MENLO PARK, Calif., Dec. 27 XTENT, Inc.(Nasdaq: XTNT), the developer of customizable drug-eluting stent (DES) systems,today announced that it has submitted its application to the designatedEuropean Notified Body for CE Mark approval of its Custom NX DES System.
XTENT's CE Mark application includes the XTENT design dossier and the drugformulation submission from Biosensors International Group. XTENT plans tobegin European sales of the Custom NX system in the second half of 2008through partnerships with leading regional distributors, following CE Markapproval.
"Completing our CE Mark filing is a major milestone toward achieving ourgoal of commercializing the Custom NX system in select European countries,"said Gregory D. Casciaro, President and CEO of XTENT. "This submission furtherdemonstrates Biosensors' commitment to the success of Biolimus A9(R) and theongoing collaboration between the two companies."
XTENT is also continuing its work with the U.S. Food and DrugAdministration (FDA) to fulfill the necessary requirements to gain approval tostart the CUSTOM IV pivotal trial. The company filed an Investigational DeviceExemption (IDE) in September. XTENT and Biosensors are in the process ofresponding to questions from the FDA. XTENT will provide an update as to theanticipated start of the CUSTOM IV trial once both companies have completeddiscussions with the FDA.
About the Custom NX DES System
Custom NX is designed to enable a more personalized approach to thetreatment of arterial disease based on each patient's individual lesioncharacteristics. The Custom NX system allows physicians to customize thelength and diameter of the stent at the site of the lesion. The systemfeatures a proprietary modular stent design that consists of multiple 6mmcobalt chromium segments coated with Biolimus A9(R) and PLA, a biodegradabledrug carrier, both developed and supplied to XTENT by Biosensors InternationalGroup. The Custom NX delivery system enables separation at each 6mm segmentand allows for the placement of up to 60mm of stent. XTENT(R) Custom NX(R) DESSystems have not been approved for sale by any regulatory authority.
XTENT, Inc. is a medical device company focused on developing andcommercializing innovative customizable drug eluting stent (DES) systems forthe treatment of coronary artery disease (CAD). CAD is the most common form ofcardiovascular disease and the number one cause of death in the United Statesand Europe. XTENT(R) Custom NX(R) DES Systems are designed to enable thetreatment of single lesions, long lesions and multiple lesions of varyinglengths and diameters, in one or more arteries with a single device.
Forward Looking Statements
This press release contains forward-looking statements within the meaningof the U.S. Private Securities Litigation Reform Act of 1995. Statements inthis press release regarding XTENT's business that are not historical factsmay be "forward-looking statements" that involve risks and uncertainties.Specifically, these statements include, but are not limited to thoseconcerning the timing of regulatory approval or commercialization of itsproducts or the achievement of any other clinical, regulatory or productdevelopment milestones. Forward-looking statements are based on management'scurrent, preliminary expectations, and are subject to risks and uncertaintiesthat could cause actual results to differ from the results predicted and whichare included in the "Risk Factors" section of our most recent quarterly reporton Form 10-Q for the quarter ended September 30, 2007. The quarterly reportwas filed with the SEC on November 2, 2007, and is available on our investorrelations website at http://www.xtentinc.com and on the SEC's website athttp://www.sec.gov. Undue reliance should not be placed on forward-lookingstatements, which speak only as of the date they are m