Aethlon Medical (OTC:AEMD) said the FDA granted an investigational device exemption for a feasibility trial of its Hemopurifier device, designed to filter pathogens and cancer cells from human blood.
The San Diego-based medical device company said the FDA approved a 10-patient study of subjects with end-stage renal cancer who carry the hepatitis C virus. If successful, the trial will set Aethlon up for pivotal studies aimed at getting the device on the U.S. market for treating hepatitis C, according to a press release.
"Obtaining FDA’s permission to initiate human studies has been our most important objective for several years," chairman & CEO Jim Joyce said in prepared remarks. "I salute the perseverance of our dedicated Aethlon team, their families, and loyal shareholders whose support allowed us to endure the challenges of navigating through FDA. We plan to reward your faith with clinical execution and progression toward a marketable therapy in the United States."
It’s a big win for Aethlon, which came close to going out of business a few years back. A contract with the U.S. Defense Advanced Research Projects Agency kept Aethlon alive in 2011, when it looked as though the company would have to shut its doors.