Cancer treatment receives ‘Breakthrough Device’ designation
Therapeutic technology company Aethlon Medical Inc has announced that it has received a ‘Breakthrough Device’ designation from the US Food and Drug Administration (FDA) to support the advancement of the Aethlon Hemopurifier for the treatment of cancer. The technology is designed for the rapid depletion of cancer-promoting exomes and life-threatening viruses.
“We are honoured to receive this breakthrough designation in oncology as it establishes an opportunity to expand the market for our Hemopurifier and advance our vision for addressing a significant unmet need in cancer care,” said Aethlon Medical Founder and CEO, Jim Joyce. “By reducing the presence of tumour-derived exosomes from the circulatory system of cancer patients, we believe our Hemopurifier can improve the benefit of existing cancer treatment regimens and emerging immuno-oncology drugs. Thus providing a rationale for potential partnering opportunities.”
The proposed indications for use under the Breakthrough Device designation includes: "The Hemopurifier is a single-use device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. Therapy with the Hemopurifier device should be an adjunct to standard of care for cancer.”