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Insightec spinout Lotus Neuro launches brain drug delivery platform

Insightec spinout Lotus Neuro launches brain drug delivery platform

Lotus Neuro, a clinical-stage biotechnology company spun out of focused ultrasound specialist Insightec, launched publicly with a platform designed to improve delivery of therapeutics across the blood-brain barrier (BBB).

The Miami-based company, which was separated from Insightec in December 2025, is pursuing a partnership-led model rather than developing its own therapeutic pipeline. Lotus Neuro plans to work with drug developers and academic groups to combine existing investigational therapies with focused ultrasound-mediated BBB opening in brain cancer, neurodegenerative diseases, and other neurologic conditions.

The approach uses low-frequency focused ultrasound alongside circulating microbubbles to temporarily open the BBB in targeted regions of the brain during drug administration. Because the therapeutic itself does not need to be chemically modified, Lotus Neuro said the technology could potentially be paired with modalities including small molecules, antibodies, antibody-drug conjugates, enzymes, gene therapies, oligonucleotides, and cell therapies.

The underlying Insightec technology has already been evaluated clinically in several neurological diseases. Lotus Neuro said it has been used in approximately 600 treatment sessions across brain tumors, Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis, including studies involving four therapeutic classes.

Among the cited studies, a multicenter Phase I/II glioblastoma study published in The Lancet Oncology in 2025 reported median overall survival of 31.3 months among patients who underwent BBB opening alongside standard chemotherapy, compared with 19.3 months in a matched control cohort. The non-randomized comparison limits conclusions about efficacy.

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A separate proof-of-concept study published in The New England Journal of Medicine in 2024 evaluated focused ultrasound alongside aducanumab in three patients with Alzheimer's disease. Amyloid reduction was greater in brain regions exposed to focused ultrasound than in corresponding untreated regions, although the study did not directly quantify antibody penetration. Other clinical studies have evaluated targeted enzyme delivery in Parkinson's disease and antibody delivery in patients with HER2-positive brain metastases.

Lotus Neuro is also funding early clinical work through its Proof of Pharmacology (POP) Challenge, launched in June 2026. The initiative supports investigators adding focused ultrasound arms to existing drug studies to determine whether therapeutics reach their intended brain targets at sufficient concentrations.

Insightec will continue to develop and commercialize the underlying focused ultrasound device platform, while Lotus Neuro focuses on its application for therapeutic delivery. The companies will maintain a scientific collaboration and share translational data. Insightec Chairman and CEO Maurice Ferré also serves on Lotus Neuro's board.

Lotus Neuro's technology remains investigational and has not received US FDA clearance or approval for drug-delivery applications.


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