Financial Performance - The company incurred net losses of $53.3 million and $60.0 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $590.7 million as of December 31, 2025[219]. - The company reported net cash used in operating activities of $40.2 million and $39.1 million for the fiscal years ended December 31, 2025 and 2024, respectively[312]. - The company anticipates that existing cash, cash equivalents, short-term investments, and revenue will be sufficient to meet capital requirements for at least the next two years[312]. - The company may need to seek additional funds in the future, which may not be available on acceptable terms or at all[312]. - The company is restricted from paying dividends or making distributions on its capital stock under its Loan and Security Agreement with Innovatus Life Sciences Fund I, LP[314]. - The company’s operating results may vary significantly annually or quarterly, potentially impacting stock price[316]. - The company has approximately $483.7 million in federal net operating loss (NOL) carryforwards and $9.7 million in state NOL carryforwards as of December 31, 2025[323]. - Federal NOLs began expiring in 2021, while state NOLs began expiring in 2020, which may limit the company's ability to utilize these carryforwards[324]. - The company generated federal and state tax credit carryforwards of approximately $10.3 million and $1.9 million, respectively, with federal credits beginning to expire in 2021 and state credits starting in 2028[323]. Market and Competition - The company relies heavily on Barostim for revenue, which is expected to continue to be the primary source of income, with limited brand recognition and market acceptance[222]. - The company faces intense competition from established medical device companies with greater resources, which could hinder its ability to gain market share for Barostim[230]. - The healthcare industry is experiencing significant cost reform, leading to consolidation that may pressure the company to provide price concessions for its product, Barostim[251]. - Economic conditions, including inflation and potential recession, could adversely affect demand for Barostim and the company's ability to raise capital[275]. - The company estimates the total market opportunity for Barostim based on the number of patients with HFrEF and assumed selling prices, but acknowledges that these estimates may not be accurate[273][274]. Sales and Marketing - The company expects to continue incurring significant sales and marketing, research and development, and regulatory expenses as it grows its U.S. commercial sales force and expands marketing efforts for Barostim[219]. - The company plans to expand its U.S. direct sales and marketing organization to drive future revenue growth, which requires significant investment in hiring and training sales personnel[223]. - The company needs to effectively demonstrate the merits of Barostim to physicians to drive adoption and sales, as physician acceptance is critical for success[224]. - The company anticipates ongoing challenges in recruiting and retaining qualified sales personnel due to high competition in the labor market[233]. Manufacturing and Supply Chain - The company is investing in enhancing manufacturing processes to meet increasing demand for Barostim, which is essential for maintaining sales forecasts[240]. - The company operates solely from its manufacturing facility in Minneapolis, Minnesota, which poses risks of operational disruption due to potential disasters or vandalism[244]. - Manufacturing output must increase to meet expected customer demand; challenges include manufacturing yields, quality control, and component supply[253]. - The company is dependent on third-party manufacturers and suppliers, which exposes it to risks related to supply shortages and performance degradation[235]. - The company relies on third-party suppliers for components, and any issues with these suppliers could affect production and profitability[243]. Regulatory and Compliance - The company must navigate complex regulatory approval processes in various jurisdictions, which can vary significantly and may delay product commercialization[263]. - The company is subject to extensive governmental regulation, which could increase costs and delay the introduction of new products[338]. - Compliance with the EU Medical Device Regulation (MDR) is required, with final approval for Barostim's compliance issued on April 9, 2025[335]. - The company must continue to submit updates for any substantial changes to the design or quality system to meet MDR requirements[335]. - The company is subject to extensive post-market regulations by the FDA and foreign authorities, and any non-compliance could result in recalls, fines, or other penalties[345]. - The company must report adverse medical events to the FDA and European regulators, and failure to do so could lead to significant sanctions and harm its reputation[350]. Risks and Challenges - The company faces risks from international operations, including compliance with trade regulations and potential penalties for non-compliance[247]. - The company is subject to product liability claims, which could adversely affect its financial results and reputation[264]. - Cybersecurity threats are increasing, and any significant disruption to the company's information technology systems could negatively impact operations and financial results[271]. - The company may experience operational disruptions due to pandemics or outbreaks of infectious diseases, impacting sales and production[282][285]. - The development and use of AI technologies present risks that could affect operations and patient care, as well as expose the company to legal and regulatory challenges[287]. - The company may face significant costs and distractions from potential intellectual property litigation, which could hinder commercialization efforts[288][289]. - The company may face challenges in protecting its intellectual property rights globally, which could adversely affect its competitive position[304]. - The company may be subject to claims regarding the wrongful use or disclosure of trade secrets, which could result in costly litigation and distract management[306]. Strategic Initiatives - The company may pursue strategic collaborations or acquisitions to enhance its product offerings, but there are risks associated with the success and integration of these efforts[276][278]. - Changes in executive leadership can disrupt operations and affect relationships with customers and suppliers, impacting financial performance[266]. - The company has opted to delay implementing new accounting standards, which may result in financial statements that are not directly comparable to those of other public companies[367]. Investor Relations - The company does not currently intend to pay dividends on its common stock, meaning returns for investors will depend on stock price appreciation[376]. - As of December 31, 2025, executive officers, directors, and significant stockholders owned approximately 37% of the outstanding voting stock, allowing them to exert significant control over shareholder matters[371]. - The company's stock price is expected to fluctuate significantly, influenced by various factors, including market volatility and potential litigation risks[363].

