Myomo Announces Two German Social Court Rulings Ordering MyoPro® Reimbursement
21 Agosto 2023 - 5:05PM
Business Wire
MyoPro patients win cases against German
Statutory Insurance System payers including BARMER, Germany’s
second-largest statutory health insurer
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 that two
insurers in Germany have been ordered to cover the MyoPro® as a
result of successful appeals before two regional social courts in
Germany. In each case, the courts confirmed that the MyoPro powered
arm orthosis is an orthopedic aid that serves to directly
compensate for disabilities. As a result of these rulings, BARMER,
Germany’s second-largest statutory health insurer, and Mobil BKK,
another large statutory health insurer, have been ordered to cover
the costs for the MyoPro for the two patients.
The MyoPro helps compensate for the limitation of individuals
with impaired arms and to restore the ability to use the impaired
arm and hand for activities of daily living after a stroke or
neuromuscular damage, as well as spinal cord and nerve injuries.
Among the complaints was one filed by a 34-year-old woman who
applied for a myoelectric orthosis following an automobile accident
that left her with a paralyzed arm.
"With these rulings, plaintiffs who were rejected for a MyoPro
by their statutory health insurance and filed appeals to obtain the
orthosis in social courts in Germany have now won three cases,
which confirm that the MyoPro is a device that can aid patients who
suffer from upper extremity impairment and should be covered by
statutory health insurance. In a previous ruling a social court
ruled in favor of a plaintiff against DAK, Germany’s third-largest
statutory health insurer. We’re pleased that numerous social courts
have confirmed the usefulness of the MyoPro for those with upper
extremity impairment,” said John Frijters, Managing Director of
Myomo Europe GmbH. “Because of the MyoPro, which detects even weak
contractions of the muscle fibers through non-invasive sensors
located inside the device, functions such as grasping, holding and
opening the hand, as well as bending, lifting and stretching the
elbow are made possible.”
The patented MyoPro technology was developed by Myomo in
collaboration with researchers at the Massachusetts Institute of
Technology and Harvard Medical School. One of the plaintiffs in
these cases, identified as Gina S., stated, "Since my incident, I
have been waiting to be able to move and use my hand and arm again
and increase my independence by performing activities of daily
living that need both hands."
Counsel for the plaintiff, Jan-Philippe von Hagen of Korten
Rechtsanwälte, added, “This ruling confirms again that qualified
individuals are eligible for a MyoPro orthosis. It is our
expectation that as a result of these rulings, many affected
Germans will now experience easier access to this orthopedic
aid."
For more information, please visit www.myomo.de/ or
www.myomo.com
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 Germany, and other
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 impact of
the additional rulings by social courts on reimbursement for the
MyoPro in Germany, which is 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:
- We have a history of operating losses and our financial
statements for the period ended June 30, 2023 include disclosures
regarding there being substantial doubt about our ability to
continue as a going concern;
- our ability to achieve reimbursement from third-party payers
for our products, including CMS for Medicare Part B patients;
- our ability to continue to serve patients with Medicare
Advantage insurance plans CMS does not cover the MyoPro;
- our revenue concentration with a particular insurance payer as
a result of focusing our efforts on patients with insurers who have
previously reimbursed for the MyoPro;
- our ability to continue normal operations and patient
interactions without supply chain disruption in order to deliver
and fit our custom-fabricated device;
- our marketing and commercialization efforts;
- 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/20230821119339/en/
For Myomo: ir@myomo.com Investor Relations: Kim Sutton Golodetz
LHA Investor Relations 212-838-3777 kgolodetz@lhai.com
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