Osteopore secures European approval for custom orthopaedic and cranial implants

Australian-Singaporean regenerative medicine company Osteopore Limited (ASX: OSX; Osteopore or the Company) – a global leader in 3D-printed biomimetic and bioresorbable implants – is pleased to announce that the Company has secured market approvals for its custom orthopaedic and cranial implants in Europe.

Osteopore has secured European Union Medical Device Regulation (EU MDR) approval for its custom orthopaedic and cranial implants to complement its previously approved off-the-shelf neurosurgical and craniofacial implants.

Osteopore’s exclusive distribution agreement with Zimmer Biomet – coupled with EU MDR regulatory clearance – positions the Company to supply high-value customised orthopaedic and cranial implants to the European market.

Additionally, Osteopore can provide off-the-shelf neurosurgical and craniofacial implants to the European market, unlocking new revenue streams for the Company.

By 2029, the European custom orthopaedic implant market is expected to grow at a CAGR of 3.3% with the market size expected to reach US$15.96 billion , which is primarily driven by an aging population and rising demand for advanced orthopaedic devices that enhance mobility and decrease recovery times.

The US$368.7 million European custom cranial implant market is projected to grow at a CAGR of 9.4% by 2030, which is mostly driven by the increased prevalence of cranial surgeries due to road accidents, sports injuries, and conditions such as brain tumours.

Commenting on the significance of EU MDR approvals in the context of Osteopore’s European expansion, CEO Dr Yujing Lim, said: 

“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,” said Dr Lim.