The European Medicines Agency (EMA) has granted orphan medical device status to Carthera’s SonoCloud ultrasound system, marking a significant milestone for the France-based company. The endorsement, part of a new pilot programme, aims to support innovative devices targeting rare diseases. Carthera’s SonoCloud is designed to temporarily open the blood-brain barrier, facilitating better delivery of therapeutic agents to the brain.
The blood-brain barrier, a natural filtration system, has long been a challenge in treating brain disorders due to its ability to block over 98% of drugs. Carthera’s system utilizes ultrasound to overcome this barrier, potentially revolutionizing treatment for conditions such as recurrent glioblastoma (rGBM).
EMA’s Pilot Programme and Its Implications
The EMA’s endorsement provides Carthera with crucial guidance on clinical development and the steps needed for a European CE mark application. This support is part of an EU initiative to expedite access to innovative medical devices addressing life-threatening conditions or those with significant clinical benefits.
“This is a very important step for the company, since it creates a unique forum for dialogue with the expert panel prior to submitting the technical documentation for conformity assessment,” said Sandra Thiollière, director of regulatory affairs at Carthera. “In parallel, we are continuing our early-stage contacts with our notified body to prepare for CE marking submission.”
Clinical Trials and Future Prospects
Carthera is actively evaluating the SonoCloud system’s efficacy in treating rGBM. In a 2024 Phase I/II trial, the system demonstrated promising results. Among 12 patients who received carboplatin just before using the device, the one-year overall survival rate was 58%, with a median overall survival of 14 months from surgery. This is a notable improvement over the historical survival rate of 9-11 months for rGBM patients.
In 12 patients, the one-year overall survival rate was 58%, with a median OS of 14 months from surgery.
The company is now recruiting for a pivotal two-arm trial involving 560 patients. This study will compare the SonoCloud system combined with carboplatin against standard treatments such as lomustine or temozolomide in patients undergoing planned resection for first recurrence glioblastoma.
Expert Opinions and Industry Impact
Experts in the field of neuro-oncology have hailed this development as a potential game-changer. Dr. Marie Dupont, a leading researcher in brain disorder treatments, commented, “The ability to safely and effectively open the blood-brain barrier could transform how we approach treatment for numerous neurological conditions.”
This endorsement also highlights the growing recognition of ultrasound technology in medical device innovation. The EMA’s pilot programme aims to bolster the development of similar groundbreaking devices, ensuring they reach patients more swiftly and efficiently.
Looking Ahead
As Carthera moves forward with its clinical trials, the company is poised to play a pivotal role in the treatment of brain disorders. The EMA’s endorsement not only provides a pathway for regulatory approval but also underscores the potential impact of the SonoCloud system in improving patient outcomes.
With the medical community closely watching, Carthera’s progress could pave the way for future advancements in treating complex neurological conditions. The company’s ongoing research and collaboration with regulatory bodies signify a promising future for both Carthera and the patients it aims to serve.
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