Adaptos® clinical study started with Hospital Orton, Oral and Planmeca
Posted on 11.06.2021 by Biomendex
The first clinical study with Adaptos® bone grafts has started, and the first patients were operated on in beginning of 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.
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. This is a considerable change in the field of implantable medical devices as conducting clinical investigations is extremely expensive and time-consuming.
The start of the clinical study is a major breakthrough for Biomendex and culmination of long preparation phase. Biomendex has built a strong team of competent personnel, clinical and industrial partners as well as experienced clinicians to plan and execute the required studies. Once the clinical performance has been proven by the this randomized and controlled clinical study, Biomendex expects to start the sales of Adaptos® products for oral and maxillofacial indication by the end of 2022.