WALTHAM, Mass., Aug. 9, 2012 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (BGMD) today announced its consolidated results of operations for the three and six months ended June 30, 2012 and provided a business update. The Company will host a conference call and webcast today, August 9, 2012, beginning at 8:30 a.m. Eastern Time (details follow below). <\/p>\n
For the quarter ended June 30, 2012, the Company reported a consolidated net loss of $6.4 million compared to a consolidated net loss of $4.8 million for the quarter ended June 30, 2011. For the six months ended June 30, 2012, the Company reported a consolidated net loss of $14.1 million compared to a consolidated net loss of $8.0 million for the six months ended June 30, 2011. <\/p>\n
At June 30, 2012, the Company had consolidated cash, cash equivalents and marketable securities totaling approximately $23.3 million. <\/p>\n
Business Update <\/p>\n
\"We are very pleased with the significant progress we have made during the past several months,\" said Eric Bouvier, president and CEO of BG Medicine. \"We continue to invest in the franchise for the BGM Galectin-3(R) test, and we have had a number of recent positive developments related to our galectin-3 program. In July 2012, we announced the filing of a 510(k) for regulatory clearance for the ARCHITECT(R) galectin-3 assay, which is used with Abbott's fully automated ARCHITECT(R) immunochemistry instrument platform. This important milestone represents the first filing of an automated platform version of the BGM Galectin-3 test from our strong group of four automated platform partners, Abbott, Alere, bioMerieux, and Siemens. In May 2012, we filed a 510(k) to extend the cleared labeling indication for the BGM Galectin-3 test to include individuals in the general adult population who are at risk for developing heart failure based on elevated levels of galectin-3. We obtained CE Mark in the European Union for this expanded indication for the BGM Galectin-3 test and we are working with our partners to begin commercialization. Finally, in June 2012, we announced that Atherotech Diagnostic Lab is now making galectin-3 testing available to its laboratory customers and physicians. <\/p>\n
\"We have been continuing our dialogue with the FDA regarding the 510(k) submission for our CardioSCORE TM test,\" continued Mr. Bouvier. \"The FDA has requested that we conduct an adjudication process to confirm certain data from our BioImage validation study. The data were originally obtained through medical insurance claims, a method previously validated in numerous peer-reviewed studies. Due to the time involved in the adjudication process, we determined that we would not be able to submit a complete response by the August 15, 2012 deadline. Therefore, we withdrew the 510(k) on August 8, 2012. We intend to submit a new 510(k) as soon as we are satisfied that the information requested by the FDA is addressed in the new submission. We remain very confident about the performance of the CardioSCORE test, and the submission of a thorough and responsive 510(k) is one of our highest priorities. <\/p>\n
\"We are looking forward to several important milestones for the Company over the next several months,\" concluded Mr. Bouvier. \"We will continue to focus on the achievement of these milestones to make our innovative products a success in the marketplace.\" <\/p>\n
Upcoming milestones include: <\/p>\n
Financial Results <\/p>\n
Three months ended June 30, 2012 <\/p>\n<\/p>\n
Excerpt from:<\/p>\n
BG Medicine Announces Fiscal 2012 Second Quarter Results<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" WALTHAM, Mass., Aug. 9, 2012 (GLOBE NEWSWIRE) -- BG Medicine, Inc Continue reading