U.S. FDA Grants 510(k) Clearance for Spectral’s DIMI
- Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
- U.S. skilled nursing facilities market represents an estimated US$2 billion market annually
TORONTO, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Spectral Medical Inc. Inc. (“Spectral” or the “Company”) (TSX: EDT), 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.
- According to the CDC, there are approximately 15,600 skilled nursing facilities (“SNFs”) in the U.S. providing care to approximately 1.7 million residents;
- An estimated 74,000 dialysis patients live in SNFs, with the majority traveling to dialysis centers to receive treatment;
- Installation of easy-to-use dialysis machines in SNFs could help reduce risks of patient travel to clinics, reduce overall costs of care and provide a new source of revenue for the SNF;
- Existing U.S. SNF markets represent an estimated US$2 billion market annually (combined devices and disposables).
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:
- DIMI evaluations at SAMI early adopter customer sites;
- Addition of three additional clinical/academic sites in the U.S. and Canada over the next six months;
- Initiate pilot evaluations in SNFs;
- Ramp up sales activity; and
- Develop a complete product portfolio (by adding ancillary disposables) for the DIMI system.
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 home HD usability and safety trial in Q4 2020. This will be a required six-month, 25-patient safety and usability trial which tests the ability of non-medical professionals to assist the patient in setting up and running the dialysis treatment;
- PD FDA 510(k) submission expected in Q4 2020. This enables patients to use DIMI for automated PD treatments at home, especially for those who are transitioning from PD to home HD;
- Special FDA 510(k) application for remote monitoring software submission expected in Q1 2021. This unlocks the full remote monitoring software suite, allowing physicians to remotely check-in and adjust a patient’s treatment regime;
- Special FDA 510(k) application for home HD submission expected in Q2 2021. This is the final step approval to allow for in-home use of DIMI.
Health Canada Approvals:
- In Q2 2020, Dialco submitted its application for DIMI. With respect to Health Canada approval timelines, there are no standard turnaround times. However, Dialco anticipates a Health Canada response in H2 2020;
- Health Canada PD use submission expected in Q4 2020 with possible approval in early 2021.
“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.”
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.
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
|Mr. Chris Seto
COO & CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
Capital Markets & Investor Relations