Today’s NeuroPulse tracks critical momentum across neurology, neurotechnology, and CNS drug development, with regulatory clearances, late-stage clinical readouts, and platform expansions reshaping near-term treatment and access dynamics. From FDA progress in epilepsy neuromodulation and adaptive sleep apnea devices to Phase 2 and Phase 3 data in Alzheimer’s disease, social anxiety, and pediatric brain cancer, today’s updates underscore a sector increasingly focused on precision delivery, durable functional outcomes, and scalable deployment across global markets, including India and Europe.
Insightec Spins Out Lotus Neuro to Advance Focused Ultrasound Therapies
Pulse:
• Insightec launched Lotus Neuro as a clinical-stage biotech focused on brain-targeted therapeutics
• Company will pair low-frequency focused ultrasound with drugs to improve BBB delivery
• Initial programs target glioblastoma and diffuse midline glioma, with neurodegeneration to follow
• Lotus Neuro is backed by Nexus NeuroTech Ventures funding
MODAG Secures Michael J. Fox Foundation Grant for Parkinson’s Imaging
Pulse:
• MODAG received a $1M research grant from The Michael J. Fox Foundation
• Funding supports the development of PET tracers targeting aggregated alpha-synuclein
• Technology aims to enable earlier Parkinson’s diagnosis and improved trial design
• Program builds on early human PET imaging data in Parkinson’s and MSA
SleepRes Receives FDA Clearance for Kricket™ Adaptive PAP Device
Pulse:
• SleepRes secured FDA 510(k) clearance for its Kricket™ Positive Airway Pressure (PAP) device for obstructive sleep apnea
• The system uses proprietary KPAP™ technology to dynamically adapt pressure throughout the breathing cycle, unlike fixed-pressure CPAP
• Device is indicated for home, hospital, and sleep-center use in patients weighing >66 lbs
• Commercial launch is planned for H1 2026 as the company scales manufacturing and clinical partnerships
NeuroPace Files PMA Supplement to Expand RNS® System Into Generalized Epilepsy
Pulse:
• NeuroPace filed a PMA supplement with the FDA seeking label expansion of its RNS® System into drug-resistant idiopathic generalized epilepsy
• Submission is supported by NAUTILUS trial data showing a 77% median reduction in generalized tonic-clonic seizures at 18 months
• Program holds FDA Breakthrough Device designation, reflecting high unmet need
• Review is expected to follow standard PMA-S timelines, with further data readouts pending
Hyperfine Wins India Approval for Swoop® Portable MRI
Pulse:
• Hyperfine received CDSCO approval to commercialize its Swoop® portable MRI system across India
• Approval opens one of the world’s largest and most underpenetrated neuroimaging markets
• Low infrastructure requirements support deployment in community and remote care settings
• Commercial rollout is planned for early 2026 via local distribution partners
Vistagen Reports Topline Phase 3 PALISADE-3 Data in Social Anxiety Disorder
Pulse:
• Vistagen reported topline results from the PALISADE-3 Phase 3 public speaking challenge study of intranasal fasedienol
• Trial failed to meet the primary endpoint of anxiety reduction versus placebo on SUDS, with no separation on secondary endpoints
• Safety and tolerability remained favorable and consistent with prior studies
• Company plans FDA engagement while implementing cost controls to extend cash runway into 2027
Tiziana Doses First Patient in Phase 2 Alzheimer’s Trial of Foralumab
Pulse:
• Tiziana dosed the first patient in a randomized Phase 2 trial of intranasal foralumab in early Alzheimer’s disease
• Study evaluates foralumab as monotherapy and in combination with approved anti-amyloid therapies
• Program is supported by TSPO-PET evidence of persistent neuroinflammation despite amyloid clearance
• Interim data are expected in 2026 to guide next-stage development
Moleculin Reports Positive Phase 1 Data for WP1066 in Pediatric Brain Tumors
Pulse:
• Moleculin reported positive results from a physician-sponsored Phase 1 trial of WP1066 in children with recurrent malignant brain tumors
• Treatment was well tolerated, with no significant toxicity observed
• Data showed immune activation and early anti-tumor responses, including a partial response in a DIPG patient
• Results support progression toward a Phase 2 clinical trial
Yesterday’s NeuroPulse
Yesterday, NeuroPulse captured a neurology landscape advancing across rare pediatric disease regulation, progressive multiple sclerosis clinical setbacks, epilepsy drug financing, augmented-reality–guided neurosurgery, and the expanding commercial footprint of psychiatric therapies in Asia. Collectively, the updates reflected a field balancing heightened regulatory scrutiny with accelerating innovation, particularly in rare disorders, surgical precision, and care infrastructure designed to shorten the path from diagnosis to treatment.
