IntraLase Announces First Use of FS Laser for Advanced Corneal Transplant Surgery; Precise Femtosecond Laser Technology Allows S
January 26 2006 - 8:01AM
Business Wire
IntraLase Corp. (Nasdaq:ILSE) today announced the first corneal
transplant cases using the IntraLase(R) FS laser have been
successfully performed in patients, marking the first major
technology advancement in corneal transplant surgery in more than
five years. The use of IntraLase's ultra-fast laser to create a
contoured, full-thickness corneal resection in preparation for
corneal transplant has the potential to make corneal
transplantation a safer, more precise procedure as the all-laser
approach gains favor among transplant surgeons. Full global launch
of this new therapeutic application is expected in Fall 2006. Three
of the country's leading ophthalmic institutes, Bascom Palmer Eye
Institute at the University of Miami, Corneal Research Foundation
of America of Indianapolis and the University of California Irvine,
Department of Ophthalmology, are among the first in the country to
adopt all-laser corneal transplant surgery. They've affirmed
IntraLase's ability to improve the surgery, considered the last
resort for patients facing blindness resulting from severe corneal
disease. The IntraLase FS laser is the first femtosecond laser
cleared for use in a variety of refractive and corneal surgeries
including LASIK, and intrastromal incisions used with ring
implants, lamellar keratoplasty, penetrating keratoplasty, and for
the preparation of the donor tissue used in corneal transplants.
The IntraLase FS laser has demonstrated its superior capability in
creating corneal incisions with micron-level accuracy unmatched by
hand-held or mechanical blades. "The natural progression of our
laser technology is to provide corneal surgeons with the ability to
shape the full-thickness resection used in corneal transplants,"
said Robert J. Palmisano, president and CEO of IntraLase. "With
minor enhancements, our laser is capable of creating optimal
incisional patterns for corneal transplants. Instead of the
straight vertical cut performed in traditional full-thickness
keratoplasty, the FS laser is programmed to create a stepped-edged
incision that may enhance the sealing and stability of the
transplanted tissue and allow for faster healing." "The early
results are excellent," noted Francis Price, M.D., director of the
Corneal Research Foundation of America and Price Vision Group and
first to perform corneal transplant surgery with the IntraLase
laser. "One of the patients had traditional full-thickness corneal
transplant surgery three years ago on one eye. The day after her
laser-assisted transplant surgery, she reported seeing better in
the laser-treated eye. While the long-term outcome remains to be
seen, the early results are very encouraging." In 2003, a scalpel
was used to create modified-shaped tissue, resembling a top hat,
during penetrating keratoplasty surgery. "The shaped top hat
configuration never achieved widespread success because of the
difficulty in manually creating the incision. The precision and
safety of the IntraLase laser inspires the surgeon to perform the
top hat incision with confidence," said William Culbertson, M.D.,
professor of ophthalmology and corneal surgeon at Bascom Palmer Eye
Institute. "The overlapping wound edge seals better biomechanically
requiring less suture tension than a traditional straight-edged
incision. The potential result would be enhanced wound strength,
less astigmatism and accelerated recovery of vision. We feel this
is a huge step forward in the rehabilitation of vision for these
patients." Latest findings on this and all other FS laser
indications will be presented at this year's American Society of
Cataract and Refractive Surgery (ASCRS) held March 18-22, 2006 in
San Francisco. 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 keratoplasties 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 26 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, 2005, as filed
with the Securities and Exchange Commission on November 8, 2005.
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.
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