Press Release

July 23, 2025

Lutroo Imaging Granted FDA Fast Track Designation for Radiocaine™, a PET Radiotracer for Pain Imaging

PALO ALTO, Calif. — Lutroo Imaging, a clinical-stage molecular imaging company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Radiocaine™, the company’s investigational PET radiotracer developed for pain imaging in humans.

Fast Track designation enables more frequent communication and rolling review, helping accelerate the path to FDA approval. Radiocaine™ may also be eligible for Priority Review, if certain criteria are met.

Radiocaine™ is a first-in-class positron emission tomography (PET) tracer designed to visualize pain-related sodium channels in peripheral nerves, marking a potential breakthrough in how chronic pain is diagnosed, localized, and objectively measured. With over 50 million U.S. adults living with chronic pain, and no approved imaging tools able to detect or monitor pain, Radiocaine™ addresses a critical unmet need in both clinical care and drug development. The ongoing opioid crisis further underscores the urgency of developing more targeted, non-opioid-based approaches to pain diagnosis and management.

Radiocaine™ is currently being evaluated in a Phase 1 clinical trial. The study is designed to assess the tracer’s safety, biodistribution, and radiation dosimetry. Results will guide subsequent trials in painful disorders such as neuropathic pain and lower back pain, where objective imaging tools are urgently needed.

About Radiocaine™
Radiocaine™ is a Fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels in pain-related peripheral nerves. These channels are upregulated in various painful conditions, including neuropathic, inflammatory, cancer, and post-surgical pain. Radiocaine™ aims to also serve as a quantitative imaging biomarker for both clinical practice and pain research.

Radiocaine™ is an investigational radiopharmaceutical. It is not approved by the U.S. Food and Drug Administration for any use and is currently only available for use in clinical trials.

About Lutroo Imaging
Lutroo Imaging is a clinical-stage, molecular imaging company developing next-generation PET radiotracers for pain and other neurological disorders. The company’s mission is to make invisible biological processes visible—redefining how human health conditions are diagnosed, monitored, and treated through precision molecular imaging.

Forward-Looking Statements          
This press release contains forward-looking statements regarding the clinical development and potential benefits of Radiocaine™. These statements involve known and unknown risks, including trial outcomes, regulatory timelines, and commercial feasibility. Actual results may differ materially. Lutroo Imaging disclaims any obligation to update forward-looking statements except as required by law.