8-K

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): December 8, 2015

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:

x 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 December 8, 2015, HeartWare International, Inc. (“HeartWare”) presented at the Oppenheimer 26^th Annual Healthcare Conference held in New York, New York. One of the topics covered in HeartWare’s presentation was HeartWare’s proposed acquisition of Valtech Cardio, Ltd. (“Valtech”). A live webcast of HeartWare’s presentation was provided through the Company’s investor relations website and is available for replay at ir.heartware.com. HeartWare’s slide presentation used at the conference is attached hereto as Exhibit 99.1 and is hereby incorporated by reference.

As previously announced, HeartWare intends to acquire Valtech as set forth in that certain Business Combination Agreement, dated as of September 1, 2015, by and among HeartWare, Valtech, HW Global, Inc., a Delaware corporation and a direct wholly owned subsidiary of HeartWare (“Holdco”), HW Merger Sub, Inc., a Delaware corporation and a direct wholly owned subsidiary of Holdco (“US Merger Sub”), Valor Merger Sub Ltd., a private company incorporated under the laws of Israel and a direct wholly owned subsidiary of Holdco (“ISR Merger Sub”) and Valor Shareholder Representative, LLC, a Delaware limited liability company, pursuant to which, subject to satisfaction or waiver of the conditions therein, HeartWare and Valtech will effect a strategic combination of their respective businesses under Holdco wherein (a) US Merger Sub shall merge with and into HeartWare, with HeartWare surviving the merger as a wholly owned subsidiary of Holdco (the “US Merger”), and (b) ISR Merger Sub shall merge with and into Valtech, with Valtech surviving the merger as a subsidiary of Holdco (the “ISR Merger,” together with the US Merger and the other transactions contemplated by the Business Combination Agreement, the “Transactions”).

Additional information concerning the proposed Transactions is included in the preliminary proxy statement/prospectus, which was originally filed by Holdco with the Securities and Exchange Commission on October 16, 2015 and amended on November 25, 2015.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	December 8, 2015 HeartWare Slide Presentation for the Oppenheimer 26th Annual Healthcare Conference.

Important Information

Additional Information about the Transactions and Where to Find It

In connection with the proposed Transactions, Holdco has filed a Registration Statement on Form S-4 that contains a preliminary proxy statement/prospectus, which is not yet final and may be further amended. Holdco intends to file a final prospectus and other relevant materials and HeartWare intends to file a definitive proxy statement and other relevant materials with the SEC in connection with the proposed Transactions. Investors and security holders of HeartWare and Valtech are urged to read these materials when they become available because they will contain important information about HeartWare, Valtech and the Transactions. The proxy statement/prospectus and other relevant materials (when they become available), and any other documents filed by Holdco or HeartWare with the SEC, may be obtained free of charge at the SEC website at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Holdco or HeartWare by directing a written request to HeartWare’s investor relations department at HeartWare International, Inc., 500 Old Connecticut Path, Framingham, MA 01701, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the Transactions.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.

Participants in the Solicitation

HeartWare, Valtech and their respective directors, executive officers, certain members of management and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of HeartWare and Valtech in connection with the proposed transaction. Information regarding the special interests of HeartWare’s directors and executive officers in the transaction is included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of HeartWare is also included in the HeartWare Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC on March 2, 2015. This document is available free of charge at the SEC website (www.sec.gov) and from Investor Relations at HeartWare at the address described above.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially from those indicated in such forward-looking statements, including, but not limited to, the ability of the parties to consummate the proposed Transactions; satisfaction of closing conditions to the consummation of the proposed Transactions; and such other risks and uncertainties pertaining to HeartWare’s business as detailed in its filings with the SEC on Forms 10-K and 10-Q, which are available on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date thereof. HeartWare assumes no obligation to update any forward-looking statement contained in this document.

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: December 8, 2015	By:	/s/ Lawrence J. Knopf
		Name:	Lawrence J. Knopf
		Title:	Senior Vice President, General Counsel and Secretary

INDEX TO EXHIBITS

Exhibit No.	Description
99.1	December 8, 2015 HeartWare Slide Presentation for the Oppenheimer 26th Annual Healthcare Conference.

