Healthcare Industry News: Cook
News Release - October 26, 2006
Introducing Laser Corneal Transplantation - the Procedure's Greatest Advancement in 50 Years - With IntraLase-Enabled KeratoplastyThe IntraLase FS Laser Revolutionizes the Sight-Saving Procedure of Last Resort for Patients; Potentially Offers Better Safety and Visual Outcomes, and Faster Healing
IntraLase Corp. Begins Worldwide Distribution to 33 Countries; Innovation May Contribute to Growth in Transplant Volume
IRVINE, Calif., Oct. 26 (HSMN NewsFeed) -- IntraLase® Corp. (Nasdaq: ILSE ) today announced the worldwide launch of its IntraLase-Enabled Keratoplasty(TM) (IEK(TM)) technology, using the company's proprietary femtosecond laser to potentially make corneal transplant surgery safer, with faster healing and better visual results, for patients suffering from severe corneal disease or damage. For the first time, patients around the globe will be able to choose the laser technology that represents the greatest advancement in the procedure in more than 50 years.
Many of the world's leading ophthalmic institutes have begun using the upgraded IntraLase FS laser, designed for use during corneal transplantation, including the University of California, Irvine, Corneal Research Foundation and the Bascom Palmer Eye Institute in the U.S. as well as the Munich Cornea Bank and the Cornea and Refractive Surgery Department at Universidad Nacional Autonoma de Mexico. The first laser in the U.S. used to create incisions for corneal transplantation, the IntraLase FS laser allows the surgeon to create complex, shaped incisions that allow the recipient and transplant tissue to fit together much like an intricate puzzle. The result is a potentially stronger graft that may require fewer sutures with patients reporting faster healing and visual recovery.
"With the excellent safety and visual results achieved with IEK, corneal transplantation now becomes a more accessible and successful treatment option for both surgeons and their patients," said Robert J. Palmisano, president and CEO of IntraLase. "By advancing corneal transplants in the course of treatment, our technology may increase corneal transplant procedure volume over the next few years."
Data collected from 23 initial IntraLase-Enabled Keratoplasty cases demonstrate significant improvement in vision over the traditional trephine approach:
* At three months post-op, 45 percent of IEK patients report visual outcomes of 20/40 or better vision -- qualifying them to drive without corrective lenses.
* In contrast, a large-scale clinical study of trephine-initiated corneal transplantations showed only 30 percent of more than 2,200 patients achieved similar visual outcomes.(1)
* Furthermore, 91 percent of IEK cases report a best corrected visual acuity of 20/80 or better at 3 months compared to 58 percent of trephine-initiated cases.
"This preliminary data shows that in just one year since the very first cases were completed, the IEK technology is making tremendous improvements in a procedure that we have been performing and developing for more than half a century," said William Culbertson, M.D. director of the Bascom Palmer Eye Institute and professor of ophthalmology at the University of Miami. "It is impressive that our early IEK cases compare so favorably against a study of 2,200 of the best trephine-initiated cases. I believe even greater results with IEK are on the horizon as we all continue to advance our technique."
With the announcement of the first IEK corneal transplant cases in January 2006, surgeons at several leading U.S. ophthalmic centers have now used the IntraLase® FS laser to make incisions in more than 100 successful corneal transplant surgeries. IntraLase received U.S. Food and Drug Administration clearance for the laser's use in penetrating keratoplasty procedures in September 2005.
The IntraLase FS laser is the first femtosecond laser cleared in the U.S. for use in a variety of corneal and refractive procedures, including creating the corneal flap for LASIK surgery. The ultra-fast laser, now in its 4th generation, pulses at 60,000 kHz to give surgeons the power and precision (+/- 10 microns) to create corneal incisions that, for the first time, can be customized to the individual patient's condition.
Laser Replaces Traditional Trephine "Cookie Cutter"
Before the advent of the IEK technology, corneal transplants were traditionally performed using a handheld, bladed "Cookie cutter" called a trephine that is stamped onto the cornea to make a circular incision with straight, vertical edges. The remaining corneal bed is cut and lifted with a scalpel, resulting in a simple, plug-shaped tissue graft. With trephine preparation, the transplanted tissue graft requires suturing around the circumference of the corneal graft as well as spot sutures to maintain its position. Sutures stay in the eye for one year or longer, and patients generally do not achieve full visual recovery for at least a year, due to increased astigmatism.
Patients Benefit From Laser's Safety, Precision and Effectiveness
Instead of the straight vertical cut performed in trephine-initiated corneal transplantation, the IntraLase FS laser is programmed by the surgeon, using IntraLase's patented computer interface, to create precisely shaped incisions in both the patient's diseased cornea and the transplant tissue. Then, the laser's infrared light beam is precisely focused to a point within the cornea where microscopic bubbles are formed to establish the incision. The laser is able to create complex incisions such as the "top hat," "zigzag" and "mushroom" that are nearly impossible for the manual, handheld trephine.
The preliminary clinical work with IEK demonstrates that by creating incision edges that fit together in an interlocking design, the graft is more stable and, therefore, may heal faster.(2) Some important advantages imparted by IEK may address patient comfort and visual functionality:
* Fewer and/or looser sutures are needed to keep the IEK incised graft in place.(2)
* Sutures are removed much earlier; before six months in initial cases versus one year or longer with traditional trephine-initiated keratoplasty.(3)
* Patients achieve their full vision faster -- many are able to return to work one month post-op.(2)
* The risk for displacement of the graft is significantly reduced as shaped incisions have demonstrated a seven-fold increase in strength.(2)
"The precision of the IntraLase FS laser makes it possible to create advanced edge profiles that optimizes the wound architecture which can lead to significantly improved outcomes over trephine-initiated procedures," said Roger F. Steinert, M.D., director of cornea, refractive and cataract surgery at the University of California, Irvine and immediate past-president of the American Society of Cataract and Refractive Surgery. "This technology represents an unprecedented advance in cornea transplantation and clearly demonstrates that the IntraLase femtosecond laser is rapidly moving us toward a revolution in corneal surgery."
IEK-Harvested Donor Tissue = Completely Customized Corneal Transplant
Several of the world's leading eye banks are using the IntraLase FS laser to prepare corneal tissue used for transplantation including the Northwest Lion's Eye Bank and Tissue Banks International. Surgeons can order customized tissue from either of these eye banks, prepared with specific edge profiles to meet the needs of their patients. During the transplant procedure, the surgeon uses the IntraLase FS laser to make the same shaped incision in the patient to remove the patient's diseased or damaged corneal tissue. Uniquely shaped edge profiles on patient tissue allows for a customized fit to the laser-prepared donor graft provided by the eye bank.
About Corneal Transplantation
Corneal transplantation has restored sight to thousands who otherwise would be blind due to corneal injury, infection, or inherited corneal disease or degeneration. Corneal transplantation replaces a diseased or scarred cornea with a new one by having the central portion of the cornea surgically removed and replaced with corneal tissue donated through an eye bank. In 2005 more than 105,000 corneal transplants were performed annually worldwide, according to EEBA 2005 Annual Statistics.
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.
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, 2006, as filed with the Securities and Exchange Commission on August 1, 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.
1. "Conclusions of the Corneal Transplant Follow Up Study," A Vail, SM Gore, B A Bradley, D L Easty, C A Rogers and W J Armitage. British Journal of Ophthalmology, 1997.
2. Personal communication with Roger F. Steinert, M.D.
3. Personal communication with Francis W. Price, M.D.
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