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Safety trial, FDA designation indicate promise of wearable kidney
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Singapore-based AWAK Technologies recently announced its peritoneal dialysis device was granted breakthrough device designation by the FDA. According to a company press release, the AWAK Peritoneal Dialysis device, also known as AWAK PD, is the world’s first wearable PD device, which allows patients with ESRD to bypass hours of therapy with large machines and undergo dialysis on the go.
Portable artificial kidney offers convenience
“When it comes to innovation, compared to the rest of the health care industry, [the] dialysis industry is literally stagnant over the last few decades,” Suresha Venkataraya, CEO of AWAK Technologies, told Nephrology News & Issues. “The current treatment modalities are not only disruptive to the patient’s daily routine but also impose a heavy cost burden on patients, payers and the caregivers.”
Venkataraya cited disruptions to the patient’s daily routine, prohibitive cost, limits on patient mobility and issues with fluid logistics and the bulkiness of traditional PD devices as some of the problems he hopes the AWAK PD will eliminate. He said the device’s sorbent technology, which enables reuse of the PD fluid, will “provide a therapy which will be more convenient and enhance patients’ quality of life to a greater extent compared to currently available technologies.”
Venkataraya said the goal for the device is to allow patients to comply with therapy in a way that does not disrupt their lifestyle.
“More compliance to [their] therapy regime results in healthy individuals, which in turn helps reduce health care cost[s] and contribute[s] to the economy,” he added.
The AWAK device is also more sustainable than traditional PD because it consumes less water.
Early trial shows promise
The portable artificial kidney, through sorbent technology, removes uremic toxins from the used dialysis fluid and regenerates fresh fluid. This makes the device less cumbersome than current modalities for patients which typically require 10 L to 12 L (22 pounds to 26 pounds) of fluid per session.
The AWAK PD was granted breakthrough device designation based on the results of a first-in-human safety trial completed in October 2018 at the Singapore General Hospital.
According to Marjorie Foo, MBChB, MRCP, FRCP, FAMS, head and senior consultant in the department of renal medicine at Singapore General Hospital and director of the hospital’s PD program, the safety trial found a consistent reduction of solutes, including urea, creatinine, phosphate and beta 2-microglobulin, as well as electrolytes over the 3 days on AWAK therapy with no adverse events.
The study results indicate that “the regenerated solution using sorbent technology is safe and [the] outcome of dialysis with the AWAK solution using tidal-based dialysis was comparable in terms of solute removal with conventional dialysis,” Foo said.
The results showing the AWAK PD could efficiently remove the accumulation of toxins indicate that the 650,000 U.S. patients with ESRD could soon have a PD option that allows them to travel.
“I think the future is bright for this wearable [device] as it is safe to carry around, compact and delivers the treatment as needed,” Foo said.
While Venkatarya believes an artificial implantable kidney is still 10 to 20 years away, he hopes to see this portable PD device become a standard of care.
The next phase of the trial entails a detailed efficacy study comparing the AWAK PD with conventional dialysis. – by Jennifer Byrne
Reference:
www.healio.com/nephrology/artificial-kidney/news/online/%7B0cf97e2a-b12f-4f4d-aa32-6ed5315b471b%7D/fda-grants-breakthrough-designation-for-wearable-pd-device
Disclosure: Venkataraya and Foo report the study was funded by the National Medical Research Council and AWAK.