EBR Systems, Inc.

ITEM 1A. RISK FACTORS

In addition to other information set forth in this report, readers should carefully consider the factors discussed in Part I, Item 1A. "Risk Factors" of our 2024 Annual Report on Form 10-K, as updated and supplemented below. Any of the risk factors disclosed in our reports could materially affect our business, financial condition or future results. The risks described here and in our 2024 Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition and/or operating results. The discussion of the risk factors below updates the corresponding disclosure under the same heading in the 2024 Annual Report on Form 10-K and may contain material changes to the corresponding risk factor discussion in our 2024 Annual Report on Form 10-K.

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We are is substantial doubt regardsubject to ongoing FDA post-marketing our ability tobligations continue as a gocerning concern. If we are unable to raiseour WiSE CRT System, which may result in significant additional capital when needed,expense, and we may be forced to delay, limit, reduce or terminate ousubject to penalties or product development programs, withdrawal if we fail to commercialization efforply with these regulatory requirements or other operations.

In April 2025, and commitments or if we receivexperience unanticipated FDA approval to commercialize regulatory issues with WiSE CRT System in the U.S., and we plan to initiate a commerci.

Our WiSE CRT Systems regulatory approval launch of WiSE iin the U.S. during the second quarter of 2025. WiSE is our only product approved for nited States is subject to certain post-marketing by the FDA obligations and our abilitycommitments to generatthe FDA. We are revenue from proquired to conduct sales and achieve profitability is wholly dependent on our ability to successfully commercialize WiSE in the U.S. Our operations have consumed substantial amounts of cash sia prospective, real-world, observational study aimed at understanding acute and long-term product performance our , inception.

As of March 31, 2025, we had working capital of $46,751,043 and accumulluding patient safety, clinical outcomes, and CRT response information associated deficit of $364,011,951. Thewith the use factors raise substantial doubt about our ability to continue as a going concern. Until we are ableof the market released WiSE. We expect to begin enrollment for this post-marketing study in December 2025, and it is scheduled to generatebe consistent and suffcluded in December 2027. Particient revenue from pants enrolled in the sales of our WiSE CRT System, our ability to ctudy will be monitored at one montinue as a going concern is dependent on our ability h, six month, and annual follow-up visits for up to raise additional capital through tfive years post implant. Failure to complete the issuance of addistudy to the satisfactional common stock or borrowings from financial institutions. Our ability to obtain addi of the FDA could result in withdrawal of WiSEs applicational capital in the equity capit approval, which would have a material markets is subject to several factoradverse effect on our business, results of operations, including market and economicfinancial conditions, our performance, and investor sentiment with and prospects. The respect to our company and our industry.

Weults of the post-marketing study may not be able to obtaalso result in additional fundwarning on acceptable terms, s or precautions for at all. As a result of geopolthe WiSE CRT System label, or expose additiconal events, includingsafety concerns the conflictsat may result in Ukraine and Gaza, inflationproduct liability, rising interest rateeputational damage with physicians and o/or withdrawal of ther conditions, product from the global creditmarket, and financial markets y of which would have experienced volatility and disruptions. If we seek additional financing to funda material adverse effect on our business activities in the future and there remains substant, results of operations, financial doubt about our ability to continue as a going concern, investors or odition and prospects.

In addition, ther financ manufacturing sourproces may be unwises, labelling to provide funding to us on commercially reasonable terms, if at all.

Moreover, the terms of any financing may a, packaging, distribution, adversely affect the holdings or the rights of our  event reporting, stockholders and the issuance of addirage, advertising, promotional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our common stock to decline. The sale of additional  and recordkeeping for WiSE are subject to extensive and ongoing regulatory requity or convertible securities would dilute all of our stockholderrements in the United States. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenantsse requirements include submissions of safety and other post-marketing information and other operatingreports, registrications that could adversely impact our ability to conduct our business. Our current lender already has a se, as well as continued compliance with curity interest in substantially all of our assets, includrent good manufacturing proceeds from the sale of our intellectuactices (cGMP), good clinical property, which may prevent or limit our ability to incur additional indebtedness.

Our funding requirements and thactices (GCP), and good laboratory practices (GLP). If we are not able timing of our need for additional capital are subject to change based on a number of factors, including:

o meet and maintain regulatory compliance for WiSE, we may seek additional capitlose marketing approval dueand be required to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our currenwithdraw our product. Withdrawal of our product would have a material adverse effect or future operating plansn our business.

Changes in economic conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business, operations, and financial condition.

Our operations and performance are impacted by global, regional and U.S. economic and geopolitical conditions. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the medical device industry. In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures. These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects. 

The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to attract non-U.S. investment, employees, customers, and suppliers. Foreign governments may also take other retaliatory actions against U.S. entities, such as decreased intellectual property protection, increased enforcement actions, or delays in regulatory approvals, which may result in heightened international legal and operational risks. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business.

Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition, and prospects. In addition, tariffs and other trade developments have and may continue to heighten the risks related to other risk factors described in our 2024 Annual Report on Form 10-K.