MTF Biologics Completes First Implantation of FlexHD® Pliable in Milestone Breast Reconstruction Clinical Trial

This is the first investigational device exemption study approved for a human acellular dermis matrix; implantation marks a significant step in obtaining Premarket Approval.

EDISON, N.J.--(BUSINESS WIRE)--MTF Biologics, a global nonprofit organization that saves and heals lives by advancing tissue and organ donation, transplantation, and research, today announced the successful implantation of FlexHD^® Pliable in the first patient enrolled in its Investigational Device Exemption (IDE) clinical study for pre-pectoral breast reconstruction. This milestone pivotal study (SHAPE) aims to evaluate the safety and effectiveness of FlexHD^® Pliable in implant-based breast reconstruction procedures.

"This first implantation marks a pivotal moment in our work to advance innovative solutions in reconstructive surgery," said Joe Yaccarino, President and CEO of MTF Biologics. "FlexHD^® Pliable has shown promising potential in pre-pectoral breast reconstruction, and this IDE study will help us rigorously evaluate its safety and effectiveness. We're committed to developing solutions that can improve outcomes and quality of life for breast cancer survivors."

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 safety and efficacy.

MTF Biologics received the first IDE approval for a human acellular dermis matrix (hADM) in June 2023. The IDE study represents a significant step toward obtaining Premarket Approval (PMA) from the U.S. Food and Drug Administration for this innovative application of FlexHD^® Pliable. FlexHD^® Pliable is an investigational device and limited by Federal (or United States) law to investigational use.

Dr. Jonathan Heistein, an American Board of Plastic Surgery certified surgeon and a member of the American Society of Plastic Surgeons, performed the first procedure and remarked on the successful implantation, "the handling characteristics of FlexHD^® Pliable made the pre-pectoral placement particularly straightforward. The material's flexibility allowed for precise positioning while maintaining the structural integrity needed for implant coverage. This could represent a significant advancement in our ability to offer patients a less invasive reconstruction option with potentially better cosmetic outcomes."

The multicenter clinical study will evaluate FlexHD^® Pliable's performance in supporting implant-based breast reconstruction procedures. The study's key endpoints include assessment of rate of surgical complications, rate of failure of the breast reconstruction procedure, patient satisfaction and patient-reported outcomes.

"The initiation of this IDE study represents years of research and development focused on optimizing FlexHD^® Pliable for breast reconstruction," said Dr. Marc Long, Executive Vice President of Research & Development and Clinical & Medical Affairs at MTF Biologics. "Our preclinical data has demonstrated safety and shown excellent handling characteristics and integration properties. Through this clinical study, we aim to show that FlexHD^® Pliable can provide surgeons with a reliable option for breast reconstruction while potentially improving the patient experience."

About FlexHD^® Pliable

FlexHD^® Pliable is a dermal allograft processed to provide the optimal balance of thickness, flexibility, and strength for breast reconstruction procedures. The tissue form is designed to support and reinforce soft tissue in breast reconstruction surgery.

For more information about the clinical trial, please visit https://clinicaltrials.gov/study/NCT06797258

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 unmatched service, resources and expertise to donors and their loved ones who give the gift of donation, people who depend on tissue and organ transplants, healthcare providers and clinicians and scientists.

The International Institute for the Advancement of Medicine (IIAM), 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 screening, coordination, and communications services to organ transplant centers, organ, tissue, and eye procurement organizations, as well as the hospitals they serve. Its sister organization, Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation) expands its reach to patients across the globe.