Seven million strong: Aroa’s sheep-derived products hit medical use milestone
Health & Biotech
Health & Biotech
Special Report: New Zealand-based soft-tissue regeneration company Aroa Biosurgery has hit a key milestone with seven million of its products now used globally in a range of medical procedures.
It’s been a big journey for Aroa Biosurgery (ASX:ARX), which was founded in 2008 under the name Mesynthes, by CEO Dr Brian Ward.
With an interest in regenerative medicine, Ward, who is also a veterinarian, began to research suitable tissue alternatives after observing that New Zealand’s pasture animals were largely free from disease.
Aroa’s source material for its soft-tissue repair products is ovine forestomach matrix (sheep rumen) sourced exclusively from New Zealand, which provides a scaffold – or framework – for new tissue to build.
The forestomach matrix is processed and sterilised to remove DNA and cells, leaving the tissue scaffold called the extracellular matrix (ECM), which has a dense network of vascular channels, a similar structure to human skin and contains more 150 proteins known to be important in the healing process.
The company’s first product using its ECM technology was Endoform, a simple sheet form designed for chronic and acute wound care.
Endoform was identified as the most expedient route to both commercialisation and establishing a compelling clinical dataset to validate efficacy.
After receiving US Food and Drug Administration (FDA) clearance in 2010, Endoform was licensed to global medical products developer, manufacturer and marketer Hollister.
A milestone year for Aroa was 2013 with the company’s first peer-reviewed clinical paper published and a second regulatory clearance was received.
To date, more than 90 peer reviewed studies have been published, validating the efficacy of the company’s ECM technology.
In 2014, Mesynthes was renamed AROA, and the company also relocated from Wellington to Auckland, where it established a purpose-built manufacturing facility close to the country’s largest international airport.
In 2015 the company entered into a partnership with Nasdaq-listed TELA Bio to launch and distribute OviTex, for abdominal wall reconstruction and hernia repair, with several co-developed Ovitex products for hernia repair and breast reconstruction being launched since the partnership began.
In 2018, Aroa reacquired the licensing rights from Hollister to its Endoform product range and went on to establish its own direct sales team in the US.
Aroa’s first Myriad product, Myriad Matrix – an extracellular matrix graft, indicated for use in soft tissue reconstruction and complex wounds – received FDA clearance in 2019.
Since then, Aroa has grown and continues to grow its high-margin Myriad family of products, which continue to be a strong performer for the company.
In January Aroa announced publication of the first results from its Myriad Augmented Soft Tissue Reconstruction Registry (MASTRR), showing significant promise in treating high-risk lower limb reconstruction cases.
Results also demonstrated a cost difference of up to 195% compared to other commercially available dermal substitutes suggesting that Myriad can be a cost-efficient solution for complex lower-limb surgeries, where cost containment is a growing priority.
There is also a growing body of clinical evidence supporting Myriad in complex trauma procedures, including in combination with negative pressure wound therapy (NPWT).
Aroa hit the Aussie bourse during the Covid-19 pandemic in July 2020. The company continues to expand its product line with Symphony, a graft for complex non-healing diabetic and venous ulcers also receiving FDA clearance in 2020.
Aroa is currently undertaking an 18-month random controlled trial of Symphony with 120 patients assessing the product’s efficacy in treating diabetic foot ulcers.
Data from the multi-centre study is forecast to be published in CY25 and set to be an important catalyst in driving Symphony sales.
Aroa is also developing its Enivo platform, a new class of product, for managing tissue cavities (or dead space) created by surgical dissection or tissue removal at a surgical site.
Aroa now has regulatory approval in more than 50 countries with its products used in more than seven million procedures to date.
The company recently entered the South African market through a distribution agreement, while additional regulatory clearances were received for Lebanon, Vietnam and Saudi Arabia.
“Reaching seven million Aroa products used in clinical applications globally is a significant milestone, highlighting the trust our customers and partners place in our devices, and the difference our ECM technology can make to healing outcomes,” Ward said.
This article was developed in collaboration with Aroa Biosurgery, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.