WALTHAM, Mass., March 31, 2015 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, today reported that it has filed a 510(k) Premarket Notification with U.S. Food and Drug Administration (FDA) for regulatory clearance of an additional indication for the BGM Galectin-3 Test.
The filing incorporates data generated from a study in which levels of the protein galectin-3, as measured using the BGM Galectin-3 Test, were evaluated in 6,762 participants in the BioImage Study. The study was intended to assess the association of elevated level of galectin-3 with the occurrence of adverse cardiovascular events in men and women who had no prior history of cardiovascular, cerebrovascular or vascular disease. The BioImage Study enrolled men and women in the United States above the age of 55 and monitored them for the occurrence of major adverse cardiovascular events such as heart attack, stroke, and death due to cardiovascular causes.
"We are pleased to have the opportunity to present these data to the FDA," said Dr. Paul Sohmer, President and CEO of BG Medicine, Inc. "Cardiovascular disease remains the leading cause of death in the United States, and we believe galectin-3 testing can assist physicians in better identifying those patients who may be at elevated risk for near-term adverse events."
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.BG-Medicine.com.
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About the BGM Galectin-3® Test
The BGM Galectin-3® Test is cleared by the U.S. FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation.
The BGM Galectin-3® Test is CE Marked and is available in Europe as an aid in assessing the prognosis of patients diagnosed with acute and chronic heart failure when used in conjunction with clinical evaluation. It is also CE Marked for adults as an aid in assessing the risk of new onset heart failure.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding our belief that galectin-3 testing can assist physicians in better identifying those patients who may be at elevated risk for near-term adverse events. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading "Risk Factors" contained in BG Medicine's annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and BG Medicine disclaims any obligation to update the information contained in this press release as new information becomes available.
CONTACT: Stephen Hall, EVP & Chief Financial Officer
(781) 890-1199
