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Since 1995
Bioteck has been producing equine-derived medical devices thanks to the application of an innovative enzymatic deantigenation system, potentially applicable to any kind of heterologous tissue. This makes it possible to produce superior quality and extremely technologically advanced surgical solutions, to simplify physicians' work and improve patients' lives
This is the year the company's corporate structure change. The investments in research, development and communication increase thanks to the increase in capital from new shareholders. The company obtains the CE marking for Bio-Gen®, Biocollagen® and Osteoplant®. The National Institute of Health declares that the medical devices manufactured by Bioteck comply with the European regulations of reference for medical devices.
Bioteck obtains the certifications ISO 9001 and ISO 13485. These certify that Bioteck's quality system complies with the strictest international standards of reference.
The new Tissue Processing Laboratory is set up in Turin. This facility becomes the new production facility of Bioteck devices as well as the new research and development site. The new facility covers two floors for more than 2000 square meters, of which 250 occupied by cleanrooms. There, new generation machinery is modified or entirely developed by Bioteck to carry out the various processes on animal tissue according to strict quality specifications applicable to implantable devices. With the start of research at the new premises, Bioteck pursues new types of products such as bone paste and the innovative and unique Flex series: bone grafts that, at first rigid, are made flexible through a special electrolytic de-mineralization process. Thus a flexible, therefore unique, bone substitute can be obtained, that offers remarkable operative advantages to the surgeon when being positioned.
The Vicenza headquarters is significantly expanded. The corporate headquarters is expanded and a more capacious warehouse is built to deal with the ever increasing demands form the market. A high standard IT system is also implemented for processing orders and managing deliveries, for better coordination between the various premises.
A new medical device is developed, the membrane in pericardium Heart® which in the same year obtains CE certification by the National Institute of Health. The membrane in pericardium is successfully employed in all fields of application of Bioteck products: Orthopedics, Dentistry and Neurosurgery. In the same year the company obtains the ANVISA certification for Brazil.

The enzymatic process of elimination of antigens is optimized, patented and registered under the name of Zymo-Teck®. The production process enters a further engineering stage to effectively deal with the increasing demand for bio-materials that Bioteck receives from all over the world

The certification process continues and leads the company to being a landmark for regenerative surgery in an ever growing number of foreign countries. It is in fact awarded the prestigious Korean KFDA certificate and contacts with the FDA intensify for obtaining authorizations for exporting to the USA. The company's growth is also embodied by the inauguration, at the Turin premises, of the brand new Production and R&D Center: 750 square meters on 3 floors especially outfitted for organizing events and training courses for customers and trade partners. In addition to that, the number of personnel employed at the scientific and regulatory affairs department is increased and significant investments are made to develop new research projects at the new Research and Development Department.

After the inauguration of its new Production and R&D Center, Bioteck organizes a first series of residential training courses attended by over 200 participants. The company is confirmed as one of the most innovative ones in the sector not just by variety and quality of the products but also for its policies. It becomes in fact the only Italian biomaterial manufacturer completely open to the public, opening the doors of its production facility and laboratories to visitors from all over the world, giving them a chance to have a firsthand look at the strict quality tests all Bioteck products undergo. With a view to utmost transparency and professionalism.
In the same year Bioteck differentiates its offer of regenerative solutions for surgeons by launching on the market 3 Synt®, its first synthetic line based on beta-tricalcium phosphate.

The offer of products and instruments for improving surgical practice in Orthopedics, Neurosurgery and Oro-Maxillo-Facial surgery is further widened. Awayr® is announced, the innovative perfusion system able to saturate any type of porous biomaterial with biological fluids or solutions: an effective answer to the risk of permanence of air in biomaterials imbibed in a traditional manner. At the same time, the offer of biomaterials for regenerative surgery is enriched with the launch of the new edition of Calcitos®, slow resorption equine origin bone substitute obtained by thermal treatment. 
Bioteck has a presence in over 70 countries, where it is able to rely on qualified and prestigious commercial partners. New market opportunities open in India, South America and Middle East and regulatory activities continue to obtain FDA and CFDA certifications for United States and China.


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