Soft-tissue regeneration company Aroa Biosurgery (ASX:ARX) has announced the US FDA has granted 510(k) clearance for its Myriad Morcells.
The product is a morcellised (powder) format of Myriad Matrix that is designed to easily conform to optimise contact with irregular wound beds.
Aroa’s vice president of research and clinical development, Dr Barnaby May, said Myriad Morcells delivers a bolus of biologically important extracellular matrix (ECM) proteins known to ‘kick start’ healing in a format that conforms to the intricacies of a wound.
“When using Myriad products for dermal reconstruction, Myriad Morcells can be used concomitantly with Myriad Matrix to accelerate granulation tissue formation. The combination of Myriad Morcells with Myriad Matrix helps provide rapid and sustained delivery of biological components important during tissue regeneration as well as a porous scaffold for cell infiltration,” said Dr May.
The new product, which is not indicated for implantation, is provided in a tray for hydration, mixing, and pouring.
Myriad Matrix is a highly perforated, multi-layered ECM graft engineered to have a high volume and surface area with interstitial spaces that are easily and rapidly accessible to cells. It uses the Aroa ECM bioscaffold technology, including important secondary molecules and residual vascular channels to support new tissue growth. Myriad Matrix enables rapid vascularisation and helps build new tissue, which may lead to faster healing, recovery and hospital discharge.
The company said earlier pre-clinical studies have shown that the Aroa ECM technology includes over 150 different components known to aid wound repair, blood vessel formation and attract stems cells.
“We are pleased with the progress we are making to grow the applications for the Myriad portfolio. 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,” said Aroa founder and CEO Brian Ward.