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HeartWare® International Announces Acquisition Of CircuLite®, Inc.



      HeartWare® International Announces Acquisition Of CircuLite®, Inc.

- Acquisition expands HeartWare's technology platform into partial support for
less sick patients -

- Investor Conference Call on Monday, December 2, 2013 at 8:00 a.m. U.S. EST -

PR Newswire

FRAMINGHAM, Mass. and TEANECK, N.J., Dec. 1, 2013

FRAMINGHAM, Mass. and TEANECK, N.J., Dec. 1, 2013 /PRNewswire/ -- HeartWare
International, Inc. (Nasdaq: HTWR), a leading innovator of less invasive,
miniaturized circulatory support technologies that are revolutionizing the
treatment of advanced heart failure, today announced that it has acquired
CircuLite^®, Inc. – developer of the SYNERGY^® Circulatory Support System,
designed to treat less sick, ambulatory, chronic heart failure patients who
are not yet inotrope-dependent.  

(Photo: http://photos.prnewswire.com/prnh/20131201/LA25652)

According to the terms of the merger agreement, HeartWare has acquired all of
the issued and outstanding equity interests of CircuLite for consideration of
$30 million, consisting of approximately $18 million in HeartWare common stock
and cash of approximately $12 million to settle CircuLite's debt and
transaction expenses, plus certain contingent success payments due upon
satisfaction of regulatory and commercial milestones not to exceed $320
million in the aggregate over a ten-year period.

"The partial-support system developed by CircuLite represents the industry's
most intriguing platform for the treatment of patients with earlier stage
heart failure," said Doug Godshall, President and CEO at HeartWare. "CircuLite
has pioneered the partial-assist approach and demonstrated that this technique
can significantly enhance the quality of life for this group of patients,
which is believed to be a substantially larger population than the end-stage
heart failure patients that HeartWare currently treats with our full-support
Ventricular Assist Devices (VADs). CircuLite's next generation endovascular
system, which will be implanted collaboratively by cardiologists and surgeons
in a hybrid cath lab setting, offers an extremely compelling interventional
approach to circulatory support. While our HVAD^® and MVAD^® Systems offer
minimally invasive treatment to end-stage heart failure patients, the SYNERGY
platform offers even less invasive and ultimately interventional options to
earlier-stage heart failure patients."

The SYNERGY Surgical System, which received CE Marking in the European Union
in 2012, is designed for long-term support and is intended to reduce the
heart's workload while improving blood flow to vital organs.  Approximately
the size and weight of a AA battery, the CE marked SYNERGY Surgical System is
implanted through a right, mini-thoracotomy procedure and does not require a
sternotomy or cardiopulmonary bypass.  With this approach, the inflow cannula
is placed in the left atrium, and the outflow graft is attached to the
subclavian artery.  CircuLite's proprietary micro-pump is then placed in a
pacemaker-like pocket and attached to the inflow cannula and outflow graft,
which connects to a wearable, external controller and battery pack.

The system is currently undergoing an upgrade to resolve issues that arose
post commercial release. Surgical System sales are expected to resume in a
controlled fashion following regulatory approval to re-launch the system in
Europe and will focus on building experience at a small number of centers of
excellence, refining training techniques and implementing additional system
upgrades in advance of a full rollout.

"The SYNERGY system is a novel entrant in the partial-support space for
treating patients with earlier stage heart failure," said Dr. Martin Strueber,
of the University Heart Center Leipzig in Leipzig, Germany.  "To date, there
is no viable option for those patients who have used biventricular pacemakers
without success and who are not yet sick enough for a VAD or cardiac
transplantation.  Having implanted SYNERGY systems and witnessed the marked
benefits to my patients and increased referrals I received for both full and
partial mechanical support, I look forward to technological advancements to
the system and a restored availability for patients.  Longer-term, the
endovascular approach, which we have explored extensively in Leipzig in
partnership with our cardiology colleagues, is truly exciting and holds
considerable promise."

"We are confident that HeartWare's technical, regulatory, sales and marketing
capabilities will have a profound impact on enabling the SYNERGY system to
reach its full potential," said Daniel Burkhoff, M.D., Ph.D., Chief Medical
Officer at CircuLite. "There is considerable opportunity for the current
SYNERGY system, and through continued investment and innovation, we believe we
could expand the circulatory support market with the launch of a
groundbreaking, endovascular treatment for patients with earlier stage heart
failure."

"The team at CircuLite created the SYNERGY Endovascular System in
collaboration with several leading cardiologists and received approval to
commence a feasibility study earlier this year.  We look forward to commencing
an investigation of this elegant device, as we believe it has the potential to
vastly expand the mechanical support market by bringing cardiologists into the
implant procedure for the first time," Mr. Godshall added.

