Tampere-based Bioretec, a manufacturer of bioabsorbable orthopaedic implants, has reached two significant milestones in quick succession. The company has now sold more than half a million Activa implants worldwide. At the same time, Bioretec has received FDA 510(k) clearance for its new ActivaScrew™ Cannulated COM bioabsorbable compression screw. Pictures and video: Tapio Yliaho The company has previously received FDA clearance for its Activa and RemeOs products. FDA clearance enables the company to commercialise the new product in the United States. The newly cleared product, a headless compression screw, is better aligned with the preferences of U.S. surgeons than its predecessor. According to industry reports, the global market for bioabsorbable orthopaedic implants is estimated at approximately EUR 1.59 billion. Bioretec No need for implant removal surgery Orthopaedic implants are used in the surgical treatment of bone fractures. Bioretec’s Activa implants gradually biodegrade in the body over approximately two years. The product is based on a biodegradable PLGA material developed by the company. Traditionally, fractures have been treated surgically by fixing the bone with permanent or long-lasting metal implants, such as screws, plates, nails and pins made from materials including titanium and stainless steel. One of the drawbacks of metal implants is that, in many cases, they need to be removed later in a separate surgical procedure. A key advantage of biodegradable orthopaedic implants is that no separate removal surgery is required. This can also reduce the risks associated with additional surgery as well as healthcare costs. Children, in particular, can benefit from biodegradable implants, as the implant gradually disappears from the body and does not restrict bone growth. Half a million implants from Tampere to the world More than 500,000 Activa implants have now been sold in over 40 countries, and the products are in active use around the world. This milestone is backed by a strong safety record: no adverse events have been reported in the FDA’s MAUDE database. According to the company, 90% of surgeons who try the product continue using it after their first procedure. Reaching the milestone of half a million implants demonstrates that a Finnish health technology innovation can achieve a significant position in healthcare globally, says Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec. Bioretec is a Tampere-based company with roots dating back to 2003. The company was founded by Pertti Törmälä, Professor of Biomaterials Engineering at Tampere University of Technology. All of Bioretec’s products are developed and manufactured in Tampere at the company’s cleanroom facility in the Hankkio industrial area, from where they are shipped to customers around the world. The long-term commitment of Bioretec’s employees is reflected in the fact that 15.5% of the company’s current workforce have been working with Activa since the product was first launched in 2007. Bioretec’s products are developed and manufactured in Tampere and shipped to markets around the world. Chief Business Officer René Eve gives a tour of the company’s production facilities. Bioretec’s Chief Business Officer René Eve says that the company’s manufacturing technology is highly scalable, creating strong potential to expand production in Tampere. Read more about health technology companies in the Tampere region and opportunities in the U.S. market: Bioretec FDA clearance Tampere Health