Healthcare Industry News: drug-eluting stent
News Release - December 27, 2007
XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System in EuropeCompany continues U.S. pivotal trial discussions with FDA
MENLO PARK, Calif., Dec. 27 (HSMN NewsFeed) -- 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® 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 customize the length and diameter of the stent at the site of the lesion. The system features a proprietary modular stent design that consists of multiple 6mm cobalt chromium segments coated with Biolimus A9® and PLA, a biodegradable drug carrier, both developed and supplied to XTENT by Biosensors International Group. The Custom NX delivery system enables separation at each 6mm segment and allows for the placement of up to 60mm of stent. XTENT® Custom NX® DES Systems have not been approved for sale by any regulatory authority.
XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent (DES) systems for the treatment of coronary artery disease (CAD). CAD is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. XTENT® Custom NX® DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding XTENT's business that are not historical facts may be "forward-looking statements" that involve risks and uncertainties. Specifically, these statements include, but are not limited to those concerning the timing of regulatory approval or commercialization of its products or the achievement of any other clinical, regulatory or product development milestones. Forward-looking statements are based on management's current, preliminary expectations, and are subject to risks and uncertainties that could cause actual results to differ from the results predicted and which are included in the "Risk Factors" section of our most recent quarterly report on Form 10-Q for the quarter ended September 30, 2007. The quarterly report was filed with the SEC on November 2, 2007, and is available on our investor relations website at http://www.xtentinc.com and on the SEC's website at http://www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. XTENT undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
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