RTI Surgical Announces First Patient Enrolled in Investigational Device Exemption (IDE) for Cortiva® Allograft Dermis in Breast Reconstruction

RTI Surgical Announces First Patient Enrolled in Investigational Device Exemption (IDE) for Cortiva® Allograft Dermis in Breast Reconstruction

November 25, 2024

Amelia Bell

[email protected]

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."