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 24, 2014
HEARTWARE INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
| | | | |
| Delaware | | 001-34256 | | 26-3636023 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
500 Old Connecticut Path
Framingham, MA 01701
(Address of principal executive offices)
Registrant’s telephone number, including area code:
508.739.0950
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:
| ¨ | 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)) |
Item 8.01 Other Events
On April 24, 2014, HeartWare International, Inc. (Nasdaq: HTWR) issued a press release announcing the issuance of a clinician and patient reminder concerning the Urgent Medical Device Correction distributed to all of its clinical sites by the company in December 2013. A copy of the release is furnished with this report as Exhibit 99.1.
Forward-Looking Statements
The release furnished with this report contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to commercialization and regulatory compliance of the HeartWare® Ventricular Assist System. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by federal securities laws and the rules and regulations of the Securities and Exchange Commission. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A “Risk Factors” in HeartWare’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. HeartWare may update risk factors from time to time in Part II, Item 1A “Risk Factors” in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| | |
Exhibit No. | | Description |
| |
| 99.1 | | Press Release issued by HeartWare International, Inc. dated April 24, 2014. |
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.
| | | | | | |
| | | | HeartWare International, Inc. |
| | | |
| Date: April 24, 2014 | | | | By: | | /s/ Lawrence J. Knopf |
| | | | | | Name: Lawrence J. Knopf Title: Senior Vice President and General Counsel |
INDEX TO EXHIBITS
| | |
Exhibit No. | | Description |
| |
| 99.1 | | Press Release issued by HeartWare International, Inc. dated April 24, 2014. |
