ReWalk Robotics Ltd.

Good day, and thank you for standing by. Welcome to the Q1 2022 Rewalk Robotics LTD Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that this call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Almog Adar, Director of Finance. You may begin.

Thank you, Justin. Good afternoon, and welcome to Reebok Robotics' fourth quarter earnings call. This is Almog Adar, Reebok Director of Finance, and with me on today's call is Larry Jasinski, Chief Executive Officer. Today, the company issued a press release detailing financial results for the three months ended March 31, 2022. This press release and the webcast of this call can be accessed through the investor relations section of the 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, forecast, 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 Reforms Act. These forward-looking statements are based on information available to rework management as of today and involves risks and uncertainties, including those noted in our press release in the Reworks 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. Reworks specifically disclaim any intent or obligation to update this forward-looking statement except as required by law. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliation, 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 dial-in information in today's press release. The archived webcast will be available on the company website www.rewalk.com. For the benefit of those who may be listening to the replay of the archived webcast, this call was aired and recorded on May 13, 2022. Since then, Rewalk may have been announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. And with that, I will turn the call over to the REWOC CEO, Larry Jasinski. Larry Jasinski Thank you, Omag.

Good day, everyone. While Q1 was a disappointing quarter in terms of closed sales, it was also a quarter where we made meaningful progress on key long-term initiatives, including positive developments with CMS, the VA, and in Germany. The closed sales in Q1 were limited to $876,000. We were about 75 percent of what we expected in Germany and only 35 percent of what was expected in the United States. The coverage contracts in Germany make processing more predictable, while the U.S. will not have a similar predictability until Medicare or private coverage is more clearly decided. The limitations in the quarter were driven by slow insurance processing. VA facilities that remain closed much of the quarter, the COVID surge with Omicron that limited trading in clinics into late February, and COVID infections within 40% of our field team during the quarter. While we had a sufficient pipeline to meet our targeted sales level, we simply could not force final insurance processing within the limitations of COVID restrictions within a timely manner to meet our sales goal. Importantly, we did not lose these potential patients during the quarter and expect recovery of most of these placements as the year progresses. Our objective of establishing a predictable coverage process within the U.S. with Medicare and private payers has progressed. We are looking closely with individual patients and CMS to establish more efficient claims processing. I'd like to cover our status on the three categories of focus identified at the start of the year. First, progress to CMS and the status of the German court case. Second, movement on our technical developments to improve our Rewalk personal system. Third, continuing development of processing infrastructures with respect to training, service, reimbursement assistance, and sales coverage to grow effectively. To add detail to these three categories, first, starting with reimbursement. Our success will be aligned with guidance from CMS on benefit category, determination of the category, subsequent pricing, methodology, and the local and national coverage process by CMS. REWOC is actively collaborating with CMS for, quote, scientific innovation and technology, unquote. This initiative directly impacts REWOC, which is defined as a novel breakthrough technology. To this end, REWOC is one of the first companies to be participating in the new process for benefit category determinations. Reimbursement and payment is a priority of the medical device industry, and CMS and REWOC are active participants in these statutory and legislative initiatives. Medicare benefit category and reimbursement will be determined through the process from the final rule on DEPOS, which is durable medical equipment, prosthetics, orthotics, and supplies, issued by CMS in December 2021. For background, We have had a formal meeting with CMS and continued communications. We have submitted supporting materials on what we believe to be an appropriate Medicare benefit category and have had a follow-up discussion regarding the process. CMS published the Healthcare Common Procedure Coding System, known as HCPCS, public meeting announcement for June the 8th. Our benefit category request for the Rewalk has been assigned to this agenda. We will provide extensive documentation to CMS support benefit category assignment, including information from the broader medical device industry, patients, and practitioners. We have progressed sufficiently to begin to submit our initial cases. We will be proactively engaging with CMS's Medicare contractors to help facilitate smooth processing of cases. Our end goal remains having a reliable and systematic method to identify and cover the appropriate patients. In Germany, the Federal Social Court has not yet processed the pending exoskeleton cases expected in Q1. The case remains on the docket and we expect the case to be heard in the coming weeks or months. Although it is one of the longest pending cases and is listed near the top of the docket, the court does not provide specific information on the timing for ruling an accepted case. When this occurs, it will be a signal for all insurers on the standards to provide exoskeleton systems. Now, the second category I identify to focus, technical developments to support market growth. We anticipate an FDA submission in mid-year 2022 for new features with the Rewalk. These new features have been awarded a breakthrough designation by the FDA as of May 14th, 2021. We are currently completing final validation testing prior to submission. Once cleared by the FDA, the new features will increase physical access for users, allow them to travel to more locations, and engage in more activities of everyday life. Our next generation design is occurring in parallel. It will make the system easier to use, improve performance, provide more data, and increase the choices of walking parameters. In April, we announced that Rewalk has joined and gained funding within the Magnet Consortium program based out of Israel, which had the goals to develop, quote, develop advanced technologies aimed at providing robots with social capabilities, enabling them to carry out various tasks and effective interactions with different users in diverse operational environments, unquote. We are hopeful this research will support an eighth generation system that can further expand adoption and the range of applicable users. The third area of focus is processing infrastructure. Infrastructure development started with defining each step of the patient's journey and determining resource requirements to achieve each element of the Medicare coverage and reimbursement process from identification through supply and maintenance of the system over the life cycle of the product. We are also setting up the process for private payers, which we expect to follow Medicare. Our model is building on the positive experiences in Germany and is lending internal and external resources. We will start testing this within our initial CMS submissions in mid-2022 and seek to expand it among other payers as contracts are established subsequently. As a company, our capital position is suitable to achieve these goals, and 2022 remains a pivotal year for the company in defining this industry and in building long-term market leadership for the Rewalk Personal Systems. We look forward to continuing to expand access to our life-changing technologies for the benefit of patients and all of our stakeholders. I now ask Almag to cover the specifics of our financials and our overall financial position.