66.7% Healing Rate with NovoSorb BTM vs 56.5% Standard Care in Diabetes Trial
PolyNovo’s NovoSorb BTM, combined with negative pressure wound therapy, significantly accelerates healing of large post-surgical diabetic foot wounds, according to new clinical trial data.
- Randomised controlled trial comparing NovoSorb BTM plus NPWT to standard care
- 66.7% complete healing at 12 months with NovoSorb BTM vs 56.5% standard care (not statistically significant)
- Significant reduction in healing time for wounds larger than 10cm² (191 vs 319 days)
- No significant difference in 12-month amputation rates
- Potential impact on outpatient adoption and US reimbursement policies
Clinical Trial Context
PolyNovo Limited has unveiled promising results from a post-market randomised controlled trial investigating the efficacy of its NovoSorb BTM dermal scaffold in treating complex diabetic foot wounds. Conducted between May 2022 and September 2024, the study enrolled 64 participants with neuroischemic diabetic foot wounds, comparing NovoSorb BTM combined with negative pressure wound therapy (NPWT) against NPWT alone, the current standard of care.
Key Findings and Significance
While the overall complete healing rate at 12 months was higher in the NovoSorb BTM group (66.7%) compared to standard care (56.5%), this difference did not reach statistical significance. However, a deeper dive into the data revealed a compelling benefit for larger wounds exceeding 10cm². In this subgroup, wounds treated with NovoSorb BTM healed significantly faster; averaging 191 days versus 319 days with standard care, a reduction of over four months.
This accelerated healing timeline is particularly meaningful given the challenges and limited treatment options for post-surgical diabetic foot wounds, which often lead to prolonged patient suffering and increased healthcare costs. The study did not find a significant difference in amputation rates at 12 months, suggesting that while NovoSorb BTM improves healing speed, it does not necessarily impact limb salvage outcomes within the study period.
Implications for Patients and Healthcare Systems
Acting CEO Dr Robyn Elliott highlighted the clinical importance of these findings, noting that a reduction in healing time by several months can substantially benefit both patients and healthcare providers. Faster wound closure reduces the risk of complications, lowers the burden on healthcare resources, and improves quality of life for patients managing chronic diabetic wounds.
Chairman David Williams pointed to the potential commercial impact, especially in the United States, where changes to Medicare reimbursement policies are anticipated in early 2026. Positive clinical evidence like this could facilitate broader outpatient adoption of NovoSorb BTM, enhancing market penetration and revenue growth for PolyNovo.
Looking Ahead
The full results will be presented at the upcoming Australian & New Zealand Society of Vascular Surgery conference in Adelaide, offering the medical community a closer look at the data. PolyNovo’s ongoing investment in expanding indications and markets for its innovative wound care technology positions the company well to capitalize on this momentum.
Bottom Line?
NovoSorb BTM’s proven speed advantage in healing large diabetic wounds could reshape treatment standards and market dynamics.
Questions in the middle?
- Will further studies confirm NovoSorb BTM’s impact on amputation rates over longer follow-up?
- How will US reimbursement changes influence NovoSorb BTM’s commercial uptake?
- What are the prospects for NovoSorb BTM’s application in other complex wound types?
