Breakthrough FDA Designation for Reflexion Cancer Radiotherapy Treatment
RefleXion Medical's SCINTIX biology-guided radiotherapy has been given FDA marketing clearance, for the treatment of early-stage and late-stage cancers.
With SCINTIX radiotherapy, the location and dose of radiation to be administered during real treatment delivery are autonomously chosen by each cancer's unique biology.
The FDA earlier designated SCINTIX biology-guided radiotherapy as a Breakthrough Device for the treatment of lung tumors because it can identify and manage multiple moving tumors.
It is delivered via the RefleXion X1 apparatus, which uses positron emission tomography (PET) and a linear accelerator (LINAC) to follow the progression of malignancy.
With the current FDA clearance, the RefleXion X1 can now treat patients with indicated solid tumors of any stage as the only dual-treatment modality platform.
The US FDA has previously authorized the X1's advanced anatomic modality for solid tumors that can be found anywhere in the body.
The SCINTIX biologic modality monitors the motion of the tumor resulting from all movements, including unanticipated patient movements as well as anticipated motion from internal processes.
Fluorodeoxyglucose F-18, also known as FDG, was the radiopharmaceutical for which it was originally approved for use.
A radiopharmaceutical is injected into the patient prior to treatment; this radiopharmaceutical interacts with cancer cells to generate emissions, and the X1 monitors these emissions to identify the radiation target.
The system must revolve at 60 rpm due to crosstalk between the X1 and the tumor, making SCINTIX the first and only radiotherapy machine to do so.
The company plans to modify SCINTIX therapy to work with the entire range of cutting-edge radiopharmaceuticals that are presently being researched and developed for various cancer types.