HIGHLIGHTS
- Aroa’s Myriad™ is further validated in a clinical study and peer-reviewed publication – Journal of Wound Care.
- Study shows 100% success rates from use of Myriad™ when patients underwent surgical reconstruction of exposed vital structures such as bone and tendon.
- Demonstrates utility of Myriad™ for both implant procedures and dermal reconstruction and across a wide range of surgical procedures.
- All patients in the study healed well with a zero rate of complications.
Soft tissue regeneration company Aroa Biosurgery Limited (ASX:ARX, ‘Aroa’ or the ‘Company’) has gained further validation for Myriad™, a device for soft tissue reconstruction, with a new study published in a leading peer reviewed scientific journal, Journal of Wound Care, official journal of the European Wound Management Association (EWMA) and World Union of Wound Healing Societies (WUWHS).
The study showed 100% healing when Myriad™ was used in six surgical reconstructions of soft tissue defects with exposed vital structures and included a variety of different wound types; e.g. full thickness scalp excision, scar revision surgery, tumor (squamous cell carcinoma) excision, traumatic wound, surgical dehiscence, and fistula.
The paper, in the Journal of Wound Care, titled “Extracellular Matrix Graft for Reconstruction Over Exposed Structures: A Pilot Case Series” was based on a study undertaken by Dr Abigail Chaffin (Tulane University, New Orleans) and Dr Gregory Bohn (Central Michigan School of Medicine).
The study can be found online at https://www.magonlinelibrary.com/doi/full/10.12968/jowc.2020.29.12.742.
Dr Chaffin, Associate Professor of Surgery and Program Director of the Tulane University Plastic Surgery Residency Program said “the study showed how the Myriad™ device can be effectively used for both implant procedures and dermal reconstruction across a wide range of different surgical procedures. All patients healed well with no complications and no infections were reported, even when Myriad™ was used in a contaminated field.”
Soft tissue loss, whether from disease, trauma, injury or surgical intervention often exposes underlying tendon or bone, referred to as ‘vital structures’ and may also include veins, arteries or nerves.
“Surgical reconstruction in these instances aims to provide coverage to these exposed structures as they are critical to normal function and are at risk of significant complications, e.g. infection or desiccation. At the same time, reconstruction of missing or damaged dermal tissues over vital structures can be challenging, as the vital structures typically have relatively low blood supply,” Dr Chaffin said.
Aroa’s Vice President of Research and Clinical Development, Dr Barnaby May said the study findings show why dermal matrices, like Myriad™ have become an accepted part of the ‘reconstructive ladder’ that includes a number of different surgical techniques the surgeon may use to reconstruct missing soft tissue to get coverage over exposed vital structures.
“Some of the procedures where Myriad™ performed well are very high-volume procedures. For example, the American Society of Plastic Surgeonsi estimates there are 4.4 million tumor resections per annum and around 180,000 scar revision procedures each year in the US, so it is very positive to see this proven efficacy and absence of complications,” Dr May said.
Myriad™ is a highly perforated, multi-layered extracellular matrix (ECM) graft engineered to have a high volume and surface area with interstitial spaces that are easily and rapidly accessible to cells. It takes advantage of the Aroa ECM™ bioscaffold technology, including important 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.
Earlier pre-clinical studies have shown that the Aroa ECM™ technology includes over 150 different components known to aid wound repair, blood vessel formation and attract stems cells.
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. In late July this year it was approved for commercial use in the European Union by European notified body DEKRA Certification B.V.
“This latest study showing the effectiveness of Myriad™ on exposed vital structures follows closely on the heels of a clinical study published last month showing the effectiveness of Myriad™ in the surgical treatment of serious cases of the inflammatory skin condition hidradenitis suppurativa and further demonstrates the many surgical applications for Myriad™,” said Aroa Founder and CEO Brian Ward.
Aroa has five commercial products approved for sale in the US based on its ECM technology, which has been used in more than four million procedures targeting chronic wounds, hernia, soft tissue and breast reconstruction. Aroa has regulatory clearance in more than 37 countries.
