Medical Policy

This document addresses intrabuccal electromagnetic field therapy, a non-invasive treatment that delivers low-level, amplitude-modulated radiofrequency electromagnetic fields at tumor-specific frequencies. The therapy is administered via a handheld device and is designed to exert systemic biologic effects on malignant cells. The TheraBionic^™ P1 device (TheraBionic Inc., Winston-Salem, North Carolina) is a handheld, battery-powered system that is FDA approved under a Humanitarian Device Exemption for the treatment of advanced hepatocellular carcinoma.

Note: Please see the following related documents for additional information:

• CG-DME-44 Electric Tumor Treatment Field (TTF) Therapy

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Intrabuccal amplitude-modulated, radiofrequency electromagnetic field therapy is considered investigational and not medically necessary for all indications, including advanced hepatocellular cancer.

This document describes clinical studies and expert recommendations, and explains why low-level, intrabuccal amplitude-modulated radiofrequency electromagnetic field therapy is not considered clinically appropriate. The following summary does not replace the not medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Intrabuccal electromagnetic field therapy for advanced liver cancer uses a handheld device to send very low energy radio waves through a small antenna placed on the tongue. The goal is to affect cancer cells throughout the body while causing few side effects. One device, TheraBionic P1, has special FDA approval for certain adults with advanced hepatocellular carcinoma, which is the most common type of liver cancer.

What the Studies Show

TheraBionic P1 is a battery powered device that sends low-level, amplitude-modulated radiofrequency electromagnetic fields into the body through an antenna-like device held against the tongue. Amplitude modulation means the strength of the radio waves changes in a pattern that may target cancer cells. In a small unpublished study of 41 people with advanced liver cancer who had already tried other treatments, about one third had stable disease for more than 6 months. Median survival ranged from about 4 to 10 months, depending on liver function. Side effects were mild and included mouth sores and fatigue. There were no serious treatment-related side effects reported. A published study involving 59 people who received the therapy compared their results with earlier studies. Survival seemed similar or slightly longer for some groups, but the study did not randomly assign treatments and used older studies for comparison. This makes it hard to know if the device caused the results or they were due to other reasons.

A similar device, AutEMdev, has been tested in a small study of 66 people. It was mainly designed to check safety, not whether it works. No serious side effects were reported, and mild sleepiness was noted. Survival results were described, but the study was not built to prove benefit. Overall, research so far includes small studies and lab research. There are no large, well-designed randomized trials that clearly show this therapy helps people live longer or feel better. Better studies are needed to know if this treatment improves health.

Is this Clinically Appropriate?

Low-level, amplitude modulated radiofrequency electromagnetic field therapy, including the TheraBionic P1 device, is not clinically appropriate for any condition, including advanced hepatocellular carcinoma. It has not been proven to improve health in high quality studies. Small studies suggest it may be safe and could help some people, but the research design limits clear conclusions.

(Return to Description/Scope)

Summary

Intrabuccal low-level, amplitude-modulated radiofrequency electromagnetic field (EMF) therapy is a noninvasive systemic treatment delivered via a handheld device to treat advanced hepatocellular carcinoma (HCC). The TheraBionic™ P1 device received FDA approval under a Humanitarian Device Exemption (HDE) in 2023 for adults with advanced HCC whose disease has progressed on first- and second-line therapies, based on small, nonrandomized studies suggesting disease stabilization and a potential overall survival benefit with minimal toxicity. The AutEMdev is a similar investigational device evaluated in a feasibility study demonstrating favorable safety. The study was not designed to assess efficacy and AutEMdev does not have FDA approval. Overall, the evidence is limited to small observational studies and preclinical data, with no adequately powered randomized trials, and no major medical societies currently recommend this therapy; accordingly, systemic EMF therapy is considered investigational and not medically necessary.

