- Spectral Medical (EDT) subsidiary Dialco has secured a 20-year licensing agreement for its DIMI Hemodialysis System in Canada and the United States
- Dialco entered into the agreement with Infomed SA
- The initial term of the agreement extends to December 31, 2026 and automatically renews for three additional five-year periods
- DIMI is indicated to treat patients with chronic renal failure with or without fluid overload
- The company will submit numerous DIMI-related FDA and Health Canada applications in Q3 2021
- Spectral is a Phase III company seeking U.S. FDA approval for Toraymyxin, its treatment for septic shock
- Spectral Medical (EDT) closed the day up 5.88 per cent trading at $0.54 per share
Spectral Medical (EDT) subsidiary Dialco has secured a 20-year licensing agreement for its DIMI Hemodialysis System in Canada and the United States.
Dialco entered into the agreement with Infomed SA, extending Dialco’s exclusive rights in the United States and Canada through 2041.
The initial term of the agreement extends to December 31, 2026 and automatically renews for three additional five-year periods.
DIMI is indicated to treat patients with chronic renal failure with or without fluid overload using hemodialysis, hemodiafiltration, hemofiltration and/or ultrafiltration.
The system does not require any plumbing, electrical infrastructure changes or monthly maintenance that other products on the market demand.
Dialco will conduct a 35-patient usability trial to demonstrate DIMI’s safety and efficacy when performing hemodialysis in the home. Management believes it has designed a usability trial and identified the external resources required to ensure a successful trial outcome.
The company will submit FDA applications for home-based peritoneal dialysis treatment, home-based hemodialysis treatment and remote patient monitoring software in Q3 2021.
The company will also submit a Health Canada application for peritoneal dialysis treatment in Q3 2021. If granted, DIMI will achieve full dialysis modality in Canada.
Dr. Gualtiero Guadagni, President of Dialco Medical, commented,
“Finalizing the long-term licensing agreement with Infomed is an important milestone for Dialco as we continue to move forward with our regulatory and commercialization paths for DIMI.
From a commercialization perspective, we believe DIMI is positioned as the ideal device to deliver chronic dialysis treatments to patients in skilled nursing facilities.”
Chris Seto, CEO of Spectral Medical, added,
“We believe DIMI is a disruptive technology that is at the forefront of addressing the most significant barriers to adoption for HHD. DIMI’s best-in-class differentiating characteristics should be an advantage in penetrating what we see as an approximately C$5 billion+ annual addressable market.”
Dialco recently received 510(k) clearance by the FDA to use DIMI within hospitals, clinics and skilled nursing facilities.
Dialco also recently received its Medical Device Single Audit Program certification, the highest quality regulatory standard in the medical device industry.
Spectral is a Phase III company seeking U.S. FDA approval for Toraymyxin, its treatment for septic shock.
Spectral Medical (EDT) closed the day up 5.88 per cent trading at $0.54 per share.
