FRAMINGHAM, Mass., Aug. 4, 2014 /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 the appointment of Katrin
Leadley, M.D., as Chief Medical Officer of HeartWare,
effective September 1, 2014.
Leadley brings to HeartWare extensive strategic leadership,
with more than 20 years of clinical and industry experience at life
sciences firms, including Quintiles, Boston Scientific Corporation
and JenaValve Technology in Munich, where she spent the last three years
as CMO leading the company's clinical, regulatory, scientific and
medical activities.
"Katrin has a wealth of clinical program management experience,
and we are confident she will be a great addition to our team,"
said Doug Godshall, President and
Chief Executive Officer. "Her knowledge of cardiovascular
device trials and her relationships with many of our international
key opinion leaders will enable her to begin making contributions
immediately. Katrin has proven experience in identifying new
market opportunities, ensuring patient safety and executing
clinical development plans and regulatory strategies to achieve
product approvals and market introductions of new medical
therapies. Katrin will help lead HeartWare through our next
stage of clinical and commercial growth, as we advance our ongoing
trials, initiate new studies and move toward obtaining regulatory
approval of devices in our pipeline."
During her time at JenaValve, Leadley oversaw the company's
global clinical programs and worldwide regulatory strategy.
She provided leadership and guidance as the company's safety
officer for all JenaValve products throughout the product
lifecycle, and she offered medical guidance to the organization's
Research & Development, marketing and physician training
programs. She was also responsible for the company's
scientific communications and for collaborating with key opinion
leaders in the field.
Previously, Leadley spent eight years at Boston Scientific –
based in San Jose, California and
Munich – where she most recently
served as Global Senior Medical Director, Clinical Sciences.
During her time at Boston Scientific, Leadley oversaw the
implementation of worldwide policies and processes for the medical
and clinical sciences function of the cardiovascular
platforms. She also provided medical oversight and
participated in preparing regulatory submissions and approvals in
the U.S. and Europe.
In addition, Leadley has held managerial positions at several
other life sciences companies based in California, including Advanced Stent
Technologies in Pleasanton,
Pulmonx in Palo Alto, and
Quintiles/The Lewin Group in San
Francisco.
Leadley earned her medical degree at Ludwig-Maximilian
University Medical School in Munich. She has authored numerous
scientific and medical publications and presented at industry
conferences and events around the world. She also was awarded
a National Institute of Health Postdoctoral Fellowship by the
School of Public Health at the University of
California at Berkeley.
Leadley will succeed David
Hathaway, M.D., who has held the position of CMO at
HeartWare since 2008 and has decided to retire.
"HeartWare would like to recognize and express our gratitude
toward Dr. David Hathaway who has
provided excellent stewardship during the past six years," said
Godshall. "Dave has played an integral role in leading us
through the clinical process to obtain regulatory approval of the
HeartWare® Ventricular Assist System in Europe and as a bridge-to-transplantation
therapy in the U.S. HeartWare values Dave's numerous,
meaningful contributions and wishes him well in his retirement, as
our organization continues to grow and build upon the foundation he
helped us create."
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 40 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, PAL, SYNERGY, CIRCULITE and HeartWare
logos are registered trademarks of HeartWare, Inc.
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®
Ventricular Assist System, continued support from international
customers, progress of clinical trials and post-approval studies,
regulatory status, research and development activities 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.
For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com
Phone: +1 508 739 0864
SOURCE HeartWare International, Inc.