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Item 1A. Risk Factors
Refer to the Risks Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of risks to which our business, financial condition, results of operations and cash flows are subject. TOthere h than as described below, there have been no material changes to the risk factors disclosed in the aforementioned Annual Report.
Expansion of U.S. tariffs could have a material, adverse effect on our financial results
On September 24, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) announced the initiation of an investigation into the effects on U.S. national security of imports of personal protective equipment, medical consumables, and medical equipment, including medical devices such as insulin pumps. BIS is conducting the investigation under Section 232 of the Trade Expansion Act of 1962 (Section 232), a law that empowers the president to restrict imports of products that threaten to impair national security. The investigation could result in overriding the tariff exemption currently in place for certain medical devices, which could have a material impact on our results of operations in future years.