XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System...

Thu Dec 27, 2007 6:00am EST

* Reuters is not responsible for the content in this press release.

XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent
System in Europe
- 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 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(R) 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(R) Custom NX(R) DES
Systems have not been approved for sale by any regulatory authority.
    About XTENT
    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 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.
SOURCE  XTENT, Inc.

Investors, Tim Kahlenberg, Chief Financial Officer of XTENT, Inc.,
+1-650-475-9400, tkahlenberg@xtentinc.com; or Media Relations, Aimee Corso,
+1-310-780-2661, acorso@wcpglobal.com, for XTENT, Inc.
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.