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Innocoll, Inc. Files 510 (k) Application for CollaRx Lidocaine Sponge


3/31/2009 8:38:58 AM

ASHBURN, Va., March 31 /PRNewswire/ --- Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Pharmaceuticals, has filed a US 510k application for its CollaRx(TM) Lidocaine Sponge for the management of painful wounds.

It is estimated that each year 13 million patients worldwide suffer from chronic wounds (venous stasis ulcers, pressure ulcers, diabetic foot ulcers, etc.) 35 percent of all chronic wounds do not heal within 5 years. Patients suffering from wound pain have been difficult to assess and have been regularly undertreated. However, it is estimated that 6 out of every 10 chronic wound patients suffer from pain associated with their wounds, and if left untreated, this pain can lead to depression, loss of appetite, and immobility, all of which have a further negative impact on the rate of healing of the wound.

The CollaRx Lidocaine Sponge is a lyophilized collagen sponge containing purified type-I collagen protein and lidocaine, a locally acting anesthetic. The product is intended to be used for the management of painful wounds including: diabetic ulcers, venous ulcers, pressure ulcers, ulcers caused by mixed vascular etiologies, full-thickness & partial thickness wounds, abrasions, traumatic wounds, 1st and 2nd degree burns and dehisced surgical wounds.

Dr. Michael Myers, President and CEO commented, "I am very pleased about the progress that we have made with the CollaRx Lidocaine Sponge. This marks our third medical device filing in the US, and demonstrates the versatility of our collagen based drug delivery technology."

About CollaRx

CollaRx is Innocoll's lead technology platform for the site specific targeted delivery of a wide variety of medicines with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll Pharmaceuticals' lead product, Gentamicin Surgical Implant, a biodegradable leave-behind implant currently in phase III development for the prevention of surgical site infections in patients or surgeries at higher risk of infection.

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx® and Liquicoll®. Innocoll has licensed its US marketing rights to its lead product, CollaRx GENTAMICIN SURGICAL IMPLANT to a division of Baxter International (NYSE: BAX - News) The product is currently in phase 3 development in the US for the prevention of surgical site infections. It is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocollinc.com.



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