RTI Surgical Completes $15M Facility Expansion in Florida for Class III Medical Devices

• RTI Surgical completes $15 million facility expansion in Alachua, Florida, to support regenerative medicine.

• New 5,000 sq-ft clean room to boost capacity for Tutoplast implants and upcoming Cortiva ADM clinical study.

RTI Surgical, a contract development and manufacturing organisation has announced the completion of a new $15 million, 5,000 sq-ft Class III medical device facility in Alachua, Florida, aiming to meet rising demand in the regenerative medicine sector. This facility, which includes a state-of-the-art clean room, expands RTI’s proprietary Tutoplast Tissue Sterilization Process capabilities, enhancing production for implants across several medical disciplines.

The expansion will support increased manufacturing of Tutoplast processed implants, used in plastic and reconstructive surgery, sports medicine, orthopedics, neuro and spine surgery. It will also serve RTI’s upcoming clinical study focused on the safety and effectiveness of Cortiva Allograft Dermis (ADM) in breast reconstruction. Cortiva ADM, commonly applied in soft tissue repair, is a graft derived from human dermis processed through the Tutoplast Tissue Sterilization Process, preserving tissue for safe implantation.

“This expansion further enhances our manufacturing capabilities as a leading CDMO in regenerative medicine,” said Olivier Visa, President and CEO of RTI Surgical. “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.”