Highlights the Firm’s Latest Progress and Momentum In direction of Worth-Enhancing Commercialization and Reimbursement
Notes that Present Board and Administration Crew Have the Proper Talent Units, Institutional Information and Third-Social gathering Relationships to Implement Reimbursement Protection and Create Lengthy-Time period, Sustainable Worth for Shareholders
Assessment of CVC Director Nominees Signifies They Would Not Add Worth to the Board, Particularly at this Vital Stage for the Firm
MARLBOROUGH, Mass. and BERLIN and YOKNEAM ILIT, Israel, Might 26, 2022 (GLOBE NEWSWIRE) — ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Firm”), a number one producer of robotic medical know-how for individuals with decrease extremity disabilities, in the present day introduced that it has filed its revised preliminary proxy assertion with the U.S. Securities and Trade Fee (the “SEC”). In reference to this submitting, the Firm’s Board of Administrators (the “Board”) issued the beneath letter to shareholders.
Might 26, 2022
Thanks in your funding in ReWalk Robotics and your confidence in our life-changing applied sciences. We’re writing to you as a result of this 12 months’s Annual Assembly of Shareholders (the “Annual Assembly”) might be particularly essential, as we’re closing in on attaining essential milestones to pave the way in which for broader affected person entry to our options, which we consider will improve worth creation.
Your Board and administration crew are working laborious to proceed to create worth by pursuing elevated entry to wearable robotic exoskeletons by expanded reimbursement protection within the U.S. and Germany. These efforts are catalysts for attaining sustainable progress stemming from our years of considerate funding in analysis, growth and innovation. In our view, ReWalk is at an thrilling inflection level on the street to broad commercialization.
Our core technique includes the next:
- Including systemic protection and reimbursement with the Facilities for Medicare and Medicaid (“CMS”) and different payers to enhance lives and create pathways for people to learn from our applied sciences
- Making significant progress on key long-term initiatives, together with creating the infrastructure for claims processing put up payer approvals and to enhance Veterans Affairs (“VA”) help post-COVID
- Advancing technical developments that increase our addressable markets and permit more practical penetration beneath current protection packages
- Increasing the Firm product portfolio to realize sooner progress on the trail to profitability
Beneath we define in additional element the thrilling progress so far and our plans for the longer term.
THE BOARD AND MANAGEMENT HAVE OVERSEEN TANGIBLE PROGRESS AGAINST PREVIOUSLY SET GOALS
Your Board and administration crew have been targeted on making a significant and sustainable marketplace for the non-public use of robotic applied sciences to vary sufferers’ lives. We have now made tangible progress, together with the next:
- Achieved 36% YOY income progress in 2021 in comparison with 2020, on account of our expanded gross sales crew, growing market entry and efficiently constructing on our contracts
- Constructed foundational medical knowledge and infrastructure that allowed us to acquire CMS Exoskeleton code issuance and progress on protection
- Prioritized working with particular person affected person circumstances to ascertain a extra environment friendly claims processing system with a view to facilitate clean processing of circumstances
- Obtained expanded Exoskeleton reimbursement protection in Germany with two further provide agreements
- Added a contract with Rebotics Know-how within the U.Ok. with a view to present the total infrastructure wanted to help growth within the U.Ok.
- Continued to drive enhancements to our ReWalk Private Exoskeleton in preparation for 2 completely different FDA submissions anticipated in 2022. These design advances increase upon our place as probably the most used private exoskeleton on this planet and can enhance performance and usefulness to additional improve adoption of the ReWalk Exoskeleton
- Achieved FDA breakthrough standing for 2 R&D merchandise that certified for CMS protection beneath the prior Medicare Protection of Revolutionary Know-how pointers, and we’re offering legislative help by working with the Medical Machine Producers Affiliation for the Transitional Protection of Rising Applied sciences protection proposals which might be supposed to change and enhance the prior proposal
- Launched Nationwide Well being Service pilot and made significant progress on our U.S. nationwide pilot initiative for our ReStore stroke product within the U.Ok. and U.S.
