Novel wearable rotating magnetic field therapy device targeting treatment of brain cancers

The National Cancer Institute awarded Biotex, Inc. $1,296,385 on September 18, 2025, under the Cancer Detection and Diagnosis Research program (CFDA 93.394) to accelerate clinical translation and commercialization of a novel wearable rotating magnetic field therapy device targeting brain cancer treatment.

The funded work develops the Oncomagnetic Device (OMTX), a non-invasive wearable that uses spinning oscillating magnetic fields to treat brain cancer tumors. OMTX generates magnetic field patterns that demonstrate selective anti-cancer effects against patient-derived glioblastoma cells and other brain cancers in culture without damaging normal astrocytes and neurons, and addresses whole-brain tumor volume. The project responds to an unmet clinical need for less toxic therapeutic approaches to brain cancer, where current treatments (surgical resection, chemotherapy, radiotherapy) carry high toxicity burdens and yield only modest survival improvements of six to eleven months.

This Phase II Small Business Innovation Research (SBIR) award is a Direct to Phase II grant to Biotex, Inc., a domestic small business. Work is performed in Texas. The period of performance runs through August 31, 2027. The Cancer Detection and Diagnosis Research program supports development of screening, early detection, and diagnostic techniques for cancer and commercialization of innovations through SBIR and Small Business Technology Transfer mechanisms.

Abstract

The overall goal of this direct to phase II sbir proposal is to accelerate the translation to the clinic and commercialization of a novel, non-invasive wearable rotating magnetic field therapy device (oncomagnetic device or omtx) targeting treatment of brain cancers. The american cancer society (ACS) estimates that there will be 25,400 new cases of brain and other central nervous system (CNS) cancers in 2024, with an estimated 18,760 deaths from these diseases. Glioblastoma (GBM) is one of the most aggressive malignancies and the most common brain cancer, (representing 45.2% of all brain and CNS cancers) occurring in ~3 of 100,000 people per year. Current treatments (surgical resection, chemotherapy, radiotherapy) take a heavy toll on patients, often causing them to quit treatment prematurely due to toxicity or disease progression. These treatments result in a poor quality of life with high rates of recurrence and modest improvements in survival rates by only 6-11 months. Immunotherapies such as checkpoint inhibitors, peptide vaccines, dendritic cell vaccines, chimeric antigen receptor (car) t cells, and oncolytic virotherapy have recently yielded promising results in pre- clinical and clinical studies, but they are still in the experimental stages. Thus, there is a great unmet need for a novel, less toxic therapeutic approach to improve clinical outcomes and quality of life for brain cancer patients. The oncomagnetic device (omtx) is a non-invasive, wearable device that uses spinning oscillating magnetic fields (somfs) to treat brain cancer tumors. Omtx generates specially devised somf patterns that demonstrate strong, selective anti-cancer effects in patient-derived GBM cells and other brain cancers in culture, without damaging cultured normal astrocytes and neurons. Omtx addresses the whole brain volume, a requirement for effectiveness against invasive infiltrating tumors like GBM. IT does not require patients to shave their head, exhibits low toxicity, and only requires 4-6 hours of treatment per day. Preliminary efficacy has already been demonstrated in mice, and omtx has been used under FDA's expanded access program in 10 patients who had failed all other therapies. Continued efforts will build on these results to optimize to a commercial-ready design, complete required design controls and validation activities, and perform a GLP safety study, supporting IDE approval for future clinical studies intended to support FDA premarket approval. We expect the end result of this effort will greatly enhance treatment and quality of life for patients impacted by brain cancers.