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Bio-Gate Concludes Orthopedic Coating Contract & Other Supplier News

Here’s what was new in the world of medical device suppliers during the week of July 3.

Bio-Gate AG, a provider in the field of innovative health technologies, has concluded a contract with a multinational medical device manufacturer for the coating of orthopaedic implants in human medicine. As part of the cooperation and the joint project management, Bio-Gate is responsible for the application engineering and the production of the HyProtect coating and also supports the regulatory approval of the implants. 

Infections with multi-resistant germs continue to be a major threat to people worldwide. The number of newly approved, more effective antibiotics has fallen by over 80 % since the 1980s, and at the same time the incidence of multi-resistant germs in hospitals has risen massively. Currently, the WHO speaks of 700,000 deaths annually in connection with antibiotic-resistant germs. If nothing is done in this context, the WHO predicts 10 million deaths and costs for the health system of 76 trillion euros for the year 2050. 

Especially in the field of implant revisions, complications in the form of implant-associated infections and inflammations are associated with sometimes life-threatening consequences for the patient and extremely high costs for the healthcare system.

Numerous scientific publications have shown that Bio-Gate's HyProtect antimicrobial coating technology is able to kill multi-resistant germs. Since 2013, more than 110 people worldwide (Germany, Switzerland, Australia, New Zealand, UK, USA) have successfully received HyProtect-coated implants in the form of custom-implants and compassionate care cases (healing trials). So far, four scientific publications on individual cases have been published. Currently, scientists and surgeons are working on the collected publication of several cases from Germany as well as Australia and New Zealand.

The existing database on the HyProtect technology as well as the successful outcome of the single patient cases in particularly at-risk patients are key elements for the cooperation agreement with the multinational implant manufacturer. The customer, together with Bio-Gate, is in the process of preparing the regulatory approval documents. Good progress is already being made on the regulatory side. In addition to the remuneration for the project management and the coatings, Bio-Gate will also receive licence payments once the implants have been launched on the market.

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