CVRx Initiates BENEFIT-HF Clinical Trial
CVRx announced initiation of the BENEFIT-HF clinical trial, a randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim in a significantly expanded heart failure population. The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026.
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- Shareholder Rights Investigation: Bragar Eagel & Squire, P.C. is investigating whether CVRx has violated federal securities laws, which could impact the company's reputation and stock price significantly.
- Performance Decline Impact: On April 7, 2025, CVRx announced weaker-than-expected preliminary first-quarter results, causing its stock price to plummet from $11.54 to $6.20, a 46.3% drop, reflecting market concerns over the development of its sales representatives.
- Sales Team Changes: During the earnings call on May 8, 2025, CEO Hykes noted that 25% of territory managers were hired in a short period, indicating significant adjustments in the sales team, which further raised investor concerns about performance.
- Call for Action: Bragar Eagel & Squire encourages affected investors to contact their attorneys to understand their legal rights, demonstrating the firm's commitment to protecting shareholder interests, which may influence the outcomes of future legal actions.
- Performance Decline: On April 7, 2025, CVRx reported weaker-than-expected preliminary Q1 results, causing shares to plummet from $11.54 to $6.20, a 46.3% drop, indicating issues with the development of new sales representatives and eroding market confidence.
- Sales Team Changes: During the earnings call on May 8, 2025, CEO Hykes disclosed that 25% of territory managers were replaced in a short period, leading to further declines in performance and shares falling from $7.78 to $4.77, a 38.8% drop, highlighting significant missteps in management's sales strategy.
- Legal Investigation Initiated: Kirby McInerney LLP is investigating whether CVRx violated federal securities laws or engaged in unlawful business practices; while no lawsuit has been filed yet, this inquiry could have profound implications for the company's future legal liabilities and financial health.
- Investor Attention: With no lawsuits currently filed, investors with information or interest in the investigation are encouraged to contact the law firm, reflecting growing concern over CVRx's future and potential legal rights.
- Securities Fraud Investigation: Pomerantz LLP is investigating whether CVRx and its executives have engaged in securities fraud or other unlawful business practices, potentially leading to significant losses for investors.
- Poor Performance Impact: CVRx's preliminary first-quarter results announced on April 7, 2025, fell short of expectations, causing the stock price to plummet 46.3% to $6.20 per share the following day, reflecting market concerns over the development of the company's sales representatives.
- Sales Team Changes: On May 8, 2025, CVRx reported weak first-quarter results and lowered its full-year revenue guidance, with the CEO noting that 25% of territory managers were replaced in a short period, exacerbating market worries about the company's future performance.
- Continued Stock Decline: Following the disappointing results, CVRx's stock price fell another 38.7% to $4.77 per share on May 9, 2025, indicating a severe lack of investor confidence in the company's outlook.
- Trial Launch: CVRx initiated the BENEFIT-HF clinical trial on Thursday, a landmark randomized study aimed at evaluating the impact of Barostim in a significantly expanded heart failure population, targeting enrollment of 2,500 patients, making it one of the largest therapeutic cardiac device trials in heart failure.
- Device Overview: Barostim is an implantable device that delivers electrical signals to baroreceptors on the carotid artery, enhancing autonomic nervous system balance and improving heart failure symptoms; it received FDA approval in 2019 and is commercially available in the U.S. and Europe.
- Market Potential: If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim by approximately three times, significantly broadening access to this neuromodulation-based heart failure management approach, which analysts believe will greatly enhance the company's total addressable market.
- Revenue Expectations: Analysts estimate that around 1,650 patients will receive Barostim therapy during the trial, with an assumed price of $30,000 per device, potentially generating an additional $50 million in top-line revenue, further boosting CVRx's market performance.
- Performance Decline Reason: CVRx attributed its weak first-quarter results in 2024 to disruptions in the salesforce caused by the retirement of the previous CEO, which adversely affected market development and the adoption of Barostim therapy.
- Stock Price Volatility: On April 8, 2025, CVRx's stock plummeted 46.3%, falling $5.34 to $6.20 per share due to disappointing preliminary results, indicating strong investor concerns about the company's outlook.
- Sales Team Restructuring Impact: During the earnings call on May 9, 2025, CEO Kevin Hykes noted that 25% of territory managers were newly hired, leading to significant variability in productivity among new hires, which further exacerbated market uncertainty.
- Investor Loss Investigation: Wolf Popper LLP is investigating potential claims on behalf of investors who suffered losses trading CVRx stock, reflecting heightened market scrutiny regarding the company's governance and management transitions.

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