POLYTECH Health & Aesthetics remains firmly committed to polyurethane-based implant technology and patient-focused innovation.
POLYTECH confirms ongoing German patent-related proceedings are exclusively related to a manufacturing process and that this matter does not concern product safety, regulatory compliance or the clinical performance of POLYTECH’s implant portfolio.
A preliminary injunction currently affecting a process for the manufacture of PU covered implants is national in scope, limited to Germany and does not constitute a final decision on POLYTECH, Microthane® or polyurethane-based implant technology more broadly. The Company has filed an appeal against the preliminary decision and is actively challenging the decision before the higher court in Munich. The matter is being pursued through the appropriate legal channels, supported by detailed legal and technical expert input. POLYTECH is confident in its position and in the strength of its appeal. The Company is taking decisive action, while maintaining a clear focus on continuity and innovation.
„PU implant technology has a long clinical and technological history.“, said Prof. Dr. Karsten Hemmrich, CEO of POLYTECH Health & Aesthetics. „It has evolved over decades through materials science, manufacturing know-how, clinical experience, and surgeon feedback. POLYTECH will continue to contribute to this field with an evidence-based and quality-driven approach.“
POLYTECH has developed an updated production process following extensive technical and legal review and is supported by external Freedom-to-Operate analysis.
POLYTECH is currently aligning the relevant legal and regulatory steps required before market-specific implementation.
POLYTECH will continue to keep partners, surgeons and relevant stakeholders informed through coordinated and approved communications, both on the progress of the legal proceedings and on further updates regarding the PU technology pathway.