SonoCloud

Low Intensity Contact Ultrasound Implant 

Medical Applications

After the surgical resection of brain tumors, treatments using chemotherapy are typically administered. Unfortunately, most drug molecules barely penetrate into the brain tissue due to the blood-brain barrier (BBB).

The SonoCloud® medical device allows for a temporary disruption of the BBB and thus an increase in the intracerebral bioavailability of chemotherapeutic agents. It can in principle be used for the treatment of primary brain tumors (gliomas, glioblastomas, astrocytomas, …) as well as secondary brain tumors (metastases). The combined annual incidence in Europe and the USA is more than 250,000 patients for these indications.

A phase 1/2a clinical trial has been started to study the transient opening of the BBB with the SonoCloud® before administration of chemotherapy in patients with recurrent glioblastoma. In the long term, the SonoCloud® system can be used for other disorders for which the BBB limits the efficacy of drug therapies (neurodegenerative diseases such as Alzheimer’s).

The SonoCloud® Treatment

The SonoCloud® medical device is implanted in the skull, normally following a surgical resection of the tumor. If the patient cannot be operated on, the SonoCloud® can be implanted in a burr hole performed for a diagnostic biopsy or during a special surgical act under local anesthesia. After implantation, the skin is used to recover the implant. The implant is activated before each chemotherapy session using a transdermal needle that connects the implant to an external generator. The connection to the implant can be performed by a nurse. The ultrasound is emitted directly to the brain tissue, without having to pass the skull, to temporarily open the blood-brain barrier. Finally, even large molecules can be effectively delivered to the brain after disruption of the BBB.

chien BHE 

The figure shows the opening of the blood-brain barrier using the SonoCloud® in an animal model. Note the contrast enhancement in the T1w MR image, which shows the region of BBB disruption. After 6 hours, the BBB integrity is restored.

 

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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.