Myomo’s orthotic arm device scores CE mark

Myomo's MyoPro device helps people move their paralyzed or weakened arms by detecting neurological signals and amplifying them.

Medical robotics company Myomo has earned a CE mark for its lightweight, wearable device that restores movement in paralyzed or weakened arms and hands. The company will begin its rollout in Germany.

The MyoPro orthosis is designed to let patients who have suffered a stroke, spinal cord injury or have another neuromuscular disability control their arm or hand using their own muscles. It is a powered brace that detects a patient’s neurological signals and amplifies them, driving motors in the brace to move the arm and hand.

“The MyoPro powered brace allows individuals suffering from paralysis or stroke to perform routine daily activities,” said Myomo CEO Paul Gudonis, in a statement. “Gaining CE Mark approval is an important milestone for our Company and for the many people in Europe who will now be able to experience the benefits of MyoPro as they struggle with upper limb paralysis.”

“We are currently working with our partner Ottobock to plan our European launch beginning in Germany,” Gudonis said. “Myomo recently conducted sales and clinical training for Ottobock staff, which has begun evaluating patients for the MyoPro device. With revenue of over a billion Euros and operations in 50 countries, Ottobock is a global market leader in technical orthopedics and prosthetics.”

The news comes after the Cambridge, Massachusetts-based company went public via a “crowdsourced IPO.” In June, Myomo completed a $5 million IPO under Regulation A+, a provision of the Jumpstart our Business Startups Act that makes it easier for smaller companies to access capital.

While Myomo missed its $15 million target, the funds will support sales, marketing and its international expansion. They will also go toward developing its product pipeline, including a pediatric version of the MyoPro device.