New U.S. Clinical Studies Provide Further Validation for Aroa Biosurgery’s Myriad™, as Products Also Approved for Use in India

New U.S. Clinical Studies Provide Further Validation for Aroa Biosurgery’s Myriad™, as Products Also Approved for Use in India




New U.S. Clinical Studies Provide Further Validation for Aroa Biosurgery’s Myriad™, as Products Also Approved for Use in India

HIGHLIGHTS

  • Further validation for Aroa’s Myriad™ from two clinical studies and peer-reviewed publications in Journal of Wound Care.
  • One study shows high success rates, from use of Myriad™ in tissue reconstruction after surgical treatment of Hidradenitis Suppurativa, an inflammatory skin condition affecting around 1% of the adult population.
  • A second study showed 100% success rates from use of Myriad™ when patients underwent surgical reconstruction of exposed vital structures such as bone and tendon, demonstrating the utility of Myriad™ for both implant procedures and dermal reconstruction and across a wide range of surgical procedures.
  • The national regulatory authority of India, the Central Drugs Standard Control Organisation (CDSCO), has approved Myriad™, Endoform® Natural and Endoform® Antimicrobial. India has significant market potential with a large volume of acute and chronic wounds and distribution expected to commence in second half of the 2021 calendar year.

AUCKLAND, New Zealand–(BUSINESS WIRE)–#aroabiosurgery–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 two studies published in successive months 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).

A 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.

The paper, 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 Maire-Claire Buckley (University of Minnesota, Minneapolis).

The study can be found online here https://www.magonlinelibrary.com/doi/abs/10.12968/jowc.2020.29.11.624.

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

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.

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, 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.

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

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 Organisation (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.

Authorised on behalf of the Aroa Biosurgery Board of Directors by Brian Ward, CEO.

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/


ihttps://onlinelibrary.wiley.com/doi/abs/10.1111/jdv.12966.

ii Bouazzi D, Chafranska L, Saunte DML, Jemec GBE. Systematic Review of 22 Complications and Recurrences After Surgical Interventions in Hidradenitis 23 Suppurativa. Dermatol Surg. 2020;46(7):914-921.

iii Ovadja ZN, Jacobs W, Zugaj M, van der Horst C, Lapid O. Recurrence Rates 25 Following Excision of Hidradenitis Suppurativa: A Systematic Review and 26 Meta-analysis. Dermatol Surg. 2020.

iv PLASTIC SURGERY STATISTICS REPORT, ASPS National Clearinghouse of Plastic Surgery Procedural Statistics 2019, American Society of Plastic Surgeons. https://www.plasticsurgery.org/documents/News/Statistics/2019/plastic-surgery-statistics-full-report-2019.pdf

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