Diality, an Irvine, Calif.-based medical device company focused on renal disease, secured U.S. Food & Drug Administration 510(k) clearance for its new hemodialysis system for acute and chronic renal failure.
The company’s Moda-flx system is designed to aid healthcare professionals with easy-to-use variable flow rate ranges and is designed to give clinicians the flexibility to easily customize each hemodialysis experience according to patient needs in one integrated system, according to the company.
The 510(k) marker is needed when a medical device company wants to market a new product commercially and must be obtained at least 90 days ahead of launch.
“Dialysis is an area of medicine long overdue for meaningful innovation,” said Dr. Allen R. Nissenson, board member at Diality in a statement. “The Moda-flx Hemodialysis System is a huge leap forward and incorporates the right mix of clinical, technical, and ease-of-use characteristics to help dialysis providers thrive in today’s challenging environment.”
In addition to the large flow rate ranges, the system also offers flexibility in integrated reverse osmosis filtration and an easy-to-use graphical user interface. The platform’s compact footprint and mobility also allow for straightforward transportation in renal care settings, the company said.
“Receiving 510(k) clinical clearance for Moda-flx is an incredible milestone in our mission of developing solutions to improve lives impacted by kidney disease,” said Osman Khawar, M.D., CEO of Diality. “We believe this platform will represent a new paradigm in the treatment of kidney disease and will help reduce the burden of care for all kidney care stakeholders.”
Treatments using the device must be administered under a physician’s prescription by a trained person who is considered competent in the use of the device.
Treatment types available include intermittent hemodialysis (IHD), sustained low-efficiency dialysis (SLED/SLEDD), and prolonged intermittent renal replacement therapy (PIRRT). The system is for use in acute, post-acute or chronic care settings.
“I envision Moda-flx will create value for patients and providers across multiple care settings where dialysis is performed,” Nissenson said.
Diality picked up $12.5 million in a series B funding round in 2020. The startup aims to partner with care providers to “re-chart the journey for all kidney disease stakeholders,” according to its website.