— Successful initial treatment of pectus excavatum patient in Australia
— Data published in the European Journal of Plastic Surgery confirms Bellaseno’s novel approach in soft tissue engineering
BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced the publication of first-in-human data of its lead program Senella® in the European Journal of Plastic Surgery. In the trial, a 22-year old patient with severe pectus excavatum received a custom-made, 3D-printed, biodegradable and highly porous Senella® scaffold filled with autologous fat graft to correct her chest deformation.
The procedure was performed by Dr. Michael Wagels, Specialist Plastic and Reconstructive Surgeon at the Princess Alexandra Hospital and Senior Lecturer at the University of Queensland, in collaboration with Distinguished Prof. Dietmar Hutmacher, Queensland University of Technology.
The highly porous polycaprolactone implant was well tolerated by the patient and resulted in an excellent aesthetic outcome. The case study describes the first-in-human trial of soft tissue engineering to camouflage a pectus excavatum defect not reconstructable by conventional techniques.
Pectus excavatum is the most common congenital chest wall deformity. Customized silicone implants are routinely used to camouflage this deformity with good short-term and aesthetic outcomes. However, permanent implants are associated with a significant long-term risk of capsular contracture, migration and extrusion.
BellaSeno´s approach based on scaffold-guided tissue engineering (SGTE) provides a promising alternative to silicone or other permanent implants. The Company´s novel implants are fully absorbable and designed to ultimately result in natural tissue without permanent remnants of foreign material in the body.
“The initial first-in-human results of Senella demonstrate that our approach holds strong potential as an alternative to potentially risky silicone implants,” said Mohit Chhaya, PhD, Co-founder and CEO of BellaSeno. “We are currently preparing a larger Phase I clinical trial with Senella to hopefully confirm our tissue engineering concept in additional patients.”
“The outcome of this explorative first-in-human application is very satifying, both in terms of aesthetics and tolerability,” said Dr. med. Tobias Grossner, CMO of BellaSeno. “We are now determined to obtain further long-term clinical data from patients requiring breast reconstruction.”
BellaSeno GmbH was founded in 2015 and is headquartered on the BioCity campus in Leipzig, Germany. The Company is developing novel absorbable soft tissue and bone reconstruction implants made by additive manufacturing (3D-printing) under ISO 13485 certification. The Company 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 is thereby co-funded from tax resources based on the budget adopted by the members of Saxon State Parliament.
Senella® is a patented porous scaffold made of absorbable Polycaprolactone (PCL) containing highly-specialized topological and design features, which act as recipients for injected fat tissue isolated with a standard liposuction procedure. The implant is designed to get absorbed over a span of two years and to provide a stable platform for the injected fat tissue to mature, adapt to its environment and stabilize. The clinical end result is a natural soft tissue – without remnants of foreign material. Senella® therefore has the potential to alleviate the complications found in current breast reconstruction and augmentation approaches.