Born from biomaterials research in Tampere, Bioretec has grown into an international medical technology company whose bioabsorbable orthopaedic implants are used around the world. With more than 500,000 Activa implants sold in over 40 countries and new FDA clearances opening opportunities in the United States, the company is entering a new phase of international growth – while keeping its product development and manufacturing in Tampere.
A Tampere innovation addressing a global healthcare challenge
Orthopaedic implants such as screws, plates, nails and pins are commonly used to stabilise bone fractures. Traditionally, many of these implants have been made from permanent metals such as titanium or stainless steel.
While effective, metal implants can create another challenge: in some cases, they need to be removed in a second surgical procedure. Tampere-based Bioretec has developed another approach.
The company’s Activa implants are made from its bioabsorbable PLGA material and gradually degrade in the body over approximately two years. This means a separate implant removal operation can be avoided, potentially reducing surgical risks and healthcare costs.
The technology can be particularly beneficial in paediatric orthopaedics, as a bioabsorbable implant disappears over time rather than remaining in the body as the child’s bones continue to grow. Today, this technology developed in Tampere is being used around the world.
More than 500,000 implants from Tampere to over 40 countries
Bioretec has now sold more than 500,000 Activa implants in over 40 countries, marking an important milestone in the company’s international growth.
According to the company, 90% of surgeons who try the product continue using it after their first experience. Bioretec also reports that no adverse events related to the product have been recorded in the US Food and Drug Administration’s MAUDE database.
“Reaching the milestone of half a million implants demonstrates that a Finnish health technology innovation can achieve a significant position in international healthcare”
Sarah van Hellenberg hubar-fisher, ceo of bioretec
The company’s ambitions extend considerably further. Industry reports estimate the global market for bioabsorbable orthopaedic implants at approximately €1.59 billion. The United States represents an important opportunity within this growing market.
FDA clearance opens new opportunities in the United States
Bioretec has already received FDA clearances for products in its Activa and RemeOs portfolios. Its latest milestone is FDA market clearance for the ActivaScrew™ Cannulated COM, a bioabsorbable cannulated compression screw. The clearance enables Bioretec to commercialise the new product in the United States.
Importantly, the product has been designed to respond more closely to the preferences and clinical practices of US surgeons, strengthening Bioretec’s offering in one of the world’s most important medical technology markets.
The combination of an established international customer base, multiple FDA clearances and a growing product portfolio gives the company a foundation for its next phase of international expansion.
Bioretec’s roots are in Tampere research
Bioretec’s story began in Tampere. The company was founded in 2003 by Pertti Törmälä, Professor of Biomaterials Engineering at Tampere University of Technology. Its roots are therefore closely connected to the region’s long-standing expertise in biomaterials, medical technology and engineering. More than two decades later, that connection remains.
All Bioretec products are developed and manufactured in Tampere, at the company’s cleanroom production facility in the Hankkio industrial area. From there, the implants are shipped to healthcare providers around the world.
The continuity of the company’s expertise is also visible in its workforce. Around 15.5% of Bioretec’s current employees have worked with the Activa product since its launch in 2007. This combination of scientific expertise, specialised manufacturing and accumulated industry knowledge provides a strong foundation for further growth.
Scaling global growth from Tampere
For international health technology companies, successful growth requires more than developing an innovative product. Manufacturing also needs to be able to respond as demand increases.
According to Bioretec’s Chief Business Officer René Eve, the company’s manufacturing technology is designed to be readily scalable. That creates opportunities to increase production in Tampere as Bioretec expands internationally.
The company’s journey demonstrates how research expertise can develop into commercial technology, international exports and scalable manufacturing within the same region.
From its origins in Tampere’s biomaterials research to more than half a million implants used internationally, Bioretec has already taken Finnish health technology to more than 40 countries. With an expanding product portfolio and new opportunities opening in the United States, the next stage of that journey is taking shape – from Tampere to global healthcare.
Bioretec in brief
- Founded: 2003
- Headquarters: Tampere, Finland
- Industry: Health technology and orthopaedic implants
- Technology: bioabsorbable orthopaedic implants
- Global reach: more than 500,000 Activa implants sold in over 40 countries
- US market: FDA clearances for products in the Activa and RemeOs portfolios
- R&D and manufacturing: Tampere, Finland
- Growth opportunity: scalable manufacturing capacity in Tampere
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Text: Katriina Istolahti & Anna Ryhänen. Video & Photos: Tapio Yliaho