Michael Barbella, Managing Editor09.01.23
Carthera is €37.5 million ($40 million) richer these days, having completed a Series B financing round led by a prominent (undisclosed) investor. Other support came from the European Innovation Council Fund (EICF) and past investors, including Panakès Partners, Relyens Innovation Santé (Turenne Santé), and Supernova Invest (via its Supernova 2 fund).
Carthera intends to use the proceeds to launch the first pivotal multicenter trial with its SonoCloud technology. The funds will also enable the company to continue developing its clinical product pipeline and technology.
“We are delighted with the outcome of our Series B funding round. The company is now in a strong position to launch an ambitious phase 3 trial and pursue the evaluation of its SonoCloud technology in multiple clinical indications,” Carthera CEO Frédéric Sottilini said. “In the next few years we are aiming at first market approval for our SonoCloud-9 device for the treatment of recurrent glioblastoma and we are eager to pursue the development of our proprietary platform technology in other brain diseases with significant unmet needs.”
Carthera is submitting its registration trial in recurrent glioblastoma (GBM) to the U.S. Food and Drug Administration (FDA) and EU competent authorities. The study will be an international, multicenter, two-arm clinical trial randomized with a one-to-one ratio. The open-label, comparative pivotal trial will evaluate the clinical benefit (overall survival0 of the SonoCloud-9 system when used to open the Blood Brain Barrier (BBB) after carboplatin chemotherapy administration. The SonoCloud-9 treatment will be compared to the standard of care (lomustine and temozolomide) in patients with first recurrence of GBM.
In parallel, the company will continue developing its SonoCloud technology platform in brain oncology and neurodegenerative indications.
“Having treated more than 100 patients in Europe and the U.S. with the SonoCloud system, with almost 500 treatment procedures performed, for Carthera to be able to continue exploring the benefit of opening the BBB by ultrasound with the financial support of renowned investment funds is a great achievement. Together with Professors Roger Stupp, Ahmed Idbaih and Adam Sonabend, we are very positive about the upcoming clinical trials. We firmly believe that the SonoCloud system can improve treatment options for patients,” said Professor Alexandre Carpentier, Carthera founder, SonoCloud inventor, and head of the neurosurgery department at AP-HP Sorbonne University.
Carthera’s SonoCloud is an implantable ultrasound device that temporarily opens the BBB on demand. Its feasibility and safety profile has been proven with multiple therapeutic agents in repeated sonication procedures. A publication by Northwestern researchers (Chicago) in Lancet Oncology demonstrated the ability of SonoCloud-9 to substantially increase the penetration of therapeutic molecules in the brain. Another publication, currently under review, will present the potential increase in survival due to better chemotherapeutic efficacy in the treatment of brain tumor patients, when used concomitantly with BBB opening with the SonoCloud.
“We are pleased to continue supporting Carthera in its next step towards its first pivotal trial in recurrent glioblastoma, since the initial results have been very positive in this indication,” said Diana Saraceni, founder and managing partner at Panakès. “We also believe its ultrasound-based platform technology has the potential to address many of the most challenging therapeutic indications in the neurodegenerative field. We are very proud to be part of this journey.”
SonoCloud emits ultrasound to temporarily increase the permeability of the blood vessels in the brain to improve the delivery of therapeutic molecules. Developed in collaboration with the Laboratory of Therapeutic Applications of Ultrasound (Laboratoire Thérapie et Applications Ultrasonores, LabTAU, INSERM) in Lyon, France, SonoCloud is an implant inserted into the skull and activated before a therapeutic agent is injected. Several minutes of low-intensity ultrasound opens the blood brain barrier for six hours and increases the concentration of therapeutic molecules in the brain. This ultrasound-induced opening of the blood-brain barrier is a world first; it offers a new treatment option for a various indications, including brain tumors and Alzheimer’s disease.
The safety of the investigational use of the SonoCloud has not yet been determined, the device has not yet received EMA or FDA approval.
Carthera is a clinical-stage medtech company developing ultrasound-based medical devices to treat numerous brain disorders. The company is a spin-off from AP-HP Paris and Sorbonne University. Founded in 2010, Carthera has offices in France (Lyon and Paris) and a subsidiary in the United States. Since its inception, the technical and clinical development of SonoCloud has received support from the National Research Agency (ANR), the French public investment bank (Bpifrance), the National Institutes of Health (NIH) and the European Innovation Council (EIC).
