The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation.
The NeuroAccess device is indicated for adult patients (aged 22 and above) who have received a known or highly suspected brain tumor diagnosis from a neurologist or neuro-oncologist. The device transiently opens the blood-brain barrier (BBB) to elevate the concentration of cell-free DNA (cfDNA) analytes in blood circulation. By increasing analyte concentration, this procedure, called SonoBiopsy, aims to facilitate already validated oncology liquid biopsy tests for patients with brain tumors.
The Breakthrough Device Designation underscores the promise of the NeuroAccess platform to address unmet medical needs by facilitating safe procedures to obtain molecular characterization of brain tumors. Under the program, Cordance Medical will receive prioritized review and accelerated interaction with the FDA.
The NeuroAccess technology employs focused ultrasound in combination with microbubbles to open the BBB in a safe, temporary and noninvasive manner. Designed to be portable, NeuroAccess aims to enable SonoBiopsy procedures broadly in community clinics and hospitals alike.
Earlier this year, studies at Washington University in St. Louis demonstrated that a SonoBiopsy procedure in patients with brain tumors was safe and feasible for facilitating liquid biopsies. Preclinical studies employing focused ultrasound and microbubble-mediated BBB disruption have shown potential benefits for a range of neurological disorders. This modality provides a targeted, transient opening of the BBB, unlocking the potential to fundamentally change both liquid biopsy and drug delivery techniques in conditions including glioblastoma multiforme (GBM), brain metastasis, Alzheimer’s, Parkinson’s and other neurologic diseases.
“This Breakthrough Device Designation from the FDA is a pivotal milestone for Cordance Medical and for patients requiring more efficacious diagnostic solutions,” said Ryan Dittamore, CEO of Cordance Medical. “We are keen to continue our clinical trials and to collaborate closely with the FDA to bring this groundbreaking technology to market.”