BellaSeno GmbH, a medtech company specializing in the development of resorbable scaffolds through additive manufacturing, has announced the commencement of two clinical trials in Australia. These trials focus on the use of resorbable implants for the treatment of pectus excavatum, a congenital chest wall deformity, and for breast implant revision or correction of congenital breast defects.
The first trial targets 10 patients with pectus excavatum, led by Dr. Michael Wagels, a renowned plastic and reconstructive surgeon. The second trial aims to enroll 20 patients requiring breast implant revision or congenital defect correction, under the guidance of Prof. Owen Ung, a leading breast surgeon.
Patients in both trials will receive porous polycaprolactone implants, produced using AI-driven additive manufacturing. These implants are designed to be absorbed by the body within up to 5 years, leaving behind natural tissue without any permanent foreign material. This innovative approach, known as scaffold-guided tissue reconstruction (SGTR), offers a promising alternative to traditional silicone or permanent implants.
The primary focus of the trials is to assess the safety of the devices during and after surgery, with secondary endpoints including the rate of adverse events, changes in fat volume, soft tissue retention, pain levels, and quality of life improvements.
Dr. Tobias Grossner, CMO of BellaSeno, emphasized the importance of these trials in demonstrating the safety and effectiveness of their approach, aiming for significant improvements in long-term safety, health, and quality of life for patients. Dr. Wagels and Prof. Ung both highlighted the potential of these resorbable implants to provide safer alternatives to current surgical materials and techniques, emphasizing the benefits of leaving behind only the patient's natural tissues.
BellaSeno's efforts are supported by substantial financial backing from private investors and government entities, reflecting the potential impact of their work on the future of soft tissue and bone reconstruction.
