Soft tissue regeneration company Aroa Biosurgery Limited (Aroa) has this week launched Myriad Morcellstm, a morcellized (powder) format of Myriad Matrixtm that easily conforms to optimize contact with irregular wound beds. It gained U.S. FDA 510(k) clearance for the new product on 6 April, which has been favourably reviewed in Surgeon Advisory Panels.
Aroa's Vice President of Research and Clinical Development, Dr. Barnaby May, said Myriad Morcellstm delivers a bolus of biologically important ECM proteins known to ?kick start' healing in a format that conforms to the intricacies of a wound.
"When using Myriadtm products for dermal reconstruction, Myriad Morcellstm can be used concomitantly with Myriad Matrixtm to accelerate granulation tissue formation. The combination of Myriad Morcellstm with Myriad Matrixtm helps provide rapid and sustained delivery of biological components important during tissue regeneration as well as a porous scaffold for cell infiltration," Dr. May said.
The new product, which is not indicated for implantation, is provided in a convenient tray for hydration, mixing, and pouring.
Myriad Matrixtm is a highly perforated, multi-layered extracellular matrix (ECM) graft engineered to have a high volume and surface area with interstitial spaces that are easily and rapidly accessible to cells. It takes advantage of the Aroa ECMtm bioscaffold technology, including important secondary molecules and residual vascular channels to support new tissue growth. Myriad Matrixtm enables rapid vascularization and helps build new tissue, which may lead to faster healing, recovery and hospital discharge.
Earlier pre-clinical studies have shown that the Aroa ECMtm technology includes over 150 different components known to aid wound repair, blood vessel formation and attract stems cells.
"We are pleased to commence distributing Myriad Morcellstm after very recently gaining U.S. FDA 510(k) clearance. Its distribution follows closely on studies showing positive clinical outcomes from the use of Myriad Matrixtm 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.
Aroa has six commercial product families approved for sale in the U.S. based on its ECM technology, which have been used in more than four million procedures targeting chronic wounds, hernia, soft tissue and breast reconstruction. Aroa has regulatory clearance in more than 44 countries.
Further information about Myriad Morcellstm and its applications can be found at https://aroabio.com/product/myriad-morcells.
Authorised on behalf of the Aroa Biosurgery Board of Directors by Brian Ward, CEO.
About Aroa Biosurgery:
Aroa Biosurgery is a soft-tissue regeneration company committed to ?unlocking regenerative healing for everybody'. We develop, manufacture, sell and distribute medical and surgical products to improve healing in complex wounds and soft tissue reconstruction. Our products are developed from a proprietary Aroa ECMtm technology platform, a novel extracellular matrix biomaterial derived from ovine (sheep) forestomach. Clinically proven with peer reviewed publications, Aroa's products have been used in more than four million procedures to date, with distribution into our key market of the United States via our direct sales force and our partner TELA Bio. Founded in 2008, Aroa is headquartered in Auckland, New Zealand and is listed on the Australian Securities Exchange (ASX:ARX). www.aroabio.com/
These press releases may also interest you
|