HyProtectTM- Focus on the antimicrobial covering of revision implants for knee and hip care in human medicine, and Aesculap can start the regulatory approval process for individual implants Broad international scope of cooperation.
FREMONT, CA: Bio-Gate AG, one of the providers of innovative technologies and individual solutions specifically for health and hygiene, has signed an extensive cooperation contract with Aesculap AG, one of the leading suppliers of implants, and a subsidiary of B. Braun, for the antimicrobial coating of revision implants for hip and knee systems. The agreement also comprises an option for using the HyProtect™ coating technology in other application parts.
The cooperation contract is internationally oriented and is based on several years of trustworthy collaboration between Bio-Gate and Aesculap on various coating projects. In recent years, companies have successfully collaborated and worked together on various studies. This includes a published osseointegration study, in which the healing process of the bone ingrowth in implants in human bone was investigated. Throughout the study, the HyProtect™ coating demonstrated excellent bone ingrowth performance.
The basis for this cooperation was the successful fulfillment of the preliminary development project for applying the HyProtect™ coating on Aesculap implants. After finishing of regulatory approvals, Bio-Gate will coat Aesculap's implants. The cooperation agreement will contribute significant growth to Bio-Gate's coating business.
More than 60 single patient human cases have been completed - validating the high antimicrobial effectiveness and quality of Bio-Gate's coating. The implants were initially used in orthopedic revision surgeries for patients with a high risk of infection. In all cases, up till now, the patients have remained free of infection. This is critical for the healing process in these patient groups since re-infections can lead to amputations or even pose life-threatening consequences. Further clinical studies to confirm the clinical evidence are planned.
Besides human medicine, Bio-Gate is also coating veterinary implants. In recent years, above 60,000 dogs have been successfully treated with antimicrobial HyProtect™ coated implants. The overall infection rate was below 0.4 percent. In regular practice, infection rates of up to 20 percent are not uncommon.
Similarly, the cooperation partners' key focus is to reduce the risk of infection for patients substantially. With the definitive agreement in place, Aesculap can now start the approval process for individual implants.