Evonik, a global leader in biomaterials for implantable medical devices, and BellaSeno GmbH, a developer of 3D printed absorbable scaffolds, today announced the signing of a long-term agreement for the use of a RESOMER® bioresorbable polymer for an innovative breast implant technology.
BellaSeno will use RESOMER® in its Senella® breast scaffold products with a proprietary additive manufacturing process. Designed to be implanted after breast reconstruction, augmentation or revision surgery, the RESOMER® polymer features mechanical properties and a degradation profile that allow the scaffold to safely absorb at a rate that matches the formation of the patient’s own tissue. Scaffolds will be available in different sizes and shapes to match the patients’ needs.
In addition to enabling 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.
First-in-human clinical trials of the Senella® scaffolds with RESOMER® are scheduled to commence in Germany this quarter. Under the agreement, Evonik will supply its 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, SVP and General Manager of the 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.”
“BellaSeno GmbH is very excited to be working together with Evonik in this collaboration,” said Dr. Simon Champ, Co-Founder and Chief Executive Officer of BellaSeno. “The level of support provided by Evonik has been excellent.”
The Health Care business line, which is part of the Nutrition & Care segment of Evonik, serves more than 1,000 pharmaceutical, nutraceutical and medical device customers worldwide. Its portfolio of RESOMER® bioresorbable polymers, Endexo® surface modification technologies and application technologies services is a core element of the Health & Care growth engine, which helps drive Evonik’s profitable and balanced growth.