Larry Jasinski
Analyst · H.C. Wainwright. Please go ahead
Thank you, Mike. Welcome, everybody, and I appreciate you joining today. Fulfilling our mission of providing access to technology that changes lives and our progress in building towards an enduring financial business advanced during Q3. The Lifeward story consists of two primary businesses: one, focused on a novel system allowing ambulation and improved health outcomes and quality of life for spinal cord injury individuals. And the other anti-gravity technology for off-waiting [ph] individuals for conditioning injury recovery, treatment of neuro disorders, weight loss and overall health and wellness. We are very excited about our novel exoskeleton technology, the ReWalk Exoskeleton because although the product has been available in the market for a number of years, we are now at the start of commercial expansion as a result of the Medicare coverage that the company was able to gain this past April. Our immediate coverage base in the United States has expanded to over 17,000 individuals with a potential and coverage of another 25,000 as access expands to additional payors. Our differentiated anti-gravity technology services a range of users from professional athletes to everyday patients. In particular, those recovering from a broad range of injuries, those seeking weight loss solutions and those with neurological impairments such as Parkinson’s, where restoring gait is so critical. The combination of the products forms a business base with operating synergy, depth of the relationships with clinics and importantly, with physical medicine and rehabilitation physicians, who prescribe and guide training on our products and up to 17,500 clinics in our direct markets. Let me relate two stories to bring these innovative designs to life. "They changed my life". That’s the story of the patient gained access to ReWalk through Medicare coverage. She notes she made peace with life in wheelchair and looked to good life. But when Medicare allowed access, she and her physician decided to try ReWalk so that she could achieve with physical activity goals and gain health benefits, such as improved pain reduction, improvement in social functioning and mental health and improved bowel health amongst a few. Since ReWalk, she relates a feeling of normalcy working in the kitchen and lists a number of health benefits from walking once again. She named her device Luke ReWalker. Another patient suffered from extensive knee pain and her weight prevented knee surgery to address her pain. With the advice of her physician, she utilized AlterG’s differential air pressure technology, and she was able to reduce your weight exercise in the AlterG. This enabled her to subsequently have the knee surgery, which allowed a major improvement in our life. This is one of the growing segments for anti-gravity technology. The company made significant progress during the quarter. Key developments: We continue to grow the business with a 39% increase over the prior year quarter. We had 20 more individuals regain ambulation from ReWalk placements in the quarter. Coverage for ReWalk started with the establishment of payment in April and the process for qualifying documentation, processing, trial and training takes time. Our range has been broad ranging from 55 days to over 1,000 days. For cases that were both sourced and completed in 2024, the claims processing time frame has been about 150 days in these cases, which we are working to shorten going forward. We have built an engine to process claims with a dedicated team of clinicians and case managers that will allow us to support the volume we see in the coming quarters. Overall, U.S. leads have expanded 62% over prior year due to our expanded coverage and commercialization efforts to drive adoption and uptake. Due to these efforts, our current U.S. pipeline with Medicare and other U.S. payors is now approximately 70 qualified contacts, which bodes well for future quarters and drives our optimistic outlook. Turning our focus to the AlterG technologies. While there’s been a lot of good that gives me and should give you great optimism for the future, the business has not delivered on my expectations this year. I am convinced this is a fantastic technology based on the high level of utilization clinics, the direct customer feedback and supporting scientific literature. It’s an important part of our strategy going forward. However, we came out of the gate slower than we planned in 2024 after the acquisition, which in retrospect should not have been surprising given the amount of change, turnover and distraction that comes with the consolidation. Secondly, we are being impacted by the delays in capital expenditures, particularly in smaller provider organizations that have been well reported in the industry. Our market intelligence tells [indiscernible] are seeing the same impact. We do continue to have optimism here as our third quarter replacement run rate was better than the first half of the year. We have the best product and to the best of our knowledge are not losing sales to competitors and the market reaction to our recently introduced NEO model has been strong with about 40 orders to date. We are also aligning our sales and market efforts with how the rehabilitation provider industry is consolidated. We are anticipating a strong fourth quarter for AlterG, which will set us up well for 2025. In 2024, we have focused on operational efficiency. We made an announcement last week about the closure of two facilities and the financial impact. This is the final step with a number of moves to consolidated efforts, leading to a streamlined organization and the ability to focus on driving ReWalk growth. Our $6.7 million adjusted operating expenses in the quarter is our lowest in the previous five quarters. This will improve as we drive ReWalk sales and capture the efficiencies of this latest consolidation. Our model supports the ability to reach breakeven and requires a sufficient pace of Medicare ramp and processes, successful penetration with the new AlterG NEO system and some recovery of funding activity in the capital equipment markets that we anticipate in 2025. Our R&D focus in 2024 was driven by the launch of the NEO and the NEO+, which were successfully launched midyear, and by the ReWalk 7-0 [ph], a system which is much easier to use and adds essential real-time transmission of data on utilization. The 7-0 is under FDA review and in the follow-up question base. We will complete the requested studies with additional data by year-end. We anticipate FDA clearance to follow in the early months of 2025. I would now like to turn the call over to Mike Lawless for a financial review. Mike?