The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to RTI Surgical’s allograft dermis, opening the door for a clinical trial to test the device in patients.
RTI Surgical’s Cortiva allograft dermis is an acellular dermal matrix derived from human tissue indicated for patients undergoing breast reconstruction as part of breast cancer treatment.
The company did not share details of the trial design in its 27 November press release but did state that enrolment is scheduled to begin in H1 2024 across sites in the US. The trial will assess the safety and effectiveness of the dermis in implant-based breast reconstruction.
In 2020, nearly 138,000 breast reconstruction surgeries were conducted in the US for women for breast cancer treatment.
Acellular dermal matrices act as a scaffold to support revascularisation for patient tissue to grow into and proliferate. They are frequently utilised to improve cell repopulation and tissue remodelling in burn treatments and hernia procedures.
The grafts consist of a scaffold of molecules that are needed for dermal proliferation, including collagens, elastin, blood vessel channels and bioactive proteins.
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RTI Surgical is the second company in the past month to gain IDE clearance for a human acellular ADM in breast cancer reconstruction. In October, the agency greenlit a trial for MTF Biologics’ FlexHD Pliable device.
The Plastic Surgery Foundation got the ADM ball rolling in breast reconstruction when it received an IDE for its device in October 2022, though its matrix is derived from non-human tissue. The Plastic Surgery’s trial is currently ongoing (NCT05316324) with an estimated 352 participants expected to enrol.
ADMs have been extensively used off-label by surgeons in breast reconstruction surgery. The FDA has previously stated that further clinical data is needed to assess the benefits and risks of using them in breast reconstruction.
RTI Surgical Holdings was renamed to Surgalign in 2020 when it sold off its OEM business. The OEM business retained the RTI Surgical name, whilst Surgalign declared bankruptcy in June 2023.