Integra Prepares to Launch Skin Regeneration Matrix

Plainsboro, N.J.-based Integra LifeSciences Holdings Corporation, a global medical technology company, is prepared to launch Omnigraft Dermal Regeneration Matrix in June pending receipt of final U.S. Food and Drug Administration (FDA) packaging approval.

The FDA approved the PMA Supplement for Integra Dermal Regeneration Template (IDRT) for the treatment of diabetic foot ulcers (DFUs) in January, based on results from the Foot Ulcer New Dermal Replacement (FOUNDER) Study. The published study, one of the largest to support the treatment of DFUs, demonstrated that Omnigraft increases wound closure by 59 percent, increases the rate of wound size reduction by 50 percent, reduces the median time to wound closure by five weeks, over standard of care, and treats patients with fewer applications than other DFU therapies. Omnigraft is indicated for use in the treatment of partial and full-thickness neuropathic DFUs that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.

Integra has held medical education events at several leading industry conferences and conducted hands-on training over the last two months.

“We have already trained more than 175 healthcare professionals on the use of Omnigraft, and are dedicated to providing best-in-class hands-on and didactic training throughout the year,” said John Mahoney, Integra’s vice president of Professional Affairs and Medical Education.

The FOUNDER Study provides the strong clinical evidence necessary to drive payer access for Omnigraft. Over 112 million covered lives have access to Omnigraft, through both private insurance and Medicare. Currently, 93 percent of Medicare patients, in 47 states, have access. Omnigraft may help to lower total cost of treatment, based on the clinical data, which demonstrated that of those patients who healed, 72 percent did so with one application and 92 percent with two applications or fewer.

Dr. Carl Van Gils, medical director of the Wound Clinic at Intermountain Healthcare’s Dixie Regional Medical Center, St. George, Utah, and a FOUNDER study participant, said, “The results of the study were remarkable, and I see Omnigraft as a game changer in terms of not only quality of care, but also the economics of healthcare. I’m looking forward to the availability of Omnigraft as another treatment option for my patients’ hard-to-heal DFUs.”

“Integra currently markets Primatrix Dermal Repair Scaffold, an acellular dermal matrix, in both the hospital and out-patient wound clinic setting for the treatment of DFUs,” said Bill Weber, Integra’s vice president and general manager, Tissue Technologies. “In addition, we recently announced an agreement to market and sell Voltac antimicrobial wound dressings, an advanced wound care technology that can be used to manage chronic and acute wounds. Once Omnigraft is launched, we will be in the unique position to offer clinicians a broad portfolio of wound care solutions.”

The FOUNDER Study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). The pivotal clinical trial enrolled 307 patients at 32 sites, and patients were monitored for up to 29 weeks. The primary endpoint of the study was the incidence of complete wound closure at 16 weeks, as assessed by the investigator. The secondary outcome measures included time to complete wound closure, rate of wound closure, incidence of recurrence, and change in quality of life metrics. The median number of applications per patient, including the initial application, for the IDRT group was one. The results from the FOUNDER Study were printed in the November/December issue of Wound Repair and Regeneration in the article “A clinical trial of Integra Template for diabetic foot ulcer treatment.”