MyoPro Approved in Australia by National Disability Insurance Scheme

Rhea-AI Summary

Myomo, Inc. (NYSE American: MYO) announced that the National Disability Insurance Scheme (NDIS) in Australia has approved reimbursement for the MyoPro device, enhancing access for patients with upper-limb paralysis. The first beneficiary, Natalee W., who suffered a brain aneurysm and stroke at 16, benefited from a trial funded by NDIS, enabling her to regain functionality in daily activities. Myomo seeks to increase market reach with this approval. The patented MyoPro technology, developed with MIT and Harvard Medical School, is designed to restore arm function through sensing the patient's EMG signals.

Positive

• NDIS approval for MyoPro enhances market access in Australia.
• Successful patient trial demonstrates MyoPro's effectiveness in daily living activities.

Negative

• Company has a history of operating losses, raising doubts about continuing as a going concern.

First reimbursement leads to greater access for patients

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, announced that for the first time, the National Disability Insurance Scheme (NDIS) in Australia approved a MyoPro for a patient with a paralyzed arm. The NDIS aids over 500,000 Australians with disabilities through reimbursement for necessary services and support.

The first MyoPro user to benefit from NDIS reimbursement is a client identified as Natalee W. Four years ago, at the age of 16, Natalee suffered a brain aneurysm and a stroke which resulted in left-side hemiparesis. The NDIS funded a two-month trial of a custom-fabricated MyoPro, which allowed Natalee to learn to use the device. Through consistent use of the MyoPro, Natalee can now perform functional activities of daily living, which she struggled with prior to using the device. Priya Armstrong, Senior Orthotist with NeuroMuscular Orthotics, stated, "For clients such as Natalee, that have been undergoing long-term rehabilitation with minimal functional improvements in their arm and hand, the MyoPro provides a sophisticated orthotic solution that enables the user to self-perform ADL tasks."

The patented MyoPro technology was developed by Myomo in collaboration with researchers at the Massachusetts Institute of Technology and Harvard Medical School. "I am so happy to have been funded for a MyoPro by NDIS," said Natalee. "I have worked so hard to regain as much function in my arm and hand, and the MyoPro has allowed me to do more than I ever imagined. I look forward to using it to increase my independence so that I don't have to rely as much on my family." John Frijters, Managing Director of International Operations for Myomo, stated, “We are pleased to see this insurance approval in Australia, which can lead to greater market access to the MyoPro for others with similar impairment and goals for independent living.”

For more information, visit www.myomo.com.

About Myomo

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 certain 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 expectations for greater market access in Australia and other geographies, 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 others:

• We have a history of operating losses and our financial statements for the period ended September 30, 2022 include disclosure regarding there being substantial doubt about our ability to continue as a going concern;

• 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 deliver and fit our custom-fabricated device;

• our marketing and commercialization efforts;

• our ability to achieve reimbursement from third-party payers for our products, including CMS for Medicare Part B patients;

• 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230206005559/en/

For Myomo:

ir@myomo.com

Investor Relations:

Kim Sutton Golodetz

LHA Investor Relations

212-838-3777

kgolodetz@lhai.com

Source: Myomo, Inc.

FAQ

What is the significance of Myomo's NDIS approval for MYO stock?

The NDIS approval allows for greater market access for Myomo's MyoPro device in Australia, potentially leading to increased revenues and improved stock performance.

Who is the first MyoPro user funded by NDIS?

The first MyoPro user funded by NDIS is Natalee W., who suffered a stroke and has seen improvements in daily activities through the device.

What technology underpins Myomo's MyoPro device?

The MyoPro technology uses non-invasive sensors to detect the patient's EMG signals, aiding in the restoration of arm function.

What financial concerns does Myomo face?

Myomo has a history of operating losses, raising significant doubt about its ability to continue as a going concern.

How can patients access Myomo's products in Australia?

Patients in Australia can access Myomo's products through NDIS reimbursement, which supports those with upper-limb paralysis.