As part of the co-operation 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 World Health Organization (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 €76tn 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.
According to market researchers Frost & Sullivan, orthopaedics was the third largest sub-segment in medical technology worldwide in 2021.
According to scientific publications (such as Projections of Primary and Revision Hip and Knee Arthroplasty in the United States, Steven Kurtz et al.), the revision sector in the USA is expected to grow by at least 100% by 2030, starting from 2022. This means about 260,000 knee revisions and 100,000 hip revisions in 2030. In comparison, primary care is expected to be 8.5 million knee revisions and 2 million hip revisions in 2030.
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 co-operation 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.
Marc Lloret-Grau, chief executive officer of Bio-Gate AG, says: "The recently concluded contract is another important step for us to successively expand the medical technology business field into another growth driver in the Bio-Gate Group.
"Now that we have already concluded the second important co-operation agreement with a multinational medical device provider, we also want to push ahead with talks with implant manufacturers in the USA."