The honor was among several given to companies at the French-American Chamber of Commerce of New England (FACCNE) awards gala, held in Cambridge, Massachusetts, in late May.
“We thank the FACCNE organization, its team and its sponsors for this wonderful recognition of our company’s progress. Over the past year, PathMaker has made great strides in advancing our non-invasive platforms toward the market,” Nader Yaghoubi, MD, PhD, company president and chief executive officer, said in a press release.
“As a clinical-stage company focused on bringing to market our first-in-class products for non-invasive neurotherapy, we are working to meaningfully change the treatment paradigm for spasticity, paralysis and muscle weakness,” Yaghoubi added.
Winner of FAB Awards are selected each year by the gala audience after finalist presentations.
MyoRegulator uses the company’s proprietary DoubleStim technology to reduce muscle spasticity. DoubleStim provides simultaneous and non-invasive stimulation at both spinal and peripheral sites to ease spasticity.
MyoRegulator was selected for the U.S. Food and Drug Administration’s (FDA) Expedited Access Pathway (EAP) in October 2015. The EAP program was established by the FDA to help patients access more quickly potentially important new medical devices by expediting their development, assessment, and review. The company was also given a four-year, nearly $5 million award in February by a branch of the National Institute of Health to advance MyoRegulator as a potential treatment of spasticity secondary to stroke.
An Institutional Review Board (IRB)-approved clinical trial testing the device in patients with spasticity through a partnership with Northwell Health and the Feinstein Institute for Medical Research, based in New York, was announced in April 2016.
In January 2017, the company partnered with the Brain and Spine Institute (ICM) in Paris, France, to collaborate on human clinical trials aiming to secure CE Mark clearance for MyoRegulator – CE Mark (Conformité Européenne) is a mandatory regulatory seal that authorizes certain products to be sold in the European Economic Area. It certifies that a product meets European health, safety and environmental requirements.
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