The U.S. Naval Medical Research Center asked the federal Food and Drug Administration for permission to take another look at Biopure Corp.’s blood substitute Hemopure.
Late last year, the FDA denied a similar request from the Navy, which hopes to use the oxygen therapeutic to treat combat injuries on the battlefield, where blood transfusions aren’t available.
The NMRC re-submitted its request March 23, asking the FDA to reconsider allowing its “Restore Effective Survival in Shock” to go forward. The study would involve both civilian trauma patients with hemorrhagic shock and soldiers and Marines injured on the battlefield.
Biopure said the U.S. Congress allocated funds for the development of Hemopure, which is approved in South Africa for treating surgical anemia, according to the company’s website.
That cash is being used for trial preparation and for preclinical studies of Hemopure in animal models, including those that mimic military trauma scenarios.
It’ll be good news for the Cambridge company if the FDA approves Navy’s request. Last fall Biopure laid off most of its workers and only has enough revenue coming in to survive until April, according to Mass High Tech.
That likely means a fire sale or even bankruptcy. Biopure posted operating losses in 2008 and 2007 of $20.8 million and $36.9 million, respectively.