Carthera intends to use the proceeds to launch the first pivotal multicenter trial with its SonoCloud technology. The funds will also enable the company to continue developing its clinical product pipeline and technology.
“We are delighted with the outcome of our Series B funding round. The company is now in a strong position to launch an ambitious phase 3 trial and pursue the evaluation of its SonoCloud technology in multiple clinical indications,” Carthera CEO Frédéric Sottilini said. “In the next few years we are aiming at first market approval for our SonoCloud-9 device for the treatment of recurrent glioblastoma and we are eager to pursue the development of our proprietary platform technology in other brain diseases with significant unmet needs.”
Carthera is submitting its registration trial in recurrent glioblastoma (GBM) to the U.S. Food and Drug Administration (FDA) and EU competent authorities. The study will be an international, multicenter, two-arm clinical trial randomized with a one-to-one ratio. The open-label, comparative pivotal trial will evaluate the clinical benefit (overall survival0 of the SonoCloud-9 system when used to open the Blood Brain Barrier (BBB) after carboplatin chemotherapy administration. The SonoCloud-9 treatment will be compared to the standard of care (lomustine and temozolomide) in patients with first recurrence of GBM.
In parallel, the company will continue developing its SonoCloud technology platform in brain oncology and neurodegenerative indications.
“Having treated more than 100 patients in Europe and the U.S. with the SonoCloud system, with almost 500 treatment procedures performed, for Carthera to be able to continue exploring the benefit of opening the BBB by ultrasound with the financial support of renowned investment funds is a great achievement. Together with Professors Roger Stupp, Ahmed Idbaih and Adam Sonabend, we are very positive about the upcoming clinical trials. We firmly believe that the SonoCloud system can improve treatment options for patients,” said Professor Alexandre Carpentier, Carthera founder, SonoCloud inventor, and head of the neurosurgery department at AP-HP Sorbonne University.
Carthera’s SonoCloud is an implantable ultrasound device that temporarily opens the BBB on demand. Its feasibility and safety profile has been proven with multiple therapeutic agents in repeated sonication procedures. A publication by Northwestern researchers (Chicago) in Lancet Oncology demonstrated the ability of SonoCloud-9 to substantially increase the penetration of therapeutic molecules in the brain. Another publication, currently under review, will present the potential increase in survival due to better chemotherapeutic efficacy in the treatment of brain tumor patients, when used concomitantly with BBB opening with the SonoCloud.
“We are pleased to continue supporting Carthera in its next step towards its first pivotal trial in recurrent glioblastoma, since the initial results have been very positive in this indication,” said Diana Saraceni, founder and managing partner at Panakès. “We also believe its ultrasound-based platform technology has the potential to address many of the most challenging therapeutic indications in the neurodegenerative field. We are very proud to be part of this journey.”
SonoCloud emits ultrasound to temporarily increase the permeability of the blood vessels in the brain to improve the delivery of therapeutic molecules. Developed in collaboration with the Laboratory of Therapeutic Applications of Ultrasound (Laboratoire Thérapie et Applications Ultrasonores, LabTAU, INSERM) in Lyon, France, SonoCloud is an implant inserted into the skull and activated before a therapeutic agent is injected. Several minutes of low-intensity ultrasound opens the blood brain barrier for six hours and increases the concentration of therapeutic molecules in the brain. This ultrasound-induced opening of the blood-brain barrier is a world first; it offers a new treatment option for a various indications, including brain tumors and Alzheimer’s disease.
The safety of the investigational use of the SonoCloud has not yet been determined, the device has not yet received EMA or FDA approval.
Carthera is a clinical-stage medtech company developing ultrasound-based medical devices to treat numerous brain disorders. The company is a spin-off from AP-HP Paris and Sorbonne University. Founded in 2010, Carthera has offices in France (Lyon and Paris) and a subsidiary in the United States. Since its inception, the technical and clinical development of SonoCloud has received support from the National Research Agency (ANR), the French public investment bank (Bpifrance), the National Institutes of Health (NIH) and the European Innovation Council (EIC).