Syntellix receives important approvals for new product lines and for additional countries
Hanover, 12 March 2019.
- Following on from the European approval for its highly innovative StarFuse® product line, Syntellix has now successfully received product registration in Europe (CE Approval) for its CSc 4.8 ceramicised compression screw, the fifth approved implant category from the MAGNEZIX® range.
- Extensive product approvals have also been received for important growth markets outside Europe in Indonesia and Mexico.
- The number of operations performed daily in Germany using Syntellix implants has almost tripled within three months.
With European CE approval and the successful first launch of its new MAGNEZIX® StarFuse® product line, Syntellix AG, a leading developer and manufacturer of highly innovative, globally unique magnesium implants for orthopaedics and trauma surgery, has now received Europe-wide approval for its next product innovation. The new implant, called MAGNEZIX® CSc 4.8, represents the expansion – long-awaited by surgeons – of the MAGNEZIX® CS screw implant portfolio, which has been used successfully in many thousands of operations and resulted in maximum patient satisfaction. For the first time, the CSc 4.8 features a newly developed magnesium-based surface ceramicisation that is also completely bioabsorbable. Together with the larger diameters and longer dimensions (up to 70 mm) now available, the range of indications that can be handled or treated using MAGNEZIX® technology to the benefit of patients has been significantly broadened and now includes five product lines. Demand for the new magnesium implants is particularly high in the field of paediatric orthopaedics and surgery. Experts and orthopaedists from many countries around the world have also expressed great interest in this further development of the Syntellix product range. Something that is also reflected in the number of advance orders.
Last week, Syntellix AG also received extensive approval for its MAGNEZIX® implants in Mexico, North America's second most important market. After Bangladesh and Indonesia, where comprehensive approval was given in 2018, the highly innovative MAGNEZIX® products have now been approved in a third market characterised by the particularly high growth and size of ist population and the correspondingly promising market prospects. With respect to population size and the resulting patient potential, Indonesia and Mexico are currently two particularly important markets for Syntellix. In Indonesia, products have already been delivered and revenues generated, and the blanket rollout is scheduled for April of this year at a major congress in Solo City on Java.
Syntellix has not only made important progress in the area of approvals though. Following successful initiatives and activities by management to intensify marketing efforts and discourse with top surgeons, university clinics and key opinion leaders, the number of daily operations with Syntellix AG's innovative implants has almost tripled in just three months in the company’s home market of Germany alone.
In Singapore, the second market in which Syntellix has been operating for some time with its own sales force and application experts, the number of users has even increased ninefold within a short period of time. Syntellix products made of MAGNEZIX® are now in use there in all major internationally renowned clinics, including Mount Elizabeth Orchard, Mount Elizabeth Novena, Gleneagles and Raffles.
Syntellix is an internationally operating medical technology company with headquarters in Hannover, Germany, that is undergoing dynamic growth. The company specialises in the research and development and marketing and sales of highly innovative transformable metallic implants. Products made from the company’s patented MAGNEZIX® are unique. In a widely acclaimed publication, they were evaluated as being superior clinically to the titanium implants commonly used. The implants break down in the body and are transformed into the body's own bone tissue, and in doing so offer an ideal combination of stability, elasticity and bioabsorbability.
Syntellix is the world's market and technology leader in the field of bioabsorbable metallic orthopaedic implants and has already been honoured with numerous important awards and prizes. In Germany these include the German Business Innovation Award 2012/13, the Future Award 2016 of the German healthcare industry, the German Medical Award 2017, the STEP Award 2017 and the Innovator of the Year 2017 award; internationally the implants were a winner in the Product of the Year category of the Sustainability Award 2018 program.