US-FDA grants breakthrough device designation to Cordance Medical NeuroAccess for liquid biopsy in brain tumours

Cordance Medical, a pioneering 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 US 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 tumour diagnosis from a neurologist or neuro-oncologist. Designed to be utilized by trained healthcare professionals, the device transiently opens the blood-brain barrier 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 tumours.

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 tumours by facilitating safe procedures to obtain molecular characterization of their tumours. 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 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 tumours was safe and feasible for facilitating liquid biopsies. Cordance Medical has partnered with SonoBiopsy investigators Dr. Eric Leuthardt and Dr. Hong Chen and recently announced the licensing of intellectual property with Washington University in St Louis.

Numerous 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 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,” 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.”

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

Cordance Medical is a seed-stage medical technology company focused on developing, validating, and distributing a patient-centric non-invasive, small-footprint, and portable clinical device-the NeuroAccess platform.

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