IDE Study Underway for RTI Surgical’s Cortiva Allograft Dermis

RTI Surgical currently is enrolling patients in ADMIRE (Acellular Dermal Matrix Investigation in Breast Reconstruction), an Investigational Device Exemption study designed to confirm the safety and effectiveness of the company’s Cortiva Allograft Dermis (ADM) in implant-based breast reconstruction.

“Our goal is to provide surgeons and patients with clinically validated options that meet the individual needs of those undergoing breast reconstruction as part of breast cancer treatment,” RTI Surgical Chief Scientific Officer Amanda LoGuidice Ph.D., said. “This study, the first allograft IDE in this field, underscores our commitment to advancing patient care through evidence-based solutions. We are eager to progress through this trial and deliver solutions that we believe will improve outcomes for patients.”

Commonly used in soft tissue repair, Cortiva ADM is a graft derived from human dermis processed using RTI’s proprietary Tutoplast Tissue Sterilization Process. ADMIRE is a prospective, multi-center, dual-arm, non-randomized clinical study that will support RTI’s pre-market approval application for a breast reconstruction indication. The study will enroll 467 female patients undergoing two-stage breast reconstruction using the pre-pectoral technique and was developed with advice and input from the U.S. Food and Drug Administration.

“I am excited to lead this important clinical trial as the National Principal Investigator. This study represents a significant step forward in advancing patient care,” stated Dr. Suhail A. Kanchwala, national principal study investigator and associate professor of Surgery at the University of Pennsylvania. “With RTI Surgical taking a bold step as a leader in this space, our collaborative efforts will generate meaningful data that can shape the future of breast reconstruction and, hopefully, will set new standards in improving patient outcomes and quality of life.”

RTI Surgical (RTI) is a contract development and manufacturing organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. The company partners with OEMs to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using its portfolio of biological materials, RTI Surgical focuses on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neuro and spine surgery. Headquartered in Alachua, Fla., RTI has facilities in the United States, Europe, and New Zealand.