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Cardium Provides Update on Excellagen 510(K) Registration and Commercialization Plans
Date:8/2/2011

y Devro. In connection with that process, the Company also expects to eventually establish its own Device Master File with the FDA's Center for Devices and Radiological Health (CDRH) covering the Company's process for manufacturing its finished 2.6% formulated fibrillar collagen gel.

Excellagen is designed to be a cost-efficient, outcomes-focused medical device for the management of wound care. The Excellagen kit developed for initial launch consists of a set of four single-use prefilled syringes designed to be applied over a course of up to four treatment procedures. At each treatment procedure, Excellagen is topically applied to the debrided wound, and then covered with a non-adherent dressing. The Company believes that Excellagen provides a unique wound care option as there are no other collagen-based wound care management dressings available for professional use in the United States that are comparable to Excellagen in terms of its product format, formulation, and fibrillar nature. Other professional-use collagen-based products include powdered and granulated collagens that require mixing with sterile water prior to use, as well as a variety of sheet-based products.

"We look forward to working with the FDA to secure regulatory clearance and the commercial launch of Excellagen. We are continuing to work with potential new collaborative partners and to explore additional product opportunities for our Excellagen formulation," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.

About Excellagen

The Company's Excellagen fibrillar collagen protein gel is designed to provide a physiologic formulation consisting of a biocompatible and biodegradable material that promotes effective wound management. Based on the unique properties of the highly purified, fibrillar Type I collagen protein used, Excellagen formulated collagen topical gel (2.6%) requires storage at standard refrigeration temperatures (2 d
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SOURCE Cardium Therapeutics
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