PLC Systems and Edwards Lifesciences to Partner in Commercialization of New Laser Technology For Surgical Cardiac Ablation
2004年2月25日 - 9:30PM
PRニュース・ワイアー (英語)
PLC Systems and Edwards Lifesciences to Partner in
Commercialization of New Laser Technology For Surgical Cardiac
Ablation 2.2 Million Americans Suffer from Atrial Fibrillation,
Most Common Form of Cardiac Arrhythmias FRANKLIN, Mass., Feb. 25
/PRNewswire-FirstCall/ -- PLC Systems Inc. announced today that the
company has entered into an exclusive, multi-year agreement with
Edwards Lifesciences Corporation for the development and
manufacture of Edwards' Optimaze surgical ablation system, a
cardiac laser technology designed to treat cardiac arrhythmias, or
heart rhythm disorders. The most common cardiac arrhythmia is
atrial fibrillation - - a disease that affects more than 2.2
million Americans and causes approximately 15 percent of all
strokesin the United States. The Optimaze system, which has
received FDA clearance, utilizes a proprietary fiber optic and
diffuser technology to give clinicians a flexible tool to create a
rise in tissue temperature resulting in thermal ablation of the
cardiac tissue. It is believed that the lesions created in this
process block the conduction of errant electrical signals in the
heart. PLC and Edwards plan to develop the Optimaze technology
platform as a basis for future, less-invasive products that enable
minimally invasive ablation treatment of cardiac arrhythmia. "This
expanded agreement with Edwards is important to PLC," stated Mark
R. Tauscher, president and CEO of PLC Systems. "It marks a
significant milestone in our long-term strategy to expand beyond
TMR and make PLC a multi-product, multi-platform company. We have
extended and deepened our relationship with Edwards, a recognized
industry leader. And lastly, we seized an opportunity to enter the
cardiac ablation marketplace, which is vastly underserved and
currently in search of improved technology solutions." "The
decision to expand the relationship with our partners at PLC was a
natural one given the continuing success with our TMR partnership,"
said Michael A. Mussallem, Edwards' chairman and CEO. "By combining
the development activities of the Optimaze laser and disposable
components within a focused organization that specializes in laser
technologies, we believe we can further enhance the technology and
accelerate the development of less invasive approaches to this
therapy." Under the exclusive, multi-year agreement, Edwards
Lifesciences will transfer to PLC assets and technologies related
to its Optimaze surgical laser ablation program. PLC will assume
the responsibility of ongoing product development and manufacturing
of the Optimaze system and disposable components. Edwards will be
the exclusive worldwide distributor of these products. PLC and
Edwards will jointly own all surgical cardiac ablation intellectual
property developed under the agreement. The companies have entered
into a revenue sharing agreement for Optimaze disposables, where by
Edwards retains approximately 65 percent and PLC receives
approximately 35 percent of all customer-generated revenue. As part
of this agreement, PLC and Edwards also modified their existing TMR
relationship, which included lengthening the term of the
distribution agreement and adjusting the domestic TMR disposable
revenue sharing arrangement, in exchange for an upfront payment of
$4.5 million from Edwards. PLC adjusted its TMR disposable revenue
share from 45 percent of customer- generated revenue to 36.5
percent. PLC will recognize the $4.5 million payment as revenue
over the next seven years. All other material termsof the
agreement, including domestic TMR laser revenue sharing and PLC's
retention of all rights to its international TMR business, remain
the same. Tauscher continued, "With today's announcement, PLC has
taken a major step forward in expanding our revenue generation
opportunities with an attractive, synergistic second business. We
believe, based on other recent transactions for cardiac ablation
technologies, the value created within PLC for our shareholders as
a result of this transaction is exceptional." Tauscher concluded,
"We have positioned PLC for stronger growth in 2005 and beyond. The
cardiac ablation laser opportunity with Edwards is a major first
step in our strategic plan to diversify PLC's products and target
new markets. While we anticipate that our research and development
investments in 2004 will contribute to an overall net loss this
year, we expect that PLC's TMR business will continue to be
profitable on a standalone basis this year. We believe the Optimaze
product will generate incremental revenues for PLC beginning in
early 2005. The $4.5 million payment, combined with our existing
cash, provides us with additional flexibility to execute our long
term strategy and pursue further strategic initiatives to create
value for our shareholders." In conjunction with this announcement
and its fourth-quarter and year-end results, which were announced
this morning in a separate release, PLC Systems will be hosting a
conference call today, February 25, at 11:00 a.m. Eastern Time. The
call may be joined via telephone by dialing (800) 884-5695 or (617)
786-2960 (for international participants) at least five minutes
prior to the start of the call. The passcode is: 27824330. A live
Webcast of the call will be available and accessible at the
investor relations section of the Company's website at
http://www.plcmed.com/. A recording of the conference call will be
available for the next 30 days on PLC's website. About PLC Systems
Inc. PLC Systems Inc. is a medical device company specializing in
the design and manufacturing of lasers and related disposable
components to treat cardiovascular diseases. Edwards Lifesciences
Corporation (NYSE:EW) is the exclusive U.S. marketer and
distributor of PLC's CO2 Heart Laser 2 system, which a cardiac
surgeon can utilize to perform CO2 transmyocardial
revascularization (TMR). CO2 TMR, pioneered by PLC Systems, is a
surgical technology for treating severe angina, or heart pain. For
more information on PLC and its products, please visit the
Company's Web site at http://www.plcmed.com/. About Edwards
Lifesciences Edwards Lifesciences is a leader in advanced
cardiovascular disease treatments and the number-one heart valve
company in the world. Headquartered in Irvine, Calif., Edwards
focuses on four main cardiovascular disease states: heart valve
disease, coronary artery disease, peripheral vascular disease and
congestive heart failure. The company's global brands, which are
sold in approximately 100 countries, include Carpentier-Edwards,
Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company
information can be found at http://www.edwards.com/. Edwards
Lifesciences, Edwards and Optimaze are trademarks of Edwards
Lifesciences Corporation. Carpentier-Edwards, Cosgrove-Edwards,
Fogarty and Swan-Ganz are trademarks of Edwards Lifesciences
Corporation and are registered in the U.S. Patent and Trademark
Office. This press release contains "forward-looking" statements.
For this purpose, any statements contained in this press release
that relate to prospective events or developments are deemed to be
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will" and similar expressions
are intended to identify forward-looking statements. While we may
elect to update forward-looking statements in the future, we
specifically disclaim any obligation to do so, even if our
estimates change, and you should not rely on these forward-looking
statements as representing our views as of any date subsequent to
the date of this press release. Actual results could differ
materially from those indicated by such forward-looking statements
as a result of a variety of important factors, including we may be
unable to successfully develop products under our new agreement
with Edwards and Edwards may be unsuccessful in distributing these
products, operational changes, competitive developments may affect
the market for our products, regulatory approval requirements may
affect the market for our products, we may be unable to convince
health care professionals and third party payers of the medical and
economic benefits of the CO2 Heart Lasers and the Optimaze System,
and there can be no assurance that all payers will reimburse health
care providers who perform TMR procedures or that reimbursement, if
provided, will be adequate, and additional risk factors described
in our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2003, and our other SEC reports. DATASOURCE: PLC
Systems Inc. CONTACT: John Jordan, Director of Investor Relations
of PLC Systems Inc., +1-508-541-8800, ext. 145 Web site:
http://www.plcmed.com/ http://www.edwards.com/
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