# Pre-clinical validation and verification of a biology-guided radiation therapy system

> **NIH NIH R44** · REFLEXION MEDICAL, INC. · 2020 · $950,000

## Abstract

Project Summary
Ablative radiotherapy is an effective way to non-invasively destroy a tumor. This high-dose treatment, however,
requires precise targeting, which is complicated by the fact that tumors in the body move with respiration.
There are a variety of technologies that implement tumor tracking to achieve ablative radiotherapy in the body.
However, these are limited to treating just a few lesions in a patient due to the complexity and invasiveness of
the necessary motion management techniques. Therefore, patients that present with later-stage disease with
more than a few metastatic sites (i.e., more than 3 lesions) are not feasibly treatable with ablative radiotherapy.
RefleXion Medical is developing the first universal method for direct real-time targeting of tumors based on
biological guidance. Utilizing positron emission tomography (PET) emissions from the patient, this new
technique allows for continuous and automatic dose conformation to multiple lesions, enabling dose escalation
to the target(s) and toxicity reduction to sensitive tissues. The concept has been proven with the development
of the first prototype machine. This proposal has four specific aims. Aims 1 and 2 are to validate the
reproducibility and robustness of the treatment approach; Aims 3 and 4 are to develop a quality assurance
(QA) device that can measure the performance of biology-guided radiotherapy (BgRT) and perform end-to-end
tests to validate that planning goals can be accurately achieved in patient-like phantoms. Success of these
aims will mitigate clinical risks and enable commercialization of the first biology-guided radiotherapy (BgRT)
system.

## Key facts

- **NIH application ID:** 9901490
- **Project number:** 5R44CA228753-03
- **Recipient organization:** REFLEXION MEDICAL, INC.
- **Principal Investigator:** Samuel Mazin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $950,000
- **Award type:** 5
- **Project period:** 2018-04-06 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9901490

## Citation

> US National Institutes of Health, RePORTER application 9901490, Pre-clinical validation and verification of a biology-guided radiation therapy system (5R44CA228753-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9901490. Licensed CC0.

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