Alpha Tau Medical Cancer Radiotherapy Gains Breakthrough Device Designation

Israeli company Alpha Tau Medical’s alpha-radiation cancer therapy Alpha DaRT has received a Breakthrough Device designation from the FDA.

Alpha Tau submitted clinical data to the FDA to support the designation, including a pilot study of the treatment for squamous-cell carcinoma (SCC) of the skin, head and neck in which almost 80 percent of the lesions showed a complete response and 100 percent demonstrated a partial or complete response.

The breakthrough designation applies to use of the Jerusalem-based company’s device to treat SCC of the skin and oral cavity without curative standard of care.