STERLING, Va.--(BUSINESS WIRE)--March 20, 2006--Aggregate data
collected using SurgiVision(R) DataLink (WaveLight Edition) software
confirms that ALLEGRETTO WAVE users are achieving similar outcomes
to those reported in the U.S. FDA trials, WaveLight, Inc. and SurgiVision
Consultants, Inc. announced today. Launched less than one year ago,
DataLink has gained a subscription base of over 30 percent the U.S.
ALLEGRETTO WAVE user community.
In a paper presented this morning at the American Society of
Cataract and Refractive Surgery (ASCRS) annual meeting, David A.
Wallace, MD, medical director of LA Sight in Los Angeles, reviewed
his experience using DataLink pooled nomogram recommendations for
his first cases using the ALLEGRETTO WAVE. Dr. Wallace reported
his 20/20 UCVA rate had increased to 94 percent from 84 percent
for his first 65 myopic eyes (up to -7D), once able to use doctor-specific
data (requiring a 2-month minimum follow-up from first cases). He
credits the improvement to the combination of laser stability, accuracy
and nomogram refinement with DataLink. This compared with a 91 percent
20/20 rate for comparable eyes in FDA studies.
"DataLink helped ease the angst that any doctor faces when transitioning
to a new laser system, and provided a starting nomogram based on
aggregate data from similar lasers, not guesswork," Dr. Wallace
stated. "The fact that I achieved an 84 percent 20/20 rate with
my first cases was reassuring, and seeing this rate increase to
94 percent with doctor-specific nomogram guidance was indeed compelling.
In addition, my enhancement rate has decreased to 3.2 percent, nearly
two-thirds less than my prior wavefront-guided platform."
DataLink is an easy-to-use, web-based software application that
provides surgical planning and outcomes analysis specifically for
the ALLEGRETTO WAVE excimer laser system. The program allows doctors
to access a secure database to gain valid starting nomograms, customize
their own nomograms and compare their surgical outcomes against
those of the broader ALLEGRETTO WAVE user community. WaveLight is
the first known laser manufacturer to provide a data processing
and benchmarking tool of this scale to its physician customers.
"Participation in the DataLink project has been advantageous
for one reason: it works. Results have been excellent and keep improving
as users contribute more data into the system," stated Guy M. Kezirian,
M.D., F.A.C.S., president and founder of SurgiVision Consultants,
Inc. "Our benchmark is for each center to achieve even better outcomes
than in the FDA trials. Because those results were generated from
multiple sites without doctor-specific nomograms, this should be
possible, and the results so far suggest that it is. The goal is
to suppress enhancement rates to a point where they almost don't
exist. We're not there yet, but we're getting close."
"DataLink is representative of WaveLight's philosophy to empower
doctors with an open sharing of data, with the end result being
clinically superior outcomes," said Wade Tetsuka, President of WaveLight,
Inc. "We are pleased at the rapid adoption of DataLink among our
user base as their participation enables WaveLight to monitor outcomes
in order to maintain the quality of results we expect from the ALLEGRETTO
WAVE."
DataLink was initiated in March 2005 and is a complimentary service
available to all accredited refractive surgeons using the ALLEGRETTO
WAVE. The SurgiVision DataLink (WaveLight Edition) is a product
of SurgiVision Consultants, Inc. of Scottsdale, AZ.
The ALLEGRETTO WAVE was the first refractive laser to receive
concurrent approvals for the treatment of myopia up to -12 diopters
with astigmatism of up to -6 diopters and hyperopia up to +6 diopters
with astigmatism of up to +5 diopters, not exceeding a mean spherical
equivalent of +6 diopters.
WaveLight AG, listed in Deutsche Borse AG's Prime Standard since
January 2003, develops, produces, and markets a high-quality, end-to-end
product portfolio in the fields of ophthalmology and aesthetics.
WaveLight's market success is based on its innovative range of products
that are the technology leaders in their areas of application and
its broad-based sales network featuring both own sales channels
and strategic partners. In the past fiscal year 2004/2005, WaveLight
generated revenues of EUR 80.7 million and EBIT of EUR 8.8 million.
Its average growth rate (CAGR) since 2000/2001 amounts to 35 percent
for revenues and 63 percent for EBIT.
Further information on WaveLight is available at: www.wavelight.com
