Home / FDA News / FDA Grants Breakthrough Device Designation to AWAK Technologies’ Wearable Peritoneal Dialysis Device

FDA Grants Breakthrough Device Designation to AWAK Technologies’ Wearable Peritoneal Dialysis Device

SINGAPORE, Jan. 11, 2019 /PRNewswire/ — AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today 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.

A world-first, the AWAK PD device disrupts the mode of delivery in which peritoneal dialysis is currently administered. The 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. End-Stage Renal Disease affects 650,000 patients per year in the US.

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 trial results showed that 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.

Suresha Venkataraya, Chief Executive Officer, AWAK Technologies, said: “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.”

About End-Stage Renal Disease

End-Stage Renal Disease (ESRD) is the fifth stage of Chronic Kidney Disease (CKD) that affects the functioning of kidneys, leading to accumulation of excess fluid and toxic wastes in the blood. People with ESRD undergo either renal transplantation or dialysis. Since renal transplantation is highly dependent on patient’s health and age, dialysis scores over as the primary treatment. It was estimated as of 2011, there were 2.7 million ESRD patients of whom 2.1 million were on dialysis. Of these 2.1 million, 10.8% of the patients are on peritoneal dialysis (PD) and the remaining 89.2% are on hemodialysis (HD)[1].

Dialysis treatment can be performed either at home, in a dialysis centre or at a hospital. In hemodialysis, blood is drawn out of the patient’s body into a synthetic filter called dialyser. In the dialyser, there are two spaces separated by a membrane, with blood passing on one side and dialysis fluid on the other side. Waste products and excess water passes from the blood through the membrane into the fluid through diffusion process. The fluid containing the waste products is then discarded while the clean blood is returned back to the patient’s body.

In peritoneal dialysis, the lining of the abdominal cavity acts like the external filter to cleanse the blood. Dialysis fluid is introduced into the abdominal cavity through a permanent tube. The fluid remains in the abdominal for a certain period of time before it is drained and discarded.

About AWAK Technologies

AWAK Technologies Pte Ltd. is a pioneering, patient-centric medical technology company with a mission to enhance the lives of dialysis patients and their caregivers by providing solutions to deliver better outcomes and improve their quality of life.

Headquartered in Singapore with an office in Burbank, California, USA, the company is dedicated to the research, development and marketing of novel, sorbent-based kidney dialysis machine for the treatment of patients with end-stage renal disease. For more information, please visit: www.awak.com

[1] Damien, P., Lanham, H. J., Parthasarathy, M., & Shah, N. L. (2016). Assessing key cost drivers associated with caring for chronic kidney disease patients. BMC Health Services Research, 16, 690. http://doi.org/10.1186/s12913-016-1922-4

Check Also

Blueprint Medicines Submits NDA to the FDA for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy …