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Innocoll, Inc. Files US 510k For CollaGUARD(TM), A Collagen-Based Advanced Wound Care Product

12/20/2005 10:45:31 AM

ASHBURN, Va., Dec. 20 /PRNewswire/ -- Innocoll, Inc. announced that its wholly owned subsidiary, Innocoll Pharmaceuticals, has filed a US 510k application for CollaGUARD(TM), an advanced wound care product based on Innocoll's proprietary CollaRx(TM) membrane technology. CollaGUARD has already received CE-mark approval for marketing in Europe and will be ready for launch in European markets in 2006. It is indicated for the management of superficial and deep wounds, including coverage of skin ulcers and temporary dermatoplasty in the case of lesions and burns. CollaGUARD will be manufactured by Innocoll's wholly owned subsidiary, Syntacoll GmbH, in Saal, Germany, and will be distributed in Europe by Innocoll Pharmaceuticals from its headquarters in Athlone, Ireland.

CollaGUARD is comprised almost entirely of purified type-I native collagen protein. Unlike alginates, hydrogels and hydrocolloids used in other categories of advanced wound care products, collagen is a fully biodegradable and bioactive material with a pharmacological action that actually stimulates the natural wound-healing process. In addition, CollaGUARD provides the barrier protection of film dressings while also taking up excess wound exudate to provide an ideal moist environment.

The worldwide market for advanced wound care dressings is worth well in excess of $1 billion. In the past, collagen-based dressings have dominated the premium priced market with the so-called "artificial skins" (collagen membranes incorporating living cells) or "synthetic skin substitutes" made of complex composite layers. Other products are based upon lyophilized collagen sponges, a relatively slow and expensive manufacturing process. By contrast, CollaGUARD is made using a new, highly streamlined and cost-effective production process.

CollaGUARD is the lead product in Innocoll's advanced wound care portfolio. Regulatory submissions in Canada, Australia, Japan and South East Asia are planned for 2006. Follow-up products currently in development include CollaGUARD(TM) Ag (a collagen-based bioactive dressing impregnated with silver for infected wounds or wounds at risk of infection) and DermaSIL(TM) (a patented collagen-silicon composite dressing for deep and heavily exuding wounds).

Dr. Michael Myers, President and CEO commented, "CollaGUARD marks our first regulatory submission in the US and provides opportunity for Innocoll to enter the US market early next year. We believe CollaGUARD is poised to take advantage of the healing benefits that collagen-based products offer over other advanced dressings. Most importantly, our membrane technology platform is geared towards mass production and will allow us to compete very effectively in this high-volume market."

About CollaRx

CollaRx is Innocoll Technologies' lead technology platform for the site specific targeted delivery of a wide variety of medicines with particular emphasis on antibiotics, analgesics, and anesthetics. The CollaRx technology is the basis of Innocoll Pharmaceuticals' lead product, COLLATAMP(R) G, which has been approved for over 10 years in 49 countries in North America, Europe, South America, Asia and Africa. COLLATAMP G is a lyophilized collagen sponge impregnated with the broad-spectrum antibiotic gentamicin and is indicated for the treatment and prevention of hard- and soft-tissue infection post-surgery.

About Innocoll, Inc.

Innocoll is a privately held, international specialty pharmaceutical company engaged in the development and commercialization of advanced, differentiated medical products using its proprietary technologies, CollaRx(TM) and Liquicoll(R) collagen-based platforms for the targeted delivery of a wide variety of medicines. For more information, please visit

Innocoll, Inc.

CONTACT: Michelle Cox, Marketing Manager of Innocoll Pharmaceuticals, +353(0)90 648 6282, or

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