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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, 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.
CVRx, a medical device company focused on neuromodulation solutions for cardiovascular diseases, will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 3:45 pm Pacific Time. The presentation will be available via a live audio webcast, with a replay accessible for 30 days. CVRx's flagship product, Barostim, is an FDA-approved device designed to reduce heart failure symptoms by improving autonomic nervous system balance through electrical pulses to baroreceptors in the carotid artery. For more details, visit ir.cvrx.com.
CVRx, Inc. announced the appointment of Kevin Hykes to its Board of Directors effective December 21, 2022. Hykes brings over 30 years of experience in the medical device sector, having held leadership roles in several companies, including Augmedics and Bardy Diagnostics. His expertise is expected to bolster CVRx's efforts to enhance the global reach of Barostim™, a neuromodulation device aimed at improving heart failure symptoms. The management expresses optimism regarding the impact of Hykes' leadership on the company's growth trajectory.
CVRx, a medical device company focused on neuromodulation solutions for cardiovascular diseases, will participate in the Piper Sandler 34th Annual Healthcare Conference on November 30, 2022, at 8:00 am Eastern Time. The presentation will be available via a live audio webcast on the company’s investor relations page. CVRx’s primary product, the Barostim™ System, is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms. The device has received FDA Breakthrough Device designation and CE Mark approvals for heart failure and resistant hypertension.
CVRx has launched the new Barostim NEO2 Implantable Pulse Generator (IPG) in the U.S., enhancing patient and physician experiences during heart failure therapy. The device is 10% smaller and offers a 20% increase in battery life, reducing replacement frequency. It features a simplified design with a single lead port, improving implantation ease. The Barostim NEO2 retains the clinically proven Barostim Therapy while providing a more convenient option for patients and healthcare providers.
CVRx, a medical device company specializing in neuromodulation solutions for cardiovascular diseases, will participate in two investor conferences on November 17, 2022, in New York, NY. The conferences include the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum and the 13th Annual Craig-Hallum Alpha Select Conference. CVRx's flagship product, Barostim, is the first FDA-approved technology aimed at treating heart failure through neuromodulation, and it has also received CE Mark approval in Europe.
CVRx reported third quarter 2022 revenue of $6.2 million, an 82% increase year-over-year. U.S. Heart Failure revenue nearly doubled to $4.9 million, driven by an expansion in sales territories and increased awareness of Barostim. Active implanting centers in the U.S. grew to 91, a 28% increase from the previous quarter. Gross profit rose to $4.8 million with a gross margin of 78%. However, the net loss widened to $9.8 million. The company expects 2022 revenue between $21.8 million and $22.3 million, with a new $50 million debt facility in place.
CVRx, a medical device company, will release its third quarter 2022 financial results on November 1, 2022, after market close. A conference call to discuss these results is scheduled for 5:30 p.m. Eastern Time on the same day and will be available via webcast. CVRx focuses on innovative neuromodulation solutions, including Barostim™, the first FDA-approved device for heart failure treatment, which uses electrical pulses to enhance baroreflex and autonomic nervous system balance. Barostim has also received CE Mark approval in Europe.
CVRx, a medical device company, announced its management team's presentation at the Canaccord Genuity 42nd Annual Growth Conference on August 11, 2022, at 8:30 am ET. The event can be accessed via a live audio webcast on the company's investor relations page. CVRx specializes in neuromodulation solutions for cardiovascular diseases, particularly the Barostim device, which is FDA-approved for heart failure treatment. Barostim uses electrical pulses to enhance the baroreflex, aiming to alleviate heart failure symptoms. Learn more at cvrx.com.
CVRx reported Q2 2022 revenue of $5.0 million, up 61% year-over-year, with U.S. Heart Failure revenue reaching $3.8 million, a 90% increase. Active implanting centers grew by 27% to 71. Gross profit rose to $3.8 million with a gross margin of 76%, driven by lower costs and higher selling prices. However, SG&A expenses surged 122% to $12.5 million, leading to a net loss of $11.1 million. CVRx anticipates full-year revenue between $20.5 million and $23.0 million, slightly raising earlier guidance. Regulatory approval for a new programmer was also received.
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