- Provides for Collaboration on Marketing and Clinical Support -
OAKLAND, Calif., Dec. 12 /CNW/ -- (Nasdaq: WHRT, TSX: WHT) -- World Heart
Corporation (WorldHeart or the Company), a developer of implantable mechanical
circulatory support systems for chronic heart failure patients, today
announced that it has entered into a strategic alliance with ABIOMED, Inc.
(Abiomed, Nasdaq: ABMD), a leading manufacturer of devices for acute
circulatory support. The alliance brings together two of the pioneering
companies in this industry, each with experienced teams, strong clinical
relationships and unique, complementary products and technologies.
Under the terms of the agreements, Abiomed will:
-- provide a secured convertible loan to WorldHeart of $5 million, funded
in two tranches, accruing interest at 8% per annum, and convertible
into WorldHeart common shares at Abiomed's option;
-- provide certain marketing and clinical support services to WorldHeart,
and will receive a warrant for an aggregate of 3,400,000 common shares
of WorldHeart as partial consideration for these clinical support and
-- have the right of first refusal to act as an exclusive worldwide
distributor for any future WorldHeart product; and
-- have the right to designate one nominee or observer to the WorldHeart
Board of Directors.
"We are excited about the opportunities presented by this strategic
alliance," said Jal S. Jassawalla, President and Chief Executive Officer of
WorldHeart. "We believe this alliance creates a winning strategy by bringing
together complementary technologies and broad device portfolios. Abiomed's
extensive and experienced field support and marketing team is well positioned
to promote and support WorldHeart's products. We are honored that they have
chosen the Levacor(TM) Rotary VAD as the long-term implantable device of
"We are excited about the opportunity to work with WorldHeart. They are
well respected in the field of circulatory support and have an extensive
network of loyal heart surgeons," commented Michael R. Minogue, Chairman,
President and Chief Executive Officer of Abiomed. "Based on the analysis of
our top scientists, and our due diligence with leading customers, we believe
that the Levacor mag-lev rotary pump represents the best solution for long-
term support applications, including bridge to transplant and destination
therapy. Abiomed remains committed and focused on heart recovery for acute
patients, especially with Impella(R) in the cath lab. However, we also
recognize the unmet clinical need for patients suffering from chronic heart
failure that can benefit from a long-term implantable LVAD."
WorldHeart and Abiomed, two of the longest established companies in the
field, currently serve complementary segments of the circulatory support
market. This alliance is expected to benefit heart failure patients and
treatment providers, promoting synergies between the two organizations in a
number of areas.
-- Products - WorldHeart's current and future products - the Novacor(R)
pulsatile LVAS and the Levacor Rotary VAD - are designed to provide
long-term support for chronic heart failure patients. Intended for use
as a bridge to transplant or for destination (life-long) therapy,
implant durations typically range from months to years. Abiomed
markets a number of devices targeting primarily recovery applications,
where support duration is measured in hours, days or months. The
portfolios of the two companies collectively span the full spectrum of
mechanical circulatory support needs, with implant durations ranging
from hours to years, and from partial to total support.
-- Clinical Relationships - The recipients of WorldHeart's chronic support
devices are under the care of heart failure cardiologists and cardiac
surgeons. Abiomed's products are administered by interventional
cardiologists as well as cardiac surgeons. Collectively, the two
companies have access to a broad base of clinical customers addressing
a wide range of cardiac conditions.
-- Marketing and Clinical Support - WorldHeart products, which have a
long-standing reputation for high quality and reliability, are now
expected to be more effectively marketed and supported. Abiomed has an
extensive marketing capability, as well as one of the largest field
support teams in the VAD industry. The two companies expect to be able
to reach a broader customer base and provide an efficient and high
level of clinical support.
-- Technology - The companies also expect to explore opportunities for
technology collaborations. For example, the transcutaneous (across-
the-skin) energy transfer system and implanted electronics developed
for the AbioCor total heart potentially could be adapted to the
Levacor, eliminating any wires through the skin to reduce the
associated infection risk.
WorldHeart's Levacor VAD, a 4th-generation rotary VAD, is the only
bearingless, fully magnetically levitated implantable centrifugal rotary pump
to have seen clinical use. In contrast to 2nd and 3rd-generation pumps with
blood-immersed mechanical or hydrodynamic bearings, the Levacor uses full
magnetic levitation to suspend the spinning rotor, eliminating wear within the
pump and allowing greater clearances around the rotor with more idealized flow
patterns. This is expected to provide improved blood compatibility and
reduced need for anticoagulation therapy, thus potentially reducing bleeding
and thromboembolic complications, which remain a significant issue with 2nd
and 3rd-generation systems. Current focus is on activities leading to the
start of a U.S. clinical trial with the Levacor. These have included Pre-IDE
submissions and subsequent productive discussions with the FDA regarding the
clinical study design.
