Diality received 510(k) clearance from the Food and Drug Administration for its hemodialysis system that could make at-home treatment a more viable option.
The Irvine-based medical device company is developing what’s called the Moda-flx hemodialysis system for acute and chronic kidney failure.
The system’s current indication is for acute and chronic care facilities under a trained professional.
Next steps for Diality include submitting for a home use indication, which would give patients the freedom to receive treatment outside of clinics where patients must often spend hours. The company said it will begin its first clinical trial once it gets its Investigational Device Exemption application approved by the FDA.
“We’re very excited to work towards a technical trial to get us the home indication so that patients and their care partners can do this by themselves in the home,” Chief Executive Osman Khawar told the Business Journal.
Diality anticipates commercializing Moda-flx within “targeted care settings” in the United States by 2025, according to Khawar.
Cost-Saving
Moda-flx acts as an artificial kidney that filters patients’ blood, removing toxins before it’s cycled back into the bloodstream.
Khawar calls the device “user friendly.” The system, about the size of a mini fridge, streamlines aspects of a traditional treatment facility into one unit on wheels.
Typically, a treatment facility has a water room with a filtration system that creates a cleansing fluid known as dialysate, which is then delivered to a dialysis machine.
Moda-flx has a built-in water system, eliminating the need for a water room entirely. This could make it easier for post-acute care facilities to begin a dialysis program by cutting down on expensive water infrastructure installation costs, according to the company.
“It’s really designed to maximize clinical flexibility, combining prescription capabilities of an in-center system with the ease of use of the next generation of home dialysis devices,” Khawar said.
The device also has a cloud-based portal that collects data and helps physicians create a personalized dialysis treatment for their patients.
The startup, founded in 2018, has already raised more than $100 million to date with a $24 million boost from a Series B2 round that closed in 2022. A vast majority of the funding has been used for submitting to the FDA and product development, Khawar said.
Home Treatment
Khawar called the current standard of care “very in-center centric.”
Moda-flx is part of the movement to bring dialysis treatment to the patients’ homes, joining other medical device companies such as San Jose-based Outset Medical (Nasdaq: OM), which in April announced a partnership with U.S. Renal Care to distribute Outset’s at-home dialysis system.
Khawar’s background has allowed him to think from both the physician and patient perspectives.
He spent nearly a decade as a nephrologist, a type of kidney specialist, at Balboa Nephrology Medical Group in San Diego. During that time, he said he saw “the benefits that patients realized when they transitioned to home dialysis.”
Khawar wanted to start Diality in Orange County due to the several medtech companies headquartered in the area, including San Clemente-based ICU Medical Inc. and RxSight Inc. in Aliso Viejo.
“There’s a lot of medtech in this space, so it’s a great environment to start and grow a medtech business,” Khawar said.
