XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System...( - Company continues U.S. pivot...),Health

- Company continues U.S. pivotal trial discussions with FDA -

MENLO PARK, Calif., Dec. 27 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT), the developer of customizable drug-eluting stent (DES) systems, today announced that it has submitted its application to the designated European Notified Body for CE Mark approval of its Custom NX DES System.

XTENT's CE Mark application includes the XTENT design dossier and the drug formulation submission from Biosensors International Group. XTENT plans to begin European sales of the Custom NX system in the second half of 2008 through partnerships with leading regional distributors, following CE Mark approval.

"Completing our CE Mark filing is a major milestone toward achieving our goal of commercializing the Custom NX system in select European countries," said Gregory D. Casciaro, President and CEO of XTENT. "This submission further demonstrates Biosensors' commitment to the success of Biolimus A9(R) and the ongoing collaboration between the two companies."

XTENT is also continuing its work with the U.S. Food and Drug Administration (FDA) to fulfill the necessary requirements to gain approval to start the CUSTOM IV pivotal trial. The company filed an Investigational Device Exemption (IDE) in September. XTENT and Biosensors are in the process of responding to questions from the FDA. XTENT will provide an update as to the anticipated start of the CUSTOM IV trial once both companies have completed discussions with the FDA.

About the Custom NX DES System

Custom NX is designed to enable a more personalized approach to the treatment of arterial disease based on each patient's individual lesion characteristics. The Custom NX system allows physicians to custom
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