ReWalk Robotics Ltd.

Good day and welcome to the Q3 2022 Rewalk Robotics Limited Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Mike Lawless, CFO of the company. Please go ahead.

Thank you, Dashnavi. Good morning, and welcome to Rewalk Robotics' third quarter 2022 earnings call. This is Mike Lawless, Rewalk Robotics' chief financial officer, and with me on today's call is Larry Jasinski, chief executive officer. Earlier this morning, Rewalk issued a press release detailing financial results for the three and nine months ended September 30, 2022. This press release and a webcast of this call can be accessed through the investor relations section of the REWALK website at rewalk.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 Reform Act. These forward-looking statements are based on information available to REWOC management as of today and involve risks and uncertainties, including those noted in our press release and REWOC's filings 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 statements. REWOC specifically disclaims any intent or obligation to update these forward-looking statements. except as required by law. A telephone replay of the call will be available shortly after the completion of this call. You'll find the dial-in information in today's press release. The archived webcast will be available on the company's website in the Investor Relations section. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on November 7, 2022. Since then, REWALK may have made announcements related to the topics discussed So please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to REWALK's CEO, Larry Jasinski.

Thank you, Mike. Good morning. Thank you for joining us today. I want to start with an update on the strategic activities that are occurring to allow the establishment and support exoskeletons through providing public or private coverage for individuals seeking a REWALK system. In the U.S., we have submitted our first case to the Medicare administrative contractors, known as the MACs, and have more submissions in process. The REWALK exoskeleton has always pioneered the exoskeleton industry, starting with our de novo FDA clearance, more recently with our breakthrough designation for the pending stare, ascend, and descend features, and have now completed the first exoskeleton submissions to CMS. The importance of submitting claims means that paralyzed Medicare beneficiaries may soon experience the benefits of functional ambulation. While coverage is in place under the code we established with CMS, the unfinished designation of the benefit category and of pricing for exoskeletons is now a part of the MAC submission process to complete the ongoing supply of exoskeletal systems. Now, CMS is using a new process and exoskeletons are unique. The timelines are not specifically defined. However, we expect to receive some guidance or response approximately 30 days after the submissions. In Germany, REWOC has led the way in establishing a coverage code and then entering into contracts with several large public and private insurers. While it has been an active process with several of the larger insurance entities, the question of whether exoskeleton provides direct or indirect disability compensation for the spinal cord injured individual seeking to walk again has been pending in the courts since May of 2017. This case is advanced to the highest and supreme court in Germany for these matters, the Federal German Social Court. This session is scheduled later this week for November the 10th and a decision is expected just after the hearing. Predictable coverage for individuals who meet the inclusion and exclusion requirements is essential for the clinical and spinal cord injury communities to be able to consider their possible options to have a better quality of life. This will also permit the industry to properly advise and help this community. In parallel with the coverage ongoing Innovation and improvements on the Rewalk personal exoskeleton system are moving forward. The company has received and is interacting with the FDA with additional information requests through the regulatory review process. This current 510K application is for the provision of navigating curves and stairs with our Rewalk exoskeleton. These additional capabilities will significantly improve users' access to more locations and environments. and increase their opportunities to achieve the benefits of functional ovulation. For our continuing technology innovation efforts, we are advancing the ReBOOT soft exoskeleton program for post-stroke home and community use. This design allows both plantar and dorsiflexion for the users of the clinic, home, and community. While the design has a breakthrough designation with the FDA, We are also presently reviewing the existing coverage codes that may support payment and have identified multiple potential coverage pathways. In parallel, we are working with an independent firm to help define the market requirements and seek feedback on the initial product concepts from all stakeholders, including users, clinicians, and payers. I'd now like to turn the call back to Mike for a review of financial details.