Health Canada Expands Approval of IntraLase FS Laser; Accelerated Commercialization Planned
IRVINE, CA -- January 13, 2005 --
IntraLase Laser Makes LASIK Procedure Safer and Provides Better Vision by Replacing the Hand-Held Blade Used in Older Process
IntraLase Corp. (Nasdaq:ILSE) announced today that Health Canada has granted a device license amendment for the company’s INTRALASE FS femtosecond (fem-to-second) laser, which replaces the hand-held blade historically used to create the corneal flap in LASIK (laser-assisted in-situ keratomileusis).
The Company plans to immediately commercialize the INTRALASE FS laser in Canada. This will expand its global presence to 18 countries worldwide. As of Sept. 30, 2004, 180 INTRALASE FS lasers were installed in ophthalmic practices worldwide, resulting in a 15 percent market share of all corneal flap procedures in the United States for the quarter. To date, more than 250,000 IntraLase-initiated LASIK procedures have been sold worldwide.
“Expanding IntraLase’s presence in the Canadian market is an exciting opportunity and further demonstrates the global potential of the INTRALASE FS laser technology,” said Robert J. Palmisano, president and chief executive officer of IntraLase Corp. “We are pleased that Canadian practitioners can offer the clinically-proven safety and improved visual outcomes of IntraLase-initiated LASIK to their patients.”
The INTRALASE FS laser is the first LASIK advancement to improve the first-step of LASIK -- creating the corneal flap. Traditionally, the corneal flap was made using a hand-held device with an oscillating metal razor blade, called a microkeratome.
Clinical studies report that the IntraLase laser significantly decreases the occurrence of blade-related complications, including invasive corneal incisions, corneal abrasions, “button-hole” cuts and improperly formed flaps; and is dramatically less likely to produce overly thin flaps or extremely thick flaps, events which could lead to serious complications.
In addition to making LASIK safer, clinical studies confirm that patients see better with IntraLase-initiated LASIK than with bladed LASIK. The study, “Randomized Prospective Clinical Study of LASIK Performed with Mechanical vs. IntraLase FS Laser Keratome,” followed 88 patients undergoing bilateral LASIK, each eye randomized for flap creation with IntraLase or the leading microkeratome. Patients in the first arm underwent Custom LASIK, while those in the second received standard LASIK. The study concludes significant visual acuity improvements were demonstrated in the IntraLase-treated eyes. Additionally, results for eyes receiving standard LASIK with IntraLase outperformed those for eyes receiving Custom LASIK with a microkeratome.
Additional data show:
-- More patients achieved 20/20 or better vision with IntraLase-initiated LASIK.
-- Patients who stated a preference preferred the post-operative vision of their IntraLase-treated eye 3-to-1 over their blade-treated eye.
-- The IntraLase laser created fewer high- and low-order aberrations, which can affect quality of vision and be associated with night glare and halos.
How the IntraLase Laser Works
Unlike a microkeratome blade that cuts across the cornea to create the flap, the INTRALASE(R) FS laser creates the flap from below the corneal surface, using an “inside-out” process.
Pulsing at a speed of one-quadrillionth of a second, the ultra-fast INTRALASE FS laser uses an infrared beam of laser light to separate tissue at the molecular level by precisely positioning a series of microscopic bubbles within a specified layer of the cornea. Thousands of these tiny bubbles are then stacked along the edge of the flap up to the corneal surface to complete the flap.
A computer interface allows the surgeon to pre-program flap specifications unique to the individual patient, including flap diameter, depth, width, side-cut architecture, hinge location and beveled edge. The IntraLase laser flap process from start to finish takes approximately 45 seconds.
During the second step of LASIK surgery, the surgeon lifts the corneal flap to allow for vision treatment by an excimer laser. When complete, the IntraLase laser flap’s beveled edge allows for accurate repositioning.
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 17 other countries. IntraLase is headquartered and manufactures its products in Irvine, Calif. For additional information, visit the company’s web site: www.intralase.com.
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; 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; the extent of adoption of our product offering by LASIK
surgeons; patients’ willingness to pay for LASIK surgery; our ability to compete against our competitors; 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 our final 424(b)(4) prospectus, as filed with the Securities and Exchange Commission on October 6, 2004.
These forward-looking statements are made only as of the date of this press release, and we assume 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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- Media Contact
- for IntraLase Corp
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