December 6, 2021 — RefleXion Medical Inc., a therapeutic oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* (BgRT) for use in treating lung tumors. The breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors. It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery.
“Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs,” said Terence Williams, M.D., Ph.D., chair of radiation oncology at City of Hope Comprehensive Cancer Center. “The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies.”
The FDA Breakthrough Devices Program recognizes medical devices that meet certain criteria and hold the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. Lung cancer is the most common cause of cancer- related death, accounting for 25% of all cancer deaths in the U.S.1 The lungs are also among the most common location for metastatic tumors arising from cancers located in other parts of the body.
“The unmet need in lung cancer is staggering,” said Todd Powell, president and CEO of RefleXion. “By harnessing the continuous biological interaction between the radiotracer and the cancer cells, BgRT has the potential to manage tumor motion with unprecedented precision. Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S.”
The vision for BgRT is to expand treatment options for patients with all stages of cancer. Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, despite the inability of current technology to reach more than one to three tumors. BgRT aims to overcome this limitation and eventually deliver radiotherapy to more sites of disease in hopes of improving outcomes for more patients with advanced disease.
For more information: reflexion.com
*The RefleXion X1 is cleared for SBRT/SRS/IMRT. BgRT is limited by U.S. law to investigational use.
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Reference
1https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html
November 13, 2025 
