| St.
Jude Medical, Inc. (NYSE:STJ) announced today that it has
signed a definitive agreement to acquire Irvine Biomedical,
Inc. (IBI) an Irvine, California privately held company which
develops electrophysiology (EP) catheter products that are
used by physician specialists to diagnose and treat cardiac
rhythm disorders. IBI products are distributed by St. Jude
Medical in Japan.
As a result of St. Jude Medical's 2003 acquisition of Getz
Bros. Co., Ltd. ("Getz") in Japan, the Company assumed
a 14% ownership position in IBI that Getz had acquired beginning
in 1997. To acquire the remaining 86% of Irvine Biomedical's
capital stock that it does not already own, St. Jude Medical
expects to pay $47 million at the closing. This amount is
net of the cash expected to be on hand at IBI on the closing
date as well as consideration from the exercise of IBI stock
options, which together total approximately $9 million. The
IBI transaction is expected to close at the end of the third
quarter.
The definitive agreement includes additional
incentive payments of up to $13 million to the non-St. Jude
Medical shareholders if IBI receives approval by specified
dates in 2005 and 2006 from the U.S. Food and Drug Administration
(FDA) of certain EP catheter ablation systems currently in
development. In connection with this acquisition, St. Jude
Medical anticipates recording an in-process R&D charge
of $8-10 million at closing. Except for the in-process R&D
charge, this transaction will not impact the Company's existing
EPS guidance for 2004. Since St. Jude Medical's Getz organization
is the IBI distributor in Japan and IBI's largest customer,
the majority of IBI's sales are already reflected in St. Jude
Medical's sales guidance for the remainder of 2004. In 2003,
IBI recorded total sales to distributors of approximately
$14 million.
Irvine Biomedical was founded in 1995 to pursue
innovative technologies to treat cardiovascular disease, with
a focus on developing medical devices for EP procedures. Its
products in development include EP catheter ablation systems
that use radio frequency and ultrasound energy. Peter Chen,
Ph.D., serves as President and CEO of IBI. Raymond Chia, Ph.D.,
is Vice President of Operations. Both Drs. Chen and Chia,
together with all operations at the IBI facility in Irvine,
California, will remain with St. Jude Medical following the
completion of the transaction.
Commenting on the agreement to acquire Irvine
Biomedical, St. Jude Medical Chairman, President and Chief
Executive Officer Daniel J. Starks said, "Our acquisition
of IBI builds on our recent announcement that we are creating
an Atrial Fibrillation Division. IBI brings to St. Jude Medical
another valuable and cohesive product development organization
with an impressive portfolio of intellectual property, EP
ablation systems using both radio frequency energy and ultrasound
energy sources, and a variety of other specialty devices designed
to help physicians treat atrial fibrillation and other cardiac
rhythm disorders. We look forward to leveraging this flow
of technology and new products with SJM's existing distribution
and significant global infrastructure to accelerate the growth
of our atrial fibrillation programs around the world. We think
our customers in the important market of Japan will be particularly
pleased by this transaction due to the significant market
share we already hold there with IBI products and the long-term
commitment this acquisition represents by our organization
to IBI product lines."
On behalf of Irvine Biomedical, President
and CEO Peter Chen said, "We look forward to the opportunity
to become part of St. Jude Medical. This transaction also
provides IBI immediate access to a broader global EP customer
base and the resources of St. Jude Medical's highly regarded
sales and sales support organization. Both IBI and St. Jude
Medical share a common objective to develop a catheter cure
for atrial fibrillation. The technology and creative resources
of both companies will continue to be highly focused on this
major health care challenge."
Electrophysiology catheters are used by physician
specialists to diagnose and treat a wide range of tachycardias.
In placing these catheters inside the heart, physicians can
determine the location of the abnormal conductive tissue that
often causes arrhythmias. If necessary, an ablation catheter
is used to apply radiofrequency (RF) or other energy to the
abnormal tissue, disabling it in a process similar to cauterization.
By destroying the abnormal tissue, physician specialists can
often cure a patient for life, eliminating the need for medication
or other therapies.
EP catheters can be used to treat atrial fibrillation
(AF), a pervasive cardiac rhythm disorder in which the upper
chambers of the heart do not beat effectively. AF results
in reduced cardiac output, exacerbates heart failure and can
result in the pooling and clotting of blood in the heart,
often leading to stroke or other neurological problems. The
prevalence of atrial fibrillation worldwide is in excess of
6 million. AF is progressive, expanding in incidence and severity
with age. The economic impact to public and private health
care systems of AF is increasing as populations' age.
The agreement to acquire Irvine Biomedical
broadens St. Jude Medical's EP catheter product line consistent
with the Company's "Surround AF" strategy, offering
cardiologists and surgeons sophisticated devices and catheter
systems to diagnose, suppress and cure atrial fibrillation.
St. Jude Medical pacemaker and ICD systems incorporate the
Company's unique AF Suppression(TM) algorithm, the first clinically
proven technology to suppress atrial fibrillation. The Company
also offers a broad range of advanced catheter systems for
use by clinicians in the clinical management of patients with
AF. An investigational device exemption (IDE) application
has been approved by the FDA for a feasibility study using
St. Jude Medical's proprietary Lineage(TM) PV catheter ablation
system.
In June, St. Jude Medical completed the acquisition
of Epicor Medical, Inc., the leader in the development of
high intensity focused ultrasound (HIFU) devices for the surgical
ablation of cardiac tissue, further strengthening St. Jude
Medical's position in the treatment of cardiac arrhythmias,
including atrial fibrillation. The Company's recently announced
Atrial Fibrillation Division focuses on medical technology
and services to help cure AF as well as address the broad
field of electrophysiology.
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