• Aroa focused on expanding clinical evidence to support use of its ECM products in soft tissue repair
  • Aroa expands Myriad Registry, the company’s largest prospective study to date
  • Interim results of Symphony for complex non-healing diabetic and venous ulcers expected in Q4 CY24

 

Special Report: Soft tissue repair company Aroa Biosurgery is continuing to advance clinical evidence supporting efficacy of its extracellular matrix (ECM) products, recently achieving two clinical milestones as it continues to invest in R&D.

Aroa Biosurgery (ASX:ARX) is focused on expanding clinical evidence supporting use of its ECM products in soft tissue repair with various trials underway, including expansion of its Myriad Registry – the company’s largest prospective study to date.

The Myriad Registry is evaluating Myriad Matrix and Myriad Morcells in a range of lower limb salvage, colorectal and trauma procedures.

Myriad Matrix is an extracellular matrix graft, indicated for use in soft tissue reconstruction and complex wounds.

Myriad Morcells is a morcellised version of Myriad Matrix that conforms to optimise contact with irregular wound beds.

In April 2024, ARX announced the initial target of 300 patients across 10 different US-based sites had been reached.

The company has now decided to extend the Myriad Registry to 800 patients across 15 sites. ARX expects to report on Myriad’s use in limb salvage in 130 patients in H1 FY25.

Two further studies assessing Myriad in trauma procedures are expected to be published later in FY25.

One of these studies will examine the use of Myriad with negative pressure wound therapy (NPWT).

Preliminary experience suggests that Myriad in combination with NPWT may accelerate healing, reduce interventions and pain.

ARX anticipates that Myriad will offer numerous benefits in trauma procedures, including improved healing quality and speed, as well as advantages from a health economics standpoint.

In release of its FY24 results recently ARX reported Myriad was a strong performer for the company.

ARX reported a 73% increase (70% on cc basis) in full-year Myriad product revenue to NZ$23.3m with active accounts growing by 31% to 218.

Morgans healthcare analyst Scott Power says he expects sales of Myriad to continue to be strong.

“ARX has growth coming for its key product Myriad (biological graft for dermal and implantable soft tissue reconstruction eg trauma, tumour removal) which we expect will represent 43% of revenue in FY25,” Power says.

 

Sheep-derived products

Founded in 2008 by veterinarian Dr Brian Ward, the company’s CEO and MD, ARX’s source material for its growing range of soft tissue repair products is ovine forestomach matrix (sheep rumen) sourced exclusively from New Zealand, where pasture animals are largely free from disease.

The forestomach matrix is processed and sterilised to remove DNA and cells, leaving the tissue scaffold (ECM) which has a dense network of vascular channels, a similar structure to human tissue, and contains more than 150 proteins known to be important in the healing process. AROA ECM acts  as a scaffold, providing s a framework for new tissue to build.

ARX has regulatory approval in more than 50 countries.

Due to their high price, biologic products have traditionally been rationed for use only in complex procedures.

However, ARX has identified ways to improve the manufacturing process, lowering the cost of producing these types of products, enabling more patients to access the benefits of regenerative healing.

 

Study of Symphony to treat diabetic foot ulcers

ARX is currently undertaking an 18-month random controlled trial of its Symphony products – a graft for complex non-healing diabetic and venous ulcers –  with its target of ~120 patients enrolments reached in June.

Interim reporting based on the first 60 patients is expected during Q4 CY24 and final reporting in Q2 CY25.

Symphony is designed for use in the outpatient wound care centre setting and combines ARX’s ECM with hyaluronic acid.

Due to its high affinity for water retention, hyaluronic acid plays an important role in keeping wounds moist which aids in healing and is included in many wound repair products.

It is designed to support healing during the proliferative phase, where cells are multiplying or increasing in numbers, to reduce time to wound closure.

“Symphony is particularly aimed at patients whose healing is severely impaired or compromised due to disease,” Ward says.

Ward says data from the multicentre study will be an important catalyst in driving Symphony sales.

ARX is forecasting positive operating cash flows in FY25. The company expects to end FY25 with a normalised EBITDA profit of NZ$2-6m.

 

 

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.

Read MoreHealth

Featured Companies

You might be interested in