Larry Jasinski
Analyst · Canaccord Genuity. Your line is now open
Thanks, Kevin. As I stated in my opening remarks, 2015 was a better year for ReWalk and we entered 2016 with significant momentum. We announced two important developments for the Department of Veterans Affairs that will have both immediate near-term implications for our business as well as long-term benefits for our industry and the FCI community. Combined with our multi-faceted reimbursement efforts that are beginning to show results, we are confident in the opportunities for our business to maintain momentum and gain further traction in 2016. Earlier this month, we announced that our first external appeal of an initial coverage denial by a health plan in the Northwest US was successful. The Independent Medical Review Organization determined that the ReWalk is not an experimental investigational technology, citing evidence in current peer review that ensures to support the use of ReWalk for patient with spinal cord injury. Additionally, and equally as important, the Independent Medical Organization’s report concludes that powered exoskeleton [indiscernible] provide non ambulatory individuals with spinal cord injury, the ability to walk at modest speed. The Independent Review and report concluded that the ReWalk was deemed medically necessary for the individual. This man was a surgeon. He suffered a spinal cord injury and remained tied to a wheelchair until the ReWalk became available. Saving the ReWalk under his insurance plan will allow him to stand up and walk at home and at work. This endorsement by an Independent Medical Review Board validates the extensive peer review literature, the quality of our product and the importance of our dedication in efforts to support patients to gain access through their insurance providers. We have similar success and a legal review of an appeal in Germany, where an employer-based fund and the local social and youth agency initially rejected the claim citing the availability of alternative methods such as wheelchairs. In response to an appeal filed on September 1st, 2015, the payment for the system was approved. ReWalk is the most studied exoskeleton in the world. Last month, a first of its kind, quality of life case study was published in the peer review journal Spinal Cord Series and Cases, which is published by the International Spinal Cord Society. The study tracks six months of ReWalk use and concluded that the patient was able to walk independently with limited supervision, and demonstrated significant improvement in several quality of life measures including mobility, risk of falling, motor skills, control of bladder and bowel function. Furthermore, the study also documented improvements in cardiovascular endurance and motor neurological status. The study used a SF-36 questionnaire, which is the standard for measuring quality of life results. As we mentioned last quarter, we are collaborating with various independent research groups to collect data on the economics of life in a wheelchair. Among other things, we want to understand the economic impact of spinal cord injury in patients and the healthcare system that supports them whether that means the cost of treatments for co-morbidity conditions or reduced earnings potential and quality of life. We believe the state [ph] goes a long way towards demonstrating the clinical and economic advantages of the ReWalk system. And on this basis, we expect it to help us achieve additional success in our coverage appeals and initial submissions. We expect the first economic publication to be available later this quarter. I'd like to turn now to the extensive work we have done and we'll continue to do with the Veterans Affair Administration. We have been talking about this for quite some time and now I am pleased to be able to share details of the work we have been doing and how we expect the two VA decisions to impact our business. The Department of Veteran Affairs is the largest single healthcare provider for individuals with spinal cord injury in the United States. Recently, the VA initiated the largest ever independent multi-center study to evaluate the quality of life and health benefits of exoskeleton use. The two arm study will include 160 participants at up to 10 VA medical centers with SCI services over the course of four years. The first cohort, we have received a non-exoskeleton related standard of care, plus the ReWalk exoskeleton. The second cohort, we have received only the current standard alter [ph]. And there were two primary outcomes measures for the study. They include the mental health component summary score of the SF-36 [ph] item health survey, which measures the vitality, social functioning, emotional and mental health of the participant. And the sum T-score of the SCI quality of life broader management difficulties, power management difficulties and pain interference item banks will be compared to those participants that only use a wheelchair from the belt [ph]. The VA will determine the pace of the study and the number and timing of ReWalk units that we'll ultimately purchase. However, we see this as a significant driver for us longer-term. Under the clinical protocol, 160 patients will be randomized with half receiving device for use in their home or community for four months. Once the subject successfully completes that portion of the trial, they will be eligible to acquire a device for a permanent use. Additionally, after the four-month study period, the control group that did not receive a ReWalk will