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PolyNovo Secures Key Regulatory Approvals for NovoSorb MTX Expansion

Story Highlights
  • PolyNovo has received FDA clearance for NovoSorb MTX up to 6 mm, enhancing its use in surgery.
  • NovoSorb MTX is now approved for marketing in Australia and importation in India, expanding its reach.
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PolyNovo Secures Key Regulatory Approvals for NovoSorb MTX Expansion

Polynovo Limited ( (AU:PNV) ) has issued an announcement.

PolyNovo Limited has achieved significant regulatory milestones for its NovoSorb MTX product line, receiving FDA 510k clearance in the U.S. for up to 6 mm thickness with new indications for tunneled/undermined wounds. This clearance is expected to enhance the product’s versatility in managing deep soft tissue defects and expand its use in plastic and reconstructive surgery. Additionally, NovoSorb MTX with a 2 mm thickness has been approved for marketing in Australia and for importation in India, broadening its market presence. These developments are poised to strengthen PolyNovo’s position in the medical technology industry and provide new opportunities for growth, particularly benefiting plastic surgeons and healthcare professionals.

More about Polynovo Limited

PolyNovo is a disruptive ASX 200 medical technology company based in Melbourne, Australia. The company specializes in products that simplify the management of acute complex wounds, offering differentiated patient outcomes across various wound etiologies. With over 67,000 patients treated in 46 countries, PolyNovo is focused on growth through new products, indications, and market expansion.

YTD Price Performance: -23.94%

Average Trading Volume: 3,870

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $542.4M

Find detailed analytics on PNV stock on TipRanks’ Stock Analysis page.

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