On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for lung tumors.
is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.
According to RefleXion, “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” and “aims to remove the uncertainty of guiding radiation delivery using images taken days before treatment.” Many patients with stage four cancer cannot use current forms of radiotherapy because existing technology is unable to efficiently track and treat multiple tumors. “The unmet need in lung cancer is staggering,” said Todd Powell, president and CEO of RefleXion. According to Cancer.Org, “[l]ung cancer is the most common cause of cancer-related death,” accounting for 25% of all cancer deaths in the United States.
As RefleXion explains, the use of PET emissions in BgRT to guide treatment makes the “cancer itself act as a fast, biological fiducial continuously signaling its locations even during motion.” As the PET tracer collects in the tumor, “a series of positron annihilation events occur resulting in the emission of two photons almost 180 degrees to each other.” The detector in the RefleXion X1 device finds these emissions and outputs images in real time. A video of RefleXion’s X1 Machine (shown below), used for BgRT, can be seen here.