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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of CVRx, Inc. - CVRX [Accessibility Statement] Skip NavigationNEW YORK, Feb. 12, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of CVRx, Inc. ("CVRx" or the "Company") (NASDAQ: CVRX). Such investors are advised to contact Danielle Peyton at [[email protected]] or 646-581-9980, ext. 7980.The investigation concerns whether CVRx and certain of its officers and/or directors have engaged in securities ...

CVRx (NasdaqGS:CVRX) Q4 2025 Earnings call February 12, 2026 04:30 PM ET Company ParticipantsJared Oasheim - CFOKevin Hykes - President and CEOMike Vallie - Healthcare Investor Relations Managing DirectorConference Call ParticipantsChase Knickerbocker - Senior Equity Research AnalystFrank Takkinen - Senior Research AnalystJohn Young - Research AnalystLily Lozada - Research AnalystMax Smock - Equity Research AnalystNone - AnalystOperatorWelcome to the CVRx Q4 2025 Earnings Call. At this time, all participant ...

CVRx (NasdaqGS:CVRX) Q4 2025 Earnings call February 12, 2026 04:30 PM ET Company ParticipantsJared Oasheim - CFOKevin Hykes - President and CEOMike Vallie - Healthcare Investor Relations Managing DirectorConference Call ParticipantsChase Knickerbocker - Senior Equity Research AnalystFrank Takkinen - Senior Research AnalystJohn Young - Research AnalystLily Lozada - Research AnalystMax Smock - Equity Research AnalystNone - AnalystOperatorWelcome to the CVRx Q4 2025 Earnings Call. At this time, all participant ...

Financial Data and Key Metrics Changes - In Q4 2025, total revenue was $16 million, a 4% increase year-over-year, while full-year revenue reached $56.7 million, reflecting a 10% growth [3][17] - Gross profit for Q4 was $13.8 million, an 8% increase, with gross margin rising to 86% from 83% a year ago [19] - Net loss for Q4 was $11.9 million, or $0.46 per share, compared to a net loss of $10.7 million, or $0.43 per share in Q4 2024 [21] Business Line Data and Key Metrics Changes - U.S. revenue was $14.9 million in Q4 2025, a 4% increase, with revenue units totaling 478, up from 460 in the prior year [17] - European revenue increased to $1.1 million, a 10% rise, with revenue units growing to 49 from 41 [18] Market Data and Key Metrics Changes - The addressable market for Barostim therapy is estimated at $10.5 billion, with only 1% penetration, indicating significant growth potential [5] - The initiation of the BENEFIT-HF trial could expand the addressable market to approximately $30 billion if successful [12] Company Strategy and Development Direction - The company focused on three strategic priorities: building a world-class sales organization, driving deep adoption in targeted centers, and reducing barriers to adoption [6] - Transition to Category I CPT codes is expected to improve patient access and reimbursement predictability, effective January 1, 2026 [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sales team's ability to execute and drive growth, despite a natural ramp-up period for new sales representatives [6][15] - The company anticipates total revenue for 2026 to be between $63 million and $67 million, with a gross margin of 84% to 86% [23] Other Important Information - The company amended its debt facility to extend the maturity date to 2031 and increase access to additional capital [14][22] - A new Chief Human Resources Officer was appointed, indicating ongoing organizational development [16] Q&A Session Summary Question: On the BENEFIT-HF trial strategy and revenue generation - Management indicated that the trial will involve a mix of existing and new commercial sites, with expected revenue from approximately 1,600 to 1,700 devices sold during the trial [26][28] Question: Growth of active accounts in Q4 - Management noted that while there was a net addition of accounts, the focus remains on deepening existing relationships, with expectations of adding around three active territories quarterly in 2026 [30][31] Question: Impact of the Category I code on treatment barriers - Management reported positive early signs of improved prior authorization approvals and expects this trend to continue as the transition progresses [36][39] Question: Path to profitability and cash management - The company has sufficient cash reserves and access to additional capital, with a focus on driving sales productivity to achieve profitability [72][74]

MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the fourth quarter and full year of 2025. Recent Highlights Total revenue for the fourth quarter 2025 was $16.0 million, an increase of 4% over the prior year quarterU.S. revenue for the fourth ...

NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP continues its investigation on behalf of CVRx Inc. ("CVRx†or the "Company†) (NASDAQ:CVRX) investors concerning the Company's and/or members of its senior management's possible violation of the federal securities laws and other unlawful business practices. [LEARN MORE ABOUT THE INVESTIGATION] What Happened? On April 7, 2025, CVRx announced weaker than expected preliminary first quarter results. In the Company's earnings press releas. ...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In CVRx (CVRX) To Contact Him Directly To Discuss Their Options If you purchased or acquired stock in CVRx and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Melissa Fortunato directly at (212) 355-4648. Click here to participate in the action. NEW YORK, Jan. 30, 2026 (GLOBE NEWSWIRE) -- What’s Happening: Bragar Eagel & Squire, P.C., a nationally recognized s ...

NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP is investigating potential claims against CVRx Inc. ("CVRx†or the "Company†) (NASDAQ:CVRX). The investigation concerns whether the Company and/or members of its senior management may have violated federal securities laws or engaged in other unlawful business practices. [LEARN MORE ABOUT THE INVESTIGATION] What Happened? On April 7, 2025, CVRx announced weaker than expected preliminary first quarter results. In the Company's earning. ...