BG Medicine (NASDAQ:BGMD) withdraws its 510(k) submission with the FDA, filed on March 31, seeking clearance for the use of its Galectin-3 Test as an aid in the assessment of the near term risk of fatal cardiovascular events in older adults who have no prior history of cardiovascular disease, cerebrovascular disease or vascular disease.
Based on discussions with the agency, the company intends to file a new 510(k) after it generates additional data demonstrating the clinical utility of test based on a broader indication to include aiding in the assessment of the near term risk of both fatal and non-fatal cardiovascular events.
Galectin-3 is currently cleared to identify clinically stable heart failure patients who are at high risk of hospitalization or mortality.
BG Medicine (NASDAQ:BGMD) amends its License and Distribution Agreement with Abbott Diagnostics (NYSE:ABT) lowering the fees paid to BG for galectin-3 tests sold by Abbott to reference laboratories. The specific amount of the reduction is undisclosed. The original fees will remain unchanged for all other customer segments.
BG chief Paul Sohmer, M.D., says, "We believe this modification to our agreement will open up a new customer segment for automated testing as well as expedite the transition for existing customers from manual to automated testing for galectin-3. We expect that, as a result, the majority of revenues currently generated from sales of manual test kits will, over time, likely be replaced by product fees generated from the sale of automated tests by our automated partners when their automated tests become available. This modification to our agreement further bolsters our efforts to accelerate adoption of galectin-3 testing.
Abbott's Diagnostics Division is marketing the automated galectin-3 test as part of the test menu of its Architect immunoassay analyzer. The test is used to help identify chronic heart failure patients who are clinically stable but have a higher risk of adverse events such as hospitalization and mortality.
Thinly traded nano cap BG Medicine (NASDAQ:BGMD) prices its public offering of 2,315,654 Series A units at $1.00 per unit. It is also offering 184,346 Series B units at $1.00 per unit to those buyers whose purchases of Series A units increase their ownership stake to more than 9.99%.
Each Series A unit consists of one share of common stock and one half of a warrant to purchase one share of common stock at $1.00 per share.
Each Series B unit consists of one fully pre-funded warrant to purchase one share of common stock and one half of a warrant to purchase one share of common stock at $1.00 per share.
Closing date is August 18. Net proceeds will be ~$2.1M.
Yesterday's close was $1.48. Shares are down 39% premarket on increased volume.
BG Medicine (NASDAQ:BGMD) commences a public offering of common stock. Net proceeds will fund the U.S. launch of the first automated test for galectin-3, support its automated partners in the development and commercialization of additional tests for galectin-3, proposed expansion of clinical claims and indications for galectin-3 testing and general corporate purposes.
BG Medicine (NASDAQ:BGMD) institutes a 1:4 reverse split of its common shares effective today. Trading in post-split shares will commence tomorrow. The action reduces the number of outstanding shares from ~34.6M to ~8.6M.
In a regulatory filing, BG Medicine (NASDAQ:BGMD) discloses that sales (and payments) of the manual version of its BGM Galectin-3 Test to Health Diagnostic Laboratory continue despite the firm's declaration of bankruptcy on June 7. Although, the launch of the automated test means that BG will be less reliant on sales of the manual version, Health Diagnostics' continued financial troubles could have a material effect on BG's business.
Abbott's (NYSE:ABT) Diagnostics Division is marketing the automated Galectin-3 Test as part of the test menu of its Architect immunoassay analyzer. The test is used to help identify chronic heart failure patients who are clinically stable but have a higher risk of adverse events such as hospitalization and mortality.