PathMaker Neurosystems Receives FDA Breakthrough Device Designation for MyoRegulator® ALS Treatment
核心洞察
PathMaker Neurosystems (搜索) received FDA Breakthrough Device Designation for its MyoRegulator (搜索)® device, a non-invasive neuromodulation treatment designed to slow functional symptom progression in ALS (搜索) patients.
The device uses proprietary multi-site direct current stimulation technology to suppress motor neuron hyperexcitability and activate protein degradation pathways in ALS (搜索) patients.
The MyoRegulator (搜索)® is currently being evaluated in the CALM clinical trial, funded by the U.S. Department of War ALSRP program.
PathMaker Neurosystems (搜索) Inc., a clinical-stage neurotechnology company, announced on December 17, 2025, that it has received FDA Breakthrough Device Designation for its MyoRegulator (搜索)® device as a non-invasive neuromodulatory intervention for slowing the progression of functional symptoms in people with amyotrophic lateral sclerosis (搜索) (ALS (搜索)).
The FDA Breakthrough Device Designation accelerates the development, assessment, and review of medical devices that may provide effective treatment alternatives for life-threatening or debilitating diseases. Companies selected for this designation receive prioritized review and expedited opportunities to interact with FDA experts throughout the review period.
Novel Neuromodulation Technology
The MyoRegulator (搜索)® device employs PathMaker's proprietary multi-site direct current stimulation (Multi-Site DCS) technology to provide non-invasive treatment designed to suppress motor neuron hyperexcitability and activate protein degradation pathways. This approach directly targets key hallmarks of the ALS (搜索) disease process, which include motor neuron hyperexcitability and the formation of protein aggregates in the cytoplasm of motor neurons (搜索).
"We are very pleased and honored to see Breakthrough Device Designation on the MyoRegulator (搜索)® device for ALS (搜索). This designation further validates our pioneering approach to ALS, as well as the tremendous unmet medical needs of people and families living with ALS," said Nader Yaghoubi, M.D., Ph.D., Co-Founder and Chief Executive Officer of PathMaker Neurosystems (搜索). "The Breakthrough Device Designation represents a significant de-risking and accelerates our path to market for this treatment."
Current Clinical Development
The MyoRegulator (搜索)® device is currently under investigation in its second clinical trial, the CALM (Controlling Amyotrophic Lateral Sclerosis (搜索) Motor Neuron Excitability) study (NCT06649955). This state-of-the-art trial is funded by the U.S. Department of War ALSRP program and represents an important step forward in advancing this novel therapeutic modality into clinical practice.
Addressing Critical Medical Need
ALS (搜索) is a progressive neurodegenerative disease that affects motor neurons (搜索) in the spinal cord and brain, causing muscle weakness, paralysis, spasticity and eventual death, typically within 2-5 years of diagnosis. The majority of cases (90-95%) are sporadic and occur in patients without known familial history of ALS, while the remaining 5-10% of cases are familial.
More than 34,000 people in the U.S. and 350,000 people worldwide are estimated to suffer from ALS (搜索). PathMaker is collaborating with world-class institutions to develop and bring to market first-in-class products for treating ALS and other neurological disorders with very high unmet medical need.
The MyoRegulator (搜索)® and MyoRegulator® ALS (搜索) are investigational medical devices and are limited by Federal law to investigational use only.