be eligible and prioritized for training to acquire a personal device for themselves. Additionally, since receiving FDA clearance for personal use, we have been working closely with the VA to support the request for materials as they established a standard operating procedure to provide exoskeletons for individuals with SCIs. In late December, the VA published its National Coverage Policy for evaluation, training and procurement of ReWalk systems for all qualified veterans throughout the country. Based on clinical research currently available, the VA now defines the use of an exoskeleton as a standard of care for qualified veterans with SCI. This is a significant step forward for us as well as for the approximately 50,000 veterans, who are paralyzed in the US, a portion of whom would qualify for a ReWalk System. This SOP offers veterans a clear path forward to receiving their own ReWalk device for use at home and in the community. The VA's new policy represents a unique opportunity to improve the health and quality of life of these individuals. We are very encouraged by the opportunities presented by both of these tracks within the VA and look forward to supporting their needs as they scale up these significant efforts. We work side-by-side with Veterans Associations and from the high level of support within the VA, Congress and the White House. The VA is leading the way in this emerging field that will ultimately benefit the broader SCI community. Our focus areas for 2016 are as follows: First, we will continue our efforts to expand reimbursement support for ReWalk by applying the same strategy that is successful with the VA. Namely engaging SCI advocacy groups, utilizing a top down and bottom-up approach for education, leveraging clinical publications and finally, expanding the health economics knowledge-based related to SCI. This year, we will advance four studies, documenting the impact of SCI in the healthcare system. Each will be published in a peer review publication throughout 2016 and early 2017. And with these we'll provide added data supporting the benefit of our technology. In parallel, we will initiate a health economics, clinical study with enrollment to begin in the second half of this year. Second, we will support the VA in facilitating the study launch and rolling out the standard operating procedure nationwide. This includes qualifying and evaluating candidates, training support for VA, SCI centers and procurement of ReWalk devices for eligible veterans. Third area of emphasis. We will continue to invest in our R&D program to develop the next generation of ReWalk devices that are slimmer, lighter and more efficient. The ReWalk 6.0 is the most advanced exoskeleton in the market with clear design and software advantages compared to known products in development today. Our first-to-market position provides us the large and growing database of user feedback, regarding our products. This confirms our work to deliver relevant improvements to existing products as well as the design of revolutionary new products. I am very encouraged by the scores of people that are now able to walk with the assistance of the ReWalk exoskeleton and the many more who will walk as a result of the strong foundation we are building. I'd like to share a few of those stories with you now. In Israel, a paralyzed young man did not want to be confined with wheelchair for his wedding. Thanks to the ReWalk, he walked down the aisle and was able to stand eye-to-eye with his bride as they exchanged their vows. In Canada, a young man who was hit in the head with an axe by the Taliban in Afghanistan lost his ability to walk. Now despite this vicious attack, the young man is walking again in his ReWalk as part of an ongoing clinical study. In San Francisco, a 17-year old was out one night, was mugged, shot and woke up paralyzed. A few years later, a person who had never met this paralyzed young man heard his story and decided to help him by raising funds by walking from the Mexican border to the Canadian border. The paralyzed young man now has a ReWalk that uses to walk on to the stage, and give inspirational talks on random act of kindness such as he experienced and how did we build his life. In South Carolina, one young man who had played basketball for his High School, before becoming paralyzed, recently return to the court and spent many hours. He was able to walk the court in his ReWalk with his own coach. He’s presently training to use his ReWalk in part of the Cooper Mountain Bridge Run. I’d like to share with you his comments about walking again. “The reason why the ReWalk Robotics Exoskeleton is so important to me and the rest of the spinal cord injury community is that we are no longer at the mercy of our injuries, which subsequently means our friends and family aren’t either. Words cannot describe how much I want to hug my girlfriend standing up or walk down the street under my own power or just talk with someone at the eye level, it’s the little things that in life that matter the most.” I am very proud of the ReWalk team and how far we progressed in our novel year as a public company. In 2015, we invested in building the foundation of the business in sales, reimbursement and innovation. Our strategies to increase commercial penetration and coverage are working and we’re confident that we’ll be able to leverage that momentum as we move to 2016. I look forward to updating you on our progress. With that, I’d like to open the call for questions. Operator, please go ahead with the instructions.