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Firm receives CE mark

By Omar Ford

Staff Writer

Myomo Inc. has received CE mark for its Myopro myoelectric arm orthosis wearable technology. The Cambridge, Mass.-based company said Myopro is a lightweight device that can restore function in the paralyzed or weakened arms and hands of individuals who have suffered a stroke, spinal cord or nerve injury, or other neuromuscular disability.

The CE mark for the device comes on the heels of Myomo going public in June. (See BioWorld MedTech, June 13, 2017.) The firm brought in $5 million in the IPO and raised $2.9 million from the private investment sale of restricted securities. Shares of Myomo (NYSEMKT:MYO) were up as high as 15 percent on Monday and closed at $9.95.

To get the device on the market in Europe, Myomo is partnering with prosthetics specialist Duderstadt, Germany-based Ottobock. The device will be launched in Germany first.

"Ottobock is such a well-established company throughout the world," Jon Naft, Myomo vice president/general manager, told BioWorld MedTech. "In order for Myomo to really ramp up [sales in Europe], it just makes sense for us to partner with [Ottobock]."

Myomo has had clearance for the device for several years. Eventually, the company will take on other markets, Naft said.

"I expect us to continue to grow to other markets outside of the U.S. and Europe," he said. "We've already received interest from countries across the globe. We are working on a plan to continue expansion."

Myopro, described as a powered brace for the arm, works by "sensing a patient's own neurological signals through noninvasive sensors on the arm. The device uses those signals to guide the prosthetic, and complete the desired movement such as picking up or carrying an item.

The device was developed using technology licensed from the Massachusetts Institute of Technology.

Naft said there aren't many options for these patients with paralysis as there are patients who have lost their limbs. He noted that amputees have electric prosthetic limbs that can be used to gain function – a stark difference from patients suffering from paralysis.

"When a patient loses function of their arm, but still has their arm, they are told there are very few options for them and to stay the course with their therapy, he said. "Patients just don't know there are solutions out there in the pipeline for them, and when you see them getting fitted for this device and start moving their fingers and arms for the first time – it's a really moving experience."

Eventually Myomo could be used to help treat other extremities.

"I do believe our technology is applicable to those other parts of the body, so I think that's something we could definitely explore in the future," Naft said. "Right now we're concentrating on the upper limb and the arm."

Tracking Myomo's movement

In June, the company released results of a study conducted at the Ohio State University School of Medicine on 18 chronic stroke participants with moderate post-stroke upper extremity hemiparesis and studied use of the Myopro powered orthosis. The subjects were tested to evaluate the degree of impairment and function without the Myopro and compare it with impairment while wearing the device.

The study titled, "Giving them a hand: wearing a myoelectric elbow-wrist-hand orthosis reduces upper extremity impairment in chronic stroke," was published in June's Archives of Physical Medicine and Rehabilitation. Researchers from the study concluded that upper extremity impairment is significantly reduced with use of the Myopro, and these changes exceeded the clinically important difference threshold of standard impairment tests.

The company also launched a new version of Myopro that improves upon previous capabilities and adds interchangeable, extended-life rechargeable batteries designed to support continuous daily use.

Even though the company has received approval in recent years, the concept behind the technology has been in existence for decades.

"There are actually research publications dating back to the 1960s showing that this type of solution could be possible," Naft said. "But back then, in order to get it to be a more commercially available product, you needed to have smaller more powerful batteries; better computer processing; better software and better algorithms."

Published  August 1, 2017

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