HIGHLIGHTS
- U.S. FDA clearance received for a new Aroa Biosurgery product Symphony™, designed to support healing during the proliferative phase to reduce the time to wound closure, particularly in patients where their healing is severely impaired or compromised due to disease.
- Product targets reduced closure time for conditions such a diabetic foot ulcers and venous leg ulcers, and where healing is impaired by other factors such as aging and smoking.
- The approval of Symphony™ and pending launch in 2021 presents a major expansion in Aroa’s product portfolio in the U.S.
- Aroa’s total addressable market for its entire product portfolio increases substantially from $1.5 billion to more than $2.5 billion.
Soft tissue regeneration company Aroa Biosurgery Limited (ASX:ARX, ‘Aroa’ or the ‘Company’) 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.
The product is designed to support the ‘proliferative’ phase of healing to reduce the time to wound closure. It is applied as a graft and is surgically fixed at the margins.
Symphony™ has been developed off the strength of Aroa’s proprietary extracellular matrix (ECM) platform – Endoform®.
“We expect Symphony™ to be particularly helpful in diabetic foot ulcers and venous leg ulcers which can be very difficult to heal. These are conditions where there is a dysfunctional extracellular matrix, reduced cell proliferation and patients may have poor blood flow, immunity and sensation,” Dr Ward said.
Symphony™ combines Endoform® and hyaluronic acid and is engineered into a highly perforated, multi-layered device with a high volume and surface area which is rapidly accessible to cells. It takes advantages of Endoform®’s scaffold, secondary molecules and vascular channels to support new tissue formation with blood vessel regrowth.
The hyaluronic acid in Symphony™ gels after rehydration and helps to maintain a moist healing environment. Hyaluronic acid is also known to improve blood vessel formation, cell migration, collagen III production, and reduce scarring.
As a cell and tissue-based product (skin substitute), Symphony™ will require a unique reimbursement code within the U.S. health system. This is expected to be in place by 2021.
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.
Their success in market comes off the back of validation from peer reviewed publications as well as past and ongoing clinical studies. Aroa has regulatory clearance in more than 37 countries and a deep patent portfolio.
“We’re excited to continue to leverage the healing potential from our core Endoform® platform and develop new applications which will help clinicians treat those people with the wounds which are hardest to heal,” said Dr Ward.
