U.S. Clinical Studies Help Further Validate Regenerative Treatment: Implications for Chronic Wounds

U.S. Clinical Studies Help Further Validate Regenerative Treatment Implications for Chronic Wounds

An investigational device for soft tissue reconstruction shows promise according to the results of a couple recent studies published in peer reviewed scientific journals. The sponsor, Aroa Biosurgery Limited (ASX: ARX), positions to the market that it’s investigation product Myriad™ gains momentum with two recent studies, one published in Journal of Wound Care, official journal of the European Wound Management Association (EWMA) and World Union of Healing Societies (WUWHS). With a focus on what can be a debilitating skin disorder called Hidradenitis Suppurativa, the study evidences the utility of the Myriad device covering implant procedures as well as derma reconstruction. With no material complications this approach could open up new treatment possibilities for those patients with the worst cases of Hidradenitis Suppurativa for example.

Hidradenitis Suppurativa: Stage III A Severe Situation

HS is a 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 population; Around 4% of HS patients are deemed to be severe cases (known as Stage III), which are difficult to treat and often require surgical excision; with resulting complications as high as 20% of cases.

What is Myriad?

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 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.

Some of the procedures where Myriad™ performed well are very high-volume procedures. For example, the American Society of Plastic Surgeons estimates there are 4.4 million tumor resections per annum and around 180,000 scar revision procedures each year in the US.

The Studies

One study published in the November 2020 edition of Journal of Wound Care 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. Titled “Extracellular Matrix Graft for the Surgical Management of Hurley Stage III Hidradenitis Suppurativa: A Pilot Case Series” was based on a study undertaken by Dr Abigail Chaffin (Tulane University, New Orleans) and Dr. Marie-Claire Buckley (University of Minnesota, Minneapolis).  The study can be read here

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.”

A Second Study

A second study, published in the December 2020 edition of the Journal of Wound Care 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 (opening of wound) and fistula

Approvals

On 9 December, Aroa also announced it has gained regulatory approval to introduce three products to the Indian market based on its Aroa ECM™ platform. The three products, Myriad™, Endoform® Natural and Endoform® Antimicrobial, have been approved under the ‘Medical Device Rules 2017’ by the national regulatory authority of India, the Central Drugs Standard Control Organization (CDSCO).

Aroa Biosurgery CEO Brian Ward says the regulatory approval is an exciting milestone for the company, given the scale of patient need in India.

“With more than 1.35 billion people, there is a high and continuing level of patient need in India. It is estimated that 20 million patients in India suffer from chronic wounds, with about 7 million suffering from diabetic ulcers. Introduction of the three products we now have approved for use will give a large number of people access to advanced wound care in a market where traditional wound care has been the primary treatment approach,” Mr. Ward says.

Aroa is targeting distribution of its products in India in the second half of the 2021 calendar year. The company is currently in discussions to appoint an experienced Indian distributor to manage a network of sub-distributors across the subcontinent.

About Aroa Biosurgery

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. Committed to ‘unlocking regenerative healing for everybody’, its products are developed from the Company’s proprietary Aroa ECM™ technology platform, a novel extracellular matrix biomaterial derived from ovine (sheep) forestomach. Clinically proven with peer reviewed publications, Aroa’s products have been used in more than four million procedures to date, with distribution into its key market of the United States by Appulse and Tela Bio. Founded in 2008, Aroa is headquartered in Auckland, New Zealand and is listed on the Australian Securities Exchange (ASX:ARX). www.aroabio.com/

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