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First LASIK With the Advanced IntraLase Method(TM) Performed on U.S. Naval Aviator
- For the First Time in the United States, LASIK
and Military Aviation Come Together as Groundbreaking Bureau of Naval Medicine Project Opens Door for Previously Ineligible Naval Aviators -
IRVINE, Calif., Dec. 11 /PRNewswire-FirstCall/
-- Marking both a milestone in U.S. Naval medicine
and refractive surgery, IntraLase(R) Corp. (Nasdaq:
ILSE) today confirmed the Navy's announcement
that the first LASIK procedure using the IntraLase
Method has been performed on an aviator as part
of a new Bureau of Naval Medicine project (http://www-nmcsd.med.navy.mil/news/news_view.cfm?nrid=258).
Currently, LASIK is not approved for use in the
U.S. military aviation community. But, after many
years of intense LASIK clinical trials on non-aviation
personnel, the new Bureau of Naval Medicine project
is underway to treat four additional aviators
with LASIK using the IntraLase Method scheduled
as part of the first step of the program.
Though LASIK has been around for many years,
concerns about the harsh aviation environment
prevented its use in U.S. Navy aviators. Aeromedical
professionals have been cautious of employing
the procedure on aviators who frequently encounter
environmental extremes such as high altitude,
dry air, wind blast and 'G' forces.
According to Capt. Steve Schallhorn, Navy Program
Manager for Refractive Surgery, "While LASIK
has been around for many years and is a common
elective procedure, this is a significant first
in the aeromedical field. Wavefront guided LASIK
using the IntraLase Method represents the best-of-the-best
and is a truly exciting advancement for critical
Navy personnel whose sight is of utmost importance
in their military duties."
The IntraLase FS laser is the first technology
for a truly all-laser, blade-free LASIK procedure,
replacing the hand-held microkeratome blade historically
used in creating LASIK corneal flaps -- the first
step of the procedure -- with a computer-guided,
ultra-fast femtosecond (fem-to-second) laser.
The IntraLase laser virtually eliminates almost
all of the most severe, sight-threatening LASIK
complications related to use of the microkeratome
and, by creating an optimal corneal surface below
the flap, provides for better visual outcomes
-- taking many patients to 20/20 vision and beyond.
While LASIK remains the most popular surgery
in the civilian community, the Naval Medical Center
San Diego's Refractive Surgery Center is the only
center currently in Department of Defense offering
LASIK using the IntraLase Method.
The first candidate was aviator, Marine Capt.
Michael Oginsky, an FA 18/D weapons and sensor
officer with VMFAT 101 at U.S. Marine Corps Air
Station Miramar. Within just four hours, Oginsky's
vision was 20/20. At the 24-hour mark, his vision
exceeded 20/20. There are four additional aviators
scheduled to take part in the first step of the
program and have LASIK using the IntraLase Method
performed.
More than 1,200 surgeons worldwide have incorporated
the blade-free IntraLase Method into their LASIK
practices. In fact, the majority of the top U.S.
ophthalmic teaching institutes including Duke
University Medical School, the Wilmer Eye Institute
at Johns Hopkins, the Bascom Palmer Eye Institute
at University of Miami, and Stanford University
use the IntraLase FS laser technology to train
future generations of LASIK surgeons.
LASIK using the Advanced IntraLase Method
The 4th Generation IntraLase FS laser uses an
infrared light beam, generating 60,000 pulses
per second, to prepare the intracorneal bed and
create the corneal flap in the first step of LASIK.
* Using an "inside-out" process, the
laser beam is precisely focused to a
point within the cornea.
* The laser pulses then create thousands of microscopic
bubbles which
define the incision within the intracorneal surface.
* Along the edge, bubbles are then stacked up
at a beveled angle -- a
feature unique to the IntraLase Method -- to the
corneal surface to
complete the flap.
* From start to finish, the IntraLase Method typically
takes 15 - 30
seconds.
* The physician then exposes the prepared corneal
bed for excimer laser
treatment (the second step of LASIK) by lifting
the flap.
* The LASIK procedure is complete when the flap
is securely repositioned
on its beveled edge.
With the IntraLase laser, the surgeon can precisely
control the critical first step of LASIK. Physician-programmed
laser specifications include flap diameter, depth,
hinge location and width, and side-cut architecture
-- factors which can be varied to meet patients'
needs. The IntraLase laser creates a distinctive
beveled-edge flap, which allows for precise repositioning,
alignment and seating after the LASIK procedure
is completed. This feature helps reduce the risk
of flap displacement, a complication seen with
microkeratome flaps.
