Aroa Biosurgery's Breakthrough: Real-World Evidence Validates Endoform's Efficacy in Treating Venous Leg Ulcers

The treatment of venous leg ulcers (VLUs) has long been a challenge in wound care, with limited therapies demonstrating consistent efficacy in real-world settings. However, Aroa Biosurgery (ASX:ARX) has achieved a critical milestone with the publication of a landmark study validating its Endoform Natural® product in a head-to-head comparison against conventional treatments. This real-world evidence (RWE) study, published in the International Wound Journal in 2025, not only underscores Endoform’s clinical superiority but also positions Aroa as a leader in advanced wound care innovation.

The Groundbreaking Study: Endoform Outperforms Competitors

The study, titled “Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers”, compared ovine forestomach matrix (OFM, Endoform Natural®) to collagen/oxidised regenerated cellulose (ORC) in 551 patients across outpatient wound care centers. Key findings include:

1. Closure Rates:
2. Endoform-treated ulcers achieved significantly higher closure rates at 24 and 36 weeks compared to ORC.

3. By 36 weeks, 68% of Endoform-treated ulcers were fully closed versus 52% for ORC (p = 0.003).

4. Time to Healing:

5. Median time to closure was 11.1 weeks for Endoform versus 12.3 weeks for ORC (p = 0.045).

6. A 40% higher probability of healing was observed with Endoform in Cox proportional hazards analysis.

7. Subgroup Analysis:

8. For complex cases requiring ≥8 applications of wound care products, Endoform outperformed ORC with statistically significant closure rates at all time points (p < 0.01).

These results, derived from a real-world, pragmatic design, reflect Endoform’s effectiveness in heterogeneous patient populations—often excluded from traditional randomized controlled trials (RCTs)—including those with diabetes, cardiovascular disease, and large ulcers.

Market Context: A Growing Demand for Advanced Wound Care Solutions

The venous leg ulcer treatment market is booming, driven by rising prevalence of chronic wounds, aging populations, and healthcare advancements. By 2025, the global market reached $4.30 billion, growing at a 7.5% CAGR, and is projected to hit $5.68 billion by 2029 (). Key growth drivers include:
- Compression therapy innovations: Dominating 40% of the market, with smart devices and AI integration.
- Biosynthetic materials: Like Endoform’s OFM, which mimic human tissue to accelerate healing.
- Emerging markets: Asia-Pacific, where diabetes and urbanization are fueling demand.

Aroa’s Endoform Natural® and Endoform Antimicrobial® are well-positioned to capitalize on this growth. The product’s large-format variant (8.5x6 inches), launched in 2025 for U.S. and Canadian markets, addresses larger ulcers and expands its use in negative pressure wound therapy (NPWT).

Financial Performance: A Strong Foundation Amid Volatility

Despite macroeconomic headwinds, Aroa has demonstrated resilience. In the first half of 2025, the company reported:
- 25% increase in product sales, driven by its Myriad line (a 45% surge, accounting for 38% of sales) with an 87% gross margin.
- Maintained annual revenue guidance of NZD 80–87 million ().

However, the stock faced volatility in early 2025, dropping from $0.80 to $0.42 amid concerns over delayed breakeven timelines. By mid-2025, it rebounded to $0.46, reflecting analyst optimism about its 92.6% undervaluation relative to fair value estimates.

Why This Study Matters for Investors

The 2025 study is a paradigm shift for Aroa:
1. Clinical Validation: It provides the first large-scale, real-world evidence of Endoform’s superiority, countering skepticism from prior RCTs.
2. Market Differentiation: With closure rates 16% higher than ORC, Endoform strengthens Aroa’s position against competitors like Smith & Nephew and Convatec, which dominate conventional wound care.
3. Cost Savings: Faster healing (median 11.1 weeks) reduces long-term healthcare costs, a key factor for insurers and governments.

Conclusion: Aroa’s Momentum in Wound Care Innovation

The publication of this real-world study marks a pivotal moment for Aroa Biosurgery. With Endoform demonstrating 40% higher healing probability, faster closure times, and robust performance in complex cases, the product is poised to capture a larger share of the $5.68 billion venous leg ulcer market.

Financially, Aroa’s strong gross margins (87% for Myriad) and maintained revenue guidance signal sustainable growth. While near-term volatility persists, the 92.6% undervaluation and expanding product pipeline (e.g., large-format Endoform) suggest significant upside potential.

For investors, Aroa represents a compelling opportunity in a high-growth, underserved market. As healthcare systems prioritize cost-effective, evidence-based solutions, Endoform’s clinical and economic benefits position Aroa as a long-term winner in advanced wound care.

Final Note: Monitor Aroa’s Q4 2025 earnings report and regulatory approvals in new markets for further catalysts. With the venous ulcer market projected to grow at 7% annually, the time to act may be now.