HONG KONG – Singapore company Awak Technologies Pte. Ltd. has been granted a breakthrough device designation from the U.S. FDA for its portable peritoneal dialysis (PD) device.

The designation for the Awak PD device was based on the results from its first-in-human safety trial, which was successfully completed in October 2018 at the Singapore General Hospital, Singapore's largest acute tertiary hospital.

The trial results showed that the 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 the wearable device.

"The 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 revolutionize the way in which PD can be delivered, and we look forward to collaborating closely with the FDA on the next stages of our development pathway," Suresha Venkataraya, the CEO of Awak, told BioWorld MedTech.

Qualifying for breakthrough device status

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.

Current PD devices use about 10 to 12 liters of a special PD fluid, which is filled every day in the patient's peritoneal cavity in the abdomen from where body toxins are absorbed, and then later the toxin-laden fluid is drained out. In a month, patients may need more than 300 liters of PD fluids, which imposes a huge logistical burden.

Other challenges include bulky machines that are disruptive to the patient's daily routine, as patients cannot move from one place to another for about 10 hours in a day.

The daily lives of close to 3 million end-stage renal disease patients are severely restricted by these challenges. Since most of their time goes into managing their dialysis therapy, they have hardly any time for other aspects of their lives.

"It is unfortunate that even today patients choose not to continue with dialysis not because they do not have access to the treatment but because they cannot handle the disruptive and burdensome regimes of the current dialysis treatments," said Venkataraya.

Close to home

Awak will start market launches for the PD device a little closer to its home base.

"We continue to stick to our original plan of launching the product in Singapore first, followed by launches in CE countries," said Venkataraya.

"In addition, given the recent development with FDA, we will work closely with the FDA and explore avenues to enter the U.S. market sooner than our earlier plans, but the exact timing of our U.S. launch is yet to be finalized," he added.

Pivotal trial in the works

Awak is also looking to initiate a pivotal trial by the end of 2019 with more patients involved and a larger geographical area.

"The results from the pivotal trial will be used for our regulatory submission. As mentioned, we will focus on launching our product first in Singapore before venturing into CE countries and the U.S. Exact commercialization typically depends on the regulatory approval timeline, hence we can't comment on the exact date of commercialization," said Venkataraya.

The device is based on Awak's Sorbent technology that enables reuse of the special PD fluid, thus not only reducing the amount of fluid needed per therapy by 90 percent, but also enabling the development of a wearable/ultraportable PD device.

"This portability and the ease of use of the device allows therapy to be delivered where the patient chooses, enhancing their quality of life as well as compliance to the therapy," said Venkataraya.

"I would like to mention our principle investigator Dr. Marjorie Foo's quote on our technology: 'The wearable dialysis device gives patients the option of "dialyze to live" and not "live to dialyze." This is as close as one can get to an artificial organ performing the functions of the kidney.'"

According to Awak, there were 2.7 million end-stage renal disease patients as of 2011, with approximately 2.1 million of them on dialysis. Of these 2.1 million, 10.8 percent were on peritoneal dialysis and the remaining 89.2 percent were on hemodialysis.