The process of taking a treatment device or medicine from concept and research to market is a very long, arduous, and extremely expensive process. There are however special status exemptions that make the process easier for orphan diseases or rarer conditions. The FDA recently announced that Novacure’s Tumor Treating Fields (TTFields) delivery system is being granted Humanitarian Use Device (HUD) status which is the first step in receiving the Humanitarian Device Exception (HDE) status. The HDE designation would allow the treatment to be marketed in conjunction with the standard chemotherapy care.
The TTfields device emits low-intensity electricity through a portable device that a patient can carry around with them. The electricity is able to prevent cancerous cells from multiplying as quickly by inhibiting the cell division process. Prelimary results have shown significant increases in survival times. Novacure’s CEo stated that “We believe that treatment with TTFields affects fundamental aspects of cell division and may have broad applicability across a variety of solid tumors. We are pleased to receive HUD designation as it is a major step towards a second regulatory approval for TTFields in the United States.”
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