The French economic promotion agency Bpifrance has awarded Boston-based PathMaker Neurosystems a grant to finance the development of its MyoRegulator, a noninvasive neurotherapy technology to treat conditions linked to neural pathway disruption, including neuromotor spasticity in patients with multiple sclerosis (MS).
Through the Programme d’Investissements d’Avenir (PIA-1), an investment program offered by Bpifrance, the grant — whose value was not disclosed — provides funds to PathMaker’s French clinical development program.
PathMaker is currently partnering with clinicians and researchers at the world-renowned Brain and Spine Institute (Institut du Cerveau et de la Moelle Epinière, or ICM) at the Pitié-Salpêtrière Hospital in Paris.
Through this collaboration, MyoRegulator will be tested in clinical trials with the goal of securing CE Mark clearance, a mandatory marking for certain products sold within the European Economic Area (which spans the European Union’s member states plus Iceland, Liechtenstein and Norway). CE Mark certifies that a product has met EU health, safety and environmental requirements.
“We are truly pleased to have received this support from Bpifrance,” Nader Yaghoubi, MD, PhD, president and CEO of PathMaker, said in a press release. “After comprehensive review of our company and technology, Bpifrance is demonstrating confidence in our efforts and we are thankful for the support and validation from this leading institution.”
PathMaker won the Universal Biotech Innovation Prize 2016, a global competition that recognizes the most innovative projects from startups and the best academic research groups in the field of biotech, medtech and digitech.
MyoRegulator is a non-invasive device to treat muscle spasticity (tight or stiff muscles) and the inability to exercise control over those muscles based on PathMaker’s proprietary DoubleStim technology, which provides simultaneous stimulation at spinal and peripheral sites.
In animals, this type of stimulation has been shown to suppress hyperexcitable spinal circuits and reduce spasticity.
MyoRegulator has received Institutional Review Board (IRB) approval by the U.S. Food and Drug Administration (FDA) for human clinical trials, confirming that such trials constitute non-significant risk (NSR) device studies. In 2015, the FDA also granted MyoRegulator its Expedited Access Pathway (EAP) designation, which helps speed the development, assessment and review of potential breakthrough products in areas of medical need.
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