Thomas Gilbert, Ph. D., Vice President, Research & Development, Integra Lifesciences Corporation
Products derived from human and animal tissues, often referred to as tissue technologies, have offered outstanding results in medical care for decadesin the specific areas of soft tissue, nerve, and tendon repairs. These products are notable for aiding individual patients suffering from severe tissue damage, while also supporting large-scale reconstruction efforts for those who were injured in disasters, including 9/11, earthquakes and wars. Medical experts such as Ian Valerio, MD, MS, MBA, of Massachusetts General Hospital, have underscored the benefits and potential opportunities of regenerative therapies in managing complex wounds. One breakthrough product --Integra® Dermal Regeneration Template (Integra Template) -- has paved the way for the continuing development of other regenerative medicine products. This year marked the 25th anniversary of the U.S. Food & Drug Administration (FDA) approval of the Integra Template.
The Integra Template underwent rigorous regulatory studies with more than 400 patients pre- and post-FDA approval. Since its inception, the Integra Template – still, the only FDA-approved regenerative dermal technology for the treatment of life-threatening burns – has revolutionized care for severe injuries. The utility for the collagen technology on which the Integra Template is based has gone well beyond the initial intended use, with additional clearances being obtained in dural and nerve repair and the management of wounds. While this global product was first used in the United States, it is now used in surgeries in more than 50 countries, including the European Union, Canada, Australia, Brazil, and Japan.Over the last 30 years, Integra Dermal Matrices have been studied in more than 300 clinical studies.
There are ample opportunities to address other conditions, expanding on this practiced approach to wound management
One example of a product that uses similar technology to the Integra Templateis the Integra® Bilayer Wound Matrix (IBWM). Recent data published in Plastic and Reconstructive Surgery: Journal of the American Society of Plastic Surgeons showed that 70 percent of wounds for lower extremity soft tissue reconstruction managed with IBWM successfully healed within 180 days. An additional study that was published in the same journal showed that the use of IBWM in lower extremity wound management resulted in shorter surgery times and length of stay in the hospital as well as cost of care compared to free flap and local flap procedures. These studies support the potential benefit of a treatment protocol that includes IBWM to reduce length of stay and total costs in certain patients, compared to patients treated with other approaches such as free flaps or local tissue rearrangement. This has become even more meaningful during the COVID-19 pandemic in generating efficiencies for getting patients in and out of the hospital, alleviating the burden on the healthcare system.
The success of Integra Template has inspired the development of other human, bovine, and porcine tissue products to support soft tissue repair, including several other technologies that are the foundation for other regenerative medicine products. These advances have facilitated tissue revascularization and repair to address conditions ranging from scar revisions to hernia to neural access repair.
While we have made major progress in the field of tissue technologies, there is more we can do in this area. There are ample opportunities to address other injuries expanding on this practiced approach to wound management. Moreover, in the next stage of innovation for regenerative medicine, we should be incorporating advanced technology into the wound assessment process. As an example, we could use a platform that would determine the best method for treating complex wounds based on a patient’s scenario, while capturing data to inform other procedures. The future of regenerative medicine involves continuing to build on the foundational matrix technology as a bridge to treating a wide array of conditions, coupled with the formalized use of data to optimize personalized care.