Carthera’s SonoCloud Ultrasound Device Gains Breakthrough Status

French firm Carthera has earned U.S. Food and Drug Administration (FDA) breakthrough status for SonoCloud-9, an ultrasound-based device to treat a wide range of brain diseases.
 
SonoCloud uses low-intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier so the brain can have higher exposure to therapeutic compounds. Therapeutic efficiency of new and existing therapies can then be harnessed to improve treatment of brain diseases like glioblastoma.
 
“There is a significant unmet need for new treatments for glioblastoma patients, who have very few available therapeutic options,” Michael Canney, chief scientific officer at Carthera told the press. “We’re excited that the FDA has acknowledged the innovative potential of the SonoCloud approach through the granting of this Breakthrough Designation.”
 
The designation was based on preliminary phase 1/2a clinical data indicating “substantial improvement” over available second-line therapy.
 
“The FDA Breakthrough Device Designation will help Carthera to efficiently advance to a pivotal trial and Premarket Approval (PMA),” said Sandra Thiollière, head of quality and regulatory affairs at Carthera. “We look forward to working closely with the FDA through this accelerated process to bring SonoCloud to patients with recurrent glioblastoma.”
 
“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,” said Frédéric Sottilini, CEO of Carthera. “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.”