Ekso Bionics, designer and creator of exoskeletons -- bionic suits --

that physically augment humans, today announced that it has received

CE Marking Certification. Henceforth, all medical devices produced by

Ekso Bionics will be certified in over 30 European Union and EFTA

countries. European rehabilitation facilities are already placing

orders for the company's newest bionic suit, Ekso, which will be

shipped to them in the coming weeks. Ekso is a wearable robot that

powers wheelchair users up, enabling them to stand and walk. The suit

fulfilled the FDA requirements earlier this year, which has enabled

the company to partner with and sell Ekso to top rehabilitation


in the United States, including the Rehabilitation Institute of

Chicago, Kessler Foundation, TIRR Memorial Hermann, Craig Hospital,

and Spaulding Rehabilitation Hospital, among many others.


Ekso is a ready-to-wear, battery-powered bionic suit designed for

users with spinal cord injuries, lower-limb weakness/paralysis and

pathologies that inhibit their ability to walk. It is strapped over

the user's clothing. The user doesn't bear the weight however, as the

suit transfers its 45 lb. (20 kg) load directly to the ground. Each

Ekso can be adjusted in a few minutes to fit most people weighing 220

pounds (100 kg) or less, and standing between 5'2" and 6'2" (157cm to

188cm), with at least partial upper body strength, and can be adjusted

to fit one user and then another in minutes. The suit provides

unprecedented knee flexion, which translates into a natural four point

gait, thereby allowing Ekso to be used as a gait training tool.

"Today, we have taken a big step towards making the Ekso walking

experience available to anyone, anywhere," stated Eythor Bender, CEO

of Ekso Bionics. "For all of us, walking is a basic need and it shows

in the strong demand for Ekso in the U.S. where it has been available

for 3 months. We've successfully delivered close to ten suits and are

taking multiple and repeat orders from preeminent rehabilitation

centers," he explained. "Bionic suits are brand new and a

game-changing technology, so we decided early on this journey to focus

on the relatively small but challenging Spinal Cord Injury (SCI)

population. Their injuries generally occur when they are young, so

they were the ideal group to collaborate with in testing and improving

Ekso, prior to our product launch. We also chose to initiate our

delivery service via rehabilitation centers, rather than offering it

first directly to consumers, because it will ensure the product's

safety as well as genuinely useful improvements. We are on track to

release a personal version within 24 months," he added.

"We're buoyed by the warm reception we are experiencing in Europe. Our

rollout here is happening much faster than we had expected," said Andy

Hayes, director of Ekso Bionics, Europe. "We are already shipping

Eksos and starting customer training next week," he commented.

The first neurological rehabilitation hospital to receive the bionic

suit in Europe is Prosperius Tiberino Rehabilitation Clinic in

Tuscany, Italy:

Prosperius is currently the only fully integrated rehabilitation

clinic in Italy, utilizing innovative technologies for the

multidisciplinary care of their clients. The first spinal cord injury

center in Europe to receive an Ekso is the Princess Royal Spinal Cord

Injury Centre, a renowned spinal treatment center and NHS facility in

Sheffield, UK

Ekso Bionics received Full ISO 13485 Quality Management System and CE

Marking Certification from the British Standards Institution (BSI), a

European certifier and Medical Device 'Notified Body.' The 'CE'

marking is legally required to show conformance to the Medical Device

Directive, thereby enabling Ekso Bionics to market its products to

over 30 European Union and EFTA countries. The ISO 13485 Standard and

Medical Device Directive equivalents usually form the base device

requirements of Australia, Brazil, Canada, Japan, New Zealand and the

rest of the world. The sale of each bionic suit to rehabilitation

centers includes "Ekso +," a comprehensive service and training


About Ekso BionicsEkso Bionics


-- formerly known as Berkeley Bionics and headquartered in Berkeley,

California with offices in London, UK -- is a privately held designer

and maker of wearable robots, or bionic suits, that physically augment


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