MONROVIA, Calif., April 12 /PRNewswire-FirstCall/ -- STAAR Surgical
Company (Nasdaq: STAA), a leading developer, manufacturer and
marketer of minimally invasive ophthalmic products, today reported
that revenue for the first quarter ended April 3, 2010 grew approximately 12% as compared
to the first quarter of 2009. In addition, the Company
announced several developments at the American Society of Cataract
and Refractive Surgeons (ASCRS) annual conference which continues
through Tuesday, April 13, in
Boston.
On March 2, 2010, STAAR divested
its German distribution subsidiary, Domilens GmbH. Operating
results for the first quarter of 2010 will not include any
contribution from Domilens, which has been classified as
discontinued operations. Comparative historic results have
also been restated to reflect the discontinued status of the
Domilens operations. The Company currently expects to report
its final first quarter results in early May, and those results
will include a gain from the divesture of Domilens.
VisianĀ® ICL revenues increased approximately 20% during the
quarter with continued very strong growth in Korea, China and France. STAAR believes that the Visian
ICL captured over 10% of the refractive surgery market in Korea
during 2009. Visian ICL revenues increased by approximately 7% in
the U.S. despite preliminary reports that industry-wide refractive
procedures continue to decline. STAAR IOL revenues increased
by approximately 11%. Revenues for Preloaded Hydrophobic
Acrylic IOLs continued with strong growth in France, while despite pricing pressures in
Japan IOL units and dollars
increased there as well. In the U.S., nanoFLEX Collamer IOL
sales increased by approximately 17% during the quarter.
"We are very encouraged with our double digit revenue growth
during the first quarter," said Barry G.
Caldwell, President & CEO. "The Company has made
very good progress on several fronts during the past year. We
have a much stronger balance sheet today and are now prepared to
focus on revenue growth in our core ICL and IOL technologies with
continued attention to our spending levels. We generated cash
flow from operations during 2009 for the first time in seven years
and now we have our objectives set to reach profitability in 2010.
I think we are off to a good start."
At the ASCRS, STAAR launched the Visian nanoPOINT 2.0 Injector
System, which enables the implantation of the ICL through an
incision size of 2.0 mm. The smaller incision size reduces
the potential of inducing astigmatism during the implantation
process. In addition, the smaller incision reduces healing
time and provides less opportunity for infection during the
procedure. The Visian nanoPOINT 2.0 also loads more easily,
making the process more user friendly for nurses and surgeons.
This newly designed injector system should encourage more
surgeons to consider implanting the ICL in an office-based
procedure.
Dr. James Lewis from Philadelphia, Pennsylvania presented on
Sunday, during the ASCRS Paper Session entitled "Intraocular
Surgery-Correcting IOLs," the updated findings of STAAR's Collamer
Accommodation Study Team (CAST). The title of his paper was,
"Binocular Near and Intermediate Visual Results with Collamer
Single-Piece Aspheric IOL." Dr. Lewis also presented his data
on over 600 eyes implanted with the nanoFLEX IOL which revealed
near vision results better than all standard IOLs and intermediate
vision results better than any IOL on the market including premium
IOLs. "My results showed that the nanoFLEX provides superior
intermediate vision as compared to four approved premium IOLs,"
said Dr. Lewis. "The nanoFLEX provides premium laptop vision
without any out of pocket cost to the patient."
STAAR is currently in the process of working with the FDA on the
protocol for a clinical study which is referred to as CAST II by
the Company. This clinical study would evaluate the nanoFLEX
Collamer IOL near and intermediate visual results with the
potential for a label change if the study provides adequate
findings. The Company is also initiating in parallel a CAST
III study which would measure the near and intermediate visual
results with a slightly re-designed nanoFLEX Collamer IOL.
The purpose of this study would be to potentially allow for a
label change regarding less spectacle dependence which could create
an additional path to the premium IOL channel for STAAR.
"Tomorrow, we will conclude a very successful ASCRS conference
for STAAR Surgical," continued Mr. Caldwell. "Highlights
include the certifying of more than 70 additional U.S. surgeons on
our Visian Toric ICL, which is currently under submission with the
FDA. To date, we have certified more than 220 surgeons in the
U.S. on the Visian Toric ICL. In addition, we conducted a
certification course on the Visian ICL for about 25 surgeons, 15 of
whom are employed by LCA-Vision, Inc. (LCAV), a leading provider of
laser vision correction services. STAAR will be working with
LCAV in the coming months to incorporate the Visian ICL into
specific refractive centers."
About STAAR Surgical
STAAR is a leader in the development, manufacture and marketing
of minimally invasive ophthalmic products employing proprietary
technologies. STAAR's products are used by ophthalmic surgeons and
include the Visian ICL, a tiny, flexible lens implanted to correct
refractive errors, as well as innovative products designed to
improve patient outcomes for cataracts and glaucoma. Manufactured
in Switzerland by STAAR, the ICL
is approved by the FDA for use in treating myopia, has received CE
Marking and is sold in more than 50 countries. More information is
available at www.staar.com.
Safe Harbor
The financial information presented in this press release for
the quarter ended April 2, 2010 is preliminary and remains
subject to review by STAAR's independent registered public
accountants. Final financial information for the quarter,
which STAAR will report in its Quarterly Report on Form 10-Q, may
differ.
All statements in this press release that are not statements of
historical fact are forward-looking statements, including
statements about any of the following: projections of earnings;
revenue; sales; cash or any other financial items; the plans,
strategies, and objectives of management for future operations or
prospects for achieving such plans; prospects for any product
approval, including approval of the Visian Toric ICL in the U.S.;
the outcome of plans to develop accommodating lenses or other
products; the financial effect of the Domilens divestiture;
statements of belief; and any statements of assumptions underlying
any of the foregoing.
These statements are based on expectations and assumptions as of
the date of this press release and are subject to numerous risks
and uncertainties, which could cause actual results to differ
materially from those described in the forward-looking statements.
The risks and uncertainties include the following: the negative
effect of the global recession on sales of products, especially
products such as the ICL used in non-reimbursed elective
procedures; the challenge of managing our foreign subsidiaries; the
risk that sales of our newly introduced products may not restore
profitability to our U.S. IOL product line; our ability to overcome
negative publicity resulting from warning letters and other
correspondence from the FDA Office of Compliance and to demonstrate
to the agency that its past concerns have been resolved; the
willingness of surgeons and patients to adopt a new product and
procedure; and the potential effect of recent negative publicity
about LASIK on the demand for refractive surgery in general in the
U.S. STAAR assumes no obligation to update its forward-looking
statements to reflect future events or actual outcomes and does not
intend to do so.
STAAR's current data on the accommodating properties of the
Collamer material derive from the reports of individual independent
clinicians and have not been subjected to large scale clinical
studies. STAAR's current nanoFLEX IOL does not currently have an
FDA labeling claim for accommodation. STAAR cannot assure that its
further research will support a claim that either its current
Collamer lenses or future designs restore the eye's ability to
accommodate. If clinical research does not support these claims, or
supports only a narrow range of accommodation, STAAR's Collamer
accommodation project may not result in increased sales. New lens
designs may require clinical research studies and applying for the
FDA's premarket approval, which are expensive and could result in
delay or denial of approval.
CONTACT:
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Investors
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Media
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EVC Group
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EVC Group
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Barbara Domingo,
415-896-6820
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Christopher Gale,
646-201-5431
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Douglas Sherk,
415-896-6820
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SOURCE STAAR Surgical Company