EX-99.1

Exhibit 99.1

Oppenheimer 26th Annual Healthcare Conference

December 8, 2015 · New York, NY

DOUG GODSHALL

PRESIDENT AND CEO

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

Safe Harbor Statement

Forward-Looking Statements

This announcement 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 the: commercialization of the HeartWare HVAD® System and introduction of the MVAD® System; timing, progress and outcomes of clinical trials; regulatory and quality compliance; research and development activities; consummation of our proposed acquisition of Valtech Cardio, Ltd. and our ability to take advantage of acquired and pipeline technology. 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.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

2

Additional Shareholder Information

Participants in the Solicitation

HeartWare, Valtech Cardio, Ltd. (“Valtech”) and their respective directors, executive officers, certain members of management and certain employees may be deemed to be participants in the solicitation of proxies in connection with the proposed acquisition of Valtech. A description of the interests in HeartWare of its directors and executive officers is set forth in HeartWare’s proxy statement for its 2015 Annual Meeting of Shareholders, which was filed with the Securities and Exchange Commission (the “SEC”) on April 30, 2015. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the proposed transaction, and a description of their direct and indirect interests in the proposed transaction, which may differ from the interests of HeartWare stockholders or Valtech shareholders generally, are set forth in a preliminary proxy statement/prospectus originally filed with the SEC on October 16, 2015 and amended on November 25, 2015.

Additional Information and Where To Find It

In connection with the proposed transactions, HW Global, Inc. (“Holdco”), has filed a Registration Statement on Form S-4 that contains a preliminary proxy statement/prospectus, which is not yet final and may be further amended. Holdco intends to file a final prospectus and other relevant materials and HeartWare intends to file a definitive proxy statement and other relevant materials with the SEC in connection with the proposed transactions. Investors and security holders of HeartWare and Valtech are urged to read these materials (when they become available) before making any voting or investment decision with respect to the transactions because they will contain important information about HeartWare, Valtech and the transactions. The proxy statement/prospectus and other relevant materials, and any other documents filed by Holdco or HeartWare with the SEC, may be obtained free of charge on the SEC website at www.sec.gov. In addition, investors and security holders may obtain free copies of these documents by directing a written request to HeartWare’s investor relations department at HeartWare International, Inc., 500 Old Connecticut Path, Framingham, MA 01701, Attention: Investor Relations.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”).

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

3

HeartWare®

Mission

We create revolutionary technology for the treatment of heart failure to allow patients to get back to life.

hVAD®System

10,000+

Patients Implanted Globally

~125

U.S. Centers

47

Countries

~180

Intl. Centers

2009: CE Mark 2012: FDA Approval

HVAD® System - A Proven Track Record

Note: Data on Centers as of September 30, 2015

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

4

HeartWare Achieves 10,000 HVAD® Implants Globally

Cumulative Implant Volume by Year

Implant Volume

12,000

10,000

8,000

6,000

4,000

2,000

10,000

0

Argentina Australia France Germany Romania Saudi Arabia

Austria Greece Serbia

Belarus Hungary Singapore

Belgium India Slovakia

Brazil Israel South Africa

Canada Italy South Korea

Chile Japan Spain

Croatia Kazakhstan Sweden

Cyprus Lebanon Switzerland

Czech Luxembourg Turkey

Republic Malaysia United Arab Emirates

‘08 ‘09 ‘10 ‘11 ‘12 ‘13’14 15*

Denmark Netherlands United Kingdom

Egypt New Zealand United States

Estonia Norway Vietnam

Thank you to the 300+ HVAD® customers around the world!

Finland Poland

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

HeartWare® Ventricular Assist System

HVAD® System Miniaturized Implantable Blood Pump Features

Pericardial placement – no pump pocket

Provides up to 10 L/min of flow

Centrifugal design, continuous flow

Hybrid magnetic / hydrodynamic impeller suspension

Optimizes flow, pump surface washing and hemocompatibility

Thin (4.2 mm), flexible driveline with fatigue-resistant cables

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the

“Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions,

Adverse Events and Instructions prior to using this device.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

6

Enabling Patients to Get Back to Life

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

7

Recent Milestones

Announced agreement to acquire Valtech Cardio

Commenced MVAD® System CE Mark international trial

Completed enrollment in ENDURANCE2 DT trial

Submitted MVAD IDE to FDA

Valtech’s Cardioband® awarded CE Mark approval

Continued ramping enrollment in HVAD® LATERAL; thoracotomy study ~60% enrolled (as of October 2015)

Surpassed 3 years of HVAD commercialization in U.S.

