Cordance Medical has announced that its device, NeuroAccess, has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA), meaning the company will receive prioritised review and accelerated interaction with the regulator.
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 utilised 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 tumours.
The NeuroAccess technology employs focused ultrasound in combination with microbubbles to open the BBB in a safe, temporary and non-invasive manner, as per a recent press release from Cordance. Designed to be portable, it aims to enable SonoBiopsy procedures broadly in community clinics and hospitals alike.
Earlier this year, studies at Washington University in St Louis (St Louis, USA) demonstrated that a SonoBiopsy procedure in patients with brain tumours was safe and feasible for facilitating liquid biopsies. The recent release further details that Cordance has partnered with SonoBiopsy investigators Eric Leuthardt and Hong Chen (both Washington University in St Louis), and recently announced the licensing of intellectual property with the university.
According to Cordance, this modality for BBB disruption provides a targeted, transient opening of the BBB, unlocking the potential to “revolutionise” 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. “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, the company’s chief technology officer and co-founder.