Five years’ journey in turning sonobiopsy from concept to commercialization

The standard method for diagnosing brain tumors has traditionally relied on magnetic resonance imaging (MRI). While MRI is informative, it lacks the ability to provide precise genetic information about tumors. Conversely, surgical biopsies can offer genetic insights but come with significant risks of morbidity and are not always feasible. Our team introduced sonobiopsy, a novel technique that uses ultrasound to safely and noninvasively release tumor-derived biomarkers from targeted brain locations into the bloodstream. This method allows for the molecular characterization of brain tumors through simple blood tests. In 2018, we published our proof-of-concept study in mice, followed by the first large animal study in healthy pigs in 2020. In 2022, we conducted our first study in a pig model of brain tumors. Concurrently, we developed neuronavigation-guided focused ultrasound devices for patient use. These milestones culminated in the IRB approval of our sonobiopsy clinical trial. We began recruiting our first patient for sonobiopsy in April 2022 and by September 2023, we published findings from our first-in-human prospective sonobiopsy trial in high-grade glioma patients. In the same year, we licensed our patents to Cordance Medical, which received FDA breakthrough device designation for the sonobiopsy devices. This talk will share the lessons learned throughout our journey from concept to commercialization.