Welcome to our dedicated page for Cvrx news (Ticker: CVRX), a resource for investors and traders seeking the latest updates and insights on Cvrx stock.
About CVRx, Inc.
CVRx, Inc. (NASDAQ: CVRX) is a commercial-stage medical device company headquartered in Minneapolis, Minnesota, specializing in the development, manufacturing, and commercialization of innovative neuromodulation technologies for the treatment of cardiovascular diseases. With a focus on addressing critical unmet needs in heart failure and hypertension, CVRx employs cutting-edge implantable technology to improve patient outcomes and quality of life.
Core Business and Technology
At the heart of CVRx's operations is its proprietary Barostim™ System, the first medical technology approved by the U.S. Food and Drug Administration (FDA) that leverages neuromodulation to treat heart failure symptoms. The Barostim device delivers targeted electrical pulses to baroreceptors located in the carotid artery wall. By activating the body's natural baroreflex, Barostim restores balance to the autonomic nervous system, addressing the underlying causes of heart failure and resistant hypertension.
The Barostim system is designed for minimally invasive implantation and offers adjustable therapy tailored to each patient's specific needs. This flexibility ensures optimized treatment outcomes while reducing the burden of symptoms such as shortness of breath, fatigue, and reduced mobility. The system's innovative approach has earned it FDA Breakthrough Device designation and CE Mark approval in the European Economic Area.
Market Position and Revenue Model
CVRx operates within the highly specialized cardiovascular medical device industry, targeting a growing market of patients with heart failure and hypertension. The company's revenue is predominantly generated in the United States, where it has established a robust commercial infrastructure, including an expanding network of implanting centers and sales territories. CVRx also maintains a presence in European markets, further broadening its reach and impact.
The company's business model focuses on direct sales of its Barostim system to hospitals and healthcare providers. By combining clinical evidence, physician education, and patient awareness campaigns, CVRx drives adoption of its technology as a standard of care for heart failure.
Clinical Validation and Industry Recognition
CVRx's Barostim technology is backed by extensive clinical research, including the landmark BeAT-HF trial, which demonstrated significant long-term benefits in heart failure patients with reduced ejection fraction. Published in peer-reviewed journals such as the European Journal of Heart Failure and the Journal of Cardiac Failure, these studies highlight Barostim's ability to reduce hospitalizations, improve quality of life, and enhance physical and psychosocial outcomes for patients.
In addition to clinical validation, CVRx has achieved key reimbursement milestones in both inpatient and outpatient settings, further facilitating access to its therapy. Recent advancements include the reassignment of Barostim to higher-paying Medicare reimbursement categories and the approval of new Category I CPT codes by the American Medical Association, reflecting its growing adoption and clinical efficacy.
Competitive Differentiation
CVRx differentiates itself from competitors through its unique focus on neuromodulation as a therapeutic approach. Unlike traditional pharmacological treatments, Barostim directly targets the autonomic nervous system, offering a novel solution for patients who do not respond adequately to guideline-directed medical therapy. This positions CVRx as a pioneer in the field of cardiovascular neuromodulation, with significant potential to redefine standards of care.
Commitment to Innovation
CVRx continues to invest in research and development to expand the clinical applications of its Barostim technology. Through ongoing clinical trials, real-world evidence collection, and investigator-initiated research, the company aims to further validate and enhance its therapy's impact on patient outcomes.
With its innovative technology, strong clinical foundation, and strategic focus on market development, CVRx is poised to make a meaningful difference in the lives of patients suffering from debilitating cardiovascular conditions.
CVRx (NASDAQ: CVRX) presented new real-world evidence at THT 2025 demonstrating significant reductions in healthcare utilization with Barostim for heart failure patients. The study, published in the Journal of Cardiac Failure, analyzed data from 306 Barostim patients using the Premier Healthcare Database.
The analysis compared 12 months pre-implant data with almost two years post-implant (1.92±1.87 years), revealing remarkable reductions in hospital visits:
- 86% reduction in all-cause hospital visits
- 84% reduction in cardiovascular hospital visits
- 85% reduction in heart-failure hospital visits
CVRx reported strong financial results for Q4 and full year 2024. Q4 revenue reached $15.3 million, up 36% year-over-year, driven by a 41% increase in U.S. Heart Failure revenue to $14.3 million. Full-year 2024 revenue was $51.3 million, showing 31% growth from 2023.
Active implanting centers increased 25% to 223, and U.S. sales territories expanded to 48. Despite revenue growth, the company reported a Q4 net loss of $10.7 million ($0.43 per share) and a full-year net loss of $60.0 million ($2.65 per share). The company raised $33.8 million through share offerings in 2024.
Looking ahead to 2025, CVRx projects total revenue between $63.0-65.0 million, with gross margins of 83-84%. Q1 2025 revenue is expected between $14.5-15.0 million.
CVRx (NASDAQ: CVRX), a commercial-stage medical device company specializing in Barostim™, an innovative extravascular neuromodulation device for cardiovascular diseases, has announced its plans to release fourth quarter 2024 financial and operating results after market close on Tuesday, February 4, 2025.
