Joint implant stirs up growing interest around the world
TUT’s Laboratory for Biomaterials and Tissue Engineering has special expertise that gives us a head start over our competitors,” says Tuija Annala, CEO of Scaffdex Ltd that brought RegJoint to the market.
More and more surgeons in Europe are opting for RegJoint developed at TUT when they are looking for affordable and biodegradable finger or toe joint implants for patients living with osteoarthritis or rheumatoid arthritis.
The biodegradable RegJoint implant is an innovation born out of research conducted in the Laboratory for Biomaterials and Tissue Engineering at TUT. The implant improves the range of motion of small joints in the hands and feet. It is made from a polylactide copolymer that has been processed into fibre.
RegJoint offers an alternative not only to permanent metal and silicone implants but also to metal screws, which hold the bones in alignment while they grow together but alter the anatomy of the limb.
“The RegJoint implant is inserted within the joint capsule of the affected finger or toe and is gradually replaced by the patient’s own fibrous tissue. The implant is soft and sponge-like, allowing new tissue to grow within the pores of the material. It acts as a scaffold that guides the growth of cells and keeps the space between the bone ends open. The implant restores mobility to the affected digit and speeds up recovery,” says Tuija Annala, CEO of Tampere-based Scaffdex Ltd.
Successful commercialization process
Scaffdex Ltd is actively seeking to enter new markets with RegJoint.
”We received CE Mark approval for the commercial sale of RegJoint in the EU in autumn 2011 and introduced the product to the Finnish and German markets. We’ve doubled our annual turnover in Germany since 2012, and RegJoint is already used throughout Europe and in Turkey. Now we’re poised to enter the Hong Kong market. The implant is undergoing registration in Israel, and we’re exploring the possibility to expand into the US market,” Annala says.
A new minimally invasive procedure whereby a damaged joint at the base of the thumb is surgically replaced with an implant through small skin incisions has generated a great deal of interest among surgeons in Central Europe. According to Annala, some of them are already operating on patients using RegJoint.
Scaffdex is looking to quintuple sales and increase staff numbers from the current three to ten over the next five years. The company depends on cash flow to finance growth and is not seeking external investments.
“Our strategy is to maintain close collaboration with universities.”
The RegJoint implant is inserted within the joint capsule of the affected finger or toe and is gradually replaced by the patient’s own fibrous tissue.
Uniform quality and cost-effective production
The joint implant has been successfully brought to the market but continues to be further developed. Now Scaffdex Ltd and TUT are involved in a two-year Bio-PolyTec project.
Bio-PolyTec is a business-driven EU project, which TUT has joined due to its expertise in the melt spinning of biodegradable fibres.
“We’re developing real-time measurement technology that allows product quality to be monitored during, rather than after, polymer processing,” says Project Manager and Researcher Elina Talvitie. She is part of the Laboratory for Biomaterials and Tissue Engineering in the Department of Electronics and Communications Engineering at TUT.
The online monitoring of product quality will reduce scrap rates, improve batch-to-batch consistency and save time. The project partners have set their sights on tripling the production rate of the polymer fibre.
“This will increase delivery reliability and help us keep costs down, so that RegJoint remains an affordable option for as many patients as possible,” Annala says.
”If the online monitoring system works well, it can also be used in the polymer processing industry in general. We’re generating and disseminating new knowledge to propel the entire biotechnology industry forward,” Talvitie adds.
In addition to Scaffdex and TUT, the Bio-PolyTec project brings together a German company that specializes in real-time measurement technology and Irish, British and Dutch companies that develop medical polymers and bioactive ceramic materials. The project partners also include Queen’s University Belfast from Northern Ireland and the Institute of Technology Sligo from Ireland. EU has awarded one million euros of funding for Bio-PolyTec, which was launched in late 2013.