The Aroa Biosurgery Ltd (ASX: ARX) share price is up 2.6% after the company shared positive news this morning. A new product from the soft-tissue regeneration company has received US Food and Drug Administration (FDA) clearance.
At the time of writing, the Aroa Biosurgery share price is trading at $1.17 after reaching an intraday high of $1.22 this morning.
Let's look closer at the news of Aroa Biosurgery's newest FDA cleared product.
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Myriad Morcells
The company's new product, Myriad Morcells, works to "kick start" a wound's healing, according to Aroa Biosurgery vice president of research and clinical development Dr Barnaby May.
Myriad Morcells uses the Aroa ECM bioscaffold technology and is a powdered version of the company's successful Myriad Matrix, a highly perforated, multi-layered extracellular matrix (ECM) graft.
The company advised that earlier pre-clinical studies showed the Aroa ECM technology included more than 150 components that help repair wounds and blood vessel formations, as well as attracting stems cells.
According to Aroa Biosurgery, the use of Myriad Matrix may lead to faster healing, recovery and hospital discharge for patients. It's designed to have a high volume and surface area with interstitial spaces that cells can easily and rapidly access.
Myriad Matrix received FDA clearance in 2017, with the first sales taking place in early 2020. Aroa Biosurgery says the product has an estimated global market size of US$350 million. In mid-2020, it was approved for commercial use in the European Union.
Aroa has six product families based on its ECM technology approved for sale in the United States. Together, they have been used in more than 4 million procedures for chronic wounds, hernia, soft tissue and breast reconstruction.
Commentary from management
Aroa Biosurgery founder and CEO Brian Ward said the company was pleased with its progress in growing the Myriad portfolio, saying:
This clearance for Myriad Morcells follows closely on studies showing positive clinical outcomes from the use of Myriad Matrix on exposed vital structures, in surgical treatment of serious cases of the inflammatory skin condition hidradenitis suppurativa and in reconstruction of complex non-healing wounds.
Aroa Biosurgery share price snapshot
Today's news comes at a good time for the Aroa Biosurgery share price, which is having a slow year on the ASX. It is currently up 5.7% year to date, having ended Thursday's trading back at its 2021 starting price.
However, shares in the company have dropped 10.7% over the last 12 months.
Aroa Biosurgery has a market capitalisation of around $342 million, with approximately 300 million shares outstanding.
