“From its inception, the novel nature of SCINTIX therapy demanded that we fundamentally rethink how to design a machine capable of delivering cancer treatment to patients that were not considered candidates for radiotherapy because of the extent of their disease,” said Todd Powell, CEO and president of RefleXion. “Likewise, our regulatory pathway encompassed unprecedented hurdles as medical device and pharmaceutical teams within the FDA worked together to create a new classification regulation for this breakthrough device and therapy.
“With initial clearance for SCINTIX therapy behind us, we will begin full commercialization and patient treatments in the coming weeks.”
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SCINTIX therapy (formerly referred to as BgRT) is delivered through the RefleXion X1 machine, which combines positron emission tomography (PET) with a linear accelerator (LINAC) to deliver a radiation dose that tracks the cancer’s motion. Immediately prior to treatment, the patient is injected with a radiopharmaceutical that interacts with cancer cells to produce signals or emissions. The X1 continuously constructs a map from the detected emissions data that determines where to aim beamlets of radiation. This crosstalk between the tumor and the X1 requires the system to rotate at 60 rpm—making it the first and only radiotherapy machine to spin at this speed.
“Autonomous radiotherapy was just a concept over a decade ago, but now for the first time in the history of cancer treatment, the individual biology of the cancer itself guides its own destruction,” said Sam Mazin, Ph.D., founder and CTO of RefleXion. “Today, I want to acknowledge and thank the many talented people who have contributed over the years to translate SCINTIX therapy to the clinic.”
Combined, tumors in the lung or bone, including those that metastasize from other primary cancers, arise in approximately 430,000 patients.1 In metastatic cancer, where patients can present with both lung and bone tumors, radiotherapy is often not considered as a treatment option due to the cumbersome clinical workflow and toxicity of treating more than one tumor in a treatment session.
RefleXion is hosting a brief live stream event from its headquarters in Hayward, Calif., about the SCINTIX therapy clearance. The live stream can be accessed on RefleXion’s YouTube channel today at 10:30 AM PST.
About RefleXion Medical
RefleXion is a privately held therapeutic oncology company located in Hayward, Calif., commercializing SCINTIX biology-guided radiotherapy, a novel treatment modality that uses a single radiotracer injection to transform cancer cells into real-time biological beacons to control external-beam radiotherapy delivery to multiple tumors. Granted Breakthrough Device designation for lung tumors and De Novo marketing authorization by the FDA, SCINTIX therapy is indicated for use in lung and bone tumors. These tumors may arise from primary lung and bone cancers or result from metastases to the lungs or bone from other primary cancers. The RefleXion X1 is also cleared for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), and intensity modulated radiotherapy (IMRT) for solid tumors located anywhere in the body. RefleXion’s vision is to extend the established safety, efficacy and cost-effectiveness of external-beam radiotherapy to patients with solid tumor malignancies of any stage.
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