Details of Financial Terms
WorldHeart and its wholly owned subsidiary, World Heart Inc., have signed
a definitive note purchase agreement with Abiomed to issue a 8% secured
convertible promissory note for the principal sum of $5 million, which funds
will be used primarily for working capital purposes. The note will be funded
in two tranches: $1 million was funded immediately and $4 million is
scheduled to be funded on or about January 3, 2008. After the second
anniversary, the note is payable on demand, or at WorldHeart's option subject
to fulfillment of certain conditions. The note is convertible into common
shares of WorldHeart, in whole or in part, at approximately $1.75 per share,
resulting in an approximately 19.9% ownership interest in WorldHeart upon
conversion. Conversion is at the option of Abiomed, at any time, and is
subject to certain limitations for the purposes of compliance with the
shareholder approval rules of the NASDAQ Stock Market and the Toronto Stock
Exchange. The transaction also includes a warrant for up to 3,400,000 common
shares of WorldHeart, at an exercise price of $0.01 per share, as partial
consideration for clinical support and marketing services. The warrant is
exercisable over a period of 60 months, subject to the same limitations as the
convertibility of the note for the purposes of shareholder approval.
WorldHeart continues to pursue and explore additional funding
alternatives to support its longer-term operations and business.
WorldHeart is a developer of long-term mechanical circulatory support
systems with broad-based next-generation technologies. The Company is
headquartered in Oakland, California, USA with additional facilities in Salt
Lake City, Utah and Herkenbosch, Netherlands. WorldHeart's registered office
is Ottawa, Ontario, Canada.
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of
medical devices that provide circulatory support to acute heart failure
patients across the continuum of care in heart recovery. Their products are
designed to enable the heart to rest, heal and recover by improving blood flow
and/or performing the pumping function of the heart.
Teleconference and Webcast Information
WorldHeart will host a joint conference call to discuss the alliance.
Jal S. Jassawalla, President and Chief Executive Officer of World Heart
Corporation and Michael R. Minogue, Chairman, Chief Executive Officer and
President of Abiomed, Inc. will participate. Interested parties may join the
teleconference at 10:00 a.m. EST, December 12, 2007, by dialing 866-356-4441
(for North America callers) or 617-597-5396 (for callers outside of North
America) and indicating passcode 37457013 at least 10 minutes prior to the
start time. A telephonic replay of the call will be available for one month
beginning approximately one hour after the call's conclusion at 888-286-8010
or 617-801-6888, accessed with passcode 23506939. Additionally, the
presentation will be Webcast, and can be accessed through the Company's
website - www.worldheart.com - by first selecting Investor Relations, then
selecting Investor Events and finally selecting the Webcast link.
WorldHeart intends to mail to all shareholders a proxy statement that
will contain important information regarding this transaction as well as other
matters. The shareholders are advised to review the proxy statement for
further information regarding the participants in the solicitation (including
their direct or indirect interests, if any). When available, copies of the
proxy statement, and other relevant documents, will be available for free at
the Securities and Exchange Commission's web site and the Company's web site
Any forward-looking statements in this release are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995
and include statements regarding the Company's expectations with respect to
the potential benefits of its strategic alliance with Abiomed, including the
ability to reach a broad base of clinical customers and efficiently market the
Company's products, the Company's future development plans for its next-
generation Levacor VAD, including the timing and scope of clinical trials, the
potential scope of use and clinical benefits of these devices, as well as
other statements that can be identified by the use of forward-looking
language, such as "believes," "feels," "expects," "may," "will," "should,"
"seeks," "plans," "anticipates," or "intends" or the negative of those terms,
or by discussions of strategy or intentions. Investors are cautioned that all
forward-looking statements involve risk and uncertainties, which could cause
actual results to differ materially from those expressed or implied by the
forward-looking statements, including without limitation: the need for
additional longer-term financing; delays in development, preclinical
qualification, regulatory approvals and clinical trials, particularly the
Levacor VAD; destination therapy adoption rate for VADs; and other risks
detailed in the Company's filings with the United States Securities and
Exchange Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2006, as amended, and it most recent Quarterly Report on
Form 10-QSB for the quarter ended September 30, 2007.
For further information:
For further information: Mr. David Pellone, +1-510-563-4775, or Ms.
Peggy Allman, +1-510- 563-4721, both of World Heart Corporation; or Mr.
Stephen Laird, +1-203-341- 0214 Web Site: http://www.worldheart.com