Blade-Free Safety and Better Vision with
All-Laser LASIK
The IntraLase laser makes LASIK safer by replacing
the hand-held microkeratome blade with the computer-guided
precision of a laser, virtually eliminating almost
all the most severe, sight-threatening blade-related
LASIK complications as a result. Leading LASIK
surgeons have reported on data of the IntraLase
Method procedures, which demonstrate an impressive
safety profile.
Beyond improving the safety of the procedure,
LASIK using the advanced IntraLase Method has
been shown clinically to deliver better visual
outcomes in both standard and Custom LASIK procedures
with more patients achieving visual acuity of
20/20, 20/15 and even 20/12.5. These remarkable
results are the product of the optimized corneal
surface prepared by the IntraLase FS laser in
creating the corneal flap. The precision of the
laser reduces the microscopic inconsistencies
on the corneal bed, providing an optimal surface
for the vision correction performed by the excimer
laser in step two of the LASIK procedure.
About IntraLase Corp.
IntraLase designs, develops, and manufactures
an ultra-fast laser that is revolutionizing refractive
and corneal surgery by creating safe and more
precise corneal incisions. Delivering on the promise
of ophthalmic laser technology, the IntraLase
FS laser, related software, and disposable devices
replace the hand-held microkeratome blade used
during LASIK surgery. The unsurpassed accuracy
of IntraLase's computer-controlled femtosecond
laser has been shown to improve safety profiles
and visual outcomes when used during LASIK. Additionally,
the IntraLase FS laser creates precision-designed
intracorneal incisions that when combined can
be used during lamellar and penetrating keratoplasty,
and intrastromal ring implantation. IntraLase
is presently in the process of commercializing
applications of its technology in the treatment
of corneal diseases that require corneal transplant
surgery. The company's proprietary laser and disposable
patient interfaces are presently marketed throughout
the United States and 32 other countries. IntraLase
is headquartered and manufactures its products
in Irvine, California. For additional information,
visit the company's web site: www.intralase.com.
Forward Looking Statements
Statements contained in this press release that
are not historical information are forward-looking
statements as defined within the Private Securities
Litigation Reform Act of 1995. Forward-looking
statements can be identified by the use of words
such as "believe," "expect,"
"anticipate," "intend," "plan,"
"estimate," "project," or
words of similar meaning, or future or conditional
verbs such as "will," "would,"
"should," "could," or "may."
Such forward-looking statements are subject to
risks and uncertainties that could cause actual
results to differ materially from those projected
or implied. Those risks and uncertainties include,
but are not limited to: the degree of continued
acceptance of LASIK surgery; potential complications
revealed by long-term follow up; the extent of
adoption of our product offering by LASIK surgeons;
general economic conditions; changes in federal
tax laws governing the ability of potential LASIK
patients to use pre-tax dollars to pay for LASIK
surgery; the scope of government regulation applicable
to our products; patients' willingness to pay
for LASIK surgery; our ability to compete against
our competitors; the effectiveness of our measures
to ensure full payment of procedure fees; the
occurrence and outcome of product liability suits
against us; our ability to adequately protect
our intellectual property; whether we become subject
to claims of infringement or misappropriation
of the intellectual property rights of others;
the continued availability of supplies from single-source
suppliers and manufacturers of our key laser components;
the ability of our managers, operations, and facilities
to manage our growth; the success of our expansion
into markets outside the United States; whether
we lose any of our key executives or fail to attract
qualified personnel; or if our new products or
applications fail to become commercially viable.
Certain of these risks and uncertainties, in
addition to other risks, are more fully described
in the company's quarterly report on Form 10-Q
for the period ending September 30, 2006, as filed
with the Securities and Exchange Commission on
October 31, 2006.
These forward-looking statements are made only
as of the date of this press release, and the
company assumes no obligation to update or revise
the forward-looking statements, whether as a result
of new information, future events, or otherwise.
OURCE IntraLase Corp.
12/11/2006
CONTACT: Liana Miller of The Goolsby Group, +1-949-276-8920,
liana@goolsbygroup.com, for IntraLase Corp.
Web site: http://www.intralase.com
(ILSE)
CO: IntraLase Corp.
ST: California
IN: HEA MTC SPM
SU:
CV-EW
-- LAM068 --
3507 12/11/2006 11:41 EST http://www.prnewswire.com
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