Cordance Medical, a medical device company focused on opening the blood-brain barrier (BBB) to facilitate liquid biopsy, announces that its device, NeuroAccess, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

The NeuroAccess device is engineered for adult patients (aged 22 and above) who have received a known or highly suspected brain tumor diagnosis from a neurologist or neuro-oncologist. Designed to be utilized by trained healthcare professionals, 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 (and on market) oncology liquid biopsy tests for patients with brain tumors. 

The FDA’s Breakthrough Device Designation is conferred upon technologies that offer superior treatment or diagnosis for life-threatening or debilitating conditions. This designation underscores the transformative promise of the NeuroAccess platform in addressing the unmet medical needs to expand the continuum of care for patients suffering from brain tumors by facilitating safe procedures to obtain molecular characterization of their tumors, according ot the company. Under the program, Cordance Medical will receive prioritized review and accelerated interaction with the FDA.

How the NeuroAccess Device Works

The NeuroAccess technology employs focused ultrasound in combination with microbubbles to open the BBB in a safe, temporary, and non-invasive manner.  Designed to be portable, NeuroAccess aims to enable SonoBiopsy procedures broadly in community clinics and hospitals alike.

Earlier this year, pioneering 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. Cordance Medical has partnered with SonoBiopsy investigators Eric Leuthardt, MD, and Hong Chen, MD, and recently announced the licensing of intellectual property with Washington University in St Louis.

Further reading: New Test Identifies Brain Tumors from Cerebrospinal Fluid

Numerous preclinical studies employing focused ultrasound and microbubble-mediated BBB disruption have shown potential benefits for a range of neurological disorders, the company says. This modality provides a targeted, transient opening of the BBB, unlocking the potential to revolutionize both liquid biopsy and drug delivery techniques in conditions like 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,” says 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.”

“The Breakthrough Device Designation demonstrates Cordance Medical’s commitment to design a safe, patient-centric device for patients with brain diseases,” added Bhaskar Ramamurthy, PhD, CTO and co-founder of Cordance Medical.

Photo: Cordance Medical