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 plans to release its first quarter 2023 financial and operational results on April 27, 2023, after market close. The company will host a conference call at 5:00 p.m. Eastern Time that day to discuss these results. Investors can access a live webcast on the investor relations page of CVRx's website. CVRx focuses on developing the Barostim™, a groundbreaking implantable neuromodulation device for cardiovascular diseases, which has received FDA approval and Breakthrough Device designation. Barostim aims to alleviate heart failure symptoms by delivering electrical pulses to baroreceptors in the carotid artery, restoring balance to the autonomic nervous system.
CVRx, a medical device company, announced preliminary results from the BeAT-HF trial at the THT conference on March 21, 2023. Conducted on the Barostim device, these results showed a 97% rate of major adverse events, with significant long-term improvements in patient outcomes. The device led to a 34% reduction in all-cause mortality compared to control, and a win ratio of 1.26 favoring Barostim. The data supports Barostim as a safe and effective therapy for heart failure. CVRx plans to submit this data to the FDA for expanded labeling and anticipates publication of full results in peer-reviewed journals.
CVRx, a medical device company specializing in neuromodulation for cardiovascular diseases, announced plans to present preliminary results from the BeAT-HF trial at the Technology and Heart Failure Therapeutics (THT) conference on March 21, 2023. Dr. Michael Zile from MUSC will present these results. The company will also sponsor a symposium titled 'Baroreflex Activation Therapy in HFrEF: New Insights from the BeAT-HF Study' during the conference. Subsequently, CVRx will hold an investor conference call at 4:30 pm ET to discuss the results. Barostim™, their FDA-approved device, aims to alleviate heart failure symptoms through autonomic balance restoration.
CVRx announced preliminary results from the BeAT-HF trial, assessing the Barostim device for heart failure treatment. The trial included 323 patients, comparing Barostim + medical therapy to medical therapy alone. While the primary endpoint was not statistically significant, additional analyses indicated potential benefits, including improved all-cause survival and quality of life. The safety profile of Barostim remained robust over 24 months. CVRx intends to submit these findings to the FDA for expanded labeling. The results will be discussed in a conference call on February 21, 2023, and presented at the THT Conference on March 21, 2023.
CVRx reported a remarkable 96% increase in fourth-quarter revenue, totaling $7.2 million compared to the previous year. Heart Failure (HF) revenue surged 121% to $6.0 million, driven by expansion into new territories and heightened awareness of Barostim. Total 2022 revenue reached $22.5 million, up 72%. The number of active implanting centers rose from 46 to 106, a 130% increase. However, the company faced a net loss of $10.5 million in Q4. For 2023, CVRx anticipates total revenue between $35 million and $38 million and gross margins of 78%-79%.
CVRx, Inc. plans to release its fourth quarter and full year 2022 financial results after market close on January 26, 2023. A conference call will follow at 5:30 p.m. Eastern Time to discuss the results, which will be available via webcast. CVRx focuses on innovative neuromodulation solutions for cardiovascular diseases, specifically the Barostim device, the first FDA-approved technology using neuromodulation to treat heart failure symptoms. Barostim has received FDA Breakthrough Device designation and is CE Mark approved for additional indications.
CVRx, Inc. announced preliminary unaudited revenue results for Q4 and full year 2022. Q4 revenue is estimated between $7.0M and $7.1M, up approximately 91% to 94% from Q4 2021. Full year 2022 revenue is anticipated to be $22.3M to $22.4M, a 71% to 72% increase from 2021. The company reported 106 active implanting centers and expects 2023 revenue between $35.0M and $38.0M with gross margins of 78% to 79%. Cash reserves stood at $106 million as of December 31, 2022.
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