In this edition of Synopulse’s NeuroPulse, the neurology ecosystem reflects accelerating regulatory actions, payer recalibrations, clinical trial milestones, and medtech breakthroughs that collectively signal a rapidly evolving treatment landscape. From major CMS reimbursement stability decisions reshaping access for neuromodulation therapies to pivotal trial clearances in ALS and SMA, the field is moving toward broader innovation, precision medicine, and earlier intervention.
Payers & Market Access – Reimbursement Stability Strengthens Therapy Uptake
CMS preserves 2026 reimbursement framework for SAINT neuromodulation
CMS finalized the 2026 OPPS rule maintaining reimbursement continuity for the SAINT neuromodulation therapy, ensuring stable access for Medicare patients with major depressive disorder. The decision follows strong support from providers and advocates, reinforcing SAINT’s adoption momentum.
Medicare boosts reimbursement for RNS System implants and replacements
CMS significantly increased physician fees for RNS implantation and replacement up 43% and 45% respectively, while also reassigning replacement procedures to the highest-paying neurostimulator APC in OPPS 2026. The shift is expected to expand neurosurgeon adoption and bolster procedural volume growth.
C2N Diagnostics secures NY State CLEP permit for PrecivityAD blood tests
New York State approved C2N’s PrecivityAD and PrecivityAD2 Alzheimer’s blood tests, enabling nationwide availability and strengthening diagnostic readiness for disease-modifying therapies. The tests demonstrate >90% accuracy in primary care and reinforce early diagnostic pathways.
NICE endorses Nanox.AI bone-health algorithms for Early Value Assessment
NICE recommended HealthOST and HealthVCF for NHS evaluation to improve early detection of vertebral fragility fractures. The inclusion positions AI-enabled opportunistic imaging as a scalable, cost-effective solution for osteoporosis risk identification.
Clinical – Key Trial Readouts, Setbacks, and Transformational First-in-Human Data
First UK multiple sclerosis patient receives CAR-T cell therapy in UCLH trial
UCLH treated the first MS patient with obese-cel (obe-cel), a next-generation CAR-T therapy designed to deplete B cells and reset autoimmune activity. The Phase 1 AUTO1-MS1 trial aims to determine feasibility, long-term remission potential, and safety in refractory MS.
FDA clears pivotal Phase 3 PARAGON trial for PrimeC in ALS
The FDA authorized NeuroSense to initiate its global Phase 3 ALS study following encouraging Phase 2b results showing biomarker and clinical improvements. The trial will enroll 300 patients and includes adaptive interim analyses to optimize sample size and assess early signals.
ANVISA authorizes first-in-human trial for next-generation SMA1 gene therapy
Brazil approved GEMMABio’s GB221 clinical trial, a CSF-delivered AAVhu68 therapy engineered to reduce toxicity and improve motor neuron transduction. With strong preclinical survival data and reduced off-target exposure, Brazil will serve as the first hub for dosing in coming months.
Novo Nordisk’s Phase 3 semaglutide trials in early Alzheimer’s miss primary endpoints
Although Evoke/Evoke+ did not meet primary outcomes, the trials showed biomarker improvements that may justify semaglutide’s future use in combination therapy strategies. ADDF underscored the importance of targeting diverse disease pathways beyond amyloid.
Discovery & Preclinical: Pipeline Innovation and Mechanistic Advancements
Harmony Biosciences reports positive bioequivalence for pitolisant GR formulation
Harmony confirmed bioequivalence between its new GR formulation and WAKIX, supporting an NDA submission in early 2026 with potential exclusivity through 2044. The formulation enables therapeutic-dose initiation without titration, improving patient experience.
MedTech: Breakthrough Platforms Redefining Imaging, Neuromodulation & Sleep Analysis
GE HealthCare files FDA 510(k) for Photonova Spectra photon-counting CT system
Built on proprietary Deep Silicon detectors, Photonova Spectra aims to deliver ultra-high-definition spectral CT imaging with improved tissue differentiation and workflow simplification. The system targets neurology, oncology, cardiac and musculoskeletal applications.
ONWARD Medical expands ARC-EX adoption and secures major regulatory milestones
ONWARD sold 40 ARC-EX systems and gained FDA clearance for home-use, while also receiving CE Mark approval in Europe. The company is preparing to launch the Empower BP pivotal study for its implantable ARC-IM platform addressing SCI-related blood pressure instability.
HoneyNaps’ FDA-cleared SOMNUM AI accelerates sleep-focused clinical trials
SOMNUM ,an AI-based PSG scoring cuts analysis time from hours to minutes, reducing trial timelines by ~50% for sleep and neurology programs. Global CRO partnerships and explainable-AI validation are enhancing its adoption in drug and device studies.
Nanox unveils NICE-supported AI imaging for early vertebral fracture detection
Nanox.AI’s HealthOST and HealthVCF algorithms were selected for NHS evaluation to improve fracture detection from routine imaging, supporting preventive osteoporosis care at population scale.
Deals, Grants & Financing – Capital Expansions Fuel Next-Wave Platforms
MindImmune raises $30M Series A to advance inflammation-targeting Alzheimer’s therapy
The company extended its Series A to $30M and appointed Isaac Stoner as CEO, advancing MITI-101 toward Phase 1 trials. The antibody blocks peripheral immune-cell infiltration into the brain, aiming to shift Alzheimer’s treatment toward upstream neuroinflammation control.
Cordance Medical secures oversubscribed $8M seed round for BBB-opening ultrasound platform
The financing supports first-in-human trials of Cordance’s noninvasive focused ultrasound system engineered to open the blood–brain barrier without imaging or head fixation. The platform holds FDA Breakthrough Device status, with strong investor and NIH backing
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