Newly-listed soft tissue regeneration company Aroa Biosurgery (ASX: ARX) has announced that its Symphony and Myriad complex wound healing products have gained clearance from international regulators.
Symphony has received approval from the US Food and Drug Administration, while Myriad received European regulatory approval via CE Mark certification.
Both approvals were confirmed by Aroa this morning and pave the way for US and European commercialisation.
Symphony regenerative healing
Symphony has been designed to support healing during the proliferative (or new tissue building) phase to reduce the time to wound closure, particularly in patients where healing is severely impaired or compromised due to disease.
Primary targets are conditions such as diabetic foot ulcers and venous leg ulcers where healing is impaired by other factors such as aging and smoking.
Symphony’s US FDA clearance substantially increases the total addressable market for Aroa’s product portfolio from $1.5 billion to more than $2.5 billion.
Chief executive officer Brian Ward said clearance allows for a commercial launch next year into the $1.15 billion US wound healing market.
“The approval of Symphony represents a major expansion in our product portfolio [and] is the next key step in our strategy to unlock regenerative healing for more patients,” he said.
“The product is applied as a graft and is surgically fixed at the margins, [giving] clinicians a new option to treat some of their most hard to heal patients.”
Symphony has been developed off the strength of Aroa’s proprietary Endoform extracellular matrix platform.
It combines Endoform with hyaluronic acid which is known to improve blood vessel formation, cell migration, collagen III production and reduce scarring, and which gels after rehydration to promote a moist healing environment.
The combined Endoform and hyaluronic acid is engineered into a highly-perforated, multi-layered device with a high volume and surface area which is rapidly accessible to cells.
The end product takes advantage of Endoform’s scaffold, secondary molecules and vascular channels to support new tissue formation with blood vessel regrowth.
“We expect Symphony to be particularly helpful in diabetic foot and venous leg ulcers which can be very difficult to heal,” Dr Ward said.
“These are conditions where there is a dysfunctional extracellular matrix, reduced cell proliferation and patients may have poor blood flow, immunity and sensation.”
As a cell and tissue-based product (skin substitute), Dr Ward said Symphony would require a unique reimbursement code within the US health system which is expected to be in place early next year.
Myriad supports rapid tissue growth
Myriad has been developed to support rapid tissue growth for dermal tissue reconstruction in complex wounds, tissue re-sections and trauma injuries.
Like Symphony, it is a highly-perforated, multi-layered Endoform graft engineered to have a high volume and surface area with interstitial spaces which are easily and rapidly accessible to cells.
It also takes advantage of Endoform’s bioscaffold, secondary molecules and vascular channels to help build new tissue which may lead to faster healing, recovery and hospital discharge.
Aroa received US FDA 510(k) clearance for Myriad in mid-2017, which led to first US sales earlier this year within a global addressable market of $487 million.
“Myriad is designed to be versatile and suitable for a range of uses and this CE Mark approval will only reinforce our ability to drive adoption and market share,” Dr Ward said.
“As it was only launched in the US a few months ago, [we believe] there is still significant potential for uptake of the product.”
Aroa has five Endoform-based commercial products cleared for sale in the US which have been used in more than 4 million procedures targeting chronic wounds, hernia, and soft tissue reconstruction.