SonoCloud

Low Intensity Contact Ultrasound Implant 

Clinical Developments

A phase 1/2a clinical trial is currently in progress to study the transient opening of the blood-brain barrier (BBB) using the SonoCloud® during chemotherapy administration in patients with recurrent glioblastoma.

This study is a prospective multidisciplinary single-arm mono-center study that is being performed by the departments of Neurosurgery and Neuro-Oncology at the Hospital Pitie Salpetriere. The study sponsor is l’Assistance Publique des Hôpitaux de Paris.

The study addresses patients with gliobastoma that have experienced recurrence after initial standard of care treatments and who are eligible for carboplatin chemotherapy. Patient inclusion is discussed on a case by case basis during multidisciplinary department meetings.

The goal of this Phase 1/2a clinical study is to temporarily disrupt the BBB using low intensity pulsed ultrasound during chemotherapy sessions with carboplatin, with the goal of increasing the concentration of chemotherapeutic agent in the brain tissue. Additional information is available on the site clinicaltrials.gov:

http://clinicaltrials.gov/ct2/show/NCT02253212?term=sonocloudrank=1

 

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  • News CarThera

    25.06.2019
    June 2019: CarThera appoints Pascal E. R. Girin as chairman of board of directors

    Pascal Girin brings wealth of experience in medical device and life sciences industries to support CarThera’s future growth. Girin has decades of business expertise in the life sciences and medical devices markets, most recently as CEO of Balt, a leader in the treatment of neurovascular diseases. Prior to this, he held numerous C-level positions at leading medical companies, including Wright Medical, Keystone Dental (a Warburg Pincus company), EV3, Baxter and Ohmeda, among others. As chairman of CarThera’s board of directors, he will bring invaluable insight to the company’s business strategy and future development.

    25.06.2019
    March 19: CarThera publishes complete results of Phase I/IIa clinical trial using its SonoCloud-1 ultrasound implant

    Final results of the phase I/IIa clinical trial (NCT02253212) on the ultrasound-induced blood-brain barrier (BBB) opening improving the efficiency of carboplatin chemotherapy for recurrent glioblastoma patients were published in AACR’s Clinical Cancer Research journal of the . Study results show a good safety profile and encouraging efficacy. These results are based on 65 sonication sessions with escalating ultrasound pressure levels. GBM patients treated with optimal pressure levels and MRI-detected disrupted BBB (11 patients) showed a median progression-free survival (PFS) of 4.11 months and a median overall survival (OS) of 12.94 months. This compares to 2.73 months and 8.64 months respectively, for GBM patients without BBB disruption (8 patients).

    13.12.2018
    CarThera closes €9M ($10.3M) Series B funding round

    €9M ($10.3M) was raised with three institutional investors, Panakès Partners, Sham Innovation Santé (advised by Turenne Capital) and Supernova Invest via its fund Supernova 2, as well as Group Arnault and historical investors. The proceeds will be used to further advance the SonoCloud technology and develop the clinical pipeline of the company. A multi-center study has already been launched in France and in the US to evaluate the SonoCloud-9 device, a new generation of implant with nine ultrasound emitters, in patients with recurrent glioblastoma. The company also has an on-going clinical study with the SonoCloud-1 device in patients with Alzheimer’s disease and one planned for patients with brain metastases.