- RTI Surgical has commenced the ADMIRE clinical trial to assess Cortiva Allograft Dermis in breast reconstruction.
- The study aims to enrol 467 patients and support a pre-market approval application for this regenerative solution.
RTI Surgical, a contract development and manufacturing organisation (CDMO) specialising in tissue engineering and regenerative medicine, announced the enrolment of the first patient in its ADMIRE study. This clinical trial is designed to evaluate the safety and effectiveness of Cortiva Allograft Dermis (ADM) for implant-based breast reconstruction.
The ADMIRE trial is a prospective, multi-centre, dual-arm, non-randomised study involving 467 female patients undergoing two-stage breast reconstruction using the pre-pectoral technique. Developed in consultation with the FDA, the trial seeks to generate robust clinical data to support a pre-market approval application for Cortiva ADM. This graft, derived from human dermis, is sterilised using RTI’s proprietary Tutoplast process and is commonly used in soft tissue repair.
“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,” said Amanda LoGuidice, PhD, Chief Scientific Officer of RTI Surgical. She highlighted the company’s commitment to delivering evidence-based solutions that advance patient care.
Dr. Suhail A. Kanchwala, the study’s National Principal Investigator and Associate Professor of Surgery at the University of Pennsylvania, added: “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.”
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