Under the terms of the merger agreement, CircuLite securityholders may be
entitled to receive additional clinical and commercial success payments, upon
achievement of specified regulatory and revenue-based milestones. 

Potential regulatory milestone payments include:

  o $20 million payable in HeartWare common stock upon full European re-launch
    of the SYNERGY Surgical System;
  o Up to $75 million payable in cash or HeartWare common stock upon CE Mark
    of the SYNERGY Endovascular System; and
  o $50 million payable in cash or HeartWare common stock upon U.S. FDA
    Pre-Market Application approval of the SYNERGY Endovascular System.

Potential revenue-based success payments include:

  o Up to $15 million payable in cash or HeartWare common stock when the
    12-month trailing sales of the SYNERGY Surgical System reach $30 million;
  o $85 million payable in cash or HeartWare common stock upon achievement of
    the 12-month trailing sales of $250 million of SYNERGY Systems (surgical
    or endovascular); and
  o Up to $75 million (subject to adjustment) in royalties on sales of
    surgical and endovascular CircuLite products payable in cash or HeartWare
    common stock.

The total upfront and earnout consideration is subject to certain performance
criteria, and cannot exceed $350 million.  All consideration may only be
earned through the eighth anniversary of the closing of the transaction, with
the exception of the milestone payment based on trailing sales of $250
million, which may be earned through the tenth anniversary.  Any payments made
in HeartWare common stock, including the upfront consideration, are calculated
using a 60-day volume weighted average price. 

This transaction was approved by the Board of Directors of HeartWare and Board
of Directors and shareholders of CircuLite.

Perella Weinberg Partners acted as financial advisor to HeartWare.  Credit
Suisse served as financial advisor to CircuLite.

Investor and Analyst Conference Call and Webcast
HeartWare will hold a conference call with slide presentation to discuss the
transaction on Monday, December 2, 2013 at 8 a.m. EST.  The conference call
may be accessed by dialing 1-877-941-4774 five minutes prior to the scheduled
start time and referencing "HeartWare."  For callers outside the U.S., please
dial +1-480-629-9760.  The slide presentation may be accessed by logging onto
the live webcast through the weblink below.

A live webcast of the call may be accessed in the Investor section of
HeartWare's website at http://ir.heartware.com/.  A replay of the webcast will
be available through the above weblink immediately following completion of the
call.

About HeartWare International
HeartWare International develops and manufactures miniaturized implantable
heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients
suffering from advanced heart failure. The HeartWare^® Ventricular Assist
System features the HVAD^® pump, a small full-support circulatory assist
device designed to be implanted next to the heart, avoiding the abdominal
surgery generally required to implant competing devices. The HeartWare System
is approved in the United States for the intended use as a bridge to cardiac
transplantation in patients who are at risk of death from refractory end-stage
left ventricular heart failure, has received CE Marking in the European Union
and has been used to treat patients in 37 countries. The device is also
currently the subject of a U.S. clinical trial for destination therapy. For
additional information, please visit the Company's website at
www.heartware.com.

HeartWare International, Inc. is a member of the Russell 2000^® and its
securities are publicly traded on The NASDAQ Stock Market.

HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of
HeartWare, Inc.

About CircuLite
CircuLite is developing disruptive solutions to improve the treatment of heart
failure. The Company –whose manufacturing operations are based in Aachen,
Germany – focuses on technology that works in conjunction with the heart to
enhance clinical outcomes and improve quality of life. SYNERGY, which received
CE Mark in 2012, features the smallest surgically-implanted blood pump for
long-term use in ambulatory chronic heart failure patients not responding to
optimal medical treatment. The company is developing a portfolio of
minimally-invasive systems based on its proprietary micro-pump platform,
including an interventional cardiology system, a right-heart system and a
pediatric system that have not yet been submitted for FDA clearance. For more
information, visit our website at www.circulite.net.

CircuLite^® and SYNERGY^® are registered trademarks of CircuLite, Inc. in the
United States.

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 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 costs and benefits to be achieved from the transaction, the
progress of clinical trials, regulatory status, research and development
activities and the technological potential and commercial success of the
Synergy 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.  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.

For additional HeartWare information:          For additional CircuLite
                                               information
Christopher Taylor                             Gail Farnan, RN
HeartWare International, Inc.                  CircuLite, Inc.
Email: ctaylor@heartwareinc.com                Email: gfarnan@circulite.com
Phone: +1 508 739 0864                         Phone: +1 555 221 4993

SOURCE HeartWare International, Inc.; CircuLite

Website: http://www.heartware.com
Website: http://www.circulite.net
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