Remplir Regulatory Application for US$750m EU-UK Market
Filed with ASX · · 3 pages · English
• Orthocell has submitted its application to the British Standards Institution (BSI) seeking approval to commercially distribute Remplir™ into the US$750 million1 EU and UK nerve repair market, comprising an estimated 500,000 surgical repairs of peripheral nerves per year. • Regulatory approval expected to be received in 3Q CY26. • Orthocell requires certifications, known as “CE” and “UKCA”, from
Earlier from Orthocell
- First Commercial Sales of Remplir Achieved in Hong Kong
- Remplir™ Nerve Sparing Prostate Cancer Surgery Commercial Opportunity Gathers Momentum with ~100 Surgeries Now Performed with Multiple Surgeons Nationwide
- Remplir gains momentum in nerve-sparing prostate surgery
- 2nd Distributor in Canada, Entire $75m Market Now Covered
- Remplir Launches in Hong Kong with First Surgical Case
Later from Orthocell
- Orthocell Hits US Milestone - 100 Remplir Units Sold.
- Orthocell Posts Seventh Straight Record Revenue Quarter
- Quarterly Activity Report & Appendix 4C
- US Market and Operational Update
- Orthocell Receives $3.0m R&D Tax Refund
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