US-based medical technology company Immunicom, Inc. has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Immunopheresis cancer treatment.
The treatment is based on a proprietary technology that selectively removes immune inhibitors from a patient's bloodstream, which potentially enables their immune system to more effectively attack cancer tumours. Preliminary preclinical studies have shown that the approach can enhance anti-cancer immune system response without causing unwanted side effects.
“We are very pleased with FDA's granting of Breakthrough Device designation for Immunopheresis, our initial immunotherapy product for treating late/end stage IV cancer patients with metastatic solid tumours," said Amir Jafri, CEO of Immunicom. “This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs sooner, while also continuing our commitment to invest in other exciting treatment options in our product pipeline.”