German additive manufacturing start-up BellaSeno has announced the signing of a long-term agreement for the use of speciality chemical company Evonik’s RESOMER bioresorbable polymer to create a new breast implant technology.
RESOMER will be used in BellaSeno’s 3D-printed Senella breast scaffold. The product is designed to be used after reconstruction, augmentation and revision surgery, and is progressively resorbed by the body and replaced with natural breast tissue.
This avoids the use of silicone implants and their associated complications such as capsular contracture, rupture and deflation. Patients will also be able to avoid going through the process of having their implants replaced every ten to 15 years, as is standard with most commercial types of breast implant.
Scaffolds will be available in multiple sizes and shapes to match the needs of individual patients.
First-in-human trials of Senella scaffolds with RESOMER are scheduled to commence in Germany before the end of 2019.
Evonik health care business line general manager Dr Jean-Luc Herbeaux said: “Evonik is pleased to be partnering with BellaSeno in the clinical development and commercialization of their innovative, 3D-printed breast implant technology.
“Senella breast implant scaffolds can potentially enhance the quality of life of millions of patients worldwide who undertake surgical procedures each year. This agreement underlines the ability of Evonik to leverage the safety and versatility of RESOMER polymers, together with our advanced application technology services, to support customers in the commercialization of innovative medical devices.”
BellaSeno received ISO 113485 certification in July 2019, making it one of only a handful of companies worldwide to offer integrated contract additive manufacturing of implants under a medical device-specific quality standard.
BellaSeno co-founder and CEO Dr Simon Champ said: “BellaSeno GmbH is very excited to be working together with Evonik in this collaboration.”