价格

CARTHERA

INST. DU CERVEAU IPEPS THE HEALTHTECH, Paris 13, Île-de-France, 法国

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试验阶段分布

阶段

试验数

占比

1 期

50.0%

3 期

50.0%

试验状态分布

已完成

25.0%

尚未招募

25.0%

招募中

50.0%

药物批准

暂无批准数据

资讯

Carthera's SonoCloud System Receives EMA Orphan Medical Device Endorsement for Brain Tumor Treatment

- Carthera has received EMA expert panel endorsement for Orphan Medical Device status of its SonoCloud ultrasound system, making it one of the first companies to benefit from this new EU pilot program. - The SonoCloud system temporarily opens the blood-brain barrier to enhance drug delivery to brain tumors, with Phase I/II trial data showing 58% one-year survival rate in recurrent glioblastoma patients. - The company is now preparing for CE marking submission and recruiting patients for a pivotal 560-patient trial comparing SonoCloud plus carboplatin versus standard care in recurrent glioblastoma.

Jul 1, 2025

Carthera Enrolls 100 Patients in Landmark SONOBIRD Trial Using Ultrasound to Breach Blood-Brain Barrier in Glioblastoma

- Carthera has reached a significant milestone in its SONOBIRD pivotal trial, enrolling 100 patients with recurrent glioblastoma across 40 sites in Europe and the US. - The groundbreaking study evaluates SonoCloud, an implantable ultrasound device that temporarily opens the blood-brain barrier to enhance carboplatin delivery, compared to standard therapies. - With FDA Breakthrough Device and Orphan Drug designations, the trial aims to enroll 560 patients by 2026, potentially transforming treatment options for this aggressive brain cancer.

Apr 22, 2025

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CARTHERA

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该机构主办的试验（4）

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma - SONOBIRD

Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9

A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

药物批准

资讯

Carthera's SonoCloud System Receives EMA Orphan Medical Device Endorsement for Brain Tumor Treatment

Carthera Enrolls 100 Patients in Landmark SONOBIRD Trial Using Ultrasound to Breach Blood-Brain Barrier in Glioblastoma