Carthera SonoCloud
[Image from Carthera’s website]

Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system.

Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible and, when activated for a few minutes using a transdermal needle connection to an external control unit, it uses low-intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB).

SonoCloud-9 disrupts the BBB for several hours, offering a window during which drug therapies can be administered, allowing the therapeutics to reach the brain in higher and more effective concentrations, according to a news release. Carthera said SonoCloud allows for the therapeutic efficacy of new and existing therapies to be unlocked and harnessed to improve the treatment of a wide range of brain diseases, including glioblastoma.

“There is a significant unmet need for new treatments for glioblastoma patients, who have very few available therapeutic options,” Carthera Chief Scientific Officer Michael Canney said in the release. “We’re excited that the FDA has acknowledged the innovative potential of the SonoCloud approach through the granting of this breakthrough designation.”

Carthera said the breakthrough nod will offer access to priority review, more intensive FDA interaction to help build an efficient device development program and commitment from experts and senior managers with the FDA who will assist the company along during the premarket review phase.

“Following the recent successful completion of our phase 1/2 trial in recurrent glioblastoma, this Breakthrough Device Designation is another important milestone supporting the potential of SonoCloud,” Carthera CEO Frédéric Sottilini said. “This step forward is also a strong signal for investors who have joined our next round of financing and for those who are considering joining. I am confident that we will soon close our Series B round, which will allow us to start our pivotal clinical trial in early 2023.”

Another disease SonoCloud may help treat is mild Alzheimer’s Disease, as the company announced positive results from a trial evaluating the safety and efficacy of the use of the technology in the treatment of Alzheimer’s in March.