24.05.2006 12:00:00
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WaveLight, Inc. Announces 10 Years of Innovation and Success; More Than $100 M in Revenues Achieved Since WaveLight's Inception
WaveLight was founded in 1996 by Max Reindl and the companycompleted its IPO just three years later. Working with Prof. TheoSeiler and his team of engineers, WaveLight developed the WavefrontOptimized(TM) ALLEGRETTO WAVE(R), a high-speed, flying spot excimerlaser designed to maintain the natural aspheric shape of the corneafollowing refractive surgery.
The ALLEGRETTO WAVE was approved by the FDA in October 2003 andmore than 100 systems are currently installed in the U.S. with 650systems available worldwide. WaveLight was the first Europeanmanufacturer to achieve approval for a refractive laser system and thesystem was granted the widest approval ranges to date. In May 2006,the FDA granted an additional approval for treatment of mixedastigmatism with the ALLEGRETTO WAVE.
"WaveLight's goal from the beginning has been to pioneer the mostinnovative and advanced technology for optimizing the optics in theeye," stated Max Reindl, founder of WaveLight AG. "The ALLEGRETTO WAVE
is designed to protect quality of vision while also providing anew level of safety for physician and patient."
WaveLight has brought several additional ophthalmic innovations tomarket internationally. In 1999, the first wavefront-guided procedurewas performed on an ALLEGRETTO WAVE excimer laser and this has becomethe leading wavefront-guided system used by ophthalmologistsworldwide. In 2002, WaveLight introduced the first operativetopography-guided system for treating eyes that have beensignificantly damaged due to previous LASIK and PRK interventions. In2003, WaveLight introduced the first asphericity-guided LASIK systemthat customizes the individual's corneal shape during treatment. Alsoin 2003, WaveLight introduced the first 500 Hz excimer laser platform.
In the U.S., WaveLight's wavefront-guided clinical trial has beencompleted and data are currently being reviewed by the FDA. Thetopography-guided clinical study is expected to commence shortly.
WaveLight announced earlier this year that the company plans todedicate all its resources to the ophthalmic market segment. As aresult, the company spun-off its aesthetic division in April 2006,which is now a fully owned subsidiary of WaveLight Aesthetic GmbHunder the leadership of Dr. Stephan Schulze. WaveLight is also in theprocess of parting from its industrial and urology divisions.
"Devoting all our efforts to ophthalmology further strengthensWaveLight's position as a strong player not only in the field ofrefractive laser surgery, but in other areas aimed at improving theoptics of the eye for the anterior segment." Reindl added. "Ourresearch and engineering assets are addressing new technologies, asshown by our introduction of microkeratomes and intraocular lenses inour European markets."
WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG, listed in Deutsche Borse AG's Prime Standard sinceJanuary 2003, develops, produces, and markets a high-quality,end-to-end product portfolio in the fields of ophthalmology andaesthetics. WaveLight's market success is based on its innovativerange of products that are the technology leaders in their areas ofapplication and its broad-based sales network featuring both own saleschannels and strategic partners. In the past fiscal year 2004/2005,WaveLight generated revenues of EUR 80.7 million and EBIT of EUR 8.8million. Its average growth rate (CAGR) since 2000/2001 amounts to 35percent for revenues and 63 percent for EBIT.
Further information on WaveLight is available at:www.wavelight.com
All information is given and all assessments are made on the basisof extremely conscientious research. However, no guarantee is givenwith regard to the information or assessments published. No liabilitywhatsoever is accepted. The above statements do not represent aninvitation to buy or sell securities. All rights reserved.
Disclaimer for Mixed Astigmatism:
a. Approval of the premarket approval application is for the
WaveLight ALLEGRETTO WAVE(TM) Excimer Laser System to perform
LASIK treatments in patients 21 years of age or older for the
reduction or elimination of naturally occurring mixed
astigmatism of up to 6.00 D at the spectacle plane; and in
patients with documentation of a stable manifest refraction
defined as less than or equal to 0.50 D of preoperative
spherical equivalent shift over one year prior to surgery.
b. LASIK is an elective procedure with the alternatives including
but not limited to eyeglasses, contact lenses, photorefractive
keratectomy (PRK), and other refractive surgeries.
c. Approval of the application is based on clinical trials in the
United States with 162 eyes treated, of which 111 were
eligible to be followed at 6 months. Accountability at 1 month
was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.
d. The studies found that of the 142 eyes eligible for the
uncorrected visual acuity (UCVA) analysis of effectiveness at
the 3-month stability time point, 95.8% achieved acuity of
20/40 or better, and 67.6% achieved acuity of 20/20 or better
without spectacles or contact lenses.
e. The clinical trials showed that the following subjective
patient adverse events were reports as "moderate to severe" at
a level at least 1% higher than baseline of the subjects at 3
months post-treatment: sensitivity to light (43.3% at baseline
versus 52.9% at 3 months); visual fluctuations (32.1% at
baseline versus 43.0% at 3 months); and halos (37.0% at
baseline versus 42.3% at 3 months).
f. Long term risks of LASIK for mixed astigmatism beyond 6 months
have not been studied.
g. The safety and effectiveness of LASIK surgery has ONLY been
established with an optical zone of 6.0 - 7.0 mm and an
ablation zone of 9.0 mm.
h. Note that the complete name for this ophthalmic laser is
"WaveLight ALLEGRETTO WAVE(TM) Excimer Laser System for laser
assisted in-situ keratomileusis (LASIK) treatments of
naturally occurring mixed astigmatism of up to 6.00 D at the
spectacle plane.
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