- Maintained a robust steadiness sheet with no debt, to help the achievement of our objectives
WE HAVE STRONG MOMENTUM HEADING INTO THE SECOND HALF OF 2022 AND ARE APPROACHING CRITICAL MILESTONES THAT REQUIRE OUR FULL BOARD’S EXPERTISE AND KNOWLEDGE
A number of pivotal milestones lay forward within the the rest of this 12 months, and collectively we’re laser-focused on leveraging the value-enhancing potential of those developments by:
- Constructing on the CMS code that was achieved by defining the profit class – with the optimistic growth that we now have been included within the June 8th first biannual Healthcare Frequent Process Coding System (HCPCS) session; in parallel, we’ll start to submit the primary Medicare circumstances as a part of the pricing and provide course of within the the rest of this 12 months
- Anticipating the issuance of a German Federal Social Courtroom ruling that may make clear the reimbursement construction for exoskeletons and assist to ascertain them as a normal of care. This may allow the growth of further provide contracts
- Trying to obtain YOY income progress with the VA reopening put up COVID-19 pandemic, German growth and the initiation of circumstances with CMS
- Specializing in new enterprise growth with the potential addition of a number of industrial product strains designed to leverage our present gross sales pathways and shorten the timeline to profitability
WE ARE COMMITTED TO ENSURING OUR BOARD IS CONTINUALLY REFRESHED WITH THE RIGHT MIX OF SKILL SETS AND EXPERIENCE TO OVERSEE VALUE CREATION
We consider we now have a robust Board with the mandatory mixture of important expertise and related expertise to assist drive our efforts to realize broader reimbursement for, and commercialization of, our life-changing applied sciences.
As a Board, we’re targeted on refreshment and evaluating on an ongoing foundation whether or not we now have the correct ability units to maximise worth in any respect ranges. Our dedication to Board refreshment is one thing we take very significantly:
- Final month, we appointed Joseph Turk, Jr., a seasoned medical machine skilled with in depth expertise in medical machine commercialization, to the Board
- Previous to that, in October 2020, we appointed Randel Richner to the Board. Ms. Richner is a healthcare coverage and reimbursement professional with over 30 years of expertise bringing well being economics and reimbursement strategic companies to the healthcare business
- Each Mr. Turk and Ms. Randel deliver important ability units in reimbursement and post-CMS reimbursement, which is what we consider ReWalk wants at this essential level
Sadly, Inventive Worth Capital Restricted Partnership (“CVC”), which claims to carry roughly 3% of ReWalk’s excellent shares, has submitted a discover of its intent to appoint candidates for election to the Board and submit two further proposals for consideration on the Annual Assembly.
We consider that each one three of our candidates up for election on the Annual Assembly – CEO Larry Jasinski, Dr. John William Poduska and Randel Richner – are essential to sustaining momentum with reimbursement and know-how growth. Their expertise and particular roles in these areas are important to our success. CVC has supplied restricted details about its nominees and has not articulated why they need to be elected to the Board. We strongly advocate that shareholders don’t vote for any of CVC’s nominees.
Moreover, amongst CVC’s proposals is the removing of three of our sitting administrators: Chairman Jeff Dykan, Yohanan Engelhardt and Yasushi Ichiki – all of whom deliver integral and distinctive ability units and expertise to the Board. CVC has supplied no rationalization as to why it believes it could be good for our Firm to take away these administrators from the Board, together with the Chairman, and we consider such removals could be detrimental to shareholders. We subsequently advocate that shareholders don’t help this proposal.
Regardless of ongoing discussions, CVC has not made religion try and work constructively with our Board, nor has it supplied us with any ideas for bettering our enterprise or every other perception into how its nominees would improve worth for all shareholders. Consequently, our Board can’t and doesn’t endorse any of the shareholder nominees. Nonetheless, we stay open to a continued dialogue with a view to keep away from a pricey, distracting and pointless proxy contest that threatens our trajectory.
Thanks in your help.
|Jeff Dykan, Chairman||Arik Dan||Yohann Engelhardt||Yasushi Ichiki||Larry Jasinski|
|Dr. John William Poduska||Randel Richner||Joseph Turk||Wayne B. Weisman|
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for people with decrease limb disabilities on account of spinal twine damage or stroke. ReWalk’s mission is to basically change the standard of life for people with decrease limb incapacity by the creation and growth of market main robotic applied sciences. Based in 2001, ReWalk has headquarters within the U.S., Israel and Germany. For extra data on the ReWalk programs, please go to rewalk.com.
ReWalk® and ReStore® are registered logos of ReWalk Robotics Ltd. in the USA and different jurisdictions.
