Diality, Inc., an Irvine, CA-based medical technology company developing a user friendly, mobile and connected hemodialysis system, closed a $28m funding round.
The company intends to use the funds for its 510(k) filing and pre-commercialization activities through initial commercial launch targeting hospitals, skilled nursing facilities, and de novo clinics, and initiation and early enrollment of its U.S. home hemodialysis clinical trial.
Led by Osman Khawar, M.D., chief executive officer, and Dan Guthrie, chief business officer, Diality is advancing a hemodialysis system 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.
FinSMEs
09/08/2023