Osteopore Granted Swiss Market Approval for Custom Bioresorbable Implants

Regenerative medicine company Osteopore (ASX: OSX) has secured market approval in Switzerland for its off-the-shelf and custom-made biomimetic and bioresorbable implants.

Approval came under the European Union’s medical device regulations (MDR) and follows the company’s partnership with US orthopaedic solutions company Zimmer Biomet to distribute its craniofacial products in Europe, the Middle East and Africa, the Asia-Pacific region, Australia, and New Zealand.

The high-value implant range provides Zimmer Biomet with opportunities to offer high-value implants to the Swiss and greater European markets to complement its range of off-the-shelf neurosurgical and craniofacial implants.

Company Milestone

Osteopore chief executive officer Dr Yujing Lim said market approval was a significant milestone for the company.

“We are delighted to be in a position to support a coordinated approach to the European market, specifically in Switzerland, with Zimmer Biomet,” he said.

“Our team of regulatory professionals have been working hard to provide us with market authorisation and we are grateful for their leadership and support.”

Implant Market

Customised implants are the largest product segment of the European cranial implant market, which analysts forecast will grow to US$527.6 million by 2027.

Projections see the customised implant market growing to $26.7 billion by 2029, driven by an ageing population and rising demand for advanced devices that enhance mobility and decrease surgical recovery times.

The approval completes Osteopore’s product portfolio, strengthening support for the company’s market entry into Switzerland and across Europe.

Trade Agreements

Despite not being a member state, Switzerland participates in the European Union’s single market through a series of bilateral treaties and agreements.

Prior to the new MDR taking effect in May 2021, a 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, the EU classified Switzerland as a “third country” similar to the UK post-Brexit.

As a result, the nation implemented its regulations for all CE-marked medical devices.