NR Times explores the latest business and pharma developments in the world of neurorehabilitation.
Green light to study novel brain injury drug candidate in hemodialysis patients
A groundbreaking clinical study has been approved by Health Canada to evaluate the safety and efficacy of a novel pharmacologic intervention aimed at preventing acute ischemic brain injury in patients undergoing routine hemodialysis.
Pegevongitide (AV-001), a made-in-Canada drug candidate codeveloped by Vasomune Therapeutics and AnGes, will work to stabilise the cerebrovasculature, which undergoes significant circulatory stress during the hemodialysis procedure.
Cerebrovascular destabilisation is linked to vascular cognitive impairment in up to 70 per cent of patients initiating routine hemodialysis.
Hemodialysis patients are uniquely vulnerable to recurrent ischemic brain injury caused by circulatory stress during treatment.
The study will assess whether Pegevongitide (AV-001) can reduce hemodialysis-induced cytotoxic brain edema and preserve white matter integrity.
Advanced neuroimaging techniques, cognitive assessments, and blood biomarkers will be used to evaluate outcomes.
Supported by a prestigious Heart and Stroke Foundation grant, the research has the potential to redefine how brain health is protected in hemodialysis patients.
Positive findings will inform a larger confirmatory trial and could lead to improved quality-of-life and functionality for this high-risk population.
GE HealthCare to acquire icometrix to strengthen neurology portfolio
GE HealthCare has entered into an agreement to acquire icometrix, a company focused on providing AI-powered brain imaging analysis for neurological disorders such as Alzheimer’s disease.
The acquisition aims to meet the growing demand for MRI in personalised treatment planning.
To complement its MR-guided AI-assisted scanning expertise with analysis and reporting in neurological disease assessment, GE HealthCare expects to integrate the icometrix icobrain platform with its MRI systems for seamless workflow.
Icobrain aria includes the first FDA-cleared computer aided detection and diagnosis solution for detecting and quantifying known side effects of amyloid targeting therapies known as Amyloid Related Imaging Abnormalities (ARIA).
GE HealthCare says the planned acquisition of icometrix aligns with its precision care strategy and is expected to strengthen the company’s clinical decision support applications for timely diagnosis and monitoring throughout the neuro treatment pathways by offering enhanced patient access to the technology.
The company’s current neuro solutions portfolio, including MR and PET scanners, pharmaceutical diagnostics and MIMneuro Software digital solutions that support quantification for amyloid imaging, enables it to offer holistic neuro solutions for its customers.
GE HealthCare intends to focus on expanding patient access to the icobrain aria solution on all vendor MRI systems through both commercial distribution and clinical integration.
The consummation of the transaction is subject to customary closing conditions, including regulatory approvals.
Financial details of the transaction have not been disclosed publicly. GE HealthCare intends to fund this transaction with cash on hand.
Regulatory clearance requested for study of ARO-MAPT for Alzheimer’s
Arrowhead Pharmaceuticals has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-MAPT.
ARO-MAPT is the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for tauopathies including Alzheimer’s disease, a progressive neurodegenerative disease characterised by cognitive and functional decline.
ARO-MAPT is Arrowhead’s first investigational RNAi-based therapy to utilise a new proprietary delivery system which, in preclinical studies, has achieved blood-brain-barrier penetration and deep knockdown of target genes across the central nervous system (CNS), including deep brain regions, after subcutaneous injections.
ARO-MAPT is designed to silence CNS expression of the microtubule associated protein tau (MAPT) gene, which encodes the tau protein.
By preventing or potentially reversing tau protein accumulation in subjects with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia, ARO-MAPT has potential to prevent or slow disease progression.
An application for approval to initiate the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials.
Pending clearance, Arrowhead intends to proceed with a Phase 1/2a placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MAPT in up to 64 healthy subjects and up to 48 subjects with early Alzheimer’s disease, defined as mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
Neu Health joins global incubator programme for Parkinson’s and Dementia care
Neu Health – a precision neurology platform for Parkinson’s and dementia – has announced its selection for the Global Incubator Programme (GIP): USA HealthTech – Medical Devices.
The six‑month programme is delivered by Innovate UK in partnership with Texas Medical Center Innovation (TMCi) with support from the Department for Business & Trade (DBT).
The competitive programme supports UK medical device and digital health companies expanding into the US market through access to the world’s largest medical complex in Houston, Texas.
The selection comes on the heels of Neu’s US launch and FDA 510(k) clearance for its smartphone-based measurement tool for resting tremor in Parkinson’s disease.
The clearance covers the first known fully phone-based system, with no wearable or in-clinic hardware, for measuring motor symptoms in Parkinson’s care.
Neu is already piloting its platform at Cedars-Sinai and Mass General Brigham, with additional US market expansions underway.
Neu Health’s platform transforms smartphone-based assessments into actionable clinical insights, helping clinicians detect neurological decline before traditional assessments.
The technology enables continuous monitoring from home while integrating seamlessly into existing clinical workflows, addressing a critical gap as most patients wait six months or longer between neurology appointments.
Through GIP, Neu will leverage TMC Innovation’s ecosystem to connect with clinical leaders, hospital systems, and investor networks within the world’s largest medical complex.
Participants also receive expert mentorship on US regulatory strategy, commercialisation, and market navigation.
The programme’s curated connections to Houston’s 1,760+ life sciences companies and investor networks create multiple pathways for partnerships and growth.
The six-month program runs from September 2025 to March 2026, combining virtual incubation with on-site immersion in Houston.
The Global Incubator Programme has proven successful for UK healthtech companies entering the US market, with previous cohorts securing significant funding, clinical partnerships, and successful market entry.
Grant awarded to advance intranasal Anti-CD3 therapy for spinal cord injury
Biotech company Tiziana Life Sciences has been awarded a research grant by the US Department of Defense (DoD) to advance its lead development candidate – intranasal foralumab, a fully human, anti-CD3 monoclonal antibody for spinal cord injury.
The funding builds on Tiziana’s strategy to expand the therapeutic potential of its intranasal anti-CD3 platform beyond autoimmune and neuroinflammatory diseases into large, underserved neurological indications.
The DoD award will support a three-year study of intranasal anti-CD3 in the acute phase of SCI, aimed at patients who present to the hospital immediately following injury.
Complementing this, a two-year Stepping Strong Breakthrough Award will expand research into the chronic phase, focusing on patients living with persistent neurological deficits.
Researchers in the Immunology of CNS Injury Program at Brigham and Women’s Hospital, a founding member of Mass General Brigham, have previously reported promising pre-clinical results using intranasal anti-CD3 demonstrating benefits in motor outcomes, suggesting potential to improve independence and quality of life.
This non-invasive therapy, delivered through the nose – avoiding surgery or infusions – is designed to rebalance the immune system, reduce microglial-driven inflammation in the injured spinal cord, and support functional recovery.
The same mechanism may be relevant in other acute CNS injuries.