Ahead Wanting Statements
Along with historic data, this press launch accommodates forward-looking statements inside the which means of the U.S. Non-public Securities Litigation Reform Act of 1995, Part 27A of the U.S. Securities Act of 1933, and Part 21E of the U.S. Securities Trade Act of 1934. Such forward-looking statements might embrace projections relating to ReWalk’s future efficiency and different statements that aren’t statements of historic truth and, in some circumstances, could also be recognized by phrases like “anticipate,” “assume,” “consider,” “proceed,” “may,” “estimate,” “anticipate,” “intend,” “might,” “plan,” “potential,” “predict,” “undertaking,” “future,” “will,” “ought to,” “would,” “search” and comparable phrases or phrases. The forward-looking statements contained on this press launch are based mostly on administration’s present expectations, that are topic to uncertainty, dangers and adjustments in circumstances which might be troublesome to foretell and plenty of of that are exterior of ReWalk’s management. Necessary components that would trigger ReWalk’s precise outcomes to vary materially from these indicated within the forward-looking statements embrace, amongst others: uncertainties related to future medical trials and the medical growth course of, the product growth course of and FDA regulatory submission evaluate and approval course of; the hostile impact that the COVID-19 pandemic has had and will proceed to have on the Firm’s enterprise and outcomes of operations; ReWalk’s capability to have adequate funds to satisfy sure future capital necessities, which may impair the Firm’s efforts to develop and commercialize current and new merchandise; ReWalk’s capability to keep up compliance with the continued itemizing necessities of the Nasdaq Capital Market and the chance that its abnormal shares might be delisted if it can’t accomplish that; ReWalk’s capability to keep up and develop its popularity and the market acceptance of its merchandise; ReWalk’s capability to realize reimbursement from third-party payors, together with CMS, for its merchandise; ReWalk’s restricted working historical past and its capability to leverage its gross sales, advertising and marketing and coaching infrastructure; ReWalk’s expectations as to its medical analysis program and medical outcomes; ReWalk’s expectations relating to future progress, together with its capability to extend gross sales in its current geographic markets and increase to new markets; ReWalk’s capability to acquire sure parts of its merchandise from third-party suppliers and its continued entry to its product producers; ReWalk’s capability to enhance its merchandise and develop new merchandise; ReWalk’s compliance with medical machine reporting laws to report hostile occasions involving the Firm’s merchandise, which may lead to voluntary corrective actions or enforcement actions akin to obligatory recollects, and the potential affect of such hostile occasions on ReWalk’s capability to market and promote its merchandise; ReWalk’s capability to realize and preserve regulatory approvals; ReWalk’s capability to keep up sufficient safety of its mental property and to keep away from violation of the mental property rights of others; the chance of a cybersecurity assault or breach of the Firm’s IT programs considerably disrupting its enterprise operations; ReWalk’s capability to make use of successfully the proceeds of its choices of securities; and different components mentioned beneath the heading “Danger Elements” in ReWalk’s annual report on Kinds 10-Ok and 10-Ok/A for the 12 months ended December 31, 2021 filed with the SEC and different paperwork subsequently filed with or furnished to the SEC. Any forward-looking assertion made on this press launch speaks solely as of the date hereof. Elements or occasions that would trigger ReWalk’s precise outcomes to vary from the statements contained herein might emerge every so often, and it’s not doable for ReWalk to foretell all of them. Besides as required by legislation, ReWalk undertakes no obligation to publicly replace any forward-looking statements, whether or not on account of new data, future developments or in any other case.
Necessary Further Info
The Firm, its administrators and sure of its government officers are contributors within the solicitation of proxies from the Firm’s shareholders in reference to the Annual Assembly. The Firm intends to file a definitive proxy assertion and a WHITE proxy card with the SEC in reference to any such solicitation of proxies from the Firm’s shareholders. SHAREHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH PROXY STATEMENT, ACCOMPANYING WHITE PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. The Firm’s definitive proxy assertion for the 2021 annual assembly of shareholders accommodates data relating to the direct and oblique pursuits, by safety holdings or in any other case, of the Firm’s administrators and government officers within the Firm’s securities. Info relating to subsequent adjustments to their holdings of the Firm’s securities may be discovered within the SEC filings on Kinds 3, 4 and 5, which can be found on the Firm’s web site at http://ir.rewalk.com or by the SEC’s web site at www.sec.gov. Info may also be discovered within the Firm’s Annual Report on Type 10-Ok for the 12 months ended December 31, 2021 and Modification No. 1 to the Firm’s Annual Report on Type 10-Ok for the 12 months ended December 31, 2021 on file with the SEC. Up to date data relating to the id of potential contributors, and their direct or oblique pursuits, by safety holdings or in any other case, might be set forth within the definitive proxy assertion and different supplies to be filed with the SEC in reference to the Annual Assembly. Shareholders will be capable to acquire the definitive proxy assertion, any amendments or dietary supplements to the proxy assertion and different paperwork filed by the Firm with the SEC at no cost on the SEC’s web site at www.sec.gov. Copies can even be out there at no cost on the Firm’s web site at http://ir.rewalk.com.