RefleXion Medical Announces First Clinical Outcomes for SCINTIX Therapy in Lung and Bone Tumors

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HAYWARD, Calif.--(BUSINESS WIRE)--Sep 30, 2025--

RefleXion Medical, an external‑beam theranostic oncology company, today announced first results from the PREMIER Registry ( NCT05406167 ) evaluating its SCINTIX ® biology-guided radiotherapy, or BgRT, platform in patients with lung and bone tumors. The findings, presented at the 2025 ASTRO Annual Meeting, showed local control of 100 percent at nine months post-treatment with no reported Grade 2 or higher adverse events. The data represent the first prospective, multi-institutional evidence of SCINTIX therapy’s clinical impact.

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The RefleXion X1 is the only dual-treatment modality platform that uses signals from injected radiotracers to autonomously direct radiation to solid tumors.

“The PREMIER Registry findings mark a milestone for our field,” said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. “We are beginning to see the clinical translation of a technology that can autonomously guide radiation based on real-time biology. Achieving 100% local control in both lung and bone tumors with imaging up to nine months after treatment, without significant toxicity, represents an important step forward in expanding the reach of radiotherapy for patients with advanced cancer.”

By Feb. 25, 2025, five cancer centers had enrolled 45 patients in the registry, with 28 providing follow-up imaging for analysis. Fifteen patients were treated for lung tumors, including early-stage and metastatic disease, and 13 for bone metastases. The median patient age was 69.5 years, with 39% female.

Across 39 follow-up scans, investigators reported a local control rate – defined as complete response (CR), partial response (PR), or stable disease (SD) – of 100% across available follow-up imaging. Tumor response rates (CR+PR) were 41% overall, including 47% for bone metastases and 35% for lung tumors. No Grade 2 or higher treatment-related adverse events were observed.

RefleXion plans to expand registry enrollment and continue long-term follow-up to strengthen the dataset and evaluate correlations between treatment parameters, imaging metrics and patient outcomes.

These early results underscore RefleXion’s goal of establishing SCINTIX therapy as a first-in-class treatment option for both localized and metastatic disease. As the registry grows, the company expects the evidence to further support BgRT’s integration into routine cancer care.

RefleXion (booth #1433) is also presenting early results characterizing performance of its future, next-generation platform 1 that offers a 20-fold increase in PET sensitivity, which may increase patient eligibility for SCINTIX therapy. Presentations will be held every 30 minutes in the RefleXion booth during exhibit hours.

About RefleXion Medical

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, and is under investigation for additional tracers and indications. The RefleXion X1 platform is also cleared for conventional image‑guided radiotherapy for solid tumors anywhere in the body. For more information, visit www.reflexion.com.

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KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: RESEARCH MEDICAL DEVICES CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY RADIOLOGY HEALTH SCIENCE ONCOLOGY

SOURCE: RefleXion Medical

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PUB: 09/30/2025 10:01 AM/DISC: 09/30/2025 10:01 AM

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