Monday, August 31, 2020
Spectral Medical Inc., today announced that its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) has been granted 510(k) clearance by the United States Food and Drug Administration (“FDA") for DIMI to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis (“HD”), hemodiafiltration (“HDF”), hemofiltration (“HF”) and/or ultrafiltration (“UF”) in hospital or clinical settings. As previously communicated, this is the first major step of the full regulatory development of DIMI. Further advances will be clearance for home and peritoneal dialysis (“PD”) use.
DIMI is an innovative renal replacement system that shares the same patented platform as Dialco’s FDA cleared SAMI system, which is indicated for continuous renal replacement therapy (“CRRT”) in the intensive care unit (“ICU”) setting. Based on a fully integrated cassette technology, the set-up, operation and management of a dialysis session is significantly simplified compared to other instruments currently available on the market. Moreover, DIMI (similarly to SAMI) is specifically designed to avoid all contact between the console and a patient's biological fluids, helping to reducing the risk of cross infection when it is used to treat multiple patients.
“The overall 510(k) clearance process was completed in less than nine months including review, and time to address and resolve deficiencies, despite the COVID-19 pandemic,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “This FDA 510(k) clearance is significant for Spectral. Not only is it an important first step in the full regulatory development of DIMI, but it also opens up significant commercial markets and opportunities which we expect would result in significant revenue growth for the Company. We look forward to working with our SAMI early adopters and other clinical teams to evaluate DIMI and run the usability trial to pursue the home market designation."
Current DIMI Market Opportunities:
As Dialco prepares to extend the indication for DIMI to include both home and PD use, Dialco will focus on the chronic dialysis centers and long-term care facilities markets. These segments offer promising markets where DIMI can offer unique advantages over current products in this space.
Dialco’s key operating activities to commercialize DIMI in the near term will focus on gaining clinical acceptance of DIMI amongst nephrologists and nurse practitioners, given the importance of peer reference in the dialysis industry. Some of the key activities include:
Remaining Regulatory Pathway:
While the U.S. SNF market is a significant opportunity, the Dialco team is focused on unlocking the full commercial capabilities of DIMI, which includes both home and PD use. The regulatory pathway forward will be on a stepwise basis, with key regulatory activities and milestones laid out below:
FDA Approvals:
Health Canada Approvals:
“We are very pleased with this clearance for DIMI by the FDA,” said Chris Seto, COO and CFO of Spectral. “Our regulatory and commercialization paths of these renal replacement products are continuing despite the challenges of limited access to hospitals and the usual selling cycle for capital equipment in hospitals.”
About Spectral
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. (“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.
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.
For further information, please contact:
Dr. Paul Walker
President and CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
pwalker@spectraldx.com
Mr. Chris Seto
COO & CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com