FDA Grants Breakthrough Device Designation for Cordance Medical’s Brain Tumor Liquid Biopsy Platform


Key Points

  • The company’s NeuroAccess™ platform is designed to noninvasively open the blood-brain barrier for liquid biopsy and drug delivery applications. 
  • The FDA’s Breakthrough Devices Program allows fast-tracking of certain novel devices and expedites patient access to treatments.
Cordance Medical logo

Cordance Medical announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its NeuroAccess device for enabling oncology liquid biopsy tests.

The Breakthrough Devices Program was established by the FDA in 2018 to allow fast-tracking of certain novel devices.

“The program offers device manufacturers an opportunity to work directly with the FDA through the premarket review stage of the approval process,” explains Jessica Foley, PhD, the Foundation’s chief scientific officer and managing director of government affairs. “The goal is to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval.”

The NeuroAccess device uses focused ultrasound plus microbubbles to temporarily and noninvasively open the blood-brain barrier (BBB) in patients with brain tumors.

The BBB is a protective layer of tightly joined cells that line the blood vessels of the brain. It prevents harmful substances (such as toxins and infectious agents) from entering the brain. Unfortunately, the BBB prevents certain drugs from reaching adequate concentrations in their targets within the brain. In addition, the BBB also prevents disease biomarkers from entering the circulatory system from the diseased brain regions – a key reason why liquid biopsy is not currently used to diagnose brain disease.

By disrupting the BBB noninvasively, the NeuroAccess device enables liquid biopsy by allowing cell-free DNA analytes to flow from the brain tumor tissue and enter the blood. The company plans to use this procedure, called SonoBiopsy™, to facilitate the use of already validated (and on market) oncology liquid biopsy tests for patients with brain tumors.

The NeuroAccess device, using several patented and patent-pending technologies, has adopted a patient-centric design and is designed to be noninvasive and portable. The procedure can take place with the patient in a seated position.

According to the company’s press release, 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 Dr. Eric Leuthardt and Dr. Hong Chen and recently announced the licensing of intellectual property with Washington University in St Louis.

Cordance Medical is pursuing noninvasive BBB opening for liquid biopsy and drug delivery techniques in conditions like glioblastoma multiforme, brain metastases, Alzheimer’s, Parkinson’s, and other neurological diseases.

See Cordance Medical’s Press Release

More about the Breakthrough Devices Program 
The Breakthrough Devices Program replaces the Expedited Access Pathway (EAP) and Priority Review for medical devices programs, as the EAP did not include 510(k) applications and the Priority Review is now limited only to drugs, and not devices. 

Devices that are subject to PMA, 510(k), or requests for de novo designation are eligible for Breakthrough Device designation if they meet two criteria: 

  1. The device provides a more effective treatment or diagnosis for a life threatening or debilitating human disease or condition than previous therapies. 
  1. The device meets at least one of the following: a) represents breakthrough technology, b) no approved or cleared alternatives currently exist, c) provides a significant advantage over current cleared or approved alternatives, d) the device’s availability is in the best interest of patients. 

Three other focused ultrasound companies have earned Breakthrough Device designation for their products. HistoSonics received the recognition for its EdisonTM histotripsy platform, Acoustiic  was granted breakthrough designation for its ultrasound arrays, and Carthera received the designation for its SonoCloud-9 device for glioblastoma.