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 that the Healthcare Quality Association on Accreditation (HQAA) has certified Myomo meets the accreditation requirements under the Social Security Act and federal regulations. Accreditation is a program in which trained external peer reviewers evaluate a healthcare organization's compliance and compare it with pre-established performance standards.
In September 2020, the Company announced that the Centers for Medicare & Medicaid Services (CMS) under the U.S. Department of Health and Human Services had authorized the Company to be a Medicare Provider. This authorization required the Company to become accredited, and it has now met that requirement.
Paul R. Gudonis, Myomo CEO, said, “Today, reimbursement for the MyoPro orthosis is approved on a case-by-case basis by many Medicare Advantage plans, state Blue Cross / Blue Shield plans, certain Medicaid and commercial insurance plans, worker’s compensation plans, and the Veterans Administration. Obtaining broader coverage would allow us to potentially better serve the qualifying beneficiaries of Medicare and other plans who suffer a paralyzed or weakened arm caused by stroke or nerve injury. I want to emphasize that we have not yet received coverage or reimbursement terms from CMS, and in fact there is no guarantee those terms will be forthcoming soon. Nonetheless, accredited provider status is an important step following on to our receiving Healthcare Common Procedure Coding System (HCPCS) codes from CMS and demonstrates we have the infrastructure in place to support Medicare patients when we have coverage from Medicare. We will continue to advocate for MyoPro coverage to help appropriate candidates obtain this useful technology for use at home, at work, and in school.”
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 Cambridge, 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 benefits expected from HQAA accreditation, 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:
- our sales 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 development programs; and
- general market, economic, environmental and social factors, including the ongoing COVID-19 pandemic, 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.