EDISON, N.J.--(BUSINESS WIRE)--MTF Biologics®, a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients, and advancing the science of tissue transplantation, today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to begin a clinical study confirming the safety and effectiveness of FlexHD® Pliable for implant-based breast reconstruction. This marks the first IDE approval for a human acellular dermal matrix for breast reconstruction granted by FDA and is an important milestone in MTF Biologics pursuing Pre-Market Approval (PMA) for FlexHD® Pliable.
“We are excited to embark on a PMA study for FlexHD® Pliable in breast reconstruction,” said Marc Long, Ph.D., executive vice president of research and development, clinical and medical affairs at MTF Biologics. “This landmark IDE approval demonstrates MTF Biologics’ commitment to meeting evolving regulatory standards and will ensure that FlexHD® Pliable continues to meet the highest quality and safety benchmarks.”
Developed in partnership with plastic and reconstructive surgeons a decade ago, FlexHD® Pliable is a tissue form cut from a deeper layer of dermis and processed using an aseptic technique. FlexHD® Pliable was designed to offer surgeons improved handling and clinical efficacy.
To support its PMA, MTF Biologics developed a clinical study in collaboration with the FDA to achieve an indication for use in breast reconstruction. The study, which will launch in late 2024, will enroll patients undergoing mastectomy and implant-based breast reconstruction at U.S. institutions.
"MTF Biologics is committed to ensuring the safety and efficacy of our tissues and dedicated to supporting plastic and reconstructive surgeons and the patients they care for each day," said Joe Yaccarino, chief executive officer of MTF Biologics. "We look forward to beginning this important clinical study and advancing efforts to ensure that surgeons and patients have access to FlexHD® Pliable."
About MTF Biologics
MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients, and advancing science. It provides exceptional service, resources, and expertise to donors and their loved ones who give the gift of donation; patients who depend on tissue and organ transplants; healthcare providers who care for donors and recipients; and clinicians and scientists advancing medicine through transplantation science and research.
The International Institute for the Advancement of Medicine, a Division of MTF Biologics, honors donors of non-transplantable organs by providing their gifts to the medical research community to combat and cure diseases. Statline, also a Division of MTF Biologics, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospitals, organ transplant centers and patients that they serve. Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation), a sister organization of MTF Biologics, expands its reach to patients across the globe. For more information, visit www.mtfbiologics.org.
