WALTHAM, Mass, July 20, 2012 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel cardiovascular diagnostics, today announced the filing of a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay, which is used with Abbott's fully automated ARCHITECT immunochemistry instrument platform. The test measures a patient's blood level of galectin-3, a protein implicated in the progression of heart failure. Subject to FDA clearance, the new application would mark the first measurement of galectin-3 on an automated platform.
"The filing of the 510(k) for the Abbott ARCHITECT marks an important milestone for BG Medicine and further demonstrates our strategy to expand the usage and availability of the galectin-3 test to broader markets," said Eric Bouvier, President and CEO of BG Medicine. "Subject to clearance by the FDA, the automated test would enable broader access and more timely information flow to physicians and their patients. We are very pleased with the Abbott collaboration and the development of the galectin-3 test on the first automated platform."
About the Galectin-3 Test, Galectin-3 and Heart Failure
BG Medicine currently markets a manual version of its galectin-3 blood test, the BGM Galectin-3® test, which was cleared by the FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. To date, data have shown that patients with elevated levels of galectin-3 are at increased risk for hospitalizations or death. BGM Galectin-3 was cleared by the FDA in 2010 and has obtained the CE mark for commercialization in the EU. BG Medicine filed for an expanded indication for the BGM Galectin-3 test with the FDA in May 2012, and has obtained CE Mark in the EU for the expanded indication. Subject to FDA clearance, the new application would expand the indicated use for the BGM Galectin-3 test to the general adult population to identify those with elevated levels of galectin-3, which is associated with an increased risk for new-onset heart failure.
Elevated 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 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 life sciences company focused on the discovery, development and commercialization of novel cardiovascular diagnostics to address significant unmet medical needs, improve patient outcomes and contain healthcare costs. The Company's first commercialized product, the BGM Galectin-3® test for use in patients with heart failure, is available in the United States and Europe. BG Medicine is also developing CardioSCORE, a blood test designed to identify individuals at high risk for near-term major cardiovascular events, such as heart attack and stroke. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.bg-medicine.com and www.galectin-3.com.
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Special Note Regarding 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 expectations concerning the role that galectin-3 plays in heart failure, our expectations regarding the impact of an automated galectin-3 test on patients' and doctors' access to these testing services and how broader access may impact broader adoption and usage of galectin-3 testing services, the clinical utility of galectin-3 testing to predict outcomes in patients at risk for heart failure, and our expectations regarding anticipated clearance of the automated versions of our galectin-3 assay by the U.S. Food and Drug Administration. 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.
Michael W. Rogers EVP & Chief Financial Officer (781) 890-1199