• NovoSorb BTM accelerates healing of large post-surgical diabetes-related foot wounds
• Significant decrease in mean time to complete healing of wounds > 10cm2
• No significant difference observed in 12-month amputation rates

PolyNovo Limited (PolyNovo or the Company) has announced the results of a post-market investigator-initiated randomised controlled trial (RCT) for post-surgical diabetes-related foot wounds (Chronic Wound Study). The study, which started in April 2022 and was announced in the Company's Annual Reports from 2022 to 2025, compared the use of NovoSorb BTM combined with negative pressure wound therapy (NPWT) to the standard of care (SOC) consisting of NPWT alone. Between May 2022 and September 2024, a total of 64 participants were enrolled, 32 with NovoSorb BTM and NPWT, and 30 to SOC. The interim analysis showed that complete wound healing in all wounds at 12 months was observed in 66.7% of NovoSorb BTM-treated wounds compared with 56.5% of SOC, although this was not statistically significant. However, a subanalysis showed a significant decrease in the mean time to complete healing of wounds > 10cm2 in the NovoSorb BTM group (191 days) compared with the SOC group (319 days). There was no significant difference observed in 12-month amputation rates. The study concludes that large surface area wounds (> 10cm2) treated with NovoSorb BTM achieved significantly faster wound closure when compared with the SOC, positioning NovoSorb BTM as a useful device in the limited treatment options for post-surgical diabetes-related neuropathic / neuroischemic wounds.

The exciting results of this study support the growing body of evidence that the NovoSorb platform products are a significant addition to the treatment regime for diabetic related wounds and ulcers. A decrease of 'time to complete healing' of over 4 months is a huge benefit to the patient and health care system.