ALACHUA, Fla., October 30, 2024; RTI Surgical ("RTI" or "the Company"), a leading CDMO pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine, announces the completion of its $15 million Class III medical device facility in Alachua, Florida. The new 5,000sq-ft clean room significantly expands RTI’s proprietary Tutoplast® Tissue Sterilization Process facility, supporting increased customer demand for Tutoplast® processed implants and RTI’s upcoming clinical study of the safety and effectiveness of Cortiva® Allograft Dermis (ADM) in implant-based breast reconstruction.
The Tutoplast® Tissue Sterilization Process preserves human tissue for implantation, and boosts manufacturing capabilities for implants used in a range of procedures including plastic and reconstructive surgery, sports medicine and orthopedics, and neuro and spine surgery. Cortiva® ADM, commonly used in soft tissue repair, is a graft derived from human dermis, processed using the Tutoplast® Tissue Sterilization Process.
Olivier Visa, President and Chief Executive Officer, RTI Surgical, said: “This expansion further enhances our manufacturing capabilities as a leading CDMO in regenerative medicine. It reinforces our commitment to investing in innovation, quality and data in tissue engineering, and will enable us to continue to develop the best solutions for patients, in partnership with our OEM customers. Thank you to everyone who has been involved in completing this expansion. We are proud to be part of the Alachua community and look forward to continuing to create further opportunities for growth and development here."