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.
CVRx, Inc. (NASDAQ: CVRX) is a commercial-stage medical device company headquartered in Minneapolis, Minnesota. The company specializes in developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Its flagship product, Barostim, leverages proprietary technology to treat high blood pressure and heart failure by utilizing the body's natural blood flow regulation system.
Barostim is an implantable device that delivers electrical pulses to the baroreceptors located in the wall of the carotid artery. These pulses activate the baroreflex, which in turn restores balance to the autonomic nervous system, reducing heart failure symptoms. Barostim is FDA-approved for heart failure patients in the U.S. and has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. The device can be tailored to meet individual patient therapy needs.
The majority of CVRx's revenue is generated from the U.S. market. The company has seen significant growth, particularly in its U.S. heart failure business, which recorded nearly 120% revenue growth compared to the previous year. As of June 30, 2023, CVRx operates with 140 active implanting centers in the U.S., up from 122 as of March 31, 2023. The company's revenue for the second quarter of 2023 was $9.5 million, marking an 89% increase over the same period in 2022.
CVRx continues to expand its reach with a growing number of implanting centers and sales territories. In Europe, the company generated $1.2 million in revenue for the second quarter of 2023, a 10% increase over the previous year. Despite facing competition, CVRx remains focused on establishing and maintaining strong sales and marketing capabilities to promote the merits of Barostim.
In recent news, CVRx announced the reassignment of Barostim to a higher-paying code by the Centers for Medicare & Medicaid Services (CMS), which will facilitate increased access to the therapy by offering hospitals sufficient reimbursement. The company also reported preliminary unaudited revenue results for the fourth quarter and full year of 2023, showing continued growth. Total revenue for the fourth quarter of 2023 is expected to be between $11.2 million and $11.3 million, representing a 56-58% increase over the fourth quarter of 2022.
As CVRx looks toward the future, the company is optimistic about further expanding the adoption of Barostim. A strong foundation, exceptional leadership, and consistent execution of its strategy position CVRx well for future commercial growth. The company is actively seeking a successor for its retiring CEO, Nadim Yared, ensuring a seamless transition and continued focus on improving patients' lives.
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.
CVRx, Inc. (NASDAQ: CVRX) has announced the publication of new data in JACC: Heart Failure, showcasing the long-term quality of life benefits of Barostim for heart failure patients with reduced ejection fraction. The data, from the BeAT-HF trial, demonstrates durable improvements up to 24 months in Minnesota Living with Heart Failure (MLWHF) and EuroQual-5D (EQ-5D) quality of life measures.
Patients receiving Barostim plus guideline-directed medical therapy (GDMT) reported significant improvements in physical and psychosocial measures compared to those receiving GDMT alone. These improvements included better ability to work around the house, sleep, and engage in activities with friends and family, as well as reduced depression and feelings of being a burden. Physically, patients reported less shortness of breath, fatigue, and pain, with increased mobility and ability to perform usual activities.
CVRx, Inc. (NASDAQ: CVRX) has announced significant changes to its Board of Directors. Kevin Ballinger and Mitch Hill have been appointed as new independent board members, effective immediately. Ballinger brings over 25 years of experience in the medical device industry, including leadership roles at Aldevron and Boston Scientific. Hill contributes more than 30 years of financial and operational experience in healthcare and technology sectors, most recently as CFO of Inari Medical.
Concurrently, long-serving board member Ali Behbahani is departing. These changes result in a seven-member Board of Directors for CVRx. The company expects the new appointments to support its strategic goals, particularly in expanding the adoption of its Barostim therapy for heart failure patients.
CVRx, Inc. (NASDAQ: CVRX) announced a significant increase in inpatient payment for its Barostim procedure. The Centers for Medicare and Medicaid Services (CMS) has reassigned the procedure to MS-DRG 276 for Fiscal Year 2025, effective October 1, 2024. This reassignment increases the national average payment from the previous range of $17,000-$23,000 to approximately $43,000.
CVRx's President and CEO, Kevin Hykes, expressed appreciation for CMS's recognition of the resource requirements associated with the Barostim implant procedure. The company believes this increased reimbursement will facilitate greater access to the therapy for heart failure patients when performed in an inpatient setting.
CVRx, a commercial-stage medical device company, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The company's management team is set to present on Wednesday, August 14, 2024, at 12:30 PM Eastern Time. This presentation will be accessible to investors and interested parties through a live audio webcast on the investor relations page of CVRx's official website.
This event provides an opportunity for CVRx to showcase its progress and future plans to a wide audience of investors and industry professionals. The company's participation in such a prominent conference may indicate its commitment to transparency and engagement with the investment community.
CVRx, Inc. (NASDAQ: CVRX) reported strong Q2 2024 financial results, with total revenue reaching $11.8 million, a 24% increase year-over-year. U.S. Heart Failure revenue grew 27% to $10.5 million. The company expanded its active implanting centers in the U.S. by 35% compared to Q2 2023. CVRx appointed new executives, including a Chief Revenue Officer, to strengthen its leadership team. Despite revenue growth, the company reported a net loss of $14.0 million, or $0.65 per share. CVRx updated its full-year 2024 guidance, projecting total revenue between $50.0 million and $53.0 million. The company remains focused on expanding therapy awareness, strengthening clinical evidence, and improving patient access for its Barostim technology.
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