Osteopore Limited (ASX:OSX) Secures EU MDR Approval for Custom Implants
Regulatory Approval
Osteopore Limited has secured European Union Medical Device Regulation (EU MDR) approval for its custom orthopaedic and cranial implants, complementing its previously approved off-the-shelf neurosurgical and craniofacial implants.
Market Opportunities
The EU MDR approval enables Osteopore to supply high-value customised implants in Europe, introducing new revenue streams. The European custom orthopaedic implant market is expected to grow at a CAGR of 3.3% by 2029, while the custom cranial implant market is projected to grow at a CAGR of 9.4% by 2030.
Executive Comments
CEO Dr Yujing Lim stated, “Securing European approvals for our custom orthopaedic and cranial implants is in step with our strategy to improve access to our high-value solutions.
“Custom cranial implant approval creates an opportunity to deepen our relationship with Zimmer Biomet, who now has access to our off-the-shelf and custom implant offering.
“Our custom orthopaedic implants have already demonstrated transformational effects on patients in earlier publications.
“With EU MDR approval, Osteopore can now boost the reach of our orthopaedic and cranial implants in Europe.”
Motley Fool contributor Kiarra Jackson has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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