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Innocoll, Inc. Receives FDA Approval for CollaGUARD™, A Collagen-Based |
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13 Oct 2006 |
Announced that its wholly-owned subsidiary, Innocoll Pharmaceuticals, has received US 510k approval for CollaGUARD™, an advanced wound care product based on Innocoll’s proprietary CollaRx™ membrane technology.
ASHBURN, VA, USA | Oct 12, 2006 | Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Pharmaceuticals, has received US 510k approval for CollaGUARD™, an advanced wound care product based on Innocoll’s proprietary CollaRx™ membrane technology. CollaGUARD is indicated for the management of superficial and deep wounds, including coverage of skin ulcers and temporary dermatoplasty in the case of lesion and burns. CollaGUARD has already received CE-mark approval for marketing in Europe.
CollaGUARD is comprised almost entirely of purified type-I 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 stimulates the natural wound healing process. In addition, CollaGUARD provides the barrier protection and transparency of film dressings, which allows the clinician to visually inspect and monitor the wound without removal.
The world-wide 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, can be manufactured using a streamlined, cost-effective production process.
CollaGUARD is the lead product in Innocoll’s advanced wound care portfolio. Follow-up products currently in development include CollaGUARD Ag (a collagen-based bioactive dressing impregnated with silver for infected wounds or wounds at risk of infection) and DermaSIL™ (a patented collagen-synthetic foam composite dressing for deep and heavily exuding wounds). Innocoll expects to file US 510k and European CE-mark registrations for both CollaGUARD Ag and DermaSIL in 2007.
Dr. Michael Myers, President and CEO commented, “This is an important milestone for Innocoll, as it marks our first regulatory approval in the US. Products based upon the CollaRx membrane technology such as CollaGUARD can be manufactured by a highly efficient and cost-effective process, which will allow us to compete very favourably against other collagen-based wound care products.”
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 and anesthetics. The CollaRx technology also forms the basis of Innocoll Pharmaceuticals’ lead product, Gentamicin Surgical Implant, a biodegradable leave-behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues.
About Innocoll, Inc.
Innocoll is a privately held, fully integrated, global, hospital specialty pharmaceutical company specializing in surgical and dermatological products. It develops and markets internationally a range of medical products using its proprietary collagen-based technologies, CollaRx™ and LiquiColl®. Innocoll, Inc. acquired the product rights for Gentamicin Surgical Implant from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP) and has since assumed all sales, marketing and distribution activities for the product. For more information, please visit www.innocoll.com
SOURCE: Innocoll, Inc. |
