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. ...

MINNEAPOLIS, Jan. 29, 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 that it plans to release fourth quarter 2025 financial and operating results after market close on Thursday, Feb. 12, 2026. The Company will host a conference call to review its results at 4:30 p.m. Eastern Time the same day. A live w ...

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 ...

CVRx, Inc. (NASDAQ:CVRX) on Thursday initiated the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim in a significantly expanded heart failure population.Barostim is an implantable device that delivers electrical signals to baroreceptors (sensory neurons that monitor blood pressure) located on the carotid artery, increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure ...

Study is Expected to Be One of the Largest Therapeutic Cardiac Device Trials in Heart Failure Ever Performed, and is Supported by CMS Category B IDE CoverageMINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B ID ...

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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]

Market Opportunity & Prevalence - The prevalence-based market opportunity for Barostim is estimated at $10.5 billion in the U S HFrEF market[8, 9] - Heart failure affects nearly 6.7 million adults in the U S [10] - The company is less than 1% penetrated into its addressable market[36] Clinical Efficacy & Safety - Barostim implantation has a 97% freedom from major complications rate[54, 56] - Barostim shows a clinically relevant 94% response rate[58] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months)[67, 68] Financial Performance & Guidance - Preliminary Q4 2025 worldwide revenue is $15 9–$16 1 million[104] - Preliminary 2025 worldwide revenue is $56 5–$56 7 million, with a gross margin of 84%-86%[104, 105] - The company expects total revenue between $63 0 million and $67 0 million for the full year of 2026[108] Growth Strategy - The company's strategy focuses on improving salesforce productivity, driving deep adoption in targeted centers, and addressing barriers to adoption[70, 71] - The company is focusing therapy awareness efforts on the clinicians and patients that surround targeted centers[84] - The company has received IDE approval for BENEFIT-HF, a potential landmark randomized controlled trial (RCT) in HF, with a trial size of 2,500 patients[94, 95]