Discussion

The TheraBionic P1 device is the first FDA-approved systemic therapy that uses amplitude-modulated radiofrequency electromagnetic fields to treat cancer. This device received U.S. Food and Drug Administration approval on September 26, 2023 under an HDE for use in adults 18 years and older with advanced HCC who have failed first- and second-line therapies. The FDA approval was based on clinical evidence indicating a probable benefit in overall survival and disease stabilization in the affected population. In the unpublished pivotal trial (NCT00534664) of 41 treated participants, a significant proportion (34.1%) achieved stable disease for more than 6 months, and survival outcomes compared favorably with historical controls. There were 2 reported incidents of grade 1 toxicity (mucositis and fatigue) and no reported incidents of grade 2, 3, or 4 toxicities.

Blackstock (2021) reported findings from a pooled case series with comparison to historical controls evaluating the safety and efficacy of amplitude-modulated radiofrequency electromagnetic fields delivered via the TheraBionic P1 device in 59 individuals with advanced HCC. The analysis combined results for 41 individuals from the pivotal trial reported to FDA and 18 additional individuals. Participants self-administered 3 hours of treatment daily. Outcomes were compared with historical placebo and active-treatment controls, including sorafenib trials. The primary endpoints were overall survival (OS), time to progression (TTP), response rate, and adverse events. Median OS among individuals with Child-Pugh A disease was 10.36 months, significantly longer than the 7.74 months reported in pooled historical placebo controls. Among those with Child-Pugh B disease, median OS ranged from 4.4-4.7 months, comparable to historical outcomes with sorafenib. The overall partial response rate was approximately 10%. Treatment was generally well tolerated, with predominantly grade 1 mucositis and fatigue and no treatment discontinuations due to adverse events. Interpretation of these findings is limited by the non-randomized study design, small sample size, heterogeneity of the study population, and reliance on cross-trial comparisons with historical controls, which are subject to selection bias and confounding. As such, the results are considered hypothesis-generating and do not establish a causal relationship between the intervention and observed outcomes.

The AutEMdev (Autem Therapeutics, Hanover, NH) is an investigational medical device developed by Autem Therapeutics that delivers low-energy amplitude-modulated radiofrequency electromagnetic fields via a small, battery-operated generator and intraoral antenna, similar in concept to the TheraBionic P1 device. In a single-site feasibility study involving 66 individuals with advanced HCC (Capareli, 2023), participants underwent 90-minute EMF exposure sessions every 2-4 weeks, either as monotherapy or in combination with standard treatments. There were no serious adverse events and only mild, self-limiting grade 1 somnolence reported. The median overall survival was 11.3 months overall (longer with combination therapy). The study was not designed to establish efficacy. The AutEMdev has not received FDA approval.

The current evidence base addressing intrabuccal low-level, amplitude-modulated radiofrequency EMF therapy consists primarily of in vitro studies, xenograft models, and a limited number of small, observational clinical investigations (Jimenez, 2019; Pinto, 2024; Tuszynski, 2022). These studies have largely focused on safety and feasibility rather than being designed or powered to assess efficacy. Accordingly, larger, well-controlled trials of sufficient methodological quality are required to determine the clinical effectiveness of this therapy.

TheraBionic and AutEMdev therapies are intrabuccal (in the mouth), low-energy amplitude-modulated radiofrequency EMF devices designed to deliver systemic EMF exposure via a spoon-shaped antenna placed on the tongue. The AutEMdev, for example, uses a 27.12 MHz carrier frequency with low-frequency amplitude modulation (10 Hz-20 kHz) at power levels well below those of mobile phones. The therapeutic concept is based on the hypothesis that specific amplitude-modulation frequencies may interact with electrically active cellular components, potentially affecting tumor cell proliferation while producing minimal toxicity. These devices are currently being studied in advanced liver cancer as monotherapy or in combination with systemic treatments, with ongoing research focused on optimizing personalized modulation frequencies.

