- CE Mark to allow commercialization of Aroa’s Myriad™ product in the EU
- Myriad™ is designed for dermal soft tissue reconstruction of complex wounds, tissue resections and injuries from trauma
- Total addressable market size globally of US$350 million for the Myriad™ product
- Launched in US in early 2020, targeting European market launch for 2021
Soft tissue regeneration company Aroa Biosurgery Limited (ASX:ARX, ‘Aroa’ or the ‘Company’) is pleased to announce it has received European regulatory approval (CE Mark) for its Myriad™ product, which supports rapid tissue growth for dermal tissue reconstruction.
The approval allows Myriad™ to be commercialized in the European Union, where it can be used in cases including dermal soft tissue reconstruction of complex wounds, tissue resections and injuries from trauma. Aroa received formal notification of the approval on 29 July 2020 from its European notified body DEKRA Certification B.V.
Myriad™ is a highly perforated, thick, multi-layered Endoform® graft that is engineered to have a high volume and surface area with interstitial spaces that are easily and rapidly accessible to cells. It takes advantage of Endoform®’s bioscaffold, secondary molecules and vascular channels to support new tissue growth. Myriad™ grafts enable rapid vascularization and help build new tissue, which may lead to faster healing, recovery and hospital discharge.
Aroa anticipates European market launch of the product to occur in 2021.
Aroa received FDA 510(k) clearance for Myriad™ in June 2017, which led to first sales in early 2020 with a total estimated market size for the product globally of US$350 million.
“As Myriad™ was only launched in the US in early 2020, there is still significant potential for uptake of the product,” said Aroa Founder and CEO Brian Ward.
“The product is designed to be versatile and suitable for a wide range of use cases, and this CE Mark approval will only reinforce our ability to drive adoption and market share with Myriad™.”
Aroa has five existing commercial products cleared for sale in the US based on the Endoform® technology, which have been used in more than four million procedures targeting chronic wounds, hernia, soft tissue reconstruction.