ReWalk Robotics CEO Issues Year-End 2023 Open Letter to Shareholders and Provides 2024 Commercial and Operational Priorities
04 Gennaio 2024 - 2:00PM
ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”),
today issued an open letter from Larry Jasinski, Chief Executive
Officer, to shareholders detailing transformational achievements in
2023 and commercial and operating priorities for 2024. The full
letter is published below:
Dear Shareholders,
On behalf of ReWalk and our Board of Directors,
I want to wish everyone a happy, healthy, and safe new year. From
the outset of ReWalk’s founding, the Company has collectively
poured its collaborative efforts into manifesting our founder’s
dream:
To deliver on
the promise to fundamentally improve the lives of individuals
living with physical or neurological injury and
disability and specifically allowing large scale
access to exoskeleton technologies.
In this spirit, 2023 was a profoundly
transformational year in ReWalk’s history. We are proud to have
made great progress in navigating the pathway to appropriate
Medicare payment for our ReWalk Exoskeleton. We also expanded our
operational foundation by acquiring and integrating the AlterG
business into our family. Both achievements have positive
commercial implications for our growth and path to profitability,
and the advances that we have made are tangible and significant.
Our most important accomplishments this past year include:
- Progress with
the Centers for Medicare & Medicaid Services (“CMS”) to
finalize a new benefit category which took effect January 1, 2024
and establish a reimbursement rate, which means that we are very
close to expanding access to our life-changing technology for all
eligible Medicare beneficiaries.
- Our acquisition
and integration of AlterG which provides us scale and commercial
capabilities to provide a broader portfolio of innovative
rehabilitation solutions allowing us to capitalize on the expanding
market for exoskeletons, both of which we believe will accelerate
our path to profitability.
- Successful
achievement of FDA clearance for use of ReWalk Personal
Exoskeletons on stairs and curbs, a breakthrough which improves
quality of experience for our users by helping them walk in more
settings and increase utilization.
These achievements serve as the foundation for
our next stage of growth and goal to drive positive shareholder
value. As such, the start of the new year is an opportune time to
spotlight the Company’s 2024 commercial and operating plans.
Highlights of Commercial and Operational
Priorities for 2024
- We expect to build on our pace of
Medicare claims submissions for reimbursement with the expected
determination of the final payment rates:
- The final Healthcare Common Procedure Coding System (“HCPCS”)
decision to establish a reimbursement rate for the ReWalk
Exoskeleton is expected in February 2024 with an effective date of
April 1, 2024.
- We enter the new year with momentum and operational processes
in place to drive growth in new Medicare claims in 2024 at a
substantially increased pace compared to 2023.
- We continue to synergistically
integrate ReWalk and AlterG:
- Our sales team is working to combine product offerings and
sales territories for greater penetration of the potential clinical
customer base.
- Our sales and marketing programs are striving to expand
awareness of our technologies to the prescribing physicians,
physical therapists, and clinical community to build a broader and
higher quality referral network and sales pipeline.
- We are working to unify our staff of clinical trainers and
network of field service engineers to provide comprehensive
training capabilities and responsive technical support.
- Our focus on advancing new
innovations to market remains unabated:
- We plan to submit a 510(k) application to the FDA during the
first quarter of 2024 for the next-generation ReWalk 7 Personal
Exoskeleton.
- The company anticipates the mid-2024 launch of a new model of
the AlterG anti-gravity systems with new features that will better
address the needs of an underpenetrated market segment of smaller,
independent clinics.
- Significant progress in growing our
business and driving a multi-year path to profitability:
- We are implementing a cost structure optimization plan which
includes a 15% reduction in force implemented at the end of
2023.
- We plan to continue to further institute organizational and
policy integrations to gain greater operating efficiency as all
management functions consolidate under one team.
- Lastly, our
determination to maintain ReWalk’s Nasdaq listing remains resolute.
We anticipate the final reimbursement rate determination by CMS and
our first reimbursement payment may drive an increase in value of
our share price during the current extension period with Nasdaq
which continues through March 31, 2024.
The moves we have made drive growth in our
business and are essential to our multi-year pathway to
profitability. We look forward to sharing on our 2023 year-end
earnings call our revenue and earnings outlook for 2024 and how the
operating efficiencies that we’re executing against contribute to
our commitment to reach non-GAAP operating profitability by
2026.
