CVRx Initiates Landmark BENEFIT-HF Trial with 2,500 Patient Enrollment Target
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6d ago
0mins
Source: Benzinga
- 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.
Get Free Real-Time Notifications for Any Stock
Monitor tickers like CVRX with instant alerts to capture every critical market movement.
Sign up for free to build your custom watchlist and receive professional-grade stock notifications.
Analyst Views on CVRX
Wall Street analysts forecast CVRX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CVRX is 12.67 USD with a low forecast of 11.00 USD and a high forecast of 14.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.160
Low
11.00
Averages
12.67
High
14.00
Current: 7.160
Low
11.00
Averages
12.67
High
14.00
About CVRX
CVRx, Inc. is a commercial-stage medical device company. The Company is focused on developing, manufacturing and commercializing advanced neuromodulation solutions for patients with cardiovascular diseases. The Company's integrated platform technology, Barostim, is designed to leverage the power of the brain and nervous system to address the imbalance of the autonomic nervous system (ANS), which causes heart failure with reduced ejection fraction (HFrEF) and other cardiovascular diseases. Barostim provides Baroreflex Activation Therapy (BAT) by sending imperceptible and persistent electrical pulses to baroreceptors located in the wall of the carotid artery to signal the brain to modulate cardiovascular function. Barostim is a minimally invasive neuromodulation device that consists of two implantable components, an implantable pulse generator (IPG) and a stimulation lead, and is programmed by a wireless clinician-controlled programmer that communicates with the IPG.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
CVRx Under Investigation for Potential Securities Violations
- 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.
Continue Reading
Pomerantz LLP Investigates CVRx for Securities Fraud
- 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.
Continue Reading