UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
Report (Date of Earliest Event Reported): June 9, 2010
STAAR
Surgical Company
(Exact
name of registrant as specified in its charter)
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Delaware
(State
or other jurisdiction
of
incorporation)
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0-11634
(Commission
File Number)
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95-3797439
(I.R.S.
Employer
Identification
No.)
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1911 Walker Ave, Monrovia,
California
(Address
of principal executive offices)
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91016
(Zip
Code)
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Registrant’s
telephone number, including area code:
626-303-7902
Not
Applicable
Former
name or former address, if changed since last report
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
7.01 Regulation FD Disclosure.
STAAR
Surgical Company’s President and Chief Executive Officer, Barry Caldwell, will
make a presentation at the Jefferies &. Co. 2010 Global Life Sciences
Conference on Wednesday, June 9, 2010 at 2:00 p.m. Eastern Daylight Time in New
York, New York. A copy of the slides to be used in Mr. Caldwell’s
presentation is furnished as Exhibit 99.1 to this Report, and is incorporated
herein by this reference.
STAAR
will offer a live audio webcast of its presentation on the Company's website,
http://www.staar.com, under “Investor Information.” An archived replay of the
presentation will be available for 30 days, also at
http://www.staar.com.
The slide
presentation includes pro forma or non-GAAP financial information. The Company
incorporates by reference its previous filings with the Securities and Exchange
Commission that provide related reconciliation information.
The
preliminary results of research on the accommodating properties of the Collamer®
lens material, and any other information about the performance of STAAR’s
products, are provided in the slide presentation for the information of
investors. They do not constitute claims of therapeutic benefit or indications
for use.
Safe
Harbor
All
statements in this Report (including the exhibits furnished with this Report)
that are not statements of historical fact are forward-looking statements,
including statements about any of the following: STAAR’s possible achievement of
profitability, 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; 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
Report 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: our history of
losses, 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; the risk that clinical research into the accommodating power of the
nanoFLEX lens may not confirm early results and we may be unable to add a new
claim to our labeling, the discretion of the FDA and other regulators in
approving new products and the risk that they will not approve our new products,
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 and
comparisons with the performance of other products included in the slide
presentation 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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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June 9,
2010
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STAAR
Surgical Company
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By:
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/s/ Barry
Caldwell
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Barry
Caldwell
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President
and Chief Executive Officer
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Exhibit
Index
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Exhibit
No.
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Description
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99.1
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Slide
Presentation dated June 9, 2010.
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