Core Viewpoint - CVRx Inc. is under investigation by Kirby McInerney LLP for potential violations of federal securities laws and other unlawful business practices following the announcement of weaker than expected preliminary first quarter results on April 7, 2025 [1] Company Summary - CVRx Inc. announced preliminary first quarter results that were weaker than expected, which has raised concerns among investors [1]

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. ...

Core Viewpoint - CVRx, Inc. is set to release its fourth quarter 2025 financial and operating results on February 12, 2026, after market close, followed by a conference call to discuss the results [1]. Company Overview - CVRx, Inc. is a commercial-stage medical device company that specializes in developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3]. - The company's flagship product, Barostim™, is the first FDA-approved medical technology that utilizes neuromodulation to alleviate symptoms in heart failure patients [3]. - Barostim is an implantable device that sends electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3]. - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation (MDR) and holding CE Mark for heart failure and resistant hypertension in the European Economic Area [3].

NEW YORK, Jan. 27, 2026 (GLOBE NEWSWIRE) -- 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 newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether CVRx and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On April 7, 2025, CVRx annou ...

Core Insights - CVRx, Inc. has initiated the BENEFIT-HF clinical trial, a significant randomized study aimed at evaluating the impact of Barostim in a larger heart failure population [1][3] - Barostim is an implantable device that enhances baroreflex signaling to improve heart failure symptoms and has been commercially available since FDA approval in 2019 [2] - The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials, randomizing 2,500 patients with a primary endpoint focused on all-cause mortality and heart failure decompensation events [3] Company Developments - If successful, the BENEFIT-HF trial could potentially triple the indicated patient population for Barostim, broadening access to this heart failure management approach [4] - Analyst commentary suggests that the trial's success could significantly increase the company's total addressable market (TAM) and attract more attention within the cardiology community [5] - The trial's design includes CMS coverage, which is seen as a key milestone that could unlock additional revenue potential, with an estimated $50 million in top-line revenue from Barostim therapy for approximately 1,650 patients [5] Market Reaction - Following the announcement, CVRx shares experienced a notable increase of 15.93%, reaching $7.60 [6]

Core Insights - CVRx, Inc. has initiated the BENEFIT-HF clinical trial, which is expected to be one of the largest therapeutic cardiac device trials for heart failure, supported by CMS Category B IDE coverage [1][4][5] - The trial aims to evaluate the Barostim™ device in a significantly expanded heart failure population, potentially tripling the indicated patient population for the device [3][5] Company Overview - CVRx, Inc. is a medical device company focused on developing innovative neuromodulation solutions for cardiovascular diseases [6] - Barostim™ is the first FDA-approved medical technology that uses neuromodulation to alleviate heart failure symptoms, receiving FDA Breakthrough Device designation in 2019 [2][6] Clinical Trial Details - The BENEFIT-HF trial will randomize 2,500 patients across approximately 150 centers in the U.S. and Germany, with the primary endpoint being a composite of all-cause mortality and heart failure decompensation events [3] - Enrollment for the trial is expected to begin in the first half of 2026 [3] Patient Population Criteria - The trial will include patients who remain symptomatic after receiving optimized guideline-directed medical and device therapies, have a left ventricular ejection fraction (LVEF) <50%, and NT-proBNP levels <5,000 pg/mL [7]

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Company Overview - CVRx has developed the world's first autonomic neuromodulation therapy specifically for the treatment of heart failure, targeting a significant market opportunity valued at $10.5 billion based on prevalence [1] - The company aims to establish this therapy as the standard of care for heart failure treatment, supported by a well-defined patient population and a highly differentiated therapeutic approach [1] Industry Context - Heart failure is a major health issue affecting nearly 6.7 million Americans, leading to over 1 million hospital discharges and emergency room visits annually, along with more than 8 million physician visits [2] - The financial burden of heart failure is substantial, with costs projected to reach nearly $70 billion per year by the end of the decade [2] Treatment Landscape - Current treatment for heart failure typically involves a combination of four drugs known as quad therapy, which is the guideline-directed Class 1 treatment [3] - A small percentage of heart failure patients are evaluated for cardiac resynchronization therapy (CRT), indicating a limited scope for existing pacing therapies [3]

CVRx Conference Call Summary Company Overview - **Company**: CVRx - **Industry**: Medical Technology (MedTech) - **Product**: Barostim, an autonomic neuromodulation therapy for heart failure treatment - **Market Size**: $10.5 billion prevalence-based market for heart failure treatment [3][6] Key Points and Arguments Heart Failure Market Dynamics - Heart failure affects approximately 6.7 million Americans, leading to over 1 million hospital discharges and emergency room visits annually, with costs projected to reach nearly $70 billion per year by the end of the decade [3][4] - Current treatment involves a combination of four drugs (quad therapy), which only 1% of patients reach optimal dosages, and over 40% discontinue within the first year [5][6] - Patients prioritize quality of life over longevity, indicating a significant unmet need for effective therapies that improve daily living [6][12] Barostim Therapy - Barostim targets the neurohormonal pathway, addressing the root cause of heart failure by restoring signaling to the brain, thus reducing the toxic effects of neurohormones [9][10] - The therapy has shown a 68% improvement in functional status and a 94% response rate in clinical outcomes [11][12] - The BeAT-HF trial demonstrated significant improvements in quality of life and exercise capacity, with a positive signal in all-cause mortality [12] Commercial Strategy - CVRx aims to establish Barostim as the standard of care through improved salesforce productivity, deep adoption in targeted centers, and addressing barriers to therapy adoption [13][21] - The company has transformed its salesforce, focusing on mentoring and training to enhance productivity [13][15] - Building networks of aligned stakeholders, including clinical and financial champions, is crucial for deeper adoption [16][17] Barriers to Adoption - Key barriers include awareness, evidence, and patient access [21][30] - The implementation of Category 1 codes has improved reimbursement processes, increasing confidence among physicians regarding patient coverage [30][31] - The company has seen a 46% approval rate for Medicare Advantage within 30 days, a significant improvement from previous years [32][46] Financial Performance and Projections - Q4 2025 worldwide revenue was approximately $15.9-$16.1 million, with a total for the year of $56.5-$56.7 million, reflecting an 11% growth rate [33] - For 2026, projected revenue is between $63 million and $67 million, with gross margins of 84%-86% [33] - The company anticipates a cash burn of $35-$40 million for 2026, with a focus on achieving cash flow break-even through increased sales productivity [38][41] Future Opportunities - The BenefitHF trial, a landmark randomized controlled trial, aims to expand the indication for Barostim, potentially tripling the total addressable market from $10 billion to over $30 billion [25][27] - The trial will enroll 2,500 patients and is expected to begin later this year, pending CMS approval [26][29] Conclusion - CVRx is positioned to significantly impact the treatment of heart failure, addressing a critical unmet need and improving the quality of life for many patients [34] - The company is focused on executing its strategy to drive adoption and achieve sustainable growth in the coming years [35][49]