Design World – August 2019

“We’re using online advertising to

inform 3 million people that there’s

something for them,” he said. “We’re

inviting them to free screening days,

where they can be evaluated by a medical

professional, and we can help them get

reimbursed.”

“When people try on the demo device,

they either laugh or cry,” said Gudonis.

“One user was a veteran who was injured

at 25. In 40 years, it was the first time

he could use that arm. Another was an

18-year-old in Milwaukee who suffered a

BPI at birth and hadn’t used her right arm

since then. She’s now using both arms.”

Users then go to local therapists to be

trained in how to use Myomo’s devices,

and the therapists themselves need

training.

“After users get insurance

authorization, they place an order, and

the local orthotist measures the arm

and hand,” Gudonis said. “Like with

prosthetics, they send an order to us for

custom fabrication. We use a shop in

Ohio, and lightweight plastic elements fit

over the robotic elements, like a custom

ski boot.”

“We have a training staff consisting

of certified prosthetists, orthotists,

and occupational therapists,” he

said. “They train clinicians on how

to evaluate patients, as well as work

with occupational therapists at rehab

hospitals around the country.”

“The software settings can be adjusted

by the clinician,” noted Gudonis. “As

muscles are used over time, the nerve

signals can get stronger and need less

amplification. We can adjust the gain

applied to each joint of the arm. In other

cases, such as ALS [amyotrophic lateral

sclerosis], signals can decrease over

time, but Myomo can help users remain

functionally independent.”

Adding capabilities

Myomo is working on a pediatric version

of the MyoPro 2. “It’s currently registered

with the FDA for adults and adolescents,”

Gudonis explained. “But millions of

children are affected by conditions like

stroke, cerebral palsy, birth brachial plexus

injuries, spinal muscular atrophy, and

AFM [acute flaccid myelitis], which is like

polio.”

To work with children, Myomo’s device

must be lighter, expandable, and “pass

the sandbox test,” he said, adding that

the MyoPro is water-resistant: “Users

can wash dishes, but they shouldn’t go

swimming or take a shower with it on.”

“We’re working with Boston Children’s

Hospital, Philadelphia Children’s Hospital,

and Easter Seals,” said Gudonis. “Some of

these improvements in terms of lighter

weight and algorithmic changes will

eventually apply to MyoPro 3.”

Scaling up

Myomo went public in June 2017 and has

raised $25 million in the public capital

markets.

“We’ve outsourced manufacturing of

some robotics components to Cogmedix

in Worcester, Mass., and a fabrication

company in Cleveland,” Gudonis said.

“We’re also talking to other custom

fabrication shops in the U.S. and Europe

to have sufficient capacity.”

“We were just doing controlled rollouts

in just a few markets, and we’re now

really scaling up commercial rollouts to

the top 50 metropolitan service areas in

the U.S.” said Gudonis. “We’re registered

with the FDA and have a medical device

license in Canada and a CE mark in

Europe.”

“For lower-extremity paralysis, there

have been a number of solutions, such as

exoskeletons from ReWalk, Ekso Bionics,

and Indego from Parker Hannifin,” he

said. “But for upper extremities, we offer

the only commercially available product,

protected with 21 patents in the U.S.,

Japan, and Europe.”

“Almost 900 devices are in use, and

we’re growing strongly now,” Gudonis

said. “Myomo built out its nationwide

distribution in the past year, and we have

our first distributors in Europe, Chile, and

Australia. Our goal is to be in all major

regional markets by the end of this year.”

RR

80 August 2019 http://www.designworldonline.com DESIGN WORLD DESIGN WORLD http://www.designworldonline.com January 2017 80

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