Human clinical trials for technology aiming to improve the quality of life after breast reconstruction to begin later this year

Evonik, a specialist in biomaterials for implantable medical devices has signed an agreement for the use of a Resomer bioresorbable polymer for innovative breast implant technology with BellaSeno, a developer of 3D printed absorbable scaffolds.

BellaSeno will use Resomer in its Senella breast scaffold products with a proprietary additive manufacturing process. They are designed to be implanted after breast reconstruction, augmentation or revision surgery. The Resomer polymer features mechanical properties and a degradation profile that allows the scaffold to safely absorb at a rate that matches the formation of the patient’s own tissue. These scaffolds will be available in different sizes and shapes to match the patients’ needs.

The process avoids the use of silicone implants which are often associated with clinical risks such as capsular contracture and device complications such as rupture and deflation.

The first-in-human clinical trials of the Senella scaffolds with Resomer are scheduled to begin in Germany this quarter. Evonik will supply its Resomer polymer for clinical and commercial use under the agreement.

Jean-Luc Herbeaux, SVP and general manager of the health care business line of Evonik commented: “Evonik is pleased to be partnering with BellaSeno in the clinical development and commercialisation 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 commercialisation of innovative medical devices.”

Simon Champ, co-founder and chief executive officer of BellaSeno said: “BellaSeno is very excited to be working together with Evonik in this collaboration.

“The level of support provided by Evonik has been excellent.”