Shareholders in biological scaffold maker Aroa Biosurgery (ASX:ARX) got a double treat on Thursday morning after the company received both FDA and European regulator approvals.

The Auckland headquartered company makes and sells products based off its Endoform platform which it acts as a biological scaffold, allowing damaged bones, skin and tissues to heal.

Aroa only listed last Friday and nearly doubled on debut. The stock broke through that barrier with this morning’s news, rising to $1.59 having listed at 75 cents.

Aroa Biosurgery (ASX:ARX) share price chart


Symphony approved in America

Arguably the more critical was the FDA’s approval of its new product Symphony.

Symphony, which is a gel based off Endoform and hyaluronic acid, aims to support complicated wound closures such as diabetic foot ulcers and venous leg ulcers.

It support new tissue formation by helping blood vessels regrow.

FDA approval has been the catalyst for success for many ASX small caps seeking to enter America because it allows sales to begin.

Aroa chief exec Brian Ward told shareholders the American market opportunity is worth $US1.15 billion ($1.6 billion).

Aroa, targeting to launch Symphony commercially in 2021, now has five existing commercial products approved for sale in the US used in over 4 million procedures.


Myriad approved in Europe

Another one of Aroa’s products is Myriad – a graft engineered to support tissue reconstruction.

Myriad was FDA approved in 2017 but overnight it received an additional green light from European authorities.

Again, the company intends commercial launch in this new market next year.

It estimates the market size for this product globally is $US350 million ($487.4 million).

“This CE mark approval will only reinforce our ability to drive adoption and market share with Myriad,” Dr Ward said.

“We’re excited to continue to leverage the healing potential from our core Endoform platform and develop new applications which will help clinicians treat those people with the wounds which are hardest to heal.”