FDA Approves Aethlon Medical Device for Clinical TestingWednesday, June 26, 2013
The U.S. Food and Drug Administration has approved for clinical testing a blood purification device developed by San Diego-based biotech Aethlon Medical Inc.
The device, called a hemopurifier, aims to eliminate life-threatening infectious diseases and cancers from blood circulation.
“Obtaining FDA’s permission to initiate human studies has been our most important objective for several years,” said Jim Joyce, Aethlon Medical chairman and CEO, in a statement.
The device is primarily focused on removing hepatitis C from the bloodstream. The publicly traded company has a market capitalization of $20.84 million. At market close on June 25, stock was trading at 12 cents a share, a 23 percent increase from the previous day.
“Aethlon Medical has been laying the groundwork necessary to implement the now approved clinical trial protocol for several years,” Rod Kenley, president of Aethlon, said in a statement. “We are finally able to move forward with our contract research and clinical partners in finalizing all of the activities that can now take place prior to initiating treatment of the first patient. While there is still some work to be done, today the biggest hurdle has been cleared and we are anxious to make rapid progress toward commercialization.”
— SDBJ Staff Report