PERTH: Aroa Biosurgery Limited has received clearance from the U.S. Food and Drug Administration (FDA) for new product Symphony, which is designed to reduce the time to wound closure, particularly where patients have severely impaired healing or are compromised by other diseases.
Aroa Chief Executive Brian Ward said that following the FDA clearance, which was formally received on 30 July 2020, the company would now target a commercial launch in the U.S. for Symphony for 2021.
“The approval of Symphony represents a major expansion in our product portfolio. This is the next key step in our strategy to unlock regenerative healing for more patients. Our total addressable market for the entire Aroa product portfolio has grown dramatically from $1.5 billion to more than $2.5 billion in the U.S.
“Symphony will give clinicians a new option to treat some of their most hard to heal patients, in what we estimate is a U.S. market size of US$1.15 billion for the product,” says Dr Ward.
Aroa has five existing commercial products approved 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.
Aroa Biosurgery is a soft-tissue regeneration company that develops, manufactures, sells and distributes medical and surgical products to improve healing in complex wounds and soft tissue reconstruction.