Advanced HCC is typically managed with systemic therapy once the disease is unresectable or metastatic. In the first-line setting, options include combination immunotherapy plus an anti-VEGF antibody or multikinase inhibitors when immunotherapy is not appropriate. Upon progression, second-line options include additional tyrosine kinase inhibitors, monoclonal antibodies targeting VEGFR2, or alternative immunotherapy regimens. Outcomes remain limited despite advances in treatment. Many affected individuals are ineligible for later-line therapy due to hepatic decompensation, and cumulative toxicities can restrict treatment sequencing. These factors highlight the need for well-tolerated complementary approaches in both first- and second-line settings.

Intrabuccal electromagnetic field therapy has been proposed as a potential treatment for advanced HCC that delivers low-energy amplitude-modulated radiofrequency electromagnetic fields using a portable device. The device produces a low-power radiofrequency carrier wave that is amplitude-modulated at tumor-specific frequencies identified through physiological responses in individuals. The energy delivered is too low to cause detectable heating and is thought to act through interactions between electromagnetic fields and cellular structures. Preclinical studies suggest that these modulated fields may slow the growth of hepatocellular carcinoma cells by increasing calcium entry into the cells and activating signals that suppress tumor growth and reduce cancer stem cells.

The therapy is administered intrabuccally via a spoon-shaped antenna placed on the tongue. This facilitates efficient coupling of the radiofrequency signal through the low-impedance oral mucosa. This configuration allows systemic distribution of low-power electromagnetic fields throughout the body, with the body effectively acting as an antenna. Dosimetry analyses demonstrate that intrabuccal administration results in whole-body absorption of non-thermal electromagnetic fields at levels substantially below international safety limits, enabling systemic exposure while minimizing the risk of tissue heating.

Electromagnetic field therapy: Delivery of very low-level, radiofrequency electromagnetic signals to the body. These signals are tuned to specific frequencies associated with certain tumors and are intended to disrupt cancer cell growth while limiting harm to normal cells.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Barbault A, Costa FP, Bottger B, et al. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009; 28(1):51.
2. Blackstock AW, Benson AB, Kudo M, et al. Safety and Efficacy of amplitude-modulated radiofrequency electromagnetic fields in advanced hepatocellular carcinoma. 4Open. 2021; 4:3.
3. Capareli F, Costa F, Tuszynski JA, et al. Low-energy amplitude-modulated electromagnetic field exposure: feasibility study in patients with hepatocellular carcinoma. Cancer Med. 2023; 12(11):12402-12412.
4. Jimenez H, Gibo D, Sharma S, et al. Treatment of glioblastoma with tumor-specific amplitude-modulated radiofrequency electromagnetic fields. Oncotarget. 2025; 16:741-757.
5. Jimenez H, Wang M, Zimmerman JW, et al. Tumour-specific amplitude-modulated radiofrequency electromagnetic fields induce differentiation of hepatocellular carcinoma via targeting Cav3.2 T-type voltage-gated calcium channels and Ca2+ influx. EBioMedicine. 2019; 44:209-224.
6. Pinto R, Ardoino L, Giardullo P, et al. A systematic review on the in vivo studies on radiofrequency (100 kHz-300 GHz) electromagnetic field exposure and co-carcinogenesis. Int J Environ Res Public Health. 2024; 21(8):1020.
7. Tuszynski JA, Costa F. Low-energy amplitude-modulated radiofrequency electromagnetic fields as a systemic treatment for cancer: review and proposed mechanisms of action. Front Med Technol. 2022; 4:869155.

Government Agency, Medical Society, and Other Authoritative Publications:

1. National Library of Medicine (NIH). Clinical Trials. Phase I/​II study of amplitude-modulated electromagnetic fields in the treatment of advanced hepatocellular carcinoma (TheraBionic). Last updated September 26, 2007. Available at: https://clinicaltrials.gov/study/NCT00534664. Accessed on March 24, 2026.
2. U.S. Food and Drug Administration (FDA). Humanitarian Device Exemption (HDE) Database. TheraBionic P1. Summary of Safety and Probable Benefit. H220001. June 23, 2022. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/H220001B.pdf. Accessed on March 24, 2026.

AutEMdev
TheraBionic^™ P1

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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