Actionable news
0
All posts from Actionable news
Actionable news in IART: Integra LifeSciences Holdings Corporation,

Integra LifeSciences Provides Update for Omnigraft(TM) Commercialization Plans, Including Expectations for an Earlier Launch

Integra LifeSciences Holdings Corporation IART, -0.93% a leading global medical technology company, today announced that the Company is prepared to launch Omnigraft(TM) Dermal Regeneration Matrix in June 2016, pending receipt of final U.S. Food and Drug Administration (FDA) packaging approval.

The FDA approved the PMA Supplement for Integra [(R)] Dermal Regeneration Template (IDRT) for the treatment of diabetic foot ulcers (DFUs) on January 7, 2016, 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%, increases the rate of wound size reduction by 50%, 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% 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% did so with one application and 92% 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...


More