New Zealand medtech start-up, Avasa, has reached a significant milestone by finalising the design of the world’s first arterial coupler. This development signals the transition to pre-FDA submission testing that will take the Avasa device into clinical use.
“The design freeze is a really exciting milestone – it has taken years of unrelenting design and testing to get here,” said Dr Nandoun Abeysekera, CEO of Avasa.
Avasa’s device solves a common challenge in microsurgery: connecting small arteries and veins.
The current method that involves manual suturing arteries is time-consuming, requiring 40 minutes per connection and highly specialized skills. The Avasa coupler simplifies and expedites this process, with preclinical animal studies showing it can reduce procedure time by 80 per cent and has so far demonstrated a 100 per cent success rate.
Dual trained as both a biomedical engineer and physician, Dr Abeysekera felt compelled to build a solution after experiencing this challenge while practicing as a plastic surgery resident.
“With a validated preproduction device, successful preclinical trials, and conclusive guidance from the FDA, we can now execute on the formal testing needed for FDA clearance and bring this important technology into the hands of surgeons,” he says.
Their coupler has undergone pre-submission reviews with the FDA, who have indicated the coupler can follow the 510(k) pathway, which offers a fast route to market clearance.
If approved, this device will address a long-standing need among plastic surgeons. According to Dr Abeysekera, nearly 90 percent of more than 100 surgeons surveyed from leading institutions such as MD Anderson, Brigham & Women’s, and Sloan Kettering wanted an arterial coupler and consider it likely to become standard of care.
Professor Jon Mathy, a Harvard and Stanford-trained plastic surgeon with over two decades of experience, says what’s exciting about the Avasa coupler is its potential to improve patient outcomes.
“When it comes to that type of surgery aimed at restoring form and function, particularly after cancer and trauma, this coupler provides value by assisting the surgeon and ensuring that blood flow remains patent after this free tissue transfer procedure,” he says.
Because the use of the Avasa coupler is also faster than traditional hand-sewing, it also reduces the amount of time a patient is under anaesthetic.
“Reducing operating time is important for the patient. The less time in theatre, the less fatigue and opportunies for complications, the better,” says Prof. Mathy.
Avasa estimates that with reducing operating times and complication, hospitals could save US$1,000 per procedure and also increase service delivery.
While Avasa’s immediate focus is on plastic and reconstructive surgeries, which represent a market valued at over US$2 billion, the technology could be applied to other vascular procedures including organ transplants and coronary artery bypass surgeries.
With the design freeze completed, Avasa is in the process of raising their Series A funding round.
Several million has already committed from existing and new investors, bringing the company closer to the first close of the round. Once complete, Avasa plans to undertake the necessary testing for FDA clearance in the next 12 months, ahead of a NZ and US market launch.
