MURRAY HILL, N.J.--(BUSINESS WIRE)--Dec. 20, 2011--
C. R. Bard, Inc. (NYSE: BCR) today announced that it has acquired
Lutonix, Inc. for a purchase price of approximately $225 million paid at
closing, with an additional $100 million to be paid upon PMA approval of
Lutonix’s drug-coated percutaneous transluminal angioplasty (PTA)
balloon. The transaction is structured as a merger.
Lutonix, located in Minneapolis, Minnesota, is conducting the first and
only investigational device exemption (IDE) trial approved by the FDA
using drug-coated balloons for the treatment of peripheral arterial
disease. Drug-coated balloons have received growing attention in recent
years as physicians look for effective ways to treat diseased arteries
without having to leave a permanent implant behind. Independent
forecasts suggest that the global peripheral vascular market for
drug-coated balloons could approach $1 billion annually over the next
decade. To date, no such device is approved for use in the United States.
The Lutonix LEVANT 2 study is a prospective, randomized, single-blinded,
multi-center pivotal IDE trial comparing the Lutonix drug-coated balloon
to standard balloon angioplasty. The trial will enroll 476 patients
across 55 sites, including 40 in the United States and 15 in Europe.
Lutonix began recruiting patients in the third quarter of 2011 and has
enrolled over 160 patients to date. Eligible patients suffer from
significant stenosis in previously unstented superficial femoral artery
or popliteal artery lesions up to 150 mm in length. These patients will
be followed for five years, with PMA submission after one year of
follow-up. At this time, the company anticipates that submission could
occur in 2014.
Lutonix received CE mark approval this year and Bard expects to start
selling the device in Europe in the second half of 2012. The company
plans to begin a larger registry study concurrent with the European
launch to support broader marketing claims and obtain additional
Timothy M. Ring, Bard’s chairman and CEO, commented, “In our
evaluations, Lutonix has the only third-generation drug-coated balloon
technology. They also have a significant lead with respect to U.S.
launch, outstanding quality and depth of pre-clinical science, a strong
clinical program, a very skilled and motivated team, and a coating
technology we believe will demonstrate superior safety and efficacy.
This position of leadership in a large potential market, combined with
our current market leadership in PTA, makes this acquisition a
compelling strategic fit for Bard.”
Bard expects this transaction to reduce 2012 earnings per share by
approximately 25 cents, excluding items that affect comparability.
C. R. Bard, Inc. (www.crbard.com),
headquartered in Murray Hill, NJ, is a leading multinational developer,
manufacturer and marketer of innovative, life-enhancing medical
technologies in the fields of vascular, urology, oncology and surgical
This press release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, which
are based on management’s current expectations, the accuracy of which is
necessarily subject to risks and uncertainties. These statements are not
historical in nature and use words such as “anticipate”, “estimate”,
“expect”, “project”, “intend”, “forecast”, “plan”, “believe”, and other
words of similar meaning in connection with any discussion of future
operating or financial performance. Many factors may cause actual
results to differ materially from anticipated results including product
developments, sales efforts, income tax matters, the outcomes of
contingencies such as legal proceedings, and other economic, business,
competitive and regulatory factors. The company undertakes no obligation
to update its forward-looking statements. Please refer to the Cautionary
Statement Regarding Forward-Looking Information in our September 30,
2011 Form 10-Q for more detailed information about these and other
factors that may cause actual results to differ materially from those
expressed or implied.
Source: C. R. Bard, Inc.
C. R. Bard, Inc.
Vice President, Investor
T. Lowry, 908-277-8365
Vice President and Treasurer