Carthera announced today that its Sonocloud-9 system has been listed as a Breakthrough Device by the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA).
The Sonocloud device uses low-intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB) and allow higher brain exposure to therapeutic compounds. By using Sonocloud, the therapeutic efficacy of new and existing therapies can be unlocked and harnessed to improve the treatment of a wide range of brain diseases, such as glioblastoma, as per a Carthera press release.
“There is a significant unmet need for new treatments for glioblastoma patients, who have very few available therapeutic options,” said Michael Canney, chief scientific officer at Carthera. “We are excited that the FDA has acknowledged the innovative potential of the Sonocloud approach through the granting of this breakthrough designation.”
The Breakthrough Device designation, intended to expedite the development and review of the medical device, was based on preliminary phase 1/2a clinical data that indicate “substantial improvement” over available second-line therapy (publication under preparation), the release adds.
“The FDA Breakthrough Device designation will help Carthera to efficiently advance to a pivotal trial and premarket approval,” 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.”
This designation will give Carthera access to priority review; more intensive FDA interaction to build an efficient device development programme; and commitment from experts and senior managers from the FDA, who will assist the company in addressing any potential challenges 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,” 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.”