- Aroa Biosurgery (ARX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Myriad Morcells product
- Myriad Morcells is a powdered form of Myriad Matrix, which received 510(k) clearance in June 2017
- Essentially, 510(k) clearance confirms that a product is safe and effective to use
- Myriad Matrix is a highly perforated, multi-layered extracellular matrix graft which is used for soft tissue repair, reinforcement and wounds
- It has been designed to maximise tissue repair while also providing flexibility and adaptability
- Additionally, it helps build new tissue, which leads to faster healing, recovery and hospital discharge
- Aroa is up a slight 2.63 per cent on the market and shares are trading at $1.17
Aroa Biosurgery (ARX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Myriad Morcells product.
Essentially, 510(k) clearance confirms that a product is safe and effective to use.
Myriad Morcells is a powered form of Myriad Matrix which received FDA 510(k) clearance in June 2017.
In late July 2020, it was approved for commercial use in the European Union by DEKRA Certification B.V.
Myriad Matrix is a highly perforated, multi-layered extracellular matrix (ECM) graft which is used for soft tissue repair, reinforcement and wounds.
It has been designed to maximise tissue repair while also providing flexibility and adaptability.
It contains more than 150 ECM proteins, such as collagen and elastin, that exist in the tissue and help in the healing process.
Additionally, it helps build new tissue, which leads to faster healing, recovery and hospital discharge.
“When using Myriad products for dermal reconstruction, Myriad Morcells can be used concomitantly with Myriad Matrix to accelerate granulation tissue formation,” Vice President of Research and Clinical Development Dr Barnaby May said.
“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,” he added.
Aroa now has regulatory clearance in more than 44 countries, and six of its products are approved for sales in the United States.
Aroa is up a slight 2.63 per cent on the market and shares are trading at $1.17 at 12:52 pm AEST.