Longest-supported HVAD patient reached 8 years on support

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

8

PIPELINE TECHNOLOGY

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

MCS Portfolio and Pipeline: Maintaining and Enhancing Competitiveness

Pumps

HVAD®

Longer sintering

DT indication

MVAD®

Next-gen, more versatile pump

CircuLite®

Class III, partial-assist device

Longhorn®

Eliminates outflow graft

Electronics

Lavare

HVAD pulsatility algorithm

HVAD Controller Upgrade

Improved patient management

Pal™

Versatile, simple and smart controller

TET

Eliminates driveline

Remote Monitoring

Connected patient care

Tools

MVAD Gimbal

Angle and depth adjustment

Thoracotomy Tools

HVAD and MVAD

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

10

The MVAD® System Has Breakthrough Potential

MVAD® Pump

PalTM Patient Peripherals

Small size enables less invasive implant and improved anatomical fit

Advanced impeller technology for advanced hemocompatibility

Lighter and thoughtfully designed peripherals to enhance patient quality of life

Exclusively for Clinical Investigation.

Investigational device to be used by Qualified Investigators Only.

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

11

qPulse™ Cycle

Customizable speed adjustments (3 settings)

Designed to promote aortic valve opening, enable ventricular washing and reduce bleeding complications

Pressure (mmHG)

120 100 80 60 40 20 0

20k 18k 16k 14k 12k 10k 8k

Speed (RPM)

Speed Aortic Left Ventricular

Exclusively for Clinical Investigation.

Investigational device to be used by Qualified Investigators Only.

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

12

MVAD® Advantage™ CE Mark Trial

Multi-center, prospective, non-randomized, single-arm trial

70 patients at 11 sites in Australia, Austria, France, Germany & the UK

Primary Endpoint: Survival at 6 months

Implantation via thoracotomy or sternotomy

First patient enrolled July 2015

mVAD AdvantageTM Trial

Exclusively for Clinical Investigation.

Investigational device to be used by Qualified Investigators Only.

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

13

MVAD® Pump in situ

SUPINE MOBILE

Exclusively for Clinical Investigation.

Investigational device to be used by Qualified Investigators Only.

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

14

MVAD® System Commentary

Controller assembly fix complete, software patch progressing toward submission efficiently

Investigation continues with no anticipated design modifications

Narrowing our focus to specific areas within our manufacturing process, which we may elect to further tighten up

Working with investigators to review status and develop restart plan

Finalizing decision tree for return to the clinic

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

15

BUSINESS COMBINATION

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare

HeartWare + Valtech: Creating the Technology Leader in Heart Failure

MVAD® System will lead a transformation of MCS portfolio and VAD market, picking up where HVAD® leaves off

Synergies with disease, customer, referral channel and delivery system will create compounding benefits over next decade

Adjustable repair of MR and TR expected to emerge as first-line option, whether surgical or interventional

Nearer-term commercial opportunity in established surgical and interventional mitral repair market with >$450M in sales

Sophisticated CardioValve™ design and delivery system to enable HeartWare leadership in mitral replacement

