RefleXion Medical Nabs FDA Clearance for Tumor Detection Platform

RefleXion Medical has received U.S. Food and Drug Administration (FDA) clearance for its next-generation, autonomously-guided oncology platform—the RefleXion X2 with SCINTIX therapy—for primary and metastatic lung and bone tumor treatment.

The X2 platform delivers a 20-fold increase in positron emissions tomography (PET) sensitivity, significantly increasing the biological signal for tumor detection. This increased sensitivity aims to expand the number of patients eligible for SCINTIX therapy.

“Clinical outcomes data¹ from our first-generation platform showed that SCINTIX biology-guided radiotherapy enables tumors to autonomously direct their own treatment,” RefleXion Co-Founder/Chief Technology Officer Sam Mazin, Ph.D., said. “The goal of the X2 platform is to scale applicability of SCINTIX therapy to a broader patient population, including those with early-stage or metastatic disease.”

The X2 platform’s key innovation is its wide field-of-view PET detector technology, which quadruples the imaging field of view to generate sharper images with less noise and improve visualization of moving tumors. The X2 expands the first generation’s field of view from 5 centimeters to 20 centimeters, expanding autonomous SCINTIX therapy delivery to a much larger area.

“We have effectively expanded the ‘eyes’ of the machine to generate more real time data over a larger portion of the patient’s anatomy, thereby covering the expected range of tumor motion during treatment,” Mazin stated.

Design advancements also allow upgrades across the existing installed base, enabling current RefleXion customers to transition to the full capabilities of the new X2 platform with minimal disruption.

RefleXion is a privately-held theranostic oncology company located in Hayward, Calif., commercializing SCINTIX biology-guided radiotherapy, a novel therapy that uses a single radiotracer injection to turn cancer cells into real-time biological beacons to guide external-beam radiotherapy. SCINTIX therapy is FDA-cleared for FDG-guided treatment of lung and bone tumors, including metastases. The RefleXion X2 platform is also cleared for conventional image-guided radiotherapy for solid tumors located anywhere in the body.

Reference
¹ Tu, Dan et al. Biology-guided radiotherapy for Lung and Bone Tumors: Early insights into Local Control Outcomes from the Prospective PREMIER Registry [NCT05406167]. Presented at ASTRO 2025, San Francisco, CA, USA.