The Food and Drug Administration (FDA) has granted Breakthrough Device designation to Immunicon for its Immunopheresis therapy, a blood-filtering device that selectively removes immune inhibitors from the bloodstream which may allow for a stronger natural immune system attack on tumors.

Immunopheresis is intended to treat late/end stage IV cancer patients with metastatic solid tumors. The device is based on a ‘subtractive’ approach as opposed to pharmaceutical or biological treatments which introduce foreign compounds into the body. In a statement, the Company said that this approach is “intended to potentially limit treatment-associated adverse effects.” 

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In preliminary preclinical studies, the device has been shown to enhance anti-cancer immune system response without causing adverse effects. “This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs soon,” said Amir Jafri, CEO of Immunicom. 

The FDA grants Breakthrough Device designation to devices that have no currently available comparator, or to technology that is deemed to offer significant advantages over existing approved alternatives.

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