In conclusion, we are excited for what’s to come
for ReWalk and all of our team members. Management will be in
attendance at various upcoming investor conferences including
participating in activities during the J.P. Morgan Healthcare
Conference in San Francisco on January 8-10, 2024. We look forward
to engaging with our stakeholders and providing future updates in
our effort to transform the lives of the thousands of people who
can benefit from our innovative technologies.
Warm regards, Larry Jasinski ReWalk Robotics
CEO
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. is a medical device company
that designs, develops, and commercializes innovative technologies
that enable mobility and wellness in rehabilitation and daily life
for individuals with neurological conditions. ReWalk’s mission is
to fundamentally change the quality of life for these individuals
through the creation and development of market leading
technologies. Through its recent acquisition of AlterG, Inc.,
ReWalk has added anti-gravity systems to its growing portfolio of
products. Founded in 2001, ReWalk has operations in the United
States, Israel, and Germany. For more information on the ReWalk
systems, please visit rewalk.com. For more information on the
AlterG systems, please visit alterg.com.
ReWalk® and ReStore® are registered trademarks
of ReWalk Robotics Ltd. in the United States and other
jurisdictions. Alter G® is a registered trademark of AlterG, Inc.
in the United States and other jurisdictions.
Forward-Looking Statements
In addition to historical information, this
press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995, Section 27A of the U.S. Securities Act of 1933, and Section
21E of the U.S. Securities Exchange Act of 1934. Such
forward-looking statements may include projections regarding
ReWalk's future performance and other statements that are not
statements of historical fact and, in some cases, may be identified
by words like "anticipate," "assume," "believe," "continue,"
"could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "future," "will," "should,"
"would," "seek" and similar terms or phrases. The forward-looking
statements contained in this press release are based on
management's current expectations, which are subject to
uncertainty, risks and changes in circumstances that are difficult
to predict and many of which are outside of ReWalk's control.
Important factors that could cause ReWalk's actual results to
differ materially from those indicated in the forward-looking
statements include, among others: ReWalk’s ability to realize the
anticipated benefits of the acquisition of AlterG, including the
possibility that the expected benefits of the acquisition will not
be realized within the expected time period or at all; potential
litigation in connection with the AlterG acquisition; uncertainties
associated with future clinical trials and the clinical development
process, the product development process and FDA regulatory
submission review and approval process; ReWalk's ability to have
sufficient funds to meet certain future capital requirements, which
could impair the Company's efforts to develop and commercialize
existing and new products; ReWalk's ability to regain and maintain
compliance with the continued listing requirements of the Nasdaq
Capital Market and the risk that its ordinary shares will be
delisted if it cannot do so; ReWalk’s ability to maintain and grow
its reputation and the market acceptance of its products; ReWalk's
ability to achieve adequate reimbursement from third-party payors,
including CMS, for its products; ReWalk's limited operating history
and its ability to leverage its sales, marketing and training
infrastructure; ReWalk's expectations as to its clinical research
program and clinical results; ReWalk's expectations regarding
future growth, including its ability to increase sales in its
existing geographic markets and expand to new markets; ReWalk's
ability to obtain certain components of its products from
third-party suppliers and its continued access to its product
manufacturers; ReWalk's ability to improve its products and develop
new products; ReWalk's compliance with medical device reporting
regulations to report adverse events involving the Company's
products, which could result in voluntary corrective actions or
enforcement actions such as mandatory recalls, and the potential
impact of such adverse events on ReWalk's ability to market and
sell its products; ReWalk's ability to gain and maintain regulatory
approvals; ReWalk's ability to maintain adequate protection of its
intellectual property and to avoid violation of the intellectual
property rights of others; the risk of a cybersecurity attack or
breach of the Company's IT systems significantly disrupting its
business operations; ReWalk's ability to use effectively the
proceeds of its offerings of securities; ReWalk’s ability to reduce
operating expenses; and other factors discussed under the heading
"Risk Factors" in ReWalk's annual report on Forms 10-K and 10-K/A
for the year ended December 31, 2022 filed with the SEC and other
documents subsequently filed with or furnished to the SEC. Any
forward-looking statement made in this press release speaks only as
of the date hereof. Factors or events that could cause ReWalk's
actual results to differ from the statements contained herein may
emerge from time to time, and it is not possible for ReWalk to
predict all of them. Except as required by law, ReWalk undertakes
no obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise.
ReWalk Investor Contact:Mike
LawlessChief Financial OfficerReWalk RoboticsE:
investorrelations@rewalk.com
ReWalk Media Relations:LifeSci
Communications E: media@rewalk.com
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