The role of clinical studies in developing synthetic bone grafts
The significance of clinical evaluation in the development of medical devices has risen profoundly in Europe during recent years. As a result of the new Medical Device Regulation (EU) 2017/745, clinical investigations have become mandatory for certain implantable or high-risk products when applying for the CE marking.
Data provided by clinical investigations plays an essential role in clinical evaluation to demonstrate safety and efficacy of a new medical device. This is a considerable change in the field of implantable medical devices as conducting clinical investigations is extremely expensive and time-consuming.
Supported with funding from the European Innovation Council (880 897 – Adaptos), Biomendex has built a strong team of competent personnel, clinical and industrial partners as well as experienced clinicians to plan and execute clinical trials to produce products for the expanding bone graft market.
On-going clinical study: Adaptos® bone grafts in oral & maxillofacial area
The first clinical study with Adaptos® bone grafts has started, and the first patients were operated on in June 2021. Sponsored by the Research Institute Orton, the study is conducted in collaboration with Oral Dentists/ Qmedical, Planmeca, and Biomendex.
The study focuses on evaluating the efficacy and safety of Adaptos® bone grafts indicated for the treatment of oral and maxillofacial bone defects in adult patients. The aim is to recruit a total of 175 patients to collect large scale data about Adaptos® in human patients.
Bone substitutes are commonly used in the treatment of oral and maxillofacial bone defects to prevent bone loss and to regenerate bone tissue. Typical applications in the oral & maxillofacial area for bone substitutes are filling of bone cavities, for instance after tooth or cyst removal, or reconstruction of bone tissue in sinus lifts. The use of bone substitutes in this application contributes both to functionality and cosmetics by preventing bone loss in the mandible and ensuring successful tooth implant attachment.
In the pipeline: Adaptos® bone grafts in orthopedic area
The second clinical study with Adaptos® bone grafts is in the pipeline. Biomendex is the sponsor of the study that aims to evaluate the efficacy and safety of Adaptos® bone grafts in orthopedic indications.
The innate capacity of bone tissue to heal after trauma without scar formation is unique compared to other tissues. Yet the bone tissue is the second most common tissue transplant after blood transfusion. In fact, a bone graft or a bone substitute is used in over 4 million operations every year to treat more severe bone defects.
The range of available bone grafts and bone substitutes is still missing an optimal synthetic material that can compete with autograft bone with respect to usability, efficacy, and safety. Adaptos® bone graft is designed to support and aid bone formation when the damaged tissue needs additional support to heal and regenerate.