Integra LifeSciences Announces Submission of a Premarket Approval Supplement Application for the Treatment of Diabetic Foot Ulcers
PLAINSBORO, N.J., Feb. 3, 2015 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced it has completed the submission of a Premarket Approval (PMA) Supplement application to the United States Food and Drug Administration (the "FDA") for a new Indication of Use of its Integra ® Dermal Regeneration Template for the treatment of diabetic foot ulcers. Integra Dermal Regeneration Template is an advanced bilayer skin replacement system designed to provide immediate wound closure and permanent regeneration of the dermis.
"We are excited about the prospects of offering the diabetic community and wound care specialists an additional treatment option for diabetic foot ulcers," said Integra's Bill Weber, Vice President and General Manager, Orthopedics & Tissue Technologies. "The completion of the PMA submission is a significant milestone and we remain on track for DFU market commercialization in 2016."
The prevalence of diabetes continues to rise, currently affecting 29 million people in the United States. Of those diagnosed, as many as 25% may experience a diabetic foot ulcer in their lifetime. The advanced wound care market is approximately $2.5 billion in the U.S., of which approximately $500 million is currently in cellular and tissue based products.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies, and spine hardware and orthobiologics. For more information, please visit www.integralife.com.
CONTACT: Integra LifeSciences Holdings Corporation
Investor Relations:
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com
Media:
Gianna Sabella
(609) 936-2389
gianna.sabella@integralife.com