Advancement in ReWalk Technology Achieves FDA Clearance as Only Personal Exoskeleton to Enable Use on Stairs and Curbs

Rhea-AI Summary

ReWalk Robotics Ltd. has received FDA clearance for its ReWalk Personal Exoskeleton to operate on stairs and curbs, making it the only device of its kind in the U.S. with such approval. This breakthrough, recognized by the FDA as a "Breakthrough Device," allows paralyzed individuals with spinal cord injuries to access diverse environments, enhancing their quality of life. The ReWalk system, which combines advanced mechanical design with proprietary software, has been successfully used in Europe for years, demonstrating safety and efficacy. The company aims to expand access to this technology through improved reimbursement pathways, reflecting a commitment to advancing mobility for spinal cord injury patients.

Positive

• FDA clearance allows ReWalk exoskeleton to operate on stairs and curbs, expanding usability.
• Designated as a 'Breakthrough Device' by the FDA for its innovative capabilities.
• Demonstrated safety and efficacy with over 18,000 stair steps logged in European users over seven years.

Negative

• None.

Paralyzed individuals with spinal cord injury will have unprecedented access to walking in everyday environments as they are no longer limited when encountering stairs and curbs

MARLBOROUGH, Mass. and BERLIN and YOKNEAM ILIT, Israel, March 07, 2023 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd., (Nasdaq: RWLK) (“ReWalk” or the “Company”), a leading provider of innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, announced today that its innovative ReWalk Personal Exoskeleton technology has received clearance from the Food and Drug Administration (“FDA”) for use on stairs and curbs in the United States, making it the only personal exoskeleton to receive FDA clearance for this indication. The clearance follows the FDA’s designation of the device as a "Breakthrough Device" in recognition of its unprecedented ability to provide ambulatory access to environments containing stairs and curbs for paralyzed individuals with spinal cord injury (“SCI”).

This revolutionary advancement combines the robust mechanical design of the ReWalk Exoskeleton with its proprietary stair climbing software to enable users with access to a wide array of everyday environments, allowing them to participate in more walking activities in their daily lives and more opportunities to experience the health benefits of walking. This feature has been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users throughout a period of over seven years and consisting of over 18,000 stair steps was collected to demonstrate the safety and efficacy of this feature and support the FDA submission.

“Our mission at ReWalk has been to achieve widespread access to the health benefits of walking in everyday life for individuals with spinal cord injury,” said Larry Jasinski, CEO of ReWalk. “Today’s announcement demonstrates our commitment from a technical perspective to improve access to a broader range of activities of daily living, such as walking up the steps to visit a friend’s home, or stepping over a curb during a neighborhood walk. In parallel, our focus continues to be to broaden access to these life changing technologies through expanding payor coverage as we continue to work with Medicare to develop the pathway to reimbursement for medically-eligible individuals.”

“To have the option to sit, stand, walk, and even step over curbs as a paralyzed individual is unimaginably rewarding,” said Simon Kindleysides, a ReWalk user and Guinness World Record holder for the most stairs climbed in an exoskeleton. “I’m in full control of the exoskeleton, and I am able to conquer stairs and other obstacles that may appear in my way. It’s been life-changing for me.”

ReWalk looks forward to expanding the possibilities for its users in the United States with this recent FDA clearance.

For more information on the ReWalk systems, please visit rewalk.com.

About ReWalk Robotics Ltd.

ReWalk Robotics Ltd. is a medical device company that designs, develops, and commercializes innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions.  ReWalk’s mission is to fundamentally change the quality of life for these individuals through the creation and development of market leading technologies. Founded in 2001, ReWalk has operations in the U.S., Israel, and Germany. For more information on the ReWalk systems, please visit rewalk.com

ReWalk® and ReStore® are registered trademarks of ReWalk Robotics Ltd. in the United States and other jurisdictions.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Such forward-looking statements may include projections regarding ReWalk's future performance and other statements that are not statements of historical fact and, in some cases, may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "should," "would," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk's control. Important factors that could cause ReWalk's actual results to differ materially from those indicated in the forward-looking statements are more fully discussed in ReWalk’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described under the heading "Risk Factors" in ReWalk's annual report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause ReWalk's actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

ReWalk Media Relations:
John Tomlin
E: media@rewalk.com

ReWalk Investor Contact:
Mike Lawless
Chief Financial Officer
ReWalk Robotics Ltd

T: +1 508-281-7274
E: investorrelations@rewalk.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/04d14a30-d432-4ff4-8c06-104a565e5942

FAQ

What is the significance of the FDA clearance for RWLK's ReWalk exoskeleton?

The FDA clearance allows RWLK's ReWalk exoskeleton to operate on stairs and curbs, enhancing its usability for paralyzed individuals.

When was the FDA clearance for the ReWalk exoskeleton announced?

The FDA clearance was announced on March 7, 2023.

How does the ReWalk exoskeleton improve mobility for users?

The exoskeleton enables users with spinal cord injuries to walk in everyday environments, including stairs and curbs.

What recognition did the ReWalk exoskeleton receive from the FDA?

It was designated as a 'Breakthrough Device' by the FDA.

How long has the stair climbing feature for ReWalk been available in Europe?

The stair climbing feature has been available in Europe since initial CE clearance.