Myomo Receives Order from the Louis Stokes Cleveland VA Medical Center to Support MyoPro Clinical Trial
August 30 2022 - 8:30AM
Business Wire
Dr. Svetlana Pundik of the Louis Stokes
Cleveland VA Medical Center to lead the investigator-initiated
study
Myomo, Inc. (NYSE American: MYO) (“Myomo” or the
“Company”), a wearable medical robotics company that offers
increased functionality for those suffering from neurological
disorders and upper-limb paralysis, today announced receipt of a
$120,000 order for MyoPro® units from Cleveland’s Louis Stokes
Veterans Administration (“VA”) Medical Center. The units will be
used in an investigator-initiated, randomized clinical trial led by
Svetlana Pundik, M.D., Assistant Professor, Department of
Neurology, Case Western Reserve University School of Medicine and
Director, Brain Plasticity and Neural Recovery Research Laboratory
and Staff Neurologist, Louis Stokes Cleveland VA Medical Center.
This independent study is further supported by the VA’s Office of
Research and Development. Revenue associated with the delivery of
these units is expected to begin to be realized in the coming
months as study subjects are fitted with their devices.
The primary objective of this trial is to study the efficacy of
the MyoPro in motor learning-based therapy for individuals with
chronic stroke (>6 months post event) with severe upper limb
motor deficits (Fugl-Meyer for Upper Limb score less than 30),
compared with motor learning-based therapy alone.
“This study by the Cleveland VA represents an important addition
to the established body of evidence documenting the benefits of
MyoPro,” said Harry Kovelman, M.D., Chief Medical Officer of Myomo.
“Randomized clinical trials represent the highest level of research
as viewed by clinical professionals and third-party payers. We look
forward to sharing the evidence Dr. Pundik and her colleagues will
provide in this new study to assess the efficacy of using the
Myopro in motor learning-based therapy for individuals suffering
with severe upper limb deficits resulting from chronic stroke.”
Additional details of the new study are available here.
About Myomo, Inc.
Myomo, Inc. is a wearable medical robotics company that offers
improved arm and hand function for those suffering from
neurological disorders and upper limb paralysis. Myomo develops and
markets the MyoPro product line. MyoPro is a powered upper limb
orthosis designed to support the arm and restore function to the
weakened or paralyzed arms of patients suffering from CVA stroke,
brachial plexus injury, traumatic brain or spinal cord injury, ALS
or other neuromuscular disease or injury. It is currently the only
marketed device that, sensing a patient’s own EMG signals through
non-invasive sensors on the arm, can restore an individual’s
ability to perform activities of daily living, including feeding
themselves, carrying objects and doing household tasks. Many are
able to return to work, live independently and reduce their cost of
care. Myomo is headquartered in Boston, Massachusetts, with sales
and clinical professionals across the U.S and representatives
internationally. For more information, please visit
www.myomo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
the Company’s future business expectations, including the timing of
revenue recognition from the devices provided for the study,
conclusions reached about effectiveness of the MyoPro arising from
the randomized clinical trial and outcomes from subsequent
discussions from commercial payers, which are subject to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are only predictions and
may differ materially from actual results due to a variety of
factors.
These factors include, among other things:
- the direct and indirect impact of the novel coronavirus
(COVID-19) on our business and operations, including fabrication
and delivery, sales, patient consultations, supply chain,
manufacturing, insurance reimbursements and employees;
- our ability to continue normal operations and patient
interactions in order to cast, deliver and fit our
custom-fabricated device;
- our marketing and commercialization efforts;
- our ability to achieve reimbursement from third-party payers
for our products;
- our dependence upon external sources for the financing of our
operations, to the extent that we do not achieve or maintain cash
flow breakeven;
- our ability to effectively execute our business plan and scale
up our operations;
- our expectations as to our product development programs,
and;
- general market, economic, environmental and social factors that
may affect the evaluation, fitting, delivery and sale of our
products to patients.
More information about these and other factors that potentially
could affect our financial results is included in Myomo’s filings
with the Securities and Exchange Commission, including those
contained in the risk factors section of the Company’s annual
report on Form 10-K, quarterly reports on Form 10-Q and other
filings with the Commission. The Company cautions readers not to
place undue reliance on any such forward-looking statements, which
speak only as of the date made. Although the forward-looking
statements in this release of financial information are based on
our beliefs, assumptions and expectations, taking into account all
information currently available to us, we cannot guarantee future
transactions, results, performance, achievements or outcomes. No
assurance can be made to any investor by anyone that the
expectations reflected in our forward-looking statements will be
attained, or that deviations from them will not be material and
adverse. The Company disclaims any obligation subsequently to
revise any forward-looking statements to reflect events or
circumstances after the date of such statements or to reflect the
occurrence of anticipated or unanticipated events.
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version on businesswire.com: https://www.businesswire.com/news/home/20220830005216/en/
For Myomo: ir@myomo.com LHA Investor Relations Kim Sutton
Golodetz 212-838-3777 kgolodetz@lhai.com
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