- The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Carthera’s innovative therapeutic ultrasound device for glioblastoma, the SonoCloud-9.
- The Breakthrough Devices Program was established in 2018 to allow fast-tracking of certain novel devices and expedite patient access to treatments.
- The FDA’s ruling was based on positive preliminary clinical data in patients with recurrent glioblastoma with the SonoCloud-9 System.
Carthera announced that their innovative therapeutic ultrasound device, the SonoCloud-9, has received Breakthrough Device designation from the US FDA.
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 SonoCloud device, invented by the neurosurgeon Alexandre Carpentier, is unique in that it is an implantable device positioned during a regular tumor debulking/resection surgery. During a four-minute procedure, it uses low-intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB) to allow higher concentrations of therapeutic agents to enter the brain. This procedure can be performed repeatedly (typically every 3-4 weeks) and takes place while the patient is undergoing standard-of-care chemotherapy treatment.
Other models of the SonoCloud system have been explored to treat a wide variety of brain disorders, including Alzheimer’s disease, brain metastases from melanoma, and preclinical glioma models. Results from a pilot trial with a first-generation device (SonoCloud-1) in recurrent glioblastoma patients were also published in 2019. The SonoCloud-9 device is primarily being tested to address one of the most challenging and deadly brain tumors – glioblastoma.
According to the company’s press release, the FDA’s breakthrough ruling was based on positive preliminary clinical data in patients with recurrent glioblastoma with the SonoCloud-9 System. This trial occurred at sites in France and the United States, and the data are currently being prepared for publication.
“There is a significant unmet need for new treatments for glioblastoma patients, who have very few available therapeutic options,” said Michael Canney, PhD, chief scientific officer at Carthera. “We’re excited that the FDA has acknowledged the innovative potential of the SonoCloud approach through the granting of this Breakthrough Designation.”
More about the Breakthrough Device Program
The Breakthrough Device Program replaced 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:
- The device provides a more effective treatment or diagnosis for a life threatening or debilitating human disease or condition than previous therapies.
- 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.
Two other focused ultrasound companies have announced that they have earned Breakthrough Device designation for their products. Acoustiic received breakthrough designation for its ultrasound arrays, and HistoSonics recieved the recognition for its EdisonTM platform.
Sean Taffler, PhD, founder and CEO of Acoustiic, wrote a blog on the topic: An Inside Look at Obtaining Breakthrough Device Designation.