The company will host a conference call and webcast at 4:30pm Eastern Time on the same day to review the results. Investors can access the webcast through the company's investor relations website at ir.cvrx.com. For telephone access, U.S. callers can dial 1-877-704-4453, while international callers should use 1-201-389-0920.
CVRx, a commercial-stage medical device company, announced preliminary unaudited fourth quarter and full year 2024 revenue results, along with its 2025 business outlook.
Fourth quarter revenue is expected to be between $15.2 million and $15.3 million, marking a 35% increase from the previous year's $11.3 million. Full year 2024 revenue is projected to be between $51.1 million and $51.2 million, a 30% increase from 2023's $39.3 million. U.S. revenue for 2024 is expected to be between $47.0 million and $47.1 million, with European revenue at $4.1 million.
For 2025, CVRx forecasts revenue between $63.0 million and $65.0 million, representing a 23% to 27% growth. The company also expects gross margins of 83%-84% and operating expenses between $100.0 million and $104.0 million. First-quarter 2025 revenue is anticipated to be between $14.5 million and $15.0 million.
Notably, the company saw a 41% increase in U.S. heart failure revenue in Q4 2024 and expanded its active implanting centers in the U.S. to 223 by the end of 2024. Additionally, CVRx raised $12.8 million in gross proceeds through its at-the-market offering, increasing its cash and cash equivalents to $105.9 million as of December 31, 2024.
CVRx (NASDAQ: CVRX), a commercial-stage medical device company, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's management team is scheduled to deliver a presentation on Wednesday, January 15, 2025, at 2:15 PM Pacific Time. Interested parties can access a live audio webcast of the presentation through the investor relations section of CVRx's website at ir.cvrx.com.
CVRx (NASDAQ: CVRX) has announced its upcoming participation in the Piper Sandler 36th Annual Healthcare Conference. The medical device company's management team is scheduled to deliver a presentation on Wednesday, December 4, 2024, at 3:30 PM Eastern Time. Interested parties can access a live audio webcast of the presentation through the investor relations section of CVRx's website at ir.cvrx.com.
CVRx announced that CMS has assigned the Barostim procedure to New Technology APC 1580, maintaining the outpatient payment of approximately $45,000 in 2025. This follows two other positive reimbursement developments: the transition to Category I CPT codes in 2026 and the reassignment to a higher-paying MS-DRG for inpatient procedures, increasing payment from $17,000-$23,000 to $43,000, effective October 2024. These changes aim to improve patient access to Barostim therapy and strengthen the company's commercial foundation.
CVRx reported strong Q3 2024 results with total revenue of $13.4 million, up 27% year-over-year. U.S. Heart Failure revenue reached $12.2 million, increasing 30%. Active implanting centers grew to 208, up 31%. The company achieved significant milestones including Barostim's reassignment to MS-DRG 276, increasing hospital payments from $17,000-$23,000 to approximately $43,000, and securing Category I CPT codes effective January 2026. However, net loss widened to $13.1 million ($0.57 per share) compared to $9.0 million in Q3 2023. The company narrowed its 2024 revenue guidance to $50.5-$51.5 million.
CVRx, Inc. (NASDAQ: CVRX) announced that the American Medical Association (AMA) CPT® Editorial Panel has accepted new Current Procedural Terminology (CPT) Category I codes for baroreflex activation therapy (Barostim) to treat heart failure symptoms. This decision, led by the Society for Vascular Surgery (SVS) and supported by the American College of Cardiology (ACC), will facilitate reimbursement for healthcare providers performing Barostim procedures and enable broader patient access.
The new codes are expected to be implemented on January 1, 2026. Until then, U.S. hospitals and physicians should continue using existing Category III codes. CVRx CEO Kevin Hykes stated that this Category I code designation represents an important milestone for the company and demonstrates the increased adoption, safety, and effectiveness of Barostim as a treatment option for heart failure patients.
CVRx, Inc. (NASDAQ: CVRX), a commercial-stage medical device company specializing in Barostim™, an innovative extravascular implantable neuromodulation device for cardiovascular diseases, has announced its plans to release third quarter 2024 financial and operating results. The results will be released after market close on Tuesday, October 29, 2024, followed by a conference call at 4:30pm Eastern Time to review the results.
Investors and interested parties can access the live webcast of the conference call on the investor relations page of CVRx's website at ir.cvrx.com. For those preferring to listen via telephone, the call-in numbers are 1-877-704-4453 for U.S. callers and 1-201-389-0920 for international callers. It is recommended to dial in approximately ten minutes before the start time.
FAQ
What is the current stock price of Cvrx (CVRX)?
What is the market cap of Cvrx (CVRX)?
What does CVRx, Inc. specialize in?
What is the Barostim system?
How does CVRx generate revenue?
What clinical evidence supports Barostim?
What sets CVRx apart from competitors?
Where is CVRx headquartered?
What regulatory approvals has Barostim received?
What are the key benefits of Barostim therapy?
What is the reimbursement status of Barostim?
What is CVRx's market focus?
