ReWalk Robotics Ltd.

Welcome to the second quarter 2022 Rewalk Robotics Limited Earnings Conference call. My name is Richard, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press 01 on your touchtone phone. I will now turn the call over to Alnuk Adar. You may begin.

Thank you, Richard. Good morning, and welcome to WeWork Robotics' second quarter 2022 earnings call. This is Almogadal, WeWork Director of Finance, and with me on today's call is Larry Jasinski, Executive Officer. Today, the company issued a press release detailing financial results for the three and six months and the June 30, 2022. This press release and webcast of this call can be accessed through investor relations section of Rework website at www.rework.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, focus, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to remote management as of today and involve risks and uncertainties, including those noted in our first release and remote filing with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statement. We will not specifically disclaim any intent or obligation to update this forward-looking statement except as required by law. Our annual press release and this call will include discussion of certain non-GAAP information. You can find our annual press release, including relevant non-GAAP reconfigurations, on our corporate website at rewalk.com. A telephone replay of the call will be available shortly after completion of this call. You will find the dialing information in today's press release The archived webcast will be available on the company's website, wework.com. For the benefit of those who may be listening to the replay or the archived webcast, this call was aired and recorded on August 9, 2022. Since then, Rework may have made announcements related to a topic to discuss, so please reference the company's most recent press releases and FCC filings. And with that, I will turn the call over to Rework's CEO, Larry Jasinski.

