ReWalk Robotics Stock

Rewalk Robotics Ltd. operates as a medical device company.

The company engages in designing, developing, and commercializing innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions. The company's initial product offerings were the ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices for individuals with spinal cord injury (SCI Products).

The company has developed its ReStore Exo-Suit device, which it began commercializing in June 2019. The ReStore is a powered, lightweight soft exo-suit intended for use during the rehabilitation of individuals with lower limb disabilities due to stroke. During 2020, the company finalized and moved to implement two separate agreements to distribute additional product lines in the United States. The company is the exclusive distributor of the MYOLYN MyoCycle FES Pro cycles to U.S. rehabilitation clinics and for the MyoCycle Home cycles available to the U.S. veterans through the U.S. Department of Veterans Affairs (VA) hospitals. The company will continue to evaluate other products for distribution or acquisition that can broaden its product offerings further to help individuals with neurological injury and disability.

The company is in the research stage of ReBoot, a personal soft exo-suit for home and community use by individuals post-stroke, and it is evaluating the reimbursement landscape and the potential clinical impact of this device.

The company's principal markets are the United States and Europe. In Europe, the company has a direct sales operation in Germany and work with distribution partners in certain other major countries. It has offices in Marlborough, Massachusetts, Berlin, Germany and Yokneam, Israel, from where the company operates its business.

The company has also been pursuing updates with the Centers for Medicare and Medicaid Services (CMS), to clarify the Medicare coverage category (i.e., benefit category) applicable for personal exoskeletons. The company is seeking a nationwide Medicare benefit category determination from CMS to designate the relevant Medicare benefit category.

In Germany, the company continues to make progress toward achieving coverage from the various government, private and worker's compensation payors for its SCI products. During the year 2020 and 2021, the company announced several new agreements with German SHIs, including TK and DAK Gesundheit, as well as the first German Private Health Insurer (PHI), which outline the process of obtaining its devices for eligible insured patients. The company is also working with several additional SHIs on securing a formal operating contract that establish the process of obtaining a ReWalk Personal Exoskeleton for their beneficiaries within their system.

ReWalk Personal and ReWalk Rehabilitation Products

The company offers two products in this category: ReWalk Personal 6.0 and ReWalk Rehabilitation, which is a ReWalk Personal 6.0 product sold with multiple sizes of its adjustable parts to allow different users the ability to train within a clinic.

ReWalk Personal 6.0 Exoskeleton is a novel product that seeks to fundamentally change the health and life experiences of users.

ReWalk Personal 6.0: Intended for everyday use at home, at work or in the community with a trained companion. The company began marketing ReWalk Personal Exoskeleton in Europe with CE mark clearance at the end of 2012. The company received FDA clearance to market ReWalk Personal in the United States in June 2014. ReWalk Personal units are all manufactured according to the same mechanical specifications. Each unit is then permanently sized to fit the individual user and the software is configured for the user's specifications by the rehabilitation center, clinic or distributor. The company is offering its 6th generation device.

ReWalk Rehabilitation: The offering for clinics who wish to implement exoskeleton training is composed of the company's Personal 6.0 unit along with multiple sizing of different parts, enabling multiple patient use. ReWalk Rehabilitation provides a valuable means of exercise and therapy. The company began marketing a unique design for use in hospitals, rehabilitation centers and stand-alone training centers in the United States and Europe in 2011 and, as of December 2020, the company eliminated the need for a unique design for the rehabilitation units and instead shifted to offering a sizing and accessory kit that adapts the Personal 6.0 base unit to enable fitting across multiple users in a clinic setting.

Additionally, the company has received regulatory approval to sell the ReWalk Personal device in other countries.

ReStore

In June 2017, the company unveiled its lightweight exo-suit ReStore system designed initially for the rehabilitation of stroke patients. In June 2019, the company received FDA clearance following CE clearance in May 2019. Following the regulatory clearances, the company began to commercialize the ReStore product.

The ReStore product includes a soft, fabric-based design, which connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern.

In 2019, the company expanded its sales and marketing presence in the United States to accelerate product penetration after receiving FDA and CE clearance. Geographically, the company's commercial priorities for the ReStore device as being the United States and Europe.

As of December 31, 2022, the company had placed 33 ReStore units.

ReBoot

The company is also in the stage of research with ReBoot, a soft exoskeleton for stroke home and community use. The ReBoot is a lightweight, battery-powered exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke. The ReBoot is a customizable personalized device intended for home and community use with an estimated market of approximately 400,000 annual stroke patients who require walking assistance after being discharged home.

Competition

The company's principal competitors in the medical exoskeleton market consists of Ekso Bionics, Rex Bionics Pty, Cyberdyne, FREE Bionics, DIH, AlterG, Wandercraft, and Bioness (acquired by Bioventus).

In addition, the company competes with alternative devices and alternative therapies, including treadmill-based gait therapies, such as those offered by Hocoma, Tyromotion, AlterG, Aretech, and Reha Technology.

Intellectual Property

As of December 31, 2022, the company had 12 issued patents in the United States and 19 issued patents outside of the United States, as well as 11 pending patent applications for its technology in the United States, China, and Europe. As such, in the United States and Europe, the company has apparatus patent claims covering the aspects of ReWalk and similar devices, which use a plurality of sensors to empower tilt-sensor technology, as well as method patent claims covering certain methods of user activation and control of systems, such as ReWalk.

The oldest of the company's issued patents relating to its tilt-sensor technology was filed in May 2001 in the United States and would typically expire in May 2021.

The company holds a registered trademark in the United States, Europe, Israel, and the United Kingdom, for the mark 'ReWalk'. The company holds a registered trademark in United States, Europe, and the United Kingdom for the mark 'ReStore'.

Government Regulation

The company's medical products and manufacturing operations are regulated by the FDA and other federal and state agencies. The company's products are regulated as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FFDCA), as implemented and enforced by the FDA.

The company's manufacturing processes are required to comply with the applicable portions of the Quality System Regulation that covers the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.

The company maintains compliance with the FDA's Quality System Regulation, 21 CFR Part 820, and the European Union's Quality Management Systems requirements, ENISO 13485:2016. The company is subject to periodic scheduled or unscheduled inspections by the FDA.

Environmental Matters

In Israel, where the company's contract manufacturer produces all of its products, businesses storing or using certain hazardous materials (including materials necessary for the company's manufacturing process) are required, pursuant to the Israeli Dangerous Substances Law 5753-1993, to obtain a toxin permit from the Ministry of Environmental Protection.

Additionally, the company is required to comply with certain laws, regulations and directives, including the Toxic Substances Control Act in the United States and REACH in the European Union, governing chemicals.

Manufacturing

The company has contracted with Sanmina Corporation (Sanmina), a contract manufacturer with expertise in the medical device industry, for the manufacture of all of its products.

Research and Development

The company's research and development expense included $4.0 million in 2022.

History

ReWalk Robotics Ltd. was founded in 2001. The company was incorporated under the laws of the state of Israel in 2001.