- 3D printed breast scaffolds to be made of RESOMER®
- Degradation of RESOMER® to match the growth of the patient’s own tissue for natural breasts
- Technology designed to improve quality of life for patients after breast reconstruction and augmentation
- Human clinical trials to commence later this year
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.
Evonik is one of the world leaders in specialty chemicals. The focus on more specialty businesses, customer-oriented innovative prowess and a trustful and performance-oriented corporate culture form the heart of Evonik’s corporate strategy. They are the lever for profitable growth and a sustained increase in the value of the company. Evonik benefits specifically from its customer proximity and leading market positions. Evonik is active in over 100 countries around the world. In fiscal 2018, the enterprise with more than 32,000 employees generated sales of €13.3 billion and an operating profit (adjusted EBITDA) of €2.15 billion from continuing operations.
About Nutrition & Care
The Nutrition & Care segment is led by Evonik Nutrition & Care GmbH and contributes to fulfilling basic human needs. That includes applications for everyday consumer goods as well as animal nutrition and health care. This segment employed about 8,200 employees, and generated sales of around €4.6 billion in 2018.
BellaSeno GmbH was founded in 2015 and is located on the BioCity campus in Leipzig, Germany. The Company is developing novel absorbable breast implants made by additive manufacturing (3D-printing). The Company has received substantial financial support from private investors as well as from the Saxony Development Bank (SAB) and the European Fund for Regional Development (EFRE). The company is thereby co-funded from tax resources based on the budget adopted by the members of Saxon State Parliament.
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.