Outset Medical, Inc.

Previous wording

You should carefully consider the risk factors discussed in Part I, “Item 1A. Risk Factors” in our 2025 Annual Report, which could materially affect our business, financial position, or future results of operations. There have been no material changes to the risk factors described in our 2025 Annual Report, except as set forth below. The risks described in our 2025 Annual Report, as updated below, are not the only risks that we face. Additional risks and uncertainties not precisely known to us, or that we currently deem to be immaterial, may also arise and materially impact our business. If any of these risks occur, our business, results of operations and financial condition could be materially and adversely affected and the trading price of our common stock could decline.

Current wording

You should carefully consider the risk factors discussed in Part I, “Item 1A. Risk Factors” in our 2025 Annual Report, as updated by the risk factors discussed in Part II, “Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2026 (Q2 2026 Quarterly Report), which could materially affect our business, financial position, or future results of operations. There have been no material changes to the risk factors described in our 2025 Annual Report, as updated by our Q2 2026 Quarterly Report, except as set forth below. The risks described in our 2025 Annual Report and Q2 2026 Quarterly Report, as updated below, are not the only risks that we face. Additional risks and uncertainties not precisely known to us, or that we currently deem to be immaterial, may also arise and materially impact our business. If any of these risks occur, our business, results of operations and financial condition could be materially and adversely affected and the trading price of our common stock could decline.

Previous wording

For example, in the third quarter of 2026, the FDA conducted another post-market, quality management system inspection of our San Jose, California facility, following a prior similar inspection in 2023. At completion of this most recent inspection, the FDA issued a Form FDA-483 identifying certain inspectional observations. We intend to provide a complete response to the FDA to address these observations in a timely manner. There is no guarantee, however, that we will be able to successfully address these observations within a specified time frame or without incurring additional, and possibly significant, costs. The FDA may also supplement the Form FDA Form-483 with further regulatory communications or actions related to the most recent observations, and any future inspections of our facility by the FDA may result in other observations, any of which could adversely affect our business.

Current wording

For example, in the third quarter of 2026, the FDA conducted another post-market, quality management system inspection of our San Jose, California facility, following prior inspections in 2023 and 2024. At completion of this most recent inspection, the FDA issued a Form FDA-483 identifying certain inspectional observations that relate to quality system processes, including CAPAs (corrective actions and preventive actions), complaint handling and reporting, change documentation and data analysis. We have provided a timely response to the FDA and have incurred costs and management has dedicated time to address these observations. The costs and expenditures of management time to address the observations are likely to continue in the foreseeable future and may be significant. There is no guarantee that we will be able to successfully address these observations and the FDA may supplement the observations with further regulatory communications and/or official action, and we may also preemptively take actions, any of which could materially and adversely affect our business or financial results.

Previous wording

In addition, we are required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products.

Current wording

In addition, we are required to conduct costly post-market testing and surveillance to monitor the safety and effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products.