AWAK Technologies recently announced the FDA has granted breakthrough device designation to its wearable PD system that incorporates AWAK’s sorbent technology.
According to a company press release, the FDA’s breakthrough 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,” according to the press release.
The company completed its First-In-Human safety trial of the AWAK PD device in October 2018 at the Singapore General Hospital, Singapore’s largest, acute tertiary hospital. The company said the trial results showed AWAK PD was able to efficiently remove the accumulation of toxins from the body and patients in the trial 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,” said AWAK Technologies CEO Suresha Venkataraya. “The designation reinforces our belief that AWAK PD has the potential to revolutionize 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.”