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Myomo, a company focused on wearable medical robotics, has received a $120,000 order for MyoPro units from the Louis Stokes Cleveland VA Medical Center. This order supports an investigator-initiated randomized clinical trial led by Dr. Svetlana Pundik, aimed at assessing the MyoPro’s efficacy in motor learning therapy for chronic stroke patients with severe upper limb deficits. Revenue from this order is anticipated in the coming months as devices are fitted to study participants.
Positive
Receipt of a $120,000 order for MyoPro units, indicating demand for the product.
Initiation of a randomized clinical trial to study the efficacy of MyoPro, potentially strengthening market position.
Support from the VA’s Office of Research and Development adds credibility to the study.
Negative
Dependence on external financing could affect operational stability.
Risks related to COVID-19 could impact business operations and device delivery.
There is no guarantee of positive trial outcomes, which could affect future product acceptance and reimbursement.
Dr. Svetlana Pundik of the Louis Stokes Cleveland VA Medical Center to lead the investigator-initiated study
BOSTON--(BUSINESS WIRE)--
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.
What is the purpose of the clinical trial associated with Myomo?
The clinical trial aims to evaluate the efficacy of MyoPro in motor learning-based therapy for chronic stroke patients with severe upper limb motor deficits.
Who is leading the clinical trial for MyoPro?
The trial is led by Dr. Svetlana Pundik from the Louis Stokes Cleveland VA Medical Center.
How much revenue is Myomo expecting from the recent MyoPro order?
Myomo expects to realize revenue of $120,000 from the order for MyoPro units in the coming months.
What are the potential market impacts of Myomo's recent clinical trial?
Successful outcomes from the clinical trial could enhance Myomo's credibility and acceptance by third-party payers, potentially driving product adoption.
