ALACHUA, Fla., November 25, 2024 – RTI Surgical (“RTI”), a leading CDMO pushing the boundaries of innovation and tissue engineering to address patient needs in regenerative medicine, today announced the enrollment of the first patient in ADMIRE (Acellular Dermal Matrix Investigation in Breast Reconstruction). This Investigational Device Exemption study is designed to confirm the safety and effectiveness of Cortiva® Allograft Dermis (ADM) in implant-based breast reconstruction.
Cortiva® ADM, commonly used in soft tissue repair, 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 which 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 FDA.
Amanda LoGuidice PhD, Chief Scientific Officer of RTI Surgical, said: “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. This study, the first allograft IDE in this field, underscores our commitment to advancing patient care through innovative, evidence-based solutions. We are eager to progress through this trial and deliver solutions that we believe will improve outcomes for patients.”
Dr. Suhail A. Kanchwala, National Principal Investigator for the study and Associate Professor of Surgery at the University of Pennsylvania, added: “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. 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.”
ENDS
About RTI Surgical
RTI Surgical (RTI) is a leading Contract Development and Manufacturing Organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using our extensive portfolio of biological materials, we focus on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neuro and spine surgery. Headquartered in Alachua, Florida, RTI has facilities in the United States, Europe and New Zealand. For more information, visit
https://www.rtix.com
For media enquiries please contact:
RTI Surgical
Amelia Bell
Tel: +1 386.418.5100
abell@rtix.com
ICR Healthcare
rtisurgical@icrhealthcare.com
