HIGHLIGHTS

  • Soft tissue regeneration company Aroa Biosurgery Limited has this week launched a new product named Myriad Morcells™, a morcellized (powder) format of Myriad Matrix™ that easily conforms to optimize contact with irregular wound beds.
  • It received U.S. FDA 510(k) clearance received for the product on 6 April 2021.
  • The morcellized format increases AROA ECM™ surface area to maximize delivery of important ECM proteins.
  • This clearance further builds on applications for the Myriad™ portfolio, following recent studies showing positive clinical outcomes for Myriad Matrix™’s use in surgical treatment of hidradenitis suppurativa, complex wounds and exposed vital structures.

SAN DIEGO--(BUSINESS WIRE)--#AroaBiosurgery--Soft tissue regeneration company Aroa Biosurgery Limited (Aroa) has this week launched Myriad Morcells™, a morcellized (powder) format of Myriad Matrix™ 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 Morcells™ 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 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,” Dr. May said.

The new product, which is not indicated for implantation, is provided in a convenient tray for hydration, mixing, and pouring.

Myriad Matrix™ 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 ECM™ bioscaffold technology, including important secondary molecules and residual vascular channels to support new tissue growth. Myriad Matrix™ 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 ECM™ 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 Morcells™ 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 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.

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 Morcells™ 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 ECM™ 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/

Contacts

Investor Simon Hinsley Investor Relations shinsley@aroabio.com + 61 401 809 653 Media Australia Matthew Wright matt@nwrcommunications.com.au +61 451 896 420

New Zealand Piet De Jong piet.dejong@baldwinboyle.com +64 21 812 766