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 whose news flow centers on its Barostim neuromodulation platform for cardiovascular disease, particularly heart failure. The company regularly issues press releases and investor updates detailing financial performance, operational metrics and developments related to Barostim.
Readers of CVRX news can expect recurring coverage of quarterly and annual financial and operating results, including revenue trends, gross margin, operating expenses, cash and cash equivalents, and the growth of active implanting centers and sales territories in the U.S. and Europe. The company also reports on reimbursement milestones, such as the transition of Barostim procedures to Category I CPT codes and CMS decisions affecting outpatient payment classifications and physician fee levels.
Another key theme in CVRx news is clinical and regulatory progress. The company has highlighted FDA actions such as the Breakthrough Device designation for Barostim and the grant of an Investigational Device Exemption for the BENEFIT-HF trial, a randomized controlled study designed to evaluate Barostim’s impact on outcomes in an expanded heart failure population. Updates on applications to the Centers for Medicare & Medicaid Services for trial coverage and other reimbursement-related developments are also part of the company’s announcements.
CVRx news releases frequently mention participation in major healthcare and investor conferences, where the management team presents the company’s strategy and Barostim-related data to the investment community. For investors and observers following CVRX, this news page provides a centralized view of earnings releases, reimbursement and coding changes, clinical trial plans, financing arrangements, and conference appearances linked to the company’s heart failure therapy platform.
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.
CVRx, a medical device company specializing in neuromodulation solutions for cardiovascular diseases, plans to release its second quarter 2022 financial results on July 28, 2022, after market close. A conference call to discuss these results will take place at 5:30 p.m. Eastern Time the same day. The event will be available via webcast and telephone registration is recommended. CVRx's flagship product, Barostim, is an FDA-approved device aimed at alleviating heart failure symptoms by enhancing the autonomic nervous system's balance.
CVRx, Inc launches its new Barostim Programmer, enhancing programming for the Barostim therapy for heart failure. Approved by the FDA, this second-generation device incorporates a modern design, upgraded cellular capabilities, and a user-friendly interface, facilitating easier programming of implantable pulse generators. CEO Nadim Yared emphasized the improvements in hardware and software, aimed at better customer support. The rollout across the U.S. market is scheduled throughout 2022.
CVRx, a medical device company, will present at the William Blair 42nd Annual Growth Stock Conference on June 6, 2022, at 3:20 pm Central Time. The presentation will be available via webcast on the company's investor relations page. CVRx is known for Barostim™, the first FDA-approved neuromodulation technology for heart failure, which delivers electrical pulses to carotid artery baroreceptors to restore autonomic balance and alleviate symptoms. Barostim has received both FDA Breakthrough Device designation and the CE Mark for heart-related conditions.
CVRx, Inc. (NASDAQ: CVRX) has received FDA approval for MR conditional labeling of its Barostim System, allowing heart failure patients with the device to safely undergo MRI scans of the head and lower extremities. This approval enhances diagnostic options for patients receiving Barostim therapy. Barostim, the first FDA-approved neuromodulation device for heart failure, helps improve symptoms by stimulating baroreceptors. In clinical studies, patients demonstrated improved walking distance, quality of life, and reduced cardiovascular events compared to a control group.
CVRx reported a 43% increase in first quarter 2022 revenue, totaling $4.1 million, driven by strong U.S. heart failure revenue growth of 133% to $2.9 million. The company achieved notable milestones, including an expansion of active implanting centers from 19 to 56 and territories from 6 to 17 year-over-year. Despite these gains, net loss widened to $10 million or $0.49 per share, and European revenue fell 18%. The outlook for 2022 remains positive, projecting total revenue between $20 million and $23 million.
CVRx announced plans to release its first quarter 2022 financial results on April 25, 2022, after market close. The company will host a conference call at 4:30 p.m. ET the same day for discussion of the results. Investors can join the call by dialing (833) 730-3980 for U.S. participants or +1 (720) 405-2140 for international callers, using the conference code 8433167. CVRx specializes in neuromodulation solutions for cardiovascular diseases, including the FDA-approved Barostim device, aimed at improving heart failure symptoms.
CVRx reported a significant 75% revenue increase for Q4 2021, reaching $3.7 million compared to Q4 2020. Key growth drivers included U.S. heart failure revenue, which soared 345% year-over-year to $2.7 million. For the full year, CVRx achieved a 115% total revenue increase to $13 million and fully repaid a $20 million loan in November 2021. The company anticipates total revenue between $20 million and $23 million for 2022, with an improved gross margin forecast of 74% to 76%.
CVRx, a commercial-stage medical device company, announced it will release its fourth quarter and full year 2021 financial results on February 15, 2022. The company will hold a conference call at 5:30 p.m. Eastern Time to discuss the results. Investors can join by dialling (833) 730-3980 for U.S. callers or +1 (720) 405-2140 internationally, referencing conference code 2879175. The FDA-approved Barostim™ device is designed to improve heart failure symptoms by stimulating the body's baroreceptors.
CVRx reported preliminary fourth quarter 2021 revenues of approximately $3.6 million to $3.7 million, a 71% to 77% increase from Q4 2020. Full year 2021 revenue is projected at $13.0 million to $13.1 million, reflecting a 113% to 116% growth from 2020. The company had 46 active implanting centers and reported cash and equivalents of $142 million. For 2022, CVRx anticipates total revenue between $20 million and $23 million with operating expenses of $55 million to $61 million. Despite challenges in Europe, the U.S. heart failure sector shows resilience.
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