Highlights:
- U.S. sales: A$41.2m, a 27.9% increase from A$32.2m in the same period last year (STLY).
- Rest of World sales: A$12.9m, up 28.6% from A$10.0m, driven by growth in the UK/Ireland, Spain, Germany, Turkey, and Hong Kong.
- First-time sales achieved in Malta, Portugal, and Peru.
- Total Group Revenue: A$59.9m, up 22.8% from A$48.8m STLY.
- FDA engagement confirms readiness to submit PMA approval application for NovoSorb®.
A Transformative Half-Year
PolyNovo Limited (ASX: PNV) has delivered impressive trading results for the first half of FY25, with significant growth in both U.S. and international markets. Total group revenue, including contributions from Biomedical Advanced Research and Development Authority (BARDA) projects, reached A$59.9m, a robust 22.8% increase from the prior period.
Expanding NovoSorb® Applications
Swami Raote, PolyNovo’s CEO, highlighted the company’s focus on expanding the NovoSorb® platform from its core application in treating burns to broader plastic and reconstructive surgery:
“We’re healing patients and achieving positive outcomes at more than twice the rate of our revenue growth. Our innovation is driving meaningful differentiation across a broad spectrum of plastic and reconstructive procedures.”
The company’s NovoSorb® Biodegradable Temporizing Matrix (BTM) and related products are finding increasing applications in dermal regeneration and surgical reconstruction, with development underway for breast sling, hernia, and orthopedic solutions.
Regulatory Progress
PolyNovo also announced a successful meeting with the FDA, where it was determined that the company has sufficient data to submit a Premarket Approval (PMA) application for NovoSorb®. Work is now underway to compile and submit the necessary materials.
Looking Ahead
The company plans to release its audited 1H FY25 results on 24 February 2025. With its strong sales performance and regulatory advancements, PolyNovo is well-positioned for continued growth in the advanced wound care and reconstructive surgery markets.
About PolyNovo®
PolyNovo is a leading medical device innovator specialising in Advanced Wound Care and Dermal Regeneration solutions. Its patented NovoSorb® polymer technology supports a range of applications, including burns, breast slings, hernia repair, and orthopedic uses.