Sam Brusco, Associate Editor10.30.23
Cordance Medical, a company focused on opening the blood-brain barrier (BBB) to facilitate liquid biopsy, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its NeuroAccess device.
NeuroAccess, which is designed for patients 22 and up with known or suspected brain tumors, helps non-invasively elevate cell-free DNA (cfDNA) analytes in blood circulation. The procedure is called SonoBiopsy and the company says it boosts existing oncology liquid biopsy assays.
The technology uses focused ultrasound combined with microbubbles to safely and temporarily open the BBB. The portable NeuroAccess device aims to bring SonoBiopsy broadly across community clinics and hospitals.
Earlier this year, pioneering studies at Washington University in St. Louis demonstrated a SonoBiopsy procedure in brain tumor patients was safe and feasible to facilitate liquid biopsies. Cordance Medical has partnered with SonoBiopsy investigators Dr. Eric Leuthardt and Dr. Hong Chen and recently announced licensing of intellectual property with Washington University in St Louis.
Cordance’s technology hopes to revolutionize both liquid biopsy and drug delivery techniques for 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," Cordance Medical CEO Ryan Dittamore told the press. "We are keen to continue our clinical trials and to collaborate closely with the FDA to bring this groundbreaking technology to market."
NeuroAccess, which is designed for patients 22 and up with known or suspected brain tumors, helps non-invasively elevate cell-free DNA (cfDNA) analytes in blood circulation. The procedure is called SonoBiopsy and the company says it boosts existing oncology liquid biopsy assays.
The technology uses focused ultrasound combined with microbubbles to safely and temporarily open the BBB. The portable NeuroAccess device aims to bring SonoBiopsy broadly across community clinics and hospitals.
Earlier this year, pioneering studies at Washington University in St. Louis demonstrated a SonoBiopsy procedure in brain tumor patients was safe and feasible to facilitate liquid biopsies. Cordance Medical has partnered with SonoBiopsy investigators Dr. Eric Leuthardt and Dr. Hong Chen and recently announced licensing of intellectual property with Washington University in St Louis.
Cordance’s technology hopes to revolutionize both liquid biopsy and drug delivery techniques for 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," Cordance Medical CEO Ryan Dittamore told the press. "We are keen to continue our clinical trials and to collaborate closely with the FDA to bring this groundbreaking technology to market."