With new clinical trial results published and a follow-up study now underway, CarThera is making strides in treating patients with serious brain tumors. We interviewed their Scientific Director, Michael Canney, PhD, to learn more about this dynamic company.

cartheraHow was CarThera started?
CarThera was founded in 2010 by Professor Alexandre Carpentier. Initially, the company was started with a grant from the French government to develop an interstitial ultrasound device for thermal ablation of brain tumors. The project was a collaboration between Pr. Carpentier and LabTAU, a French laboratory specializing in therapeutic ultrasound and led by Jean-Yves Chapelon and Cyril Lafon (INSERM, Lyon, France). Shortly after this project was started, the company also began developing the SonoCloud, an intracranial implant emitting low intensity pulsed ultrasound (LIPU) that temporarily opens the blood-brain barrier (BBB).

How did you get involved with CarThera?
I started working with CarThera in 2010 while completing a postdoctoral fellowship at LabTau/INSERM in Lyon. I actively participated in all of the development phases of the SonoCloud device.

Tell us about CarThera’s company structure: ownership, lead executives, and their roles.
The company was started with funding from the French government in 2010, and after, obtained several rounds of funding from angel investors as well as additional grants from the French government. CarThera recently secured $10.3 million in Series B funding to launch a multi-center clinical trial in France and the United States in patients with recurrent glioblastoma (GBM) to test the SonoCloud-9 device.

The management team is made up of experienced medtech and biotech specialists with a strong track record in product and clinical development. Frederic Sottilini is the CEO. He held various management positions over the past 20 years at the international level and has built solid experience in launching new medical technologies. François Lacoste, the Chief Technology Officer, has more than 25 years of experience in developing and bringing to market innovative ultrasound-based medical devices. Carole Desseaux, the Chief Clinical Officer, held management roles in the pharmaceutical and biotech industry including Operations, Clinical Development, and Clinical Affairs.

In general, what is the current status of CarThera?
CarThera has just closed a successful round of venture capital funding from several European VCs and is beginning a new clinical trial in GBM patients with the SonoCloud-9 implantable ultrasound device to evaluate the effect of enlarged opening of the BBB prior to administration of chemotherapy.
How many years has SonoCloud been in development, and what are its origins?

The initial concept for the SonoCloud device was born out of an idea that Pr. Alexandre Carpentier had while attending the International Society for Therapeutic Ultrasound (ISTU) conference in Aix-en-Provence in 2009.

What are some of the technical challenges your group has had to overcome to develop a fully noninvasive system?
The GBM patients who receive the device typically undergo surgery to remove the brain tumor. Our device is placed at the end of this surgery, in lieu of a bone flap. By implanting the device, the acoustic field is repeatable on demand and very well known. In addition, the activation of the device to disrupt the BBB is very fast (less than 10 minutes for each procedure), and it does not require an MRI, which makes it easy for medical centers to use and adopt. In addition, there will be no large capital outlays for medical centers or other infrastructure to develop.

What challenges do you have to tackle moving forward?
Developing a new medical device concept has regulatory challenges that must be overcome. CarThera has been working closely with the US Food and Drug Administration (FDA) and European regulatory agencies on a path for approval so that this new technology can become available for patients.

Tell us about your clinical studies and the results.
CarThera has completed an initial safety and feasibility study using the SonoCloud-1 and SonoCloud-3 devices in 25 patients with glioblastoma (NCT02253212). In that study, BBB disruption was performed monthly prior to administration of carboplatin chemotherapy. The study was performed in collaboration with Hôpital Pitié-Salpêtrière in Paris, France. SonoCloud-1 results were published in Science Translational Medicine (Carpentier et al. 2016) and Clinical Cancer Research (Idbaih et al. 2019).

CarThera is now beginning a new clinical trial using an enlarged version of the device (SonoCloud-9) in patients with GBM (NCT03744026). This study will take place at clinical sites in France and the United States.

CarThera is also exploring the use of this technology in patients with Alzheimer’s disease and brain metastases.

What are the benefits of your technology over other companies?
Our technology allows for broad disruption of the BBB over a large volume and may be advantageous for diseases like GBM, which are widespread and diffuse in the brain. The monthly treatment to disrupt the BBB using our device is very simple and can be performed on awake patients in a 10 minute procedure without MRI monitoring.

Have you learned any lessons from observing the experiences of other companies?
We have learned the importance of the regulatory process in the development of new medical devices and the challenges in bringing a new technology like the SonoCloud to patients.

Do you partner with other companies?
Yes, CarThera is actively looking for partnerships with other companies, particularly pharmaceutical companies that want to pair their drug with the SonoCloud device to enhance its penetration into the brain.

Is your system approved for commercial use in any markets? If so, how is it being used in these markets?
Our device is not approved for commercial use in any markets. It is currently being evaluated in clinical trials in France, and we plan to also begin clinical studies in the US this year.

Which health conditions or diseases will your technology be used for?
Glioblastoma, Brain Metastases, Alzheimer’s disease, and other neurodegenerative diseases.

Is there anything else we should know about CarThera?
CarThera has just opened a US subsidiary and is excited to begin clinical trials and develop additional partnerships in the US.

Carthera 10treatments smThis image shows the monthly tumor evolution in a patient treated by the SonoCloud-1. This patient received 10 monthly treatments to disrupt the BBB prior to carboplatin chemotherapy. The hyperintense region shown in the contrast-enhanced tumor on a T1w MRI shows the tumor decreasing within the acoustic field of the SonoCloud-1 device (additional details in Idbaih et al. 2019, Clinical Cancer Research.)


Past Coverage
Progress in Focused Ultrasound for Glioblastomas January 2019
CarThera Closes Successful Funding Round December 2018
Therapeutic Ultrasound Course (MOOC) Now Available Online September 2018
Meeting Report: ASCO 2017 June 2017
New Center of Excellence Focuses on Collaborations and Education February 2017
CarThera Secures €5.7 Million in Funding October 2016
Research Roundup July 2016
CarThera SonoCloud Safely Allows Chemotherapy to Reach Glioblastomas June 2016
CarThera Opens the Blood-Brain Barrier with Ultrasound November 2014

 

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