HIGHLIGHTS
- Further validation for Aroa’s MyriadTM from clinical study and peer-reviewed publication in Journal of Wound Care.
- Study shows high success rates, from use of MyriadTM in tissue reconstruction after surgical treatment of Hidradenitis Suppurativa, an inflammatory skin condition affecting around 1% of the adult population.
- All patients in the study reported no complications or recurrences at long term follow up (~3+ to 12+ months).
Soft tissue regeneration company Aroa Biosurgery Limited (ASX:ARX, ‘Aroa’ or the ‘Company’) has gained further validation for MyriadTM, a device for soft tissue reconstruction, with a new study published in a leading peer reviewed scientific journal, Journal of Wound Care. The study showed 100% healing when Myriad™ was used in eight surgical reconstructions to address inflammatory skin condition Hidradenitis Suppurativa (HS). No major complications were reported out to three months, or longer.
The paper, titled “Extracellular Matrix Graft for the Surgical Management of Hurley Stage III Hidradenitis Suppurativa: A Pilot Case Series” was based on as study undertaken by Dr. Abigail Chaffin (Tulane University, New Orleans) and Dr. Maire-Claire Buckley (University of Minnesota, Minneapolis).
Journal of Wound Care is the official journal of both the European Wound Management Association (EWMA) and the World Union of Wound Healing Societies (WUWHS).
Dr Chaffin, Associate Professor of Surgery and Program Director of the Tulane University Plastic Surgery Residency Program said “the study demonstrated the utility of the Myriad™ device for both implant procedures and dermal reconstruction, with no significant complications reported and offers a potential solution for people suffering the most serious cases of Hidradenitis Suppurativa.”
HS is a skin condition where the tissue becomes highly inflamed, and often involves infected lesions, particularly in the groin and armpit areas. It is estimated to affect around 1% of the adult populationi. Around 4% of HS patients are deemed to be severe cases (known as Stage III)ii, which are difficult to treat and often require surgical excision; with resulting complications as high as 20% of cases.iii
Aroa’s Vice President of Research and Clinical Development, Dr Barnaby May said the study findings show that Myriad™, a unique engineered extra-cellular matrix (ECM) graft for soft tissue reconstruction and complex wounds, is effective in the surgical treatment of HS and for reducing surgical complications.
“In the study, all patients who underwent surgical reconstruction for Stage III HS using Myriad™, either as an implant or for regeneration of the dermis, healed well and only one minor complication was reported. Equally important, for such a painful and debilitating condition, all patients reported no complications or recurrences at long term follow up after three months or more,” said Dr May.
Myriad™ is a highly perforated, thick, multi-layered ECM 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 Aroa’s 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. Pre-clinical studies have shown that Aroa’s ECM technology includes over 150 different components that are 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.
“Myriad™ is still in the relatively early stages of commercial distribution, and validation through this clinical study and peer reviewed publication will support uptake of Myriad™ in the treatment of serious cases of HS which has a debilitating impact on people suffering from this condition,” said Aroa Founder and CEO Brian Ward.
The study can be found online at https://www.magonlinelibrary.com/doi/abs/10.12968/jowc.2020.29.11.624
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.
