Market Opportunity - The addressable market in the U.S. for products aimed at individuals with upper extremity paralysis is estimated at 3 million existing cases, with up to 20% potentially qualifying for MyoPro reimbursement[30]. - Approximately 250,000 new patients are added annually due to strokes and related injuries, with an estimated 25,000-50,000 potentially suitable for MyoPro each year[31]. - The MyoPro is expected to improve function in upper limbs for children with brachial plexus injuries, with a new version called MyoPal available in the next 1-2 years[42]. - The backlog of MyoPro units reached 272, representing an 18% increase from 230 units at the end of 2023, with an estimated maximum potential revenue of approximately 34,300 and 34,300 for the Motion W and approximately 67,500 for the Motion G, effective January 1, 2025[87]. - The MyoPro is classified as Durable Medical Equipment (DME) under Medicare, and reimbursement is contingent on the device being deemed medically necessary and not experimental[88]. - The reclassification of MyoPro billing codes into the brace benefit category is expected to increase sales volume from that channel in 2025 and beyond[89]. Product Development and Innovation - Myomo's strategy includes introducing the MyoPro3 and MyoPal devices, aimed at expanding their product offerings for different age groups[29]. - The MyoPro technology utilizes patented electromyography control, allowing patients to self-initiate movement through their muscle signals[27]. - The MyoPro 2, introduced in June 2017, features improvements in control technology and a longer-lasting battery, while the MyoPro2+ was launched in January 2022 with enhanced capabilities[52]. - Clinical studies have shown statistically significant improvements in functional task performance for users of the MyoPro, including gains in motor function for individuals with chronic arm weakness[54]. - The company is committed to ongoing R&D, focusing on innovations in robotics, machine learning, and material science to enhance product offerings[50]. Intellectual Property - Myomo holds 35 patents in the U.S. and various countries, with expiration dates ranging from 2027 to 2042, and has 12 pending patent applications[34]. - Myomo holds 35 issued patents, with the longest term extending intellectual property rights until 2042[66]. - Myomo has 8 pending U.S. patent applications and 4 foreign applications under examination[66]. Financial Position - As of December 31, 2024, the company had approximately 24.7 million in unrestricted cash, restricted cash, and cash equivalents, primarily held for working capital purposes[295]. - The company invests cash in overnight money market funds that focus on short-term government or government-backed securities[295]. - The company aims to preserve capital to fund its operations[295]. Manufacturing and Operations - The manufacturing operations have moved to a new facility in Burlington, MA, which has double the manufacturing floor space compared to the previous location, with a current capacity of 120 units per month[96]. - The company plans to hire more than 100 additional employees by the end of 2025 to increase clinical, reimbursement, and manufacturing capacity[98]. Compliance and Regulations - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute, which imposes strict compliance requirements[80]. - The company is subject to various federal and state healthcare laws, which could impact business operations and result in significant penalties if non-compliance is determined[84]. - The EU Medical Devices Regulation (EU MDR) requires compliance with general safety and performance requirements for medical devices[72]. - The FDA's Quality Management System Regulation Final Rule will become effective on February 2, 2026, impacting product development processes[77]. - The company actively maintains a quality management system in accordance with FDA's QSR and ISO 13485:2016 standards[77]. Market Presence and Relationships - The company has established relationships with major rehabilitation facilities, enhancing its market presence and patient referral network[36]. - The company has entered agreements with O&P providers in multiple countries, including the UK, Germany, and Australia, and received orders from providers outside the U.S. in 2024[59]. - The MyoPro has been approved by the VA system for impaired veterans, with over 130 VA facilities ordering devices for their patients[57]. - Myomo aims to establish itself as a market leader in myoelectric-controlled orthotics, leveraging its first-mover advantage in the U.S. and presence in international markets[55]. Employee Relations - The company has experienced no work stoppages and considers its relationship with employees to be good, with all employees subject to contractual agreements[97]. - The company’s future success is heavily reliant on its ability to attract and retain highly skilled employees and personnel[98]. Revenue Generation - Myomo's Motion G product generated 98% of the company's product revenue for the year ended December 31, 2024[66].
Myomo(MYO) - 2024 Q4 - Annual Report