IRVINE, Calif.--(BUSINESS WIRE)--Sept. 7, 2005-- Global Innovator in Femtosecond Laser Technology Receives Industry's First 510K Clearance for Creating Corneal Resections Performed in a Variety of Therapeutic Procedures.

IntraLase Corp. (NASDAQ:ILSE) today announced it has received a new 510K clearance from the U.S. Food and Drug Administration for use of the IntraLase FS30 femtosecond laser in creating the corneal resections performed in lamellar keratoplasty and penetrating keratoplasty procedures. The IntraLase FS30 laser is the first and only laser to receive clearance for use in penetrating keratoplasty.

For the first time surgeons can use the power and precision of the laser to complete resections in a wide variety of corneal therapeutic applications. The new clearance allows use of the IntraLase FS30 laser to create deep corneal incisions and the full-thickness resections required for penetrating keratoplasty. The Eye Bank Association of America estimates that more than 32,000 corneal transplant procedures were performed in the U.S. in 2004.

The new application of the IntraLase FS30 laser is the direct result of the company's ongoing collaboration with the world's leading corneal surgeons to develop innovative techniques with and enhancements of the technology.

"This really opens up the door for additional uses of this extremely versatile device," said Roger Steinert, M.D., professor and vice chairman of the department of ophthalmology at the University of California, Irvine, and president of the American Society of Cataract and Refractive Surgeons. "In our initial clinical work, we found that the laser has the ability to create shaped, full-thickness corneal transplants that are much stronger than traditional penetrating keratoplasty transplants with less induction of astigmatism. In addition, transplants created with the laser may require less suturing and faster visual rehabilitation.

"IntraLase is developing commercially available software for these new applications as well as a new curved applanation lens to facilitate deep corneal dissections. The laser's current flat applanation lens provides the thin, planar flaps that have recently been shown to improve LASIK outcomes.

"This technology may have additional applications in the deep stroma, including Descemet's Stripping with Endothelial Keratoplasty (DSEK) procedures," said Francis Price, M.D., of the Price Vision Group in Indianapolis. "The laser's flat applanation surface provides very uniform and smooth anterior resections. But for deep stromal resections, a curved applanation provides a smoother interface. In the future, IntraLase FS30 will utilize both flat and curved applanation surfaces, providing the best solution for any application."

The IntraLase FS laser was commercially introduced in late 2001 as the first laser available for creating corneal flaps. The IntraLase laser is also cleared for anterior lamellar keratoplasty and intrastromal ring implantation surgeries, which like LASIK benefit from customized architecture and unsurpassed accuracy. As of June 30, 2005, 293 IntraLase FS lasers have been installed in refractive practices worldwide and approximately 18 percent of LASIK procedures in the U.S. used the IntraLase laser to create the corneal flap.

About IntraLase Corp.

IntraLase designs, develops, and manufactures an ultra-fast laser, related software, and disposable devices used to create a corneal flap, the first step in LASIK surgery for the correction of vision. The company's products improve the safety, precision, and visual results of LASIK procedures by providing a computer-controlled laser solution in place of the hand-held mechanical, metal-bladed microkeratome traditionally used to create corneal flaps. IntraLase lasers are also used in surgical approaches to the treatment of diseased corneas. The company's lasers and disposable per procedure patient interfaces are presently marketed throughout the United States and 21 other countries. IntraLase has headquarters and manufactures its products in Irvine. 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 June 30, 2005, as filed with the Securities and Exchange Commission on Aug. 10, 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.

CONTACT:
For further information call Sigmacon Medical Products, 1-800-898-7455

SOURCE: IntraLase Corp.