FDA grants breakthrough designation for AWAK’s Peritoneal Dialysis device

The breakthrough designation was granted by the FDA after reviewing the results from the First-In-Human safety trial of AWAK PD device which was successfully completed at the Singapore General Hospital in October 2018.
By Dean Koh

A screengrab of an animated simulation of how AWAK's peritoneal dialysis device works. Credit: AWAK

Earlier this week, AWAK Technologies (AWAK), a Singapore-headquartered medical technology company focused on dialysis using regeneration technology for end-stage renal disease, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and ultra-portable PD system that incorporates AWAK’s patented sorbent technology.

Peritoneal dialysis is one of the two methods of treating kidney failure, the other being hemodialysis. The latter is typically performed at a dialysis centre or in a hospital by trained healthcare professionals, and treatment can be very time-consuming and inconvenient for the patient. Peritoneal dialysis can be carried out at home, at work, or on trips, but requires careful supervision. It gives the patient more control.

The AWAK PD device allows dialysis to be performed “on-the-go”, overcoming the challenge of long hours of therapy and connection to large-size dialysis machines, currently faced by renal patients. According to the FDA, Breakthrough Device Designation is granted to expedite the development and review of certain devices that demonstrate potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. To qualify as a Breakthrough Device, there must either be no FDA approved alternative treatments available or the technology must offer significant advantages over the existing approved alternatives.

This designation was granted by the FDA after reviewing the results from the First-In-Human safety trial of AWAK PD device which was successfully completed in October 2018 at the Singapore General Hospital, Singapore’s largest acute tertiary hospital. The single-arm pilot study enrolled 15 adults between the ages of 21 and 80 undergoing regular PD treatment. Each patient had to complete 9 dialysis sessions of 3.5 hours each with AWAK PD over three continuous days.

Preliminary results showed that AWAK PD was able to efficiently remove the accumulation of waste substances from the body. Patients also did not experience any serious adverse events during dialysis with AWAK PD.

“Breakthrough Device Designation is an important milestone in the development of AWAK PD following the recent positive clinical study results. The designation reinforces our belief that AWAK PD has the potential to revolutionise the way in which peritoneal dialysis can be delivered and we look forward to collaborating closely with the FDA on the next stages of our development pathway,” said Suresha Venkataraya, Chief Executive Officer, AWAK Technologies.

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Above photo: A SMART AMR IRG researcher optimizing prototype assay.
Credit: Singapore-MIT Alliance for Research and Technology (SMART)