Bioretec passes 500,000 Activa implants sold, wins FDA clearance for ActivaScrew

Bioretec has sold more than 500,000 Activa implants worldwide and secured FDA 510(k) clearance for its ActivaScrew Cannulated COM, clearing the way to market the headless compression screw in the United States.

The newly cleared ActivaScrew is designed to better match U.S. surgeons' preferences than its predecessor. The company previously won FDA clearance for its Activa and RemeOs lines, and the latest approval enables commercialization of the new screw in the U.S. The clearance continues a recent trend of Tampere health-technology companies winning U.S. 510(k) approvals, following three local startups earlier this year that won 510(k) clearances. Industry estimates put the global market for bioabsorbable orthopaedic implants at about EUR 1.59 billion.

Activa implants are made from a proprietary biodegradable PLGA material and are designed to dissolve in the body over roughly two years, avoiding a second operation to remove metal fixtures. They are particularly valuable for children, where a disappearing implant can reduce restrictions on bone growth and lower the risks and costs tied to removal surgery.

The Activa range has been used in more than 40 countries and more than 500,000 implants have been sold, with no adverse events recorded in the FDA's MAUDE database. Nine in ten surgeons who try the product continue to use it after their first procedure, a retention figure the company cites as evidence of clinical acceptance.

"Reaching the milestone of half a million implants demonstrates that a Finnish health technology innovation can achieve a significant position in healthcare globally," said Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec. René Eve, chief business officer, added that the company's manufacturing technology is highly scalable and creates strong potential to expand production in Tampere, noting all products are developed and manufactured at the cleanroom facility in the Hankkio industrial area.

Founded in 2003 by Pertti Törmälä, professor of biomaterials engineering at Tampere University of Technology, the firm says long-term staff commitment is high: 15.5% of its current workforce have worked with Activa since the product launch in 2007. It plans to use the FDA clearance and scalable manufacturing to pursue growth in the large U.S. market.