Aroa Biosurgery

Market position

Aroa is an ASX-listed New Zealand biotechnology company in the soft-tissue regeneration and biosurgery market, supplying wound care and surgical reconstruction products to hospitals, surgical centres and clinicians. It targets the international biosurgery market, and its Endoform product had sold more than one million units in the United States as of 2015.

Aroa's products are built on a single proprietary platform, AROA ECM, an extracellular matrix sourced from ovine forestomach, which is configured into multiple formats spanning wound care, surgical reconstruction and hernia repair. The company describes its reinforced bioscaffold portfolio for complex hernia as addressing limitations of existing products. It holds FDA clearances, CMS reimbursement for an ECM-based product across sites of care, ISO 13485:2016 certification since 2011 and MDSAP certification covering the US, Canada, Australia and Brazil.

Technology

The AROA ECM platform is an extracellular matrix derived from ruminant/ovine forestomach that acts as a scaffold supporting the body's natural tissue repair processes. It is fabricated into multiple product configurations: dermal templates and restorative bioscaffolds (Endoform), surgical soft tissue bioscaffolds (Myriad Matrix), particulate and fenestrated forms (Myriad Morcells, Myriad Meshed), a combination cellular and tissue product blending AROA ECM with hyaluronic acid (Symphony), and reinforced bioscaffolds for hernia repair. The company also develops proprietary tissue processing and fabrication technology.

Go-to-market

Aroa combines a direct commercial organisation, including a US-based commercial team and general manager for US commercial operations, with distribution and development partnerships. TELA Bio, a Nasdaq-listed company based in Malvern, Pennsylvania, commercialises OviTex in the United States and Europe. Customer service and product enquiries are handled from the US office in San Diego.

Surgeons, clinicians, hospitals and surgical centres treating acute and chronic wounds, complex wounds, soft tissue reconstruction, and ventral hernia repair and abdominal wall reconstruction; end patients include those with diabetic and venous ulcers.

Geography

International headquarters are at 64 Richard Pearse Drive, Māngere, Auckland 2022, New Zealand, with a US office at 9155 Brown Deer Rd, Unit 2, San Diego, California. Products are commercialised in the United States and Europe, and the company's quality system certification covers the United States, Canada, Australia and Brazil. Employees are reported across Oceania, North America and Asia.

History

The company was founded in February 2008 as Mesynthes, based on the regenerative properties of ruminant forestomach extracellular matrix technology initially investigated by Dr. Brian Ward. It first contracted scientists from Industrial Research Ltd before building an internal development team. Endoform Dermal Template, its first product, was launched in the US by Hollister in 2013 following FDA clearance and CMS reimbursement. Its first commercial surgical product, a Reinforced Bioscaffold developed with Tela Bio, received FDA clearance in December 2014, with US clinical studies in ventral hernia repair and abdominal wall reconstruction beginning in May 2015. In early 2014 the company moved into a purpose-built Auckland facility, and in June 2015 Mesynthes was renamed Aroa Biosurgery to reflect a strategic focus on soft tissue repair and reconstruction. In 2018 Aroa reacquired Endoform Dermal Template and formed a joint venture around it, and expanded its quality system certification under MDSAP. The company is listed on the Australian Securities Exchange under the ticker ARX.