[NEWS] B-Temia gains traction with 510(k) clearance for mobility device

Man wearing Keeogo about to climb stairs
Keeogo provides stability and strength to stroke patients with limited mobility. Credit: B-Temia Inc.

September 14, 2020 By Annette Boyle

B-Temia Inc.’s Keeogo mobility device is on the move in the U.S. now that it has received 510(k) clearance from the U.S. FDA. Unlike currently available exoskeletons that move for patients, the Keeogo (keep on going) Dermoskeleton system amplifies signals from patients who can initiate movement but need additional assistance.

“This U.S. market clearance is the biggest milestone of our global regulatory expansion, as the USA is the largest medical device market. It also gives us great confidence for the other regulatory approvals we are currently completing for additional territories,” said B-Temia’s president and CEO Stéphane Bédard.

The U.S. action specifically covers use of the device for stroke patients in rehabilitation settings. “Stroke is just the entry door,” Bédard told BioWorld. “We want to extend U.S. authorization for other indications in the future. We’ve done very well for stroke patients and want to do the same for those with multiple sclerosis, osteoarthritis of the knee, Parkinson’s disease, and partial spinal cord injuries.”

The company also hopes to gain clearance for patients to use the device on a day-to-day basis, not just during rehab sessions. “Keeogo has as its main purpose providing the person the ability to regain their activity on a daily basis walking, shopping, out in the yard. That’s why we invented it,” Bédard added. “We will reach that level in the U.S., but with the FDA, you have to go step-by-step for each indication.”

Keeogo already has much broader authorization in Europe where it received CE mark authorization in December 2019. In the 28 European countries covered by the CE mark, Quebec-based B-Temia can market the system to provide additional strength and stability to users with musculoskeletal weakness or lower limb instability both at home and in clinics. The system has been approved by Health Canada since 2015 for a range of indications as well.

The technology

Keeogo is a lightweight motorized walking assistive device that boosts leg power. Its dermoskeleton technology employs artificial intelligence (AI) to help individuals with impaired mobility walk, run, sit, and climb. Underpinned by a model of human biomechanics and the basics elements of gait, the AI uses additional mathematical equations to intervene properly in the movement.

The AI, housed on a belt worn at the waist, interprets information transmitted by sensors strapped to the leg to understand the user’s intent and then provides the compensation needed so they can achieve their goal. It is unique in that it does not replace an individual’s motion, only augments it. “If you don’t walk, it won’t move,” said Bédard. “It will add its response to your own characteristic speed and cadence and is fully customizable to the specifics of a disease and person. We’re only able to achieve this level of sophistication with AI.”

By augmenting the user’s motions, Keeogo works to help them regain or retain their autonomy and mobility. “When you go in the lab with Keeogo, you extend your range of motion, augment stride length, and increase the biomechanical ability to walk,” explained Bédard. “When you repeat recursive exercises, you build your capacity. You extend what you’ve done in the past– the body has a memory of that – and Keeogo synchronizes the motions, extends the gait, so that day after day you regain capacity.” In Parkinson’s and other degenerative diseases, the system helps patients hold onto their independence and not fall into a pattern of doing less and less as the disease progresses and movement becomes more challenging.

Notably, the system is not tied to an idealized motion. “We’re not trying to perfect the individual’s gait, just to improve it. We want to keep the individual’s natural gait. They will improve themselves as they use the system,” Bédard said.

Aside from its clinical applications, B-Temia also continues to develop its military version of Keeogo, the Onyx exoskeleton, for the U.S. Army. It has worked with Lockheed Martin since 2017 to support soldiers tasked with carrying loads of more than 100 pounds. Under that weight, people naturally change their gait. In addition, the weight puts such pressure on the joints that it often leads to both acute and chronic musculoskeletal injuries.

Future plans

“The approval also confers additional credibility for the corporation that will open a lot of doors in terms of investors, financing, and partnerships,” Bédard said.

He plans to spend the next several weeks determining how to execute properly on commercialization in the U.S. and elsewhere so that the device can be easily acquired by individuals who could benefit. “Our next challenge is to establish a good strategy. There are many options on the table and we want to make sure we choose the right structure, partners and channels.

Source: https://www.bioworld.com/articles/497746-b-temia-gains-traction-with-510k-clearance-for-mobility-device

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