Thanks, Omar. Good morning. Thank you for joining us today. As you'll see from our results, we made important progress in the quarter on our key objective of establishing a growing and sustainable market with broad community coverage. Our original mission of improving the health and well-being of the paralyzed community through enabling an individual to regain ambulation as a part of their daily life is in our sights. Our experiences and data on the impact on their physical health, their quality of life, and involvement in the community is now extensive and remains compelling. To start, I'd like to walk through the status on the three focus areas I identified at the start of the year. As a reminder, these areas are, first, progress with CMS and the status of the German Corps case. Second, executing on technical developments to improve our REWALK personal system. Third, continuing to develop processing infrastructure and support materials for training, service, reimbursement assistance, and sales coverage to grow effectively. Starting with CMS, we were placed on the biannual Healthcare Common Procedure Coding System Public Meeting Agenda, known as HCPCS, to present the basis for a Medicare benefit category determination for the Rewalk Personal Prosthetic Exoskeleton System. On June the 8th, we presented before CMS at its HCPCS meeting detailing why CMS should promptly assign the Rewalk Personal Prosthetic Exoskeleton to the artificial leg prosthetic benefit category because this is a medically proven and necessary technology. We stress three points in this discussion. One, Rewalk meets Medicare's statutory definition of a prosthetic device. Medicare considers artificial legs, arms, and eyes to be covered under the prosthetic device benefit category as well as devices that, quote, place all or part of the function of a permanently inoperative or malfunctioning internal body organ, unquote. Two, Rewalk satisfies Medicare's definition of a prosthetic device. REWALK is a device as defined by the FDA in the de novo clearance. And third, REWALK acts as a pair of artificial legs for individuals who are permanently paralyzed or otherwise disabled due to spinal cord injury. It enables functional ambulation of the lower legs where such ambulation would otherwise be impossible due to the injury of an internal body organ, the spinal cord. There are also multiple clinical applications and industry speakers supporting REWOC's benefit category assignment, which was highly encouraging. In addition, following the meeting, we provided a detailed submission to the agency. CMS is now considering a request, and we anticipate guidance on this recommendation in late Q3 or in Q4. In parallel, we were advised to submit our first claims for CMS beneficiaries from the pool of patients that have been waiting for many years to regain ambulation. The initial claims are planned in the coming months, and this activity will help advance this process. Now a brief update on Germany. The pending case with the German Federal Social Court has not yet been ruled on by the court. Although timing of any ruling is up to the court, we are one of the oldest cases currently on their agenda. The second category, regarding the technical developments on the Rewalk Personal Exoskeleton System. We have submitted a 510 application in June 2022 to enable stair and curb navigation with our Rewalk Exoskeleton. These additional capabilities will significantly improve users' access to more locations and environments and will make the Rewalk Exoskeleton the first of its kind to receive FDA clearance for stair and curb functionality for personal use. This application previously received a breakthrough device designation with the FDA and is currently pending FDA clearance, which is anticipated later this year. In addition, we are developing multiple improvements to the Rewalk system with a seventh generation design that is intended to improve usability, add new features, and expand capabilities for monitoring utilization data. We believe these improvements continue to provide a significant advantage with the Rewalk as the most functional design in the marketplace. In parallel, we are continuing to advance the Reboot soft exosuit program for post-stroke home and community use. The team at Harvard has continued to evaluate the device for home use and has recently completed a study in which four systems were provided to participants for home and community use in the Boston area to examine functionality and utilization. The study was supportive of advancing the program to the next stage of development. We're now moving to a commercial design plan and a review of the related business plan. As the first in its kind system providing powered propulsion during walking in the home and community, this design also received a breakthrough device designation with the FDA. As a home use device, coverage and reimbursement is a key element in advancing this innovative concept to commercial use. With the breakthrough device designation, we are closely monitoring progress of the TCET, Transitional Coverage of Emerging Technologies Program, which could provide Medicare coverage guidance for breakthrough devices like the reboot. This is still an active consideration, and the comment period was recently delayed from October 2022 until April 2023. A final decision and its outcome will affect the pathway for many breakthrough technologies like the reboot. The third category, processing infrastructure and support. An important element in the processing of claims with Medicare and others is a provision of data and a structure that meets the requirements for every insurer. As part of this, REWOC has completed a comprehensive dossier that documents the extensive clinical evidence which supports the REWOC personal prosthetic exoskeleton that has crossed the threshold to prove the prescription of the system is reasonable and necessary and therefore satisfies the requirement for medical necessity. This dossier includes information on the disease burden, realist clinical and empirical evidence, a summary of economic value modeling, and expert opinions, including societal support. The conclusion in this summary states, quote, the REWALK exoskeleton enables trained patients with SCI to perform core weight-bearing and functional ambulation tasks, such as standing and walking, within home and community settings. Ambulation is beneficial in and of itself but also produces physical and mental benefits that counter the long-term consequences of SCI," unquote. This exhaustive document will support efforts with insurers going forward. We have it structured to be able to modify it to meet the request of each insurer. A summary of key studies in the public hearing, which included 14 studies with approximately 900 subjects covering 10 improved health outcome categories, was presented with a request on the benefit metaphor category determination. In a Stanford survey of 253 innovators, the time cycle for coverage for highly innovative technologies like the REWALK exoskeleton has averaged 4.7 years. With REWALK, we have advanced from code creation in late 2020 through clinical evidence, are now in the process of determining the benefit category, are preparing to submit our first claims to Medicare, which will also support pricing decisions. We possess supporting advocacy groups, and we have an established plan for case oversight and long-term follow-up, which is all part of moving to the final stages of coverage and reimbursement. We have also developed a detailed workflow and defined processing requirement model, host coverage. We are contracting most of the required short-term resources to process the early cases, and we'll build and contract resources to support growth in 2023 and beyond. Most of our revenue base is reliant on coverage, but our cases with most insurers have been built on a case-by-case basis without sufficient definition. An important measurement for this market is that an environment with defined and controlled reimbursement, such as we see in the German contracts, our revolts are becoming reasonably predictable. In the United States, we have several workman's compensation cases that continue through multiple levels of appeals occurring between the individual seeking to walk and their respective insurers. When none were lost from our pipeline, many have been delayed, and the process remains unpredictable until coverage and clear definitions are in place, such as we see in places like Germany. I'd now like to turn the call over to Amogh for a review of financial details. Amogh?