As medical device company PathMaker Neurosystems Inc. begins exploring clinical trials in the U.S., it has unveiled expansion plans into France that will facilitate the company’s move into the European market.
The Boston-based company, founded in 2014, is hoping to commercialize technology that uses non-invasive electrical pulses to address neurological motor disabilities, such as paralysis, muscle weakness and muscle tone disorders.
While the company is moving forward with clinical trials in the U.S., it hopes to move forward with clinical trials in France in the next year with the establishment of operations at the bioincubator at the Brain and Spine Institute at the Pitié-Salpêtrière Hospital in Paris.
“For us, if you’re a medical device company, you have to be thinking about not only the U.S., but how you’re going to obtain European approval and get access to the European market,” said Dr. Nader Yaghoibi, president and CEO of PathMaker, in an interview. “France has been proactive and the relationship…has been growing in the last few years.”
Yaghoibi added that receiving CE Mark approval – the regulatory approval required for commercialization in Europe – is easier than obtaining Food and Drug Administration approval in the U.S.
“It’s a matter of being able to be on the ground there, move forward with our regulatory strategy with an eye to getting market approval,” Yaghoibi said.
The technology was developed by and licensed from City University of New York. While doctors have been using electricity to address neuromotor disorders for some time, Yaghoibi said his company’s technology is novel in that the electrical pulses are sent through the body without the need for surgery or other invasive techniques.
A weak direct current is applied to the spinal chord by devices placed on a person’s back and stomach, and is able to influence the signals in the spinal chord that go from the brain to the body’s muscles.
The market for the device is in the billions, Yaghoibi said, considering the 12 million patients in the U.S. and Europe have a muscle condition known as hypertonia, and the 21 million patients in the U.S. with muscle weakness and paralysis.
“There are huge numbers (of patients) and inadequate treatments,” Yaghoibi said.
The company, which has five employees, is privately funded. Yaghoibi said it is working on additional financing rounds.