Current Report Filing (8-k)
30 April 2015 - 8:30PM
Edgar (US Regulatory)
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): April 29, 2015
NUVASIVE, INC.
(Exact
name of registrant as specified in its charter)
|
|
|
|
|
Delaware |
|
000-50744 |
|
33-0768598 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
7475 Lusk Boulevard, San Diego, California 92121
(Address of principal executive offices) (Zip Code)
(858) 909-1800
(Registrants 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):
|
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On April 29, 2015, NuVasive, Inc. (the Company) issued a press release announcing that it has reached an agreement in
principle with the U.S. Department of Justice related to the previously disclosed subpoena issued to the Company in 2013 by the Office of Inspector General of the Department of Health and Human Services. A copy of this press release
is furnished as Exhibit 99.1 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 NuVasives results to differ materially
from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among
others, the risk that the Company is unable to finalize a written settlement agreement with the OIG and/or that the amount required to the United States in resolution of the above-referenced matter may increase, risks associated with
litigation and/or regulatory enforcement actions which could cause the Company to incur significant legal expenses and/or prevent it from making, using or selling certain of the Companys products, risks associated with acceptance of the
Companys minimally disruptive surgical products by spine surgeons, development and acceptance of new products or product enhancements, expansion of the Companys network of sales representatives, and the other risks and uncertainties
described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. NuVasives 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.
Item 9.01 |
Financial Statements and Exhibits. |
|
|
|
|
|
99.1 |
|
Press release issued by NuVasive, Inc. on April 29, 2015. |
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
NUVASIVE, INC. |
|
|
|
|
|
|
|
Date: April 30, 2015 |
|
|
|
By: |
|
/s/ Jason
Hannon |
|
|
|
|
|
|
|
|
Jason Hannon |
|
|
|
|
|
|
|
|
Executive Vice President & General Counsel |
|
|
EXHIBIT INDEX
|
|
|
Exhibit
Number |
|
Description |
|
|
99.1 |
|
Press release issued by NuVasive, Inc. on April 29, 2015. |
Exhibit 99.1
NuVasive® Reaches Agreement in Principle to Settle OIG Matter
SAN DIEGO, CA 04/29/15 NuVasive, Inc. (NASDAQ: NUVA) (NuVasive or the
Company), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, today announced that it has reached an agreement in principle with the U.S. Department of
Justice (DOJ) related to the previously disclosed subpoena issued to the Company in 2013 by the Office of Inspector General of the Department of Health and Human Services (OIG). Subject to completion of a
definitive written settlement agreement, the Company has agreed to pay $13.8 million, including fees, to the United States to resolve this matter. The Company does not currently anticipate entering into a corporate integrity agreement
with the OIG as part of the settlement. Finalizing the written settlement agreement could take several months.
The Company cooperated
fully with the inquiry, has responded to the concerns raised by the government, and has continued to work hard to enhance and sustain a culture of compliance throughout its operations. Resolution of the matter avoids the time and expense of a
potentially lengthy litigation process.
About NuVasive
NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and
procedurally-integrated solutions for the spine. The Company is the third largest player in the $9.0 billion global spine market. NuVasive offers a comprehensive spine portfolio of more than 90 unique products developed to
improve spine surgery and patient outcomes. The Companys principal procedural solution is its Maximum Access Surgery, or MAS®, platform for lateral spine fusion. MAS was designed to
provide safe, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure, and a broad offering of application-specific implants and fixation devices designed to
address a variety of pathologies.
NuVasive cautions you that statements included in this news release 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 NuVasives results to differ materially from
historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, the risk that the Company is unable to
finalize a written settlement agreement with the OIG and/or that the amount required to the United States in resolution of the above-referenced matter may increase, risks associated with litigation and/or regulatory enforcement actions
which could cause the Company to incur significant legal expenses and/or prevent it from making, using or selling certain of the Companys products, risks associated with acceptance of the Companys minimally disruptive surgical products
by spine surgeons, development and acceptance of new products or product enhancements, expansion of the Companys network of sales representatives, and the other risks and uncertainties described in NuVasives news releases and
periodic filings with the Securities and Exchange Commission. NuVasives 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.
Investor/Media Contact:
Stacy Roughan
NuVasive,
Inc.
1-858-909-1812
Nuvasive (NASDAQ:NUVA)
Historical Stock Chart
From Apr 2024 to May 2024
Nuvasive (NASDAQ:NUVA)
Historical Stock Chart
From May 2023 to May 2024