Diality Inc., a medical technology company that develops user-friendly, mobile-connected hemodialysis systems with a prescription range that leads its classRecently announced the completion of a $28 million round of investment. The round will be used to support Diality's 510(k) application and pre-commercialization activities through initial commercial launch for hospitals, skilled nursing facilities, and new clinics. The funding will also support the initiation and early registration of the Diality U.S. home hemodialysis clinical trial.
We are pleased that this funding will support our strategy to bring to market a novel hemodialysis system that covers the widest range of prescriptions, from low-dose expansion** to high-dose in-center**." The latter is currently the most commonly prescribed for about 85% of hemodialysis patients"Osman Khawar, MD, CEO of Diality, says he is a practicing nephrologist. "Our goal is to provide the most flexible hemodialysis system that can be used in any medical setting, including the home. ”
Diality's hemodialysis systems are suitable for use by professionals as well as for patients and their caregivers. The 510(k) application will cover dialysis prescriptions, including intermittent hemodialysis (IHD), continuous inefficient (daily) dialysis (SLED SLEDD), and extended intermittent renal replacement** pirrt). This clinical trial is a prospective, non-randomized, multicenter, open-label study that will be applied under an investigational device exemption (IDE). The 510(k) is expected to enable the Company's products to be marketed in hospitals, skilled nursing facilities, and new clinics, while the IDE is expected to enable the product to be used in the home.
Dan Guthrie, Chief Commercial Officer at Diality, said:"With more than 550,000 patients on dialysis in the U.S.** and an estimated total addressable market for Diality hemodialysis systems at over $7 billion, our hemodialysis systems have significant commercial potential. While significant progress has been made in the development of hemodialysis equipment, there is still a significant gap in the market for hemodialysis systems that truly meet the needs of all healthcare settings. The Diality Hemodialysis System has twice the dialysate flow rate of competitive products, allowing for fewer or shorter times per week, achieving standard dialysis efficacy metrics more effectively than existing devices in its class. ”