98% OF DRUG THERAPIES ARE BLOCKED OUT OF THE BRAIN BY THE BLOOD-BRAIN BARRIER

Approximately 98% of known drugs do not reach the brain because of the Blood-Brain Barrier (BBB). While this natural defence protects the brain, it also severely limits the efficacy of drugs, such as chemotherapies, antibodies and gene therapies: this is the main bottleneck for drug development in neurology. To compensate for reduced efficacy, clinicians rely on high systemic doses or invasive intracerebral delivery, increasing toxicity and costs. Consequently, 60 to 70 million patients worldwide—including those with brain cancers, neurodegenerative disorders and genetic diseases—remain without effective therapeutic options.

THERASONIC OPENS THE BLOOD-BRAIN BARRIER WITH FOCUSED ULTRASOUND, LETTING DRUGS INTO THE BRAIN WITHOUT SURGERY

TheraSonic lets drugs into the brain by opening the BBB without surgery: its technology leverages transcranial Focused Ultrasound (FUS) to induce a fully reversible permeabilisation of the BBB, allowing therapeutic molecules to diffuse into the diseased brain regions. This process is surgery-free and painless, with full BBB opening achievable in less than 1h in ambulatory settings. A robotic guidance system ensures FUS targeting accuracy and repeatability, enabling the treatment of multiple brain areas (e.g., brain metastases) or large brain volumes (e.g., diffused neurodegeneration) during each session. This approach facilitates repeat treatments and simplifies integration into the clinical workflow.

ANIMAL TESTS DEMONSTRATE DOUBLED SURVIVAL IN BRAIN CANCER MODELS

TheraSonic’s technology relies on 15 years of scientific research conducted at 2 leading French institutions, CEA and CNRS. The program was led by co-founders B. Larrat and A. Novell, internationally recognised experts in therapeutic ultrasound, establishing a robust scientific foundation supporting both FUS efficacy and safety (40+ peer-reviewed publications).

In rodent models, FUS–mediated BBB opening enabled up to a 19-fold increase in drug delivery across a wide range of molecular sizes and up to a 2.5-fold improvement in efficacy, with a doubling of survival in brain cancer models. In non-human primates, 30+ procedures demonstrated safe, repeatable BBB opening, a 7-fold increase in contrast agent concentration in the target areas, high targeting accuracy and absence of adverse events.

THE 2026 FIRST-IN-HUMAN ON BRAIN CANCER IS PROMOTED BY GUSTAVE ROUSSY, WORLD-RENOWNED CANCER CENTRE

Based on strong preclinical results, TheraSonic submitted its First-in-Human (FIH) authorisation request in February 2026. The first brain cancer patient shall be enrolled in mid-2026, marking the transition from preclinical validation to clinical application. This milestone is supported by strategic healthcare partnerships: the company secured €2.7M in funding, including €1M in equity from venture studio M2Care and Gustave Roussy Hospital — 1st cancer hospital in Europe and official sponsor of the FIH. TheraSonic will initiate the clinical evaluation through a feasibility and safety study in brain cancer, with a second pilot trial on brain metastases already in preparation for 2028.

BEYOND CANCER, THERASONIC IS A VERSATILE PLATFORM FOR MULTIPLE BRAIN DISEASES

TheraSonic’s technology may extend to neurodegenerative diseases, genetic disorders and neurotoxicity, boosting the efficacy of existing treatments and future drug candidates. This creates multiple strategic pathways, including partnerships and acquisitions by major medical device or pharmaceutical groups. By enabling these therapies to reach the brain effectively, TheraSonic can unlock significant clinical benefits across oncology, rare diseases and chronic neurological conditions.

WHY NOW? BRAIN DISEASES ARE RISING, THE ULTRASOUND MARKET IS DOUBLING

TheraSonic stands at the crossroads of two fast-growing fields: brain diseases and therapeutic FUS. Brain diseases affect about 60–70M people worldwide today and are projected to reach 150M by 2050, driven by an ageing population and increasing diagnosis rates. The global therapeutic ultrasound market is valued at approximately $3.5B and expected to grow to $6.9B by 2030 (8.2% CAGR). Momentum is supported by rising demand for non-invasive treatments, a growing number of FUS clinical programs, and 1,800+ drug candidates in development for neurodegenerative diseases.

THERASONIC IS FUNDRAISING TO DEVELOP THE COMMERCIAL VERSION OF THE CLINICAL DEVICE

This fundraising will support product industrialisation and regulatory preparation, transforming a clinical prototype into a market-ready platform. With strong preclinical foundations and a clinical launch underway, TheraSonic aims to unlock the full potential of existing and future drugs and expand treatment possibilities for millions of patients worldwide.