Companies / TheraBionic

Medical device company profile

TheraBionic

U.S. medical device company making the TheraBionic P1 system, authorized under an FDA Humanitarian Device Exemption for a defined advanced liver-cancer population.

Medical Device Manufacturer and DeveloperOncology

Headquarters🇺🇸Bloomfield Township, Michigan, United States

Founded2018

Commercial statusCommercially availableU.S. HDE-authorized · Defined advanced-HCC indication

Employees2–10LinkedIn company-size range

Estimated revenueNot confirmed

Disclosed fundingUS$4.3 millionAngel-investor capitalization reported for 2018–2023 in NCI showcase

Official websitewww.therabionic.com ↗

Company overview

TheraBionic is a medical device company with a current U.S. contact address in Bloomfield Township, Michigan. Co-inventor and co-founder Boris Pasche serves as CEO and board chair; the technology also has a related German TheraBionic company.

Its P1 system delivers low-level amplitude-modulated radiofrequency electromagnetic fields through an intrabuccal antenna placed on the tongue. The portable system is intended for prescribed use in eligible patients with advanced hepatocellular carcinoma.

FDA granted the system a Humanitarian Device Exemption in September 2023. The authorized population is adults with advanced hepatocellular carcinoma who have failed first- and second-line therapy. Studies in earlier-line liver cancer or other cancers are separate investigational uses and should not be presented as broadly authorized cancer treatment.

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Leadership

4 people

Boris Pasche, MD, PhDCo-founder, Chief Executive Officer & Board Chair ^[6]

Valerie Pasche, MDChief Operating Officer ^[6]

Stefan Grant, MD, JD, MBAGeneral Counsel ^[6]

Alexandre BarbaultCo-founder & Co-inventor ^[6]

Products & regulatory status How does MedTechIndex get this information?

Summary

FDA granted H220001 on September 26, 2023 for adults aged 18 or older with advanced hepatocellular carcinoma who have failed first- and second-line therapy. The HDE pathway is based on safety and probable benefit; it should not be represented as a conventional PMA demonstration of effectiveness. ^[5][3][2]

FDA approved supplement S004 on May 27, 2026 for labeling changes and additional contraindications. It is a supplement to H220001, not a second original device authorization. Earlier-line HCC and other cancer applications remain distinct research uses. ^[5][3][2]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-11-05.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Intrabuccal radiofrequency electromagnetic-field treatment system

TheraBionic P1 system ↗

Handheld generator with a connected intrabuccal antenna for prescribed radiofrequency electromagnetic-field treatment. Its U.S. HDE indication is limited to eligible adults with advanced hepatocellular carcinoma after failure of first- and second-line therapy. ^[7][3][2]

U.S. HDE-authorized · Defined advanced-HCC indication