Round up: second FDA indication extension for rehabilitation device, and more
Neuro Rehab Times explores the latest business developments in the world of neurorehabilitation
MedRhythms and Edwards Health Care Services enter into agreement
MedRhythms, a neurologic and physical rehabilitation company with the world’s first prescription music platform, has announced a strategic partnership with Edwards Health Care Services (EHCS), a provider of direct-to-home medical products.
The partnership enables nationwide distribution of MedRhythms’ currently available devices, InTandem, for adults with chronic stroke walking impairments and MOVIVE for people with Parkinson’s disease (PD), to patients with Medicare and/or commercial insurance.
“This partnership marks a significant expansion in access to both InTandem and MOVIVE,” said Joel Behnke, CCO of MedRhythms.
“Building on our nationwide coverage for Veterans, people living with chronic stroke and Parkinson’s disease who have Medicare or commercial insurance can now access this life-changing therapy, making it easier for patients to begin their rehabilitation journey from the comfort of home.”
The EHCS distribution partnership builds on MedRhythms’ national reimbursement infrastructure, following recent Center for Medicare and Medicaid Services (CMS) decisions to establish a unique Healthcare Common Procedure Coding System (HCPCS) code (E3200), finalise the CMS payment determination for the code, and confirm the benefit category as durable medical equipment (DME) for gait modulation systems that use rhythmic auditory stimulation (RAS).
This new distribution partnership extends those access pathways to patients with Medicare and/or private insurance, enhancing MedRhythms’ commitment to deliver innovative solutions to underserved patient populations.
“At Edwards Health Care Services, we are committed to improving access to innovative therapies that help people live healthier, more independent lives,” said Matthew Edwards, CEO of EHCS.
“Through this partnership with MedRhythms, we can deliver proven neurorehabilitation solutions directly to patients’ homes, supporting better mobility and quality of life for those managing Stroke Recovery and Parkinson’s disease.”
“Our partnership with EHCS is a consequential milestone in MedRhythms’ growth trajectory,” said Larry Jasinski, CEO of MedRhythms.
“It enhances our ability to scale nationally, strengthens our commercial infrastructure, and advances our mission to improve the lives of people with neurologic diseases.
“With expanded access through commercial insurance, Medicare, and VA coverage, MedRhythms is positioned to drive meaningful clinical impact while building a strong business in a large and growing market.”
Wandercraft gains second FDA indication extension for Atalante X
High-level spinal cord injury and multiple sclerosis patients can now use the world’s first self-balancing exoskeleton to stand, walk and regain upright motion safely, helping to restore upright mobility.
Wandercraft, a company that develops self-balancing exoskeletons and humanoids, announced that the US Food and Drug Administration (FDA) has cleared expanded indications and upgraded features for its flagship rehabilitation device, Atalante X.
The clearance follows expanded CE Mark certification for enhanced clinical features and a wider range of neurologic conditions, such as tetraplegia and tetraparesis.
The extension of indication authorises use in individuals with spinal cord injury (SCI) from levels C4 to L5 and in those with multiple sclerosis (MS), broadening access to upright, hands-free gait therapy.
This advancement in rehabilitation builds upon earlier FDA indications for SCI at levels T5-L5 and for individuals with hemiplegia due to cerebrovascular accidents (CVA).
“This extension of indication for Atalante X marks a significant advance in neurorehabilitation and patient access to technology that enables them to walk again,” said Matthieu Masselin, CEO of Wandercraft.
“It enables therapists to personalise training for complex patients, now going as far as to the joint level, and help even more people with severely limited upper-body strength to experience upright movement safely and confidently – something which many thought was impossible.”
Atalante X is in over 100 rehabilitation and research centers worldwide enabling thousands of patients to take over one million steps per month, with recent deployments in Moody Neurorehabilitation Institute and Rancho Research Institute.
Findings from a multicenter retrospective study of 547 training sessions among patients with high-level spinal cord injury, supported the FDA’s decision, confirming the safe use of Atalante X among this patient population in rehabilitation and suggest potential functional benefits in tetraplegic patients.
“We now have data confirming what we had observed in practice, that Atalante X can be used safely and effectively by people with high-level spinal cord injuries and Multiple Sclerosis,” said Maria Ida Iacono, global chief regulatory, quality and clinical affairs officer of Wandercraft.
“Participants showed encouraging functional improvements, with a solid safety profile and high levels of user satisfaction.”
NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS
NeuroSense Therapeutics, a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, has announced that the FDA has completed the review of the Investigational New Drug (IND) amendment application.
The FDA has now authorised the company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).
With the FDA’s clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.
The global pivotal Phase 3 trial, PARAGON, is powered at over 95 per cent to achieve its primary endpoint and to expand upon the results of NeuroSense’s Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favorable safety and tolerability profile.
“This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS.
“We believe this progress lays a strong foundation for additional achievements across several fronts in the near future,” stated Alon Ben-Noon, CEO of NeuroSense.
“We recognise the significant unmet need of people living with ALS and remain committed to delivering a meaningful therapy through our efforts.”
The prospective, double-blind, 12-month placebo-controlled trial, has an open label extension to evaluate safety and efficacy of PrimeC.
The trial will employ an adaptive design allowing for interim analyses to optimise sample size and assess early efficacy and futility boundaries.
New data highlighting circular RNAs as new class of blood-based biomarkers for Alzheimer’s
New clinical data highlights circular RNAs (circRNAs) as a novel, non-invasive blood biomarker platform for the early detection of Alzheimer’s Disease (AD).
The research demonstrates that circRNAs offer comprehensive insights into the multiple disrupted disease pathways central to AD’s biology and pathology.
Circular Genomics, a neurological and psychiatric precision medicine company, has announced that these new findings from its Alzheimer’s disease (AD) programme will be presented at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference on December 3, 2025, in San Diego, CA.
The data will highlight the company’s proprietary circRNA biomarker platform and its ability to identify AD patients early in the disease process ultimately leading to more timely interventions.
Circular RNAs (circRNAs) are non-coding RNAs that are enriched in the brain and dysregulated in neurodegenerative diseases.
Unlike linear RNA or protein biomarkers, circRNAs are highly stable, and are known to modulate critical AD biologic and pathogenic pathways, including neuroinflammation, oxidative stress, neural plasticity, synaptic dysfunction, and amyloid/tau pathology.
This unique molecular signature strongly supports the platform’s potential for use across the entire spectrum of the disease, from preclinical stages through established dementia.
This breakthrough represents a significant step forward in shifting AD diagnosis from a late-stage reactive assessment to an early stage proactive identification of disease biology and pathology.
Circular Genomics explains that its platform integrates advanced transcriptomics from whole blood to generate advanced models of AD disease risk and progression based on disease-specific circRNA signatures.
