PathMaker Wins Innovation Prize for Neurotherapies to Treat Spasticity, Muscle Weakness

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by Patricia Silva, PhD |

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PathMaker Neurosystems is the winner of the Universal Biotech Innovation Prize 2016 for its innovative, non-invasive neurotherapy technologies to treat conditions linked to neural pathway disruption, including multiple sclerosis (MS). The selection was announced at Innovation Days, an international event honoring the best in the life sciences and held in Paris on Oct. 3–4.

Launched in 2009 by a division of the Universal Medica Group, called Universal Biotech, the prize rewards project holders in health fields like biotech, medtech, diagnostics and e-health. Competing this year with 259 entrants from 38 countries, PathMaker was selected after four evaluation rounds, with awards granted in both the Medtech and Biotech categories.  The company will receive a shared prize of €30,000 (about $33,o00), plus consulting services.

A jury panel of international specialists evaluated the companies according to the scientific quality of their innovation, level of intellectual property, quality of the human resources, project feasibility, and chance of success on the market or investor interest.

“At PathMaker, we are tremendously honored and excited to have been awarded the Innovation Prize 2016,” Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker, said in a press release. “This prestigious prize reflects not only the rapid progress our expert team has made in translating fundamental discoveries into novel therapeutic devices, but the human impact our non-invasive technology will have for patients with paralysis, muscle weakness and spasticity.”

PathMaker is developing non-invasive neurotherapy systems for patients with neuromotor disorders, such as multiple sclerosis, cerebral palsy, and stroke. According to the company, these disorders affect 48 million people in the U.S., Europe, and China alone.

PathMaker’s first product, MyoRegulator, is a non-invasive treatment for muscle spasticity (tight or stiff muscles, and the inability to exercise control of those muscles) based on the company’s proprietary DoubleStim technology, which provides simultaneous stimulation at spinal and peripheral sites. The stimulation has been shown in animal studies to suppress hyperexcitable spinal circuits and reduce spasticity.

MyoRegulator is now in Institutional Review Board (IRB)-approved human clinical trials. In addition, the U.S. Food and Drug Administration (FDA) has given positive confirmation that clinical trials for MyoRegulator constitute non-significant risk (NSR) device studies, and an Investigational Device Application would not be necessary for the trial to proceed. MyoRegulator was also one of the first products designated for the FDA’s Expedited Access Pathway (EAP), a new pathway intended to speed the development, assessment, and review of potential breakthrough products in areas of medical need.

According to an announcement in April, PathMaker began a clinical study, together with Northwell Health and The Feinstein Institute for Medical Research, to evaluate the safety and efficacy of MyoRegulator in the treatment of muscle spasticity.

The company’s second product, MyoAmplifier, is an advanced platform, again based on TripleStim technology, providing simultaneous and non-invasive stimulation to cortical (motor cortex), spinal and peripheral muscle sites. The system integrates magnetic and electrical stimulation to treat patients with paralysis and muscle weakness. It has been shown in animal studies and in preclinical human studies to stimulate disrupted motor pathways and enable delivery of stronger cortical signals, driving a stronger muscle response.

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