DGAP-News: BG Medicine Announces Obtaining CE Mark and Launching of Automated BGM Galectin-3 Test
(firmenpresse) - BG Medicine Inc.
02.01.2013 22:05
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First Automated Test Launches in Europe and Territories Recognizing the CE Mark
WALTHAM, Mass., 2013-01-02 22:05 CET (GLOBE NEWSWIRE) --
BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and
commercialization of novel cardiovascular diagnostics, announced today that the
first automated version of the BGM Galectin-3(r) blood test has obtained a CE
Mark, an important step in the company's commercial strategy.
The BGM Galectin-3 test will be distributed through bioMerieux's VIDAS(r)
immunoassay platform which includes about 27,000 installed instruments
worldwide. bioMerieux is one of four diagnostic instrument manufacturers
partnering with BG Medicine to commercialize automated versions of the BGM
Galectin-3 test, and the first to obtain a CE Mark. bioMerieux is preparing a
phased launch of the test in Europe and in certain other territories that
recognize the CE Mark.
'The BGM Galectin-3 test has the potential to play a major role in improving
the management of heart failure,' said Eric Bouvier, President and Chief
Executive Officer of BG Medicine. 'The launch of the first automated version of
our test is a watershed and exciting moment for our company. Through its broad
CE-marked installed base, bioMerieux is in a position to drive the adoption of
the test in Europe. Offering an automated version of the galectin-3 assay is
critical for us to obtain broad-based and rapid global adoption. Partnering
with bioMerieux, as well as Abbott, Alere and Siemens provides BG Medicine
tremendous international coverage to drive commercial adoption over the next
several years.'
The CE Mark for bioMerieux's automated version of the BGM Galectin-3 test is
the latest in a series of steps designed to further BG Medicine's
three-pillared business model for the test, which is focused on rapid
commercial adoption driven by sales through automated partners, specialized
labs and the targeting of US hospitals with high readmissions rates. Recent
developments in this commercial strategy have included:
-- The launch of a major campaign to grow BGM Galectin-3 test sales in
hospital settings. BG Medicine launched a new campaign in November 2012
focused on the urgent need to reduce rates of unplanned hospital
readmissions. The Centers for Medicare&Medicaid Services (CMS)
guidelines that went into effect on October 1, 2012 will result in new
financial penalties expected to reach an aggregate of nearly $300 million
in 2013 and nearly $1 billion by 2015, if improvements are not made.
Because heart failure patients with elevated levels of galectin-3 are
two-to-three times more likely than other heart failure patients to be
readmitted to the hospital within 30 days of discharge, the company
believes that identifying and risk-stratifying these high-risk patients
through galectin-3 testing is a potentially valuable and cost-effective
tool in a hospital's strategy to reduce unplanned 30-day readmissions. The
company expects this initiative will accelerate the sales ramp-up and the
widespread adoption of galectin-3 testing.
-- The conversion of a medical liaison organization to a US-based sales
organization. BG Medicine is transforming its current field force from an
awareness- and education-focused organization into one with a sales mission
and growth strategy. The field force will focus initially on promoting
galectin-3 testing at a core set of hospitals with higher-than-average
readmission rates, which are at risk of incurring significant financial
penalties due to new rules affecting readmissions set by CMS.
-- The opening of a CLIA (Clinical Laboratory Improvement Amendments)
certified clinical laboratory. BG Medicine expects to open the BG Medicine
CLIA laboratory in the first half of 2013 in order to make galectin-3
testing available to more hospitals and other health care providers. The
company expects this CLIA lab will further strengthen the company's own
infrastructure to support sales made directly by BG Medicine.
'2013 is poised to be a year of great progress in our commercial strategy for
the manual and automated versions of the BGM Galectin-3 test and we are pleased
to begin the year with this important development in the execution of this
strategy,' continued Mr. Bouvier.
About Galectin-3 and Heart Failure
Galectin-3 is a unique carbohydrate-binding lectin, or protein, that binds to
carbohydrates called beta-galactosides. Galectin-3 has been implicated in a
variety of biological processes important in the development and progression of
heart failure, and is believed to be a primary mediator of progressive cardiac
fibrosis (abnormal thickening and stiffening of the heart muscle) and adverse
remodeling (changes in the structure of the heart). Higher levels of galectin-3
are associated with a more aggressive form of heart failure and 30% or more of
mild to moderate heart failure patients will have elevated levels of
galectin-3. Heart failure affects an estimated 5.8 million Americans, with
approximately 670,000 new cases occurring each year. The direct and indirect
cost of heart failure in the United States for 2010 is estimated to be $39.2
billion.
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD) is a diagnostics company focused on the
development and commercialization of novel cardiovascular tests to address
significant unmet medical needs, improve patient outcomes and reduce healthcare
costs. The Company has two products: the BGM Galectin-3(r) test for use in
patients with chronic heart failure is available in the United States and
Europe; and the CardioSCORE(tm) test for the risk prediction of major
cardiovascular events will be launched in Europe in the first half of 2013. For
additional information about BG Medicine, heart failure and galectin-3 testing,
please visit www.bg-medicine.com and www.galectin-3.com.
The BG Medicine Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=10352
Forward-Looking Statements
Certain statements made in this news release contain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities and Exchange Act of 1934, as amended, that
are intended to be covered by the 'safe harbor' created by those sections.
Forward-looking statements, which are based on certain assumptions and describe
our future plans, strategies and expectations, can generally be identified by
the use of forward-looking terms such as 'believe,' 'expect,' 'may,' 'will,'
'should,' 'could,' 'seek,' 'intend,' 'plan,' 'estimate,' 'anticipate' or other
comparable terms. Forward-looking statements in this news release address our
beliefs that bioMerieux, as our first partner to launch an automated version of
our galectin-3 test, is in a position to drive the adoption of galectin-3
testing in Europe; our belief that identifying and risk-stratifying high-risk
patients through galectin-3 testing is a potentially valuable and
cost-effective tool in a hospital's strategy to reduce unplanned 30-day
readmissions; our expectations that our hospital readmissions initiative will
accelerate the sales ramp-up and adoption of galectin-3 testing; our
expectation that we will open our own CLIA lab in the first half of 2013; and
our expectations that having our own CLIA lab will further strengthen our
ability to strengthen sales of our diagnostic tests. Forward-looking statements
are based on management's current expectations and involve inherent risks and
uncertainties which could cause actual results to differ materially from those
in the forward-looking statements, as a result of various factors including
those risks and uncertainties described in the Risk Factors and in Management's
Discussion and Analysis of Financial Condition and Results of Operations
sections of our recent filings with the Securities and Exchange Commission,
including our most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q. We urge you to consider those risks and uncertainties in evaluating
our forward-looking statements. We caution readers not to place undue reliance
upon any such forward-looking statements, which speak only as of the date made.
Except as otherwise required by the federal securities laws, we disclaim any
obligation or undertaking to publicly release any updates or revisions to any
forward-looking statement contained herein (or elsewhere) to reflect any change
in our expectations with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
Chuck Abdalian
EVP&Chief Financial Officer
(781) 434-0210
News Source: NASDAQ OMX
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