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XTENT's Customizable
Drug-Eluting Stent Gets European CE Mark Approval
Company Needs Financing
to Avoid Scheduled Layoffs
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March 20, 2009 -- Hopefully,
for the innovative stent manufactured by XTENT, Inc. (Nasdaq:
XTNT), yesterday's European approval has not come too late. On
Thursday, the company announced that it has received CE Mark approval
for its
CUSTOM
NX drug-eluting
stent
(DES) System.
The
CE Mark indicates that the CUSTOM NX DES System may be marketed
in the European Union as well as other countries that recognize
the CE Mark and that the product complies with applicable safety
and quality standards. The approval includes both the Custom NX
36, a 36 millimeter stent and the Custom NX 60, a 60 millimeter
stent.
On January 23 the company, running out of
cash, announced that it would be forced to terminate all but nine
of its employees as of Monday,
March 23, unless it found a buyer or resolved
its economic difficulties
in
other ways. Whether this approval is one of the "other ways" is
yet to be seen. The company now needs cash and financial backing
in order to manufacture and market its stent.
XTENT's stock price closed today at $.70,
up 350% from its low in January, but a fraction of the
$16 it traded for when it went public two years ago. The company's
situation has much to do
with the current economic landscape and shrinking of credit,
and less to do with
the company's main product: the customizable stent -- a concept
that has much merit.
Click
for a video of how the XTENT's
length can be customized during
a PCI
(Source: XTENT, Inc.)
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One difficulty that interventional
cardiologists face is choosing the proper length of stent for
a blockage. Too short a stent doesn't completely cover the
diseased area, a situation which become high risk for increased
cell growth
around its edges and subsequent restenosis (blockage).
Likewise,
if the stent is too long, metal is being placed in
a healthy section of the artery, something which also increases
the risk of blockage. With the XTENT, physicians can tailor
the length of the stent during the procedure. The XTENT is
a cobalt-chromium metal stent, covered with a
biodegradable
coating which eludes Biolimus A9™, a drug which suppresses
excess cellular growth, licensed from Biosensors. |
Regarding today's news, President and CEO
of XTENT, Gregory D. Casciaro, stated:
"Receipt
of the CE Mark is an important accomplishment and a validation
of the strength
of
our
clinical
data. It
is a tribute to the hard work and dedication of our people
as well as the collaborative effort of our drug coating
provider, Biosensors.
We look forward to the opportunity to bring this revolutionary
new technology to patients and physicians throughout
the European Union."
The CE Mark approval of the Custom NX DES System
represents a number of important firsts in the treatment of coronary
artery disease including:- Approval of the first ever customizable
stent system
- Approval of the Custom NX 60, the
longest coronary stent system ever to
be approved for sale
- Approval of the first stent system
to allow treatment of multiple lesions using one catheter
- Approval of the first stent system
to incorporate a post dilation feature on the delivery catheter
The Custom NX DES System has not been approved
for sale in the United States.
To gain U.S. approval, the company would need to
run a large clinical trial, well beyond its current capabilities.
It has been speculated that XTENT would be a bargain acquisition
by one of the four major stent companies, Boston Scientific, Johnson
& Johnson/Cordis, Abbott or Medtronic. However, since January,
when the company's total market valuation was $5 million, none of
the four have made offers, and the company's value is now at $16
million and gaining.
Reported by Burt Cohen, March 20,
2009
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