The Senella breast scaffold product, which is designed to be implanted after breast reconstruction, augmentation or revision surgery, progressively resorbs as it is replaced by the formation of natural breast tissue. The process avoids the use of silicone implants, which are associated with clinical risks such as capsular contracture and device complications such as rupture and deflation. The scaffolds are printed in various sizes and shapes to suit patient anatomies and needs.
The first clinical trials of the Resomer-based Senella scaffolds are scheduled to begin in Germany before the end of the year. Under the terms of the agreement, Evonik will supply the Resomer polymer for clinical and commercial use.
“Evonik is pleased to be partnering with BellaSeno in the clinical development and commercialization of their innovative, 3D-printed breast-implant technology,” said Dr. Jean-Luc Herbeaux, Senior Vice President and General Manager of Evonik’s Health Care business line. “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,” said Herbeaux.
BellaSeno received ISO 113485 certification in July 2019, as reported in PlasticsToday. It is one of only a handful of companies worldwide to offer integrated contract additive manufacturing of implants under the ISO quality management standard specific to medical devices.