What's Your Problem? Using Sound Waves to Destroy Tumors
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Nov 13, 2025 
Mike Blue, CEO of HistoSonics, shares his fascinating journey from a garage-built ultrasound prototype to an FDA-approved cancer treatment device. He discusses how converging sound waves create bubble clouds that destroy tumors non-invasively. After a setback with a failed clinical trial, he rebranded the technology and attracted funding. Blue also reveals insights from the pivotal HOPE for Liver trial, showcasing impressive results and patient outcomes, while addressing challenges in scaling their innovative treatment for various cancers.
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Why FDA Demanded A Single-Organ Start
- FDA wanted a single-organ initial study because histotripsy is novel and organ responses vary.
- Starting with the liver balanced novelty risk with clinical need and regulatory conservatism.
Pivotal Trial With Very Sick Patients
- The Hope for Liver pivotal trial enrolled very sick patients required by the FDA.
- Despite advanced disease, one-year local tumor control was about 90% in treated lesions.
Local Control ≠ Systemic Cure
- Destroying a tumor locally doesn't cure metastatic cancer when many untreated lesions remain.
- The study's scope (treating up to three lesions) meant patients kept systemic disease elsewhere.