FDA granted Shreis Scalene Sciences Breakthrough Device Designation for the Cytotron, a CE-marked, whole-body therapeutic medical device.
The Center for Devices and Radiological Health granted the designation.
The company’s designation request stated that “The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of the breast, liver, and pancreas.”
Shreis, while actively pursuing collaborations for clinical trials in the current proposed indications for use, intend to also submit a request for Breakthrough designation in other solid tumors such as adult and pediatric brain tumors, lung cancer, and other life-limiting diseases.
