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IRVINE, Calif.--(BUSINESS WIRE)--Diality Inc., a medical technology company developing a user friendly, mobile and connected hemodialysis system with a category leading prescription range, today announced the closing of a $28 million investment round. The funding will be used to support Diality’s 510(k) filing and pre-commercialization activities through initial commercial launch targeting hospitals, skilled nursing facilities, and de novo clinics. The funding will also support initiation and early enrollment of Diality’s U.S. home hemodialysis clinical trial.

“As we continue our mission of developing solutions to improve lives impacted by kidney disease, we are pleased that this funding will support our strategy to bring to market our novel hemodialysis system, which covers the broadest range of prescriptions, from low dose extended treatments to high dose in-center treatments. The latter represents the most common prescription in use for about 85% of hemodialysis patients today. Our goal is to provide the most flexible hemodialysis system that can be used in any healthcare setting, including the home.”

Osman Khawar M.D.,CEO of Diality

iality’s Hemodialysis system is designed to be used by both professional staff as well as patients and their caregivers. The 510(k) filing will cover dialysis prescriptions including intermittent hemodialysis (IHD), sustained low-efficiency (daily) dialysis (SLED/SLEDD) and prolonged intermittent renal replacement therapy (PIRRT). The clinical trial is a prospective, non-randomized, multicenter, open-label study to be filed under an Investigational Device Exemption (IDE). The 510(k) is expected to enable the company’s commercial launch in hospitals, skilled nursing facilities and de novo clinics, while the IDE is expected to enable home use.

“With over 550,000 patients receiving dialysis in the U.S. and the total addressable market for Diality’s hemodialysis system estimated at over $7 billion, the commercial potential for our hemodialysis system is significant. While meaningful progress has been made in the development of hemodialysis devices, a major shortfall remains in the market for a hemodialysis system that truly meets the needs of all care settings. With the ability to achieve dialysate flow rates up to twice those of the competitors in the category, Diality’s hemodialysis system allows for fewer treatments per week or shorter time per treatment, achieving standard dialysis efficacy metrics more efficiently than existing devices in the category”

Dan Guthrie Chief Business Officer

This article was originally published by Sam Choinski and can be viewed here

Diality raises $28M for Regulatory, Clinical & Commercial initiatives