• Osteopore secures market approval in Switzerland under the European Union (EU) Medical Device Regulation (MDR)
• The approval follows Osteopore's successful transition to MDR in 2023 and partnership with Zimmer Biomet in 2024
• The approval of Osteopore's off-the-shelf and custom-made implants strengthens support for market entry into Switzerland and across Europe

Osteopore Limited (ASX: OSX), an Australian-Singaporean regenerative medicine company, has announced that it has secured market approval for Switzerland. Switzerland participates in the EU's single market through a series of bilateral treaties and agreements, despite not being a member state. Prior to the EU's new Medical Device Regulation (MDR) taking effect on 26 May 2021, the Mutual Recognition Agreement (MRA) enabled the trade of CE-marked medical device products between the EU and Switzerland. In the absence of a renewed MRA covering CE-marked medical devices under the MDR, Switzerland was classified as a 'third country' similar to the UK post-Brexit. Following Osteopore's successful transition to the MDR in 2023, the Company struck an exclusive agreement with Zimmer Biomet (NYSE and SIX: ZBH), to distribute its MDR-approved craniofacial products in Europe, the Middle East and Africa (EMEA), Asia Pacific (APAC), Australia and New Zealand. Subsequently, Osteopore secured additional market approvals for its custom-made implants used in neurosurgery and orthopaedic surgery. Osteopore's additional custom-made neurosurgery implants, together with its off-the-shelf products, provide Zimmer Biomet with a complete suite of products to approach the Swiss and European markets. The cranial implant market in Europe is expected to reach USD527.6 million by 2027, the largest product segment being customised implants.