MENLO PARK, Calif., June 12 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced a progress update regarding its application to the designated European Notified Body for CE Mark approval of its Custom NX(R) DES System. XTENT's European Notified Body confirmed that recently presented six-month follow up results from the CUSTOM III study will be incorporated by the Drug Agency, which reviews the drug formulation submission of XTENT's CE Mark application, into its current review cycle. XTENT's CE Mark application, which included two components, the XTENT design dossier and the drug formulation submission, was filed in December 2007.
"Given the positive results of CUSTOM III, we are encouraged that the Drug Agency, which has already approved Biolimus A9(R) and PLA combinations on two other DES platforms, has accepted the additional data for review. This, we believe strengthens an already robust submission for our Custom NX System," said Gregory D. Casciaro, XTENT's President and CEO. The company anticipates a response from its European Notified Body regarding its CE Mark application this summer.
About the Custom NX(R) 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 6 mm cobalt chromium segments coated with Biolimus A9(R) and PLA, a biodegradable drug carrier. The Custom NX delivery system enables the stent length to be adjusted in 6mm increments and allows for the placement of up to 60mm of stent at one or more locations. The Custom NX DES System has 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(R) Custom NX(R) 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: XTENT's expectations with respect to the timing or results of its regulatory filings, the timing of responses to its regulatory filings and the timing of the commercialization of its products. 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 XTENT's quarterly report on Form 10-Q for the quarter ended March 31, 2008. This quarterly report was filed with the SEC on May 13, 2008, and is available on the company's 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
|SOURCE XTENT, Inc.|
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