BG Medicine Inc. said its galectin-3 test to predict the risk of dying from heart failure did well in a controlled, peer-reviewed clinical trial published in the journal Clinical Research in Cardiology.
The report summarizing the study, "Prognostic value of galectin-3, a novel marker of fibrosis, in patients with chronic heart failure: data from the DEAL-HF study," showed that the Waltham, Mass-based company’s test for the galectin-3 biomarker was "a significant predictor of mortality risk," according to a press release. The trial followed 232 patients with an average age of 71 (plus or minus a decade), 72 percent of whom were male. After six-and-a-half years, 98 of the patients, or 37.4 percent, had died.
Adjusted for age, gender, renal dysfunction and severity of heart failure, the test helped predict the risk of dying, according to the release. It’s available in the European Union and other countries in Europe but hasn’t been cleared in the U.S. or Canada. BG Medicine said it’s applied for 510(k) clearance from the Food & Drug Administration for the test, which is manufactured under contract by Corgenix Medical Corp. (OTC:CONX).
Late last month, BGM registered for an initial public offering with the federal Securities and Exchange Commission, almost exactly two years after spiking its first IPO attempt. According to a preliminary prospectus, the company generated about $8.5 million in revenues during 2009, a 42 percent decline from the prior year. BGM, which débuted in February 2000 as Beyond Genomics Inc. — posted a $16.1 million net loss during 2009 and spent about $18 million in cash on operations last year.
Cambridge, Mass.-based Flagship Ventures now owns more than 44 percent of the firm; other significant stakeholders include the Gilde Europe Food & Agribusiness Fund, a Dutch venture capital group, and two strategic corporate partners, Humana Inc. and Koninklijke Philips Electronics N.V.
According to its previous IPO bid, BG Medicine expected to raise up to $45 million through the sale of 4.5 million shares at $10 apiece. Jefferies & Co. and UBS Investment Bank have signed on as lead underwriters for the current offering.