Pathmaker wins 3 new patents for neuromodulation technology in ALS
Patents add to the 40+ global patents already protecting Pathmaker technology
Pathmaker Neurosystems has received three new patents — two in the U.S. and one in Japan — that cover the use of its noninvasive neuromodulation technology in people with amyotrophic lateral sclerosis (ALS).
The patents, which specifically cover the systems and methods used for treating ALS and related diseases, add to the more than 40 global patents already protecting the company’s proprietary technology. This technology is incorporated into the company’s MyoRegulator, a noninvasive nerve-modulating device being investigated in clinical trials of ALS.
“We are gratified to see these latest patent issuances,” Nader Yaghoubi, MD, PhD, cofounder and CEO of Pathmaker, said in a company press release. “We have been pioneering the application of neuromodulation to ALS, and these issuances bring additional validation and protection for our novel approach.”
ALS is caused by the progressive damage and death of motor neurons, the nerve cells that control movement, leading to disease symptoms such as muscle weakness and problems with moving, swallowing, and breathing.
The exact mechanisms that drive nerve cell damage in ALS aren’t fully understood, but hyperexcitability, where nerve cells fire electrical signals more often than they should, is thought to play a role. This excess activation and abnormal firing puts a strain on nerve cells and eventually drives damage and nerve cell loss.
How does the MyoRegulator work on ALS?
Pathmaker’s MyoRegulator is designed to ease hyperexcitability. The device delivers a gentle electrical current to specific areas of the spinal cord and peripheral nerves, that is, the nerve cells outside the brain and spinal cord, to modulate nerve signals in spinal motor neurons.
The electrical signals, which are delivered through electrodes placed along the arms and spinal column, can also activate cellular mechanisms important for protein degradation. The accumulation and aggregation of abnormal proteins are hallmark features of ALS that significantly contribute to nerve cell damage. By reducing hyperexcitability and boosting the degradation of faulty proteins in motor neurons, the device should preserve motor neuron health and slow ALS progression.
MyoRegulator has been tested in ALS patients as part of a Phase 1 clinical trial (NCT06165172). The participants were treated with the device three times a week for about six weeks, with a week of rest in between, and were then followed for 10 weeks. The goal was to determine if the device is safe and well tolerated, and to assess for preliminary signs of efficacy. The trial has been completed, but the results haven’t been announced yet.
The company has also launched a second trial called CALM (NCT06649955) to further investigate MyoRegulator in about 15 adults with ALS. Funded by the U.S. Department of Defense, the trial involves treatment three times a week for four weeks, followed by a six-month follow-up.
The aim is to gather additional data on the device’s safety and feasibility, which will be determined by the number of patients who can complete all treatment sessions at the defined stimulation levels. Secondary endpoints include changes in functional disability, quality of life, muscle strength, lung function, and excitability.
MyoRegulator has been designated a breakthrough medical device by the U.S. Food and Drug Administration (FDA). This status is given to devices that are expected to improve the diagnosis or treatment of life-threatening or debilitating conditions. It’s intended to speed up the development and review of medical devices by providing more frequent meetings with the FDA along with certain other incentives.
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