MONROVIA, Calif., May 20 /PRNewswire-FirstCall/ -- STAAR Surgical
Company (Nasdaq: STAA), a leading developer, manufacturer and
marketer of minimally invasive ophthalmic products, today announced
CE Mark approval for a range of product improvements to the
Company's Visian Implantable Collamer® Lens (ICL™) that more than
doubles the current Visian addressable market in Europe. Included in the approval, STAAR
Surgical received CE Mark approval for a Hyperopic Toric ICL which
is designed for patients with both hyperopia, as well as
astigmatism. Patients with hyperopia often referred to as
farsightedness; have difficulty focusing on objects that are close
up. Astigmatism is usually caused by an irregularly shaped
cornea that causes blurred vision. Such patients are beyond the
effective reach of existing surgical technologies and the Visian is
the only option which will allow for the treatment of both
conditions with one procedure.
"We believe these expanded offerings will provide the broadest
correction approval of any refractive technology for surgeons in
countries where the CE Mark applies and will allow the surgeon to
treat virtually any patient who is a candidate for refractive
surgery," said STAAR Surgical CEO Barry G. Caldwell.
"This approval will now allow surgeons to treat myopic
patents from -0.5D to -2.75D with the new Visian ICL,
hyperopic patients from +0.5D to +2.75D with the new Hyperopic
ICL and both myopic and hyperopic astigmatic patients with up
to 6 diopters of astigmatism. The addition of quarter diopter
increments for low myopes (-0.5D to -2.75D) and low hyperopes
(+0.5D to +2.75D) should optimize refractive targeting the sweet
spot of the LASIK range and allow the surgeon to deliver an even
more customized solution. STAAR is committed to the
continuous improvement and expansion of patient benefits offered by
the Visian ICL product line and additional Visian ICL features are
in our pipeline. Our goal is to continue to offer new
technology benefits in order to maintain the Visian ICL's
leadership role in the refractive lens market."
With the CE Mark approval STAAR Surgical now offers Visian ICLs
in the applicable countries ranging from myopic ICLs at -18.0D to
hyperopic ICLs at +10.0D without interruption. Additionally STAAR
can offer Visian Toric ICLs up to 6.0 diopters of cylinder for the
entire range. For diopter ranges between -3.0D and +3.0D, the
CE Mark approval has been expanded to quarterly increments from the
previous 0.5 increments. Specifically, diopter range of ICL
models will be extended to now cover the following diopters:
- Positive spheric, 0.25D increments from +0.5D to +2.75D, 0.5D
increments from +3.0D to +10.0D.
- Negative spheric, 0.25D increments from -0.5D to -2.75D, 0.5D
increments from -3.0D to -18.0D.
- Toric addition, 0.5D increments from +0.5D to +6.0D for all
diopters from -18.0D to +10.0D, excluding quarter diopters,
including 0.0D.
In addition to the expanded diopter range and Hyperopic Toric CE
Mark approval, STAAR Surgical also designed several enhancements
that increase physician ease of use of the Visian ICL during
implant. These improvements include: the addition of
perforating holes in the lens haptic to assist with removal of
viscoelastics, improved lubricity on injector cartridges for ease
of insertion, and new laser marks for the TICL designed to improve
the surgeon's ability to see the axis during and after
implantation.
"We've also been approved to begin packaging Visian ICL products
for CE markets in BSS, Balanced Salt Solution, which is the same
storage medium for product marketed in the U.S. We will also
be submitting data to improve the current two-year shelf life to
five years. These approvals are the first step toward
allowing us to move our global refractive business to a unified
platform that should lead to greater manufacturing efficiencies,"
added Mr. Caldwell.
STAAR Surgical first received CE Marking for the ICL in 1997,
indicating the product is approved by the European Union (EU) and
by other countries that recognize the CE Mark.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for
over 25 years, designs, develops, manufactures and markets
implantable lenses for the eye. All of these lenses are
foldable, which permits the surgeon to insert them through a small
incision. A lens used to replace the natural lens after
cataract surgery is called an intraocular lens or "IOL." A
lens used in refractive surgery as an alternative to LASIK is
called an Implantable Collamer® Lens or "ICL." Over 150,000
Visian ICLs have been implanted to date; to learn more about the
ICL go to: www.visianinfo.com. STAAR has approximately 300
full time employees and markets lenses in approximately 50
countries. Headquartered in Monrovia, CA, it manufactures in the following
locations: Nidau, Switzerland;
Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA. For more information,
please visit the Company's website at: www.staar.com or call
626-303-7902.
Collamer® is the registered trademark for STAAR's proprietary
biocompatible collagen copolymer lens material.
Safe Harbor
All statements in this press release that are not statements of
historical fact are forward-looking statements, including any
statements about the effect of new product approvals on our
business, any 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
willingness of surgeons and patients to adopt a new product and
procedure; the entrenched market position of laser-based procedures
for many conditions treated by the Visian ICL, patterns of Visian
ICL use that have typically limited our penetration of the
refractive surgery market, 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.
CONTACT:
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Investors
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EVC Group
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EVC Group
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Doug Sherk,
415-896-6820
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Christopher Gale,
646-201-5431
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SOURCE STAAR Surgical Company