trained and qualified individual considered to be competent in the use of this device).
“With DIMI licensed in Canada, Dialco can continue to move down its commercialization pathways,” said Dr. Gualtiero Guadagni, President of Dialco Medical. “DIMI’s versatility addresses many of the barriers to adoption for home hemodialysis, and positions DIMI as the ideal device for multiple segments of chronic dialysis patients across Canada. DIMI provides patients and their care partners with the option and flexibility to dialyze conveniently at home, while reducing lengthy and time exhaustive travel to in-centre hemodialysis. For nursing homes this provides the opportunity to care for their patients safely on site. Additionally, DIMI’s use of pre-packaged dialysate fluid bags addresses water quality issues as barriers to hemodialysis in rural and indigenous communities. Ultimately, we believe DIMI can assist healthcare networks across Canada to meet the needs of chronic dialysis patients while improving health outcomes and reducing costs.”
Remaining Health Canada Approval:
There remains one final Health Canada license for DIMI to unlock the full dialysis modality of the device. Management expects to make its submission to Health Canada for peritoneal dialysis (“PD”) in Q3 2021. Currently, there are no competing chronic dialysis devices with multiple modality. DIMI is the only device capable of performing both HD and PD, which helps late-stage PD patients transition to HD seamlessly.
DIMI Value Proposition: Addressing Barriers to Adoption for Home HD
The DIMI renal replacement system is 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. The DIMI system comes fully assembled and uses pre-packaged dialysis fluid bags providing greater portability and versatility.
Table 1: DIMI vs. Competitors
(w/Reverse Osmosis (“RO”)
|Usability & Training||
|Home renovation required||
Chris Seto, COO and CFO of Spectral, commented, “The Health Canada license for the DIMI RRT system is an important milestone in creating value for our shareholders. We believe DIMI is a disruptive technology that is at the forefront of addressing the most significant barriers to adoption for HHD, and DIMI’s best-in-class differentiating characteristics should be an advantage in penetrating both the Canadian and U.S. markets. We look forward to providing meaningful updates as commercial developments unfold.”
Dialco recently received its Medical Device Single Audit Program (“MDSAP”) certification, which is the highest quality and regulatory standard in the medical device industry.
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 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 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.
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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