Combined pipeline creates unique opportunity for differentiated value creation

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®

17

Covering the Spectrum of Heart Failure

Heart Failure Continuum

Today

Cardioband Mitral HVAD

Tomorrow

Cardinal Mitral and Tricuspid

Cardioband Mitral and Tricuspid

MVAD HVAD

Future

Cardinal Mitral and Tricuspid

Cardioband Mitral and Tricuspid

Cardiovalve

CircuLite

MVAD

HVAD

Longhorn

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare® 18

Valtech: Consistent, Meaningful Milestone Cadence

2016 2017 2018 2019

Cardioband Launch

Cardioband IDE

Cardinal Launch EU

Cardioband TR FIM

Cardiovalve FIM

Cardioband TR IDE

Cardinal IDE

Cardioband PMA

Cardioband TR CE Mark

Cardinal PMA

Cardiovalve IDE

Cardiovalve CE

Cardioband TR PMA

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare® 19

Expanding Cardioband® Commercial Footprint

Cardioband® Center Locations in Europe & Israel

FRANCE

Paris – Hôpital Bichat-Claude Bernard

GERMANY

Bad Nauheim – Kerckhoff-Klinik

Berlin – Vivantes Klinikum Am Urban

Bonn – Universitätsklinikum Bonn

Frankfurt – CardioVasculäres Centrum Frankfurt

Hamburg – Asklepios Klinik St. Georg

Hamburg – HGH Universitäres Herz- und

Gefäßzentrum Hamburg GmbH

Hamburg – Universitätsklinikum Hamburg-Eppendorf (UKE)

Köln – Universität zu Köln

Mainz – Universitätsmedizin der Johannes Gutenberg

Universität Mainz

München – Ludwig Maximilians Universität (LMU) Klinikum

Rostock – Universitätsmedizin Rostock

ISRAEL

Haifa – Rambam Health Care Campus

Petah Tikva – Rabin Medical Center

ITALY

Catania – Ospedale Ferrarotto

Milan – Ospedale San Raffaele (OSR)

Rome – Policlinico Tor Vergata

NETHERLANDS

Nieuwegein – St. Antonius Ziekenhuis

SWITZERLAND

Zurich – UniversitätsSpital Zürich

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

Valtech HeartWare®

Replacement Will Eventually Have Strong Place in the Market; Repair Represents Much Stronger Near- and Mid-Term Opportunity as Valve Technology Matures

Repair

Transapical Replacement

Transseptal Replacement

Phase I: Repair + Early TA Replacement

Phase II: Repair + Mature TA and Early TS Replacement

Phase III: Repair + Mature TS Replacement

Repair Repair safer, available first and more proven

Broader use in earlier disease stages and lower-risk patients

Mature repair market

Younger FMR patients

Growth in DMR segment

Replacement

Early transapical replacement outcomes varied

Mostly reserved for high-risk severe FMR patients

Mature transapical, early transseptal replacement

Mature transseptal, replacement valves

Older FMR patients

Select DMR etiologies

Note: Transapical (TA), Transseptal (TS).

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare® 21

Combined Portfolio Provides Leadership Position in Two of the Highest-Growth Areas in Heart Failure

2015 VAD Class IV Class III 2030

$800M +7% CAGR $2.2B

Valve Mitral Tricuspid

$600M +18% CAGR $7.5B

Source: HTWR estimates.

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare® 22

Video and Slide Replay Available…

HeartWare®

HeartWare® International Analyst and Investor Meeting

Thursday, November 05, 2015 9:00 am EST

Webcast

00:33:19/03:47:33

Slide Search Slides Speakers Downloads

FMR / FTR Summary

Advanced CHF is a growing problem with significant mortality and repeat hospitalization

Most patients with CHF have FMR and in very advanced stages FTR

GDMT and resynchronization therapy work

Surgery is seldom used

Transcatheter therapy and MCS are major opportunities

A vertically integrated device company capable of managing different stages of CHF disease state makes total sense

Valtech HeartWare® 70

Slide 69 of 286

For more information and to view the Analyst & Investor Meeting video webcast replay, please visit HeartWare.com

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare® 23

Priorities for the Months Ahead…

Advance discussions with shareholders regarding proposed Valtech acquisition; facilitate diligence process

Complete MVAD® review and implement any appropriate actions identified

Resume enrollment in CE Mark clinical trial of MVAD System

Pursue initiation of MVAD System clinical trials in U.S. and Canada

Complete Warning Letter remediation process

Complete follow-up for ENDURANCE2 DT trial

Secure approval in U.S. for Lavare Cycle

Complete enrollment in HVAD® LATERAL thoracotomy IDE study

Advance CircuLite® System toward clinic

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare® 24

Thank You

HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

HeartWare®