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.
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/
i https://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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201216005360/en/
Investor Simon Hinsley Investor Relations shinsley@aroabio.com +
61 401 809 653
Media Australia Matthew Wright
matt@nwrcommunications.com.au +61 451 896 420
New Zealand Piet De Jong
piet.dejong@baldwinboyle.com +64 21 812 766
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