Scantox Expands CNS Discovery Capabilities with SonoCloud® Blood-Brain Barrier Disruption Technology

Enabling Earlier, Exposure-Driven Decisions

For many CNS programs, uncertainty around brain exposure can delay or derail development—particularly as therapeutic modalities evolve beyond traditional small molecules. Many researchers still rely on imperfect surrogates such as CSF compound levels to assess CNS exposure. Scantox’s integration of SonoCloud® technology allows sponsors to directly evaluate whether limited BBB penetration is constraining efficacy, and to test delivery enhancement strategies within the same study design where pharmacology is assessed.

“CNS discovery goes beyond confirming target engagement—it requires evidence that the molecule reaches the target at therapeutically meaningful levels,” said Lone Bruhn Madsen, CSO Discovery at Scantox. “By combining transient ultrasound-mediated BBB disruption with our broad portfolio of validated CNS models, we enable sponsors to separate delivery risk from target biology risk and make more informed go/no-go decisions earlier in discovery.”

Treatment-Agnostic Approach

SonoCloud® uses low-intensity pulsed ultrasound (LIPU), combined with microbubbles, to transiently and reversibly increase BBB permeability—supporting enhanced delivery of therapeutics to specific brain regions during a controlled window. Critically, this approach is modality-agnostic: it can be applied to small molecules, biologics, gene therapies, or other emerging modalities where BBB penetration may be limiting. Unlike other BBB modulation approaches such as brain shuttles, SonoCloud® requires no compound redesign—allowing sponsors to evaluate existing molecules without reformulation. This means that researchers can strongly increase target engagement for their existing compounds, while building on already generated data, without having to start from scratch.

This flexibility enables sponsors to evaluate delivery hypotheses at an early stage, refine the therapeutic window by increasing drug concentration at the anticipated site of action while strengthening the efficacy-to-tolerability balance, and reduce program risk faster by separating delivery constraints from a genuine lack of pharmacological effect.

Scantox’s Competitive Advantage: Integrated Solution

What sets this partnership apart is Scantox’s ability to combine the SonoCloud® technology with its deep expertise in CNS disease modeling—all within the same, integrated preclinical study.

“We provide an end-to-end solution,” Madsen said. “Sponsors choose Scantox for our validated in vivo models across neurodegenerative diseases—Alzheimer’s, Parkinson’s, ALS, Huntington’s—as well as psychiatric disorders such as depression and anxiety, pain, and rare neurological conditions. Now they can integrate BBB disruption directly into those same studies, address key exposure–response questions, and move forward without relying on multiple vendors or complex handoffs.”

This integrated approach means fewer vendors and faster timelines, translational readouts from day one linking brain exposure directly to pharmacodynamic endpoints, and customized study designs tailored to each therapeutic candidate’s pharmacokinetic profile.

Addressing BBB Challenges Earlier in Development

The SonoCloud® platform brings clinically validated ultrasound technology into the preclinical space, where delivery questions can now be addressed systematically within validated disease models, in a species-independent, translational manner—eliminating the need for specialized tools to address interspecies differences.

“The main challenge in advancing impactful therapeutics in the field of CNS diseases has always been delivery to the brain. Developing effective translational delivery methods that can be tested in disease-relevant models is nearly impossible due to interspecies specificities,” said Pierre de Rossi, PhD, Director of Preclinical Research at Carthera. “This partnership between Carthera and Scantox allows sponsors to access a clinically validated delivery strategy within an extensive CNS model portfolio, filling that gap and enabling them to evaluate delivery strategies within rigorous preclinical studies before entering the clinic.”

Note: SonoCloud® is an investigational device currently in Phase 3 clinical trials and is not yet approved for clinical use outside of clinical trials.

About Scantox

Scantox is an integrated preclinical CRO supporting sponsors from discovery through IND-enabling nonclinical development, with operations in Denmark, Sweden, Austria, and the United Kingdom. We combine Discovery, Regulatory Toxicology, and Pharmaceutical Development & Analytical in one coordinated platform—helping clients generate high-quality, regulator-ready data while keeping timelines and execution aligned across disciplines. Scantox is recognized for deep expertise in CNS pharmacology and Göttingen minipig research, with advanced genetic toxicology capabilities including Big Blue® transgenic rodent and DuplexSeq™ mutagenesis assays. Founded in 1977, Scantox is today owned by Impilo, the leading Nordic healthcare investment company.

About Carthera

Carthera is a clinical-stage medtech company focused on developing innovative ultrasound-based medical devices to treat a wide range of brain disorders. The company is a spin-off from AP-HP Paris and Sorbonne University. Carthera leverages the inventions of Pr. Alexandre Carpentier, head neurosurgeon at AP-HP Sorbonne university, who has achieved worldwide recognition for his innovative developments in treating brain disorders. Carthera is developing SonoCloud®, an intracranial implant that temporarily opens the Blood-Brain Barrier (BBB). The device is currently in clinical trials in Europe and the United States. It received FDA Breakthrough Device Designation in 2022, and FDA/EMA Orphan Drug Designation in 2023 for carboplatin when used with SonoCloud. Founded in 2010 by Pr. Alexandre Carpentier, run by CEO Frederic Sottilini and chaired by Oern Stuge MD, Carthera has offices in France (Lyon and Paris) and a subsidiary in Boston, Massachusetts, USA. 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). www.carthera.eu.

About SonoCloud®

SonoCloud® is an innovative medical device developed by Carthera. It emits ultrasound to temporarily increase the permeability of the blood vessels in the brain to improve the delivery of therapeutic molecules. Invented by Pr. Alexandre Carpentier and 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 prior to injection of a therapeutic agent. 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 disruption of the blood-brain barrier is a world first; it offers a new treatment option for a wide range of indications, including brain tumors and Alzheimer’s disease. SonoCloud is an investigational product, the device has not yet received EMA or FDA approval.