Market Overview

PathMaker Neurosystems Announces Initiation of Landmark European Clinical Trial Evaluating MyoRegulator™ for Non-Invasive Treatment of Spasticity


Neurosystems Inc
., a clinical-stage bioelectronic medicine
company developing breakthrough non-invasive systems for the treatment
of neuromotor disorders, announced that it has initiated and
successfully enrolled the first patient in its European clinical trial
to evaluate MyoRegulator™
for the non-invasive treatment of spasticity secondary to stroke. The
clinical trial is being conducted by France's prestigious Brain
and Spine Institute
(Institut du Cerveau et de la Moelle
Epinière – ICM) at the Pitié-Salpêtrière
in Paris, and is being sponsored by INSERM
(Institut National de la Santeì Et de la Recherche Meìdicale), France's
public institute for science and technology which operates under the
joint authority of the French Ministries of Health and Research.

MyoRegulator™ is an investigational, first-in-class, non-invasive
neuromodulation device based on PathMaker's proprietary DoubleStim™
technology, which provides simultaneous non-invasive stimulation at
spinal and peripheral sites. MyoRegulator is the first neuromodulation
device intended for the treatment of patients suffering from spasticity,
a muscle control disorder characterized by tight or stiff muscles and an
inability to control those muscles. MyoRegulator was one of the first
"breakthrough" medical devices selected for the U.S.
Food and Drug Administration's
(U.S. FDA) Expedited
Access Pathway (EAP) program
and is now in IRB-approved human
clinical trials in the U.S. and in Europe. The landmark trial is
designed as a monocentric, randomized, double-blinded, sham-controlled
study that will evaluate the performance and safety of the MyoRegulator
device in active versus sham treated patients, and represents the first
trial evaluating the use of this device in lower limb spasticity.

Jean Charles Lamy, Ph.D., Research Associate at ICM and Head of
the CENIR-PANAM core facility at ICM focused on non-invasive stimulation
said, "We are excited to see the MyoRegulator clinical study begin at
ICM. For patients experiencing spasticity following stroke, a serious
condition that can often inhibit patients from participating in everyday
activities, a non-invasive treatment is an appealing alternative to the
use of injected botulinum neurotoxins which can be associated with
serious adverse effects, painful repeated intramuscular injections and
high costs."

"This trial is yet another milestone for PathMaker as we advance our
development strategy to rapidly bring to market an entirely novel,
non-invasive approach to treating spasticity," said Nader Yaghoubi,
M.D., Ph.D., President and Chief Executive Officer of PathMaker. "We
expect the results from this trial and our U.S. trial to enable
regulatory approvals in both Europe and the U.S."

About Brain and Spine Institute - ICM
The Brain and Spine
Institute (Institut du Cerveau et de la Moelle Epinière – ICM) in Paris,
France is a world-class research establishment cofounded by private
benefactors and French public institutions such as INSERM, CNRS, APHP
and Sorbonne Université. It is innovative in both its conception and its
organization. By bringing together patients, doctors and researchers
under the same roof, it aims to facilitate the rapid development of
treatments for diseases of the nervous system so that they can be
applied to patients as quickly as possible. The center has the best
scientists from every domain and every country and they are conducting
groundbreaking research in this area. From a scientific standpoint, the
ICM's approach is novel to the extent that its research is
decompartmentalized. Its 24 research teams work independently but are
associated along thematic lines that encourage the pooling of expertise
and the implementation of joint projects. For more information, please

About PathMaker Neurosystems Inc.
PathMaker Neurosystems is
a clinical-stage bioelectronic medicine company developing breakthrough
non-invasive systems for the treatment of patients with chronic
neuromotor conditions. With offices in Boston (U.S.) and Paris (France),
we are collaborating with world-class research institutions to rapidly
bring to market disruptive products for treating spasticity, paralysis
and muscle weakness. More than 48 million patients in the U.S., Europe
and China suffer disabilities due to stroke, cerebral palsy, multiple
sclerosis, spinal cord injury, traumatic brain injury, Parkinson's
disease and other neurological disorders. At PathMaker, we are opening
up a new era of non-invasive neurotherapy for patients suffering from
chronic neuromotor conditions. For more information, please visit the
company website at

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