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Orthocell LtdASX: OCC

Investor Presentation - US FDA 510(k) Clearance for Remplir

Apr 3, 2025 at 10:44 PM EDT · Issued by Orthocell Ltd

Filed with ASX · Apr 3, 2025 at 10:44 PM EDT · 21 pages · English

On 6ix: 6ix.com/news/investor-presentation-us-fda-510k-clearance-for-remplir

Orthocell Ltd on 6ix

In the deck

  • Orthocell — Investor Presentation (April 2025)21 slidesApr 4, 2025

Story so far

  • US FDA Application Submitted for Remplir as US Launch NearsDec 19, 2024
  • Major Milestone with First Sales of Remplir in SingaporeDec 12, 2024
  • Outstanding Remplir Study Results Pave Way for FDA ClearanceDec 2, 2024

Earlier from Orthocell

  • First Sales of Striate in Germany, Austria & Swiss RegionMar 25, 2025
  • Regulatory approval to commence Striate sales in SingaporeMar 17, 2025
  • S&P DJI Announces March 2025 Quarterly RebalanceMar 7, 2025
  • Orthocell Receives $3.18 million R&D Tax RefundJan 19, 2025
  • Third Consecutive Quarter of Record Revenue for OrthocellJan 7, 2025

Later from Orthocell

  • Regulatory Approval for Striate in US$65M Brazilian MarketApr 8, 2025
  • First US Distributors Signed for Remplirs US$1.6B marketApr 23, 2025
  • Remplir Approved to Commence Sales in US$84M Thai MarketApr 27, 2025
  • Pause in TradingApr 29, 2025
  • Replacement Trading HaltApr 29, 2025
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