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AWAK Technologies recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their AWAK Peritoneal Dialysis (PD) device, a portable and wearable PD system fitted with AWAK’s proven and patented sorbent technology. AWAK is a Singaporean medical technology pioneer that produces solutions for end-stage renal disease.
Breakthrough Device Designation is granted by the FDA to expedite the development and review of select technologies that show potential to provide a superior treatment or diagnosis of permanently debilitating or life-threatening diseases. Breakthrough Device Designation qualifications include a current absence of FDA approved alternatives or the device must demonstrate critical benefits over current alternatives.
The AWAK PD device provides world-first technology in its mode of delivery. The device allows dialysis to be undergone “on-the-go”, which mitigates the cumbersome long hours of typical therapy and connection to large dialysis machines that are typically faced by the 650,000 end-stage renal patients in the United States.
The FDA granted this designation upon their review of the results from the First-In-Human safety trial of the AWAK PD device, completed in October of last year at the Singapore General Hospital. The results from this trial demonstrated that the AWAK PD device efficiently removed toxin buildup in the body and that the trial patients experienced no serious adverse complications during dialysis with the device.
Dialysis market research published by iData Research finds that peritoneal dialysis is a significant driver in the growth of the dialysis market as it offers a treatment option that many patients prefer. This is due to minimal lifestyle interruptions and a low ASP despite only one PD device required per patient.
“Breakthrough Device Designation is an important milestone in the development of AWAK PD following the recent positive clinical study results,” said Suresha Venkataraya, Chief Executive Officer, AWAK Technologies. “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.”
For Further Information
More on the dialysis device market in the US can be found in a series of reports published by iData Research entitled the US Market Report Suite for Dialysis Devices and Concentrates.