Product News
A Look Back: 25-Year History of Integra® Dermal Regeneration Template
This month marks the 25th anniversary of the U.S. Food & Drug Administration (FDA) approval of the Integra® Dermal Regeneration Template (IDRT) for the treatment of life-threatening burns. This regulatory milestone in 1996 – the first approval with a claim of regeneration of dermal tissue – was a pivotal moment for Integra and took more than two decades of research.
Judith O’Grady, corporate vice president of Global Regulatory Affairs, oversaw the effort under the leadership of Dr. Richard Caruso, the founder of Integra. Dr. Caruso had the vision to make this technology for IDRT commercially available and engaged with the inventors, John Burke, M.D., Harvard University and Massachusetts General Hospital, and Ioannis Yannas, Ph.D., Massachusetts Institute of Technology to acquire the technology. O’Grady’s work involved managing a distinct complex clinical model, multiple meetings with burn surgeons with the FDA and development of a training manual and program for clinicians.
O’Grady said, “Integra Dermal Regeneration Template transformed the paradigm for the treatment of life-threatening burns. We worked closely with the FDA to get this groundbreaking technology approved for use in patients. The product has become the gold standard for the treatment of life-threatening burns and improving outcomes for patients. This moment in history propelled our growth to become a global leader in tissue technologies.”
IDRT has been celebrated across noteworthy venues. The FDA listed the standout product in its annual report twice and used its own resources to develop a video on the product for burn centers. IDRT has also been featured on the Discovery Channel and multiple news programs globally. The product was in an exhibit in the Chicago Museum of Science and Industry as well as a kiosk in Disneyland. Further, it is part of FDA emergency preparedness and has been used for emergencies like 9/11 and other humanitarian causes worldwide.
Today, IDRT remains the only FDA-approved regenerative skin technology for the treatment of life-threatening burns, and its indications not only include third-degree burns, but also scar revisions and chronic wounds. It is approved in more than 50 countries outside the U.S., including the U.K., Germany, Canada, Australia, Brazil, and Japan.