NeuroAccess: a Focused Ultrasound System for SonoBiopsy of the Brain

PROJECT SUMMARY Cordance Medical aims to address an unmet critical need in the management of brain tumor patients through the development of the NeuroAccess™ system. This focused ultrasound device is designed for safe, temporary, and non-invasive blood-brain barrier (BBB) opening, enabling a novel liquid biopsy technique termed SonoBiopsy™. The major obstacle to the widespread clinical adoption of liquid biopsies for brain tumors is the BBB, which restricts the passage of circulating free DNA (cfDNA) from the brain tumor into the bloodstream. The long-term goal is to transform the clinical management of malignant brain tumor patients by providing timely and critical molecular information for therapy selection, monitoring disease progression, and aiding in the differentiation between true progression and pseudo-progression. The overall objective of the proposed FDA- clearance clinical trial is to demonstrate the safety and efficacy of SonoBiopsy using the NeuroAccess system. We will recruit 70 patients with either recurrent primary brain tumors, such as glioblastoma (GBM), or new brain metastases. We have strong preliminary data that demonstrates the device's safety and precision in BBB opening through rigorous pre-clinical testing and evaluation in large animal models. Two specific aims guide the trial: 1) To demonstrate the safety and efficacy of SonoBiopsy in primary brain tumors by achieving safe BBB opening and significantly increasing cfDNA concentrations above the limit-of-detection of 10ng/ml; and 2) To validate the technique in secondary brain tumors by detecting novel or private mutations in at least 20% of the SonoBiopsy specimens compared to baseline, using truncal genomics to confirm specificity. This project is innovative because it offers a non-invasive, cost-effective, and community-centric solution, setting the stage for widespread adoption of SonoBiopsy. The proposed research is significant because it has the potential to catalyze the accumulation of translational SonoBiopsy knowledge and ultimately advance the diagnosis and treatment of brain tumors. The project aligns with Cordance Medical's mission to develop innovative solutions for neurologic diseases and is backed by a seasoned team of medical device leaders. Recognizing the importance of the regulatory path, Cordance Medical has obtained an FDA Breakthrough Device Designation for this application and has been enrolled into FDA TAP in alignment with obtaining a Class II clearance. By enabling the regular acquisition of tumor genetic and molecular signatures without the need for invasive procedures, the NeuroAccess system stands to substantially improve brain tumor management across various healthcare settings.