Myomo (MYO) 24th Annual Needham Virtual Healthcare Conference summary

Key business developments

• Medicare reimbursement since April last year has expanded access to over 600,000 potential candidates in the U.S., with a large prevalence population of 3 million individuals with upper limb paralysis.

• The company holds a first-mover advantage, strong patent position, and is the only provider in the U.S. market, with expansion into Germany and a joint venture in China.

• Over 3,000 devices have been delivered, with accelerating revenue growth and a clear reimbursement pathway, including a 2.4% fee increase effective January 1.

• Direct billing channel represented 82% of Q4 revenue, with Germany accounting for 12% and the O&P channel targeted for significant growth in 2025.

• Medicare Advantage and VA coverage, as well as contracts with major insurers, are driving further market penetration.

Product and technology highlights

• The device uses proprietary non-invasive brain-computer interface technology to amplify faint EMG signals, enabling paralyzed individuals to regain arm and hand function.

• Custom fabrication and remote measurement kits allow for personalized fitting and broader access.

• The MyoPro is FDA Class II, 510(k) exempt in the U.S., and CE marked in Europe.

• The company has a robust IP portfolio with 35 U.S. patents extending to 2042.

• Ongoing R&D investment aims to accelerate new product development and maintain technological leadership.

Financial performance and outlook

• Q4 revenue reached a record $12.1 million, with full-year revenue at $32.6 million and gross margin of 71.2%.

• Operating expenses are expected to exceed $40 million in 2025, with R&D spend doubling to support growth.

• Positive free cash flow of $2.4 million was generated in Q4, with $24.9 million in cash and investments at year-end.

• Full-year 2025 revenue guidance is $50–$53 million, reflecting a 54%–63% growth rate.

• Tariff impacts are expected to be minimal, with less than 100 basis points effect on gross margin.