MURRAY HILL, N.J.–(BUSINESS
WIRE)–C. R. Bard, Inc. 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
Lutonixs 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 clinical data.
Timothy M. Ring, Bards 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 specialty products.
Posted by Sean Fenske, Editor-in-Chief, MDT