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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): February 26, 2010
NUVASIVE, INC.
(Exact name of registrant as specified in its charter)
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| Delaware
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000-50744
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33-0768598 |
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(State or Other
Jurisdiction of
Incorporation)
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(Commission File
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(I.R.S. Employer
Identification Number) |
7475 Lusk Boulevard, San Diego, California 92121
(Address of principal executive offices, with zip code)
(858) 909-1800
(Registrant’s telephone number, including area code)
n/a
(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 (see General
Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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| Item 7.01 |
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Regulation FD Disclosure |
On February 26, 2010, NuVasive, Inc. issued two press releases announcing that each Aetna and
United Healthcare reversed their respective previous policies that labeled XLIF as experimental and
investigational.
As previously announced, NuVasive posts updates regarding the policy status of the larger insurance
companies in the United States with respect to XLIF on its investor relations page of its corporate
website at www.nuvasive.com. NuVasive will post an update on its website related to the subject
matter covered by the press releases and invites the public to visit
the website to stay informed of
this and other updates. Copies of the press releases are furnished as Exhibit 99.1 and Exhibit 99.2
hereto.
NuVasive cautions you that statements included in this Current Report on Form 8-K that are not a
description of historical facts are forward-looking statements that involve risks, uncertainties,
assumptions and other factors which, if they do not materialize or prove correct, could cause
NuVasive’s results to differ materially from historical results or those expressed or implied by
such forward-looking statements. The potential risks and uncertainties that could cause actual
growth and results to differ materially include, but are not limited to: the uncertain process of
seeking regulatory approval or clearance for NuVasive’s products or devices, including risks that
such process could be significantly delayed; the risk that government or private payers may deny
reimbursement to hospitals for use of the Nuvasive’s products; the risk that NuVasive may be
unsuccessful in its efforts to convince government or private payers to provide adequate
reimbursement for its products; the possibility that the FDA may require significant changes to
NuVasive’s products or clinical studies; the risk that products may not perform as intended and may
therefore not achieve commercial success; the risk that competitors may develop superior products
or may have a greater market position enabling more successful commercialization; the risk that
additional clinical data may call into question the benefits of NuVasive’s products to patients,
hospitals and surgeons; and other risks and uncertainties more fully described in NuVasive’s press
releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public
filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes
no obligation to update any forward-looking statement to reflect events or circumstances arising
after the date on which it was made.
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| Item 9.01 |
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Financial Statements and Exhibits |
(d) Exhibits
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99.1 |
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Press release issued by NuVasive, Inc. on February 26, 2010,
announcing Aetna’s reversal of reimbursement policy related to XLIF |
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99.2 |
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Press release issued by NuVasive, Inc. on February 26, 2010,
announcing United Healthcare’s reversal of reimbursement policy related to XLIF |
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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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NUVASIVE, INC.
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| Date: February 26, 2010 |
By: |
/s/ Alexis V. Lukianov
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Alexis V. Lukianov |
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Chairman and Chief Executive Officer |
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EXHIBIT INDEX
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| Exhibit |
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Description of Document |
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99.1 |
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Press release issued by NuVasive, Inc. on February 26, 2010,
announcing Aetna’s reversal of its reimbursement policy related to
XLIF |
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99.2 |
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Press release issued by NuVasive, Inc. on February 26, 2010,
announcing United Healthcare’s reversal of its reimbursement policy related
to XLIF |
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