Additional Studies Planned for BellaSeno´s Resorbable Tissue Regeneration Scaffold

Additional, investigator-initiated clinical trials of BellaSeno GmbH’s novel regenerative scaffolds for bone reconstruction and chest-wall defects (pectus excavatum) will be conducted in Germany and Italy, respectively, the company announced today. BellaSeno received market authorization last year for its custom-made, resorbable bone and pectus excavatum scaffolds in Europe.

“We are excited that several European university hospitals have decided to evaluate our scaffolds in independent clinical trials. This will help us obtain further clinical evidence on our proprietary approach of treating both soft and hard tissue defects,” BellaSeno CEO Dr. Mohit Chhaya said. “The addition of real-world data will be beneficial for our planned market approval for off-the-shelf breast and bone reconstruction products in the U.S. and EU.”
 
The clinical pectus excavatum trial in Italy will enroll 10 patients total, with four subjects having already undergone surgery. While initial clinical use cases in Australia demonstrated promising outcomes last year, this is the first time that a fully resorbable sternal prosthesis is being used in Europe. For each patient, the prosthesis was individually designed and 3D printed using polycaprolactone, a proven medical material in use for decades (e.g., for resorbable suture material). The Italy trial will also consist of a two-year patient follow-up to assess the scaffold’s surgical outcome. 
 
After BellaSeno published initial clinical data for the scaffolds, four European university hospitals announced plans to set up independent, investigator-initiated studies to further investigate the company’s technology. One of the first sites—the Clinic for Trauma and Reconstructive Surgery at the University Hospital Heidelberg (Germany)—plans to initiate its trial this quarter under the lead of Professor Dr. med. Gerhard Schmidmaier, primary investigator. This study will include up to 20 patients with a two-year follow-up.
 
“We look forward to learning more about the scientific background of BellaSeno’s technology, especially how such a scaffold is being vascularized while it secures the position of the autologous bone graft in a large size defect,” Schmidmaier stated. “The initial results are promising, and as a team, we are committed to supporting these trials comprehensively. This technology has the potential to deliver a step change in the field of regenerative medicine, and we are eager to demonstrate the benefits it brings to patients with complex reconstructive needs.”
 
BellaSeno´s MDR-certified manufacturing platform is designed to meet the requirements of medical scaffolds ranging from soft tissue to bone and enables the production of both custom-made and off-the-shelf sterile medical implants.
 
BellaSeno GmbH was founded in 2015 and is headquartered on the BioCity campus in Leipzig, Germany, with a subsidiary in Brisbane, Australia. The company is developing novel resorbable soft tissue and bone reconstruction implants made by additive manufacturing (3D-printing) under ISO 13485 certification. BellaSeno has received substantial financial support from private investors as well as from the Saxony Development Bank (SAB), the European Fund for Regional Development (EFRE), Germany´s Federal Ministry of Education and Research (BMBF) and the Australian government. The company also has been co-funded from tax resources.