BG Medicine Announces Receipt of CE Mark for its Galectin-3 Blood Test and Initiates Commercialization in the European Union
27 January 2010
BG Medicine Waltham, MA, USA — BG Medicine, Inc., a privately-held developer of biomarker-based in vitro diagnostics, today announced the commercial launch in the European Union of a new, CE-marked test for the measurement of galectin-3 in human plasma or serum. Galectin‐3 was first shown by researchers at the University of Maastricht, The Netherlands, to play an integral role in the development and progression of heart failure.“This is an important point in our development of galectin-3 testing and a milestone for the company," noted Pieter Muntendam, MD, President and CEO of BG Medicine. "Heart failure is a complex and heterogeneous condition, and the objective of our BGM Galectin-3™ test is to redefine heart failure on the basis of underlying disease processes, not as it is currently addressed based solely on the nature and severity of signs or symptoms.”
About Galactin-3 (www.bgmgalectin-3.com)
Galectin-3 is a protein that is involved in the biological processes leading to cardiac fibrosis and scarring, which play an important role in heart failure development and progression. Several studies have shown that galectin-3 may provide valuable insight about heart failure and its underlying disease processes. The BGM Galectin-3 test is currently available for clinical use only in the European Union and certain other European countries as an aid in the stratification of patients diagnosed with heart failure. The BGM Galectin-3 test is not available for sale or distribution in the United States or Canada. The Company has submitted a 510(k) application to obtain clearance from the U.S. Food and Drug Administration to sell the test in the United States.
About BG Medicine (www.BG-Medicine.com)
BG Medicine is a life sciences company focused on the discovery, development, and commercialization of novel diagnostics based on biomarkers to improve patient outcomes and contain healthcare costs. BG Medicine’s proprietary technology platform enables rapid and cost effective discovery of new high-value diagnostics biomarkers over a broad range of therapeutic areas.
About Gilde Healthcare Partners (www.gildehealthcare.nl)
Gilde Healthcare Partners is headquartered in Utrecht and has over EUR 300 million (USD 420 million) under management in healthcare funds. A successful builder of healthcare businesses across Europe and the US, Gilde is actively looking to lead new investments in therapeutics, diagnostics, medical devices and healthcare services. By investing in companies with clear achievable business models, Gilde has used its financial resources and network to create significant value for both its investors and the entrepreneurs it backs.
Companies that Gilde Healthcare Partners has pro-actively supported span all aspects of healthcare and include Ablynx (Belgium), Acacia (UK), Agendia (Netherlands), AMT (Netherlands), Ascendis (Denmark), BG Medicine (US), Chroma Therapeutics (UK), Conatus (US), Flowcardia (US), Glycart (Switzerland), Innate Pharma (France), MTM (Germany), Profibrix (Netherlands), Santaris (Denmark) and Symphogen (Denmark).
