2023-10-04  〉RENOLIT SE, an initial seed round investor of the Inovedis GmbH, participated in a series A funding round totaling 4 million € that has been closed today. The Inovedis GmbH is a medical technology start-up that aims to simplify surgical procedures and improve patient outcomes. The company developed an innovative surgical technique for rotator cuff repair based on a new implant system called SINEFIX^™. The SINEFIX implants, produced by RENOLIT Healthcare of medical grade PEEK™, received FDA clearance in 2023.

The recent funding will be used to support the commercial launch of the SINEFIX^™ implant system in the United States where more than 1 million rotator cuff surgeries are performed each year. It will also go towards sponsoring the clinical trial taking in Germany to generate data needed in support of CE marking and expansion of sales into Europe.

The SINEFIX^™ innovative surgical technique

“The SINEFIX surgical technique will shorten the procedure time and potentially improve the tendon to bone fixation while using less implants,” says Stefan Welte, inventor of SINEFIX and co-founder. “This is due to the higher pull-out forces than double row fixation with suture anchors allowing the implant to be used in porous bones. This simplified technique is designed to reduce the risk of complications due to surgical errors and significantly shortens surgery time, contributing to time and cost savings in clinical surgeries.”

RENOLIT Healthcare – manufacturer of medical implants

The system consists of a plate with two anchors and additional teeth that ensure the distance to the bone. Plate and anchors are made of medical grade PEEK™ (polyetheretherketone), known for its biocompatibility, biostability and chemical stability. Besides, the material features good mechanical properties, bone-like stiffness, and solid resistance to environmental stress cracking.

As a manufacturer of the plate and the fine SINEFIX^™ implants, RENOLIT Healthcare, a strategic market unit of RENOLIT, was able to contribute its extensive know-how in the field of polymer materials and precision injection molding. In addition, the market unit’s cleanrooms are certified according to ISO13485 and met the production conditions of implantable medical devices.

RENOLIT Healthcare is always investigating new application fields for advanced polymer solutions. For example, as a strategic partner of 3D-Systems, the developer of the world’s first 3D printer with clean room integration, we will enable the manufacturing of patient-tailored medical implants and medical instruments using high performance polymers, including PEEK. The filament-based extrusion technology (Fused Layer Modeling, FLM) made printing of implants for highly sensitive areas possible – in real time, exactly where they are needed, at the point of care. This makes surgical interventions faster, easier, and safer.

About Inovedis

Inovedis GmbH is a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions. Since its founding in 2019, Inovedis has been developing SINEFIX™ to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received FDA clearance in 2023.

SINEFIX is not approved for sale outside the U.S.