BellaSeno GmbH, a Leipzig-based medical technology company developing resorbable scaffolds using additive manufacturing technologies, today announced the start of two clinical trials in Australia. It's about implants, the remedy for funnel chest (pectus excavatum) create or replace silicone implants.
Ten patients are expected to participate in the first study pectus excavatum (pectus excavatum), a common congenital chest wall deformity where the sternum is sunken into the rib cage. Director of studies is Dr. Michael Wagels, Director of the Herston Biofabrication Institute (HBI), Consultant in Plastic and Reconstructive Surgery at Princess Alexandra Hospital, Director of the Australian Center for Complex Integrated Surgical Solutions (ACCISS) and Senior Lecturer at the University of Queensland. BellaSeno published initial human data back in 2021 showing that the implant is capable of repairing a defect in the pectus excavatum to conceal, which cannot be reconstructed with conventional techniques.
The second study is expected to enroll 20 patients who require either breast implant revision or surgery to correct congenital breast defects. The principal investigator for the second study is Prof. Owen Ung, Director of the Comprehensive Breast Cancer Institute (CBCI), Consultant Breast Surgeon at the Royal Brisbane and Women's Hospital and Professor of Surgery at the University of Queensland, Australia.
In both studies, patients will receive porous polycaprolactone implants that are manufactured in Bellaseno's AI-driven additive manufacturing facilities using a non-contact process. This innovative production system was developed in 2021 together with the Fraunhofer Institute for Production Technology IPT (Aachen), funded by the BMBF as part of "KMU-innovativ". Polycaprolactone has been used in healthcare as an absorbable suture material for decades.
After the implants have been inserted in a compressed form using a minimally invasive procedure, the structure unfolds and is then transplanted with the patient's own fat tissue obtained through liposuction. Within up to five years, the polycaprolactone scaffold is completely absorbed and replaced by fat cells, leaving no permanent residue of foreign material in the body. This so-called scaffold-guided tissue reconstruction is a promising alternative to silicone implants or other permanent implants.
"This study is a very important step for us to show that our approach is not only safe, but also results in significant improvements in long-term safety, health and quality of life," said Dr. medical Tobias Grossner, CMO of BellaSeno. "We very much hope that the studies will once again validate our concept of scaffold-supported tissue reconstruction."
“It is important to us that patients have access to healthier alternatives to permanent implants. There is a strong demand for the restoration of a completely natural breast tissue with no potentially risky remnants in the body. We believe that BellaSeno's solutions can play an important role in meeting these needs,” added Prof. Owen Ung, principal investigator of the breast study.
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