CVRx, Inc. (CVRX) recently announced the availability of additional data supporting the long-term benefits of Barostim. This includes the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure. These data highlight the long-term sustained benefits of Barostim in heart failure (HF) patients with reduced ejection fraction.It should be noted that BeAT-HF is a multi-center, prospective, randomized, controlled trial that began in April 2016 to develop scient ...

MINNEAPOLIS, April 16, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ:CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, today announced that it plans to release first quarter 2024 financial and operating results after market close on Tuesday, April 30th, 2024. The Company will host a conference call to review its results at 5:00pm ...

MINNEAPOLIS, April 16, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, today announced that it plans to release first quarter 2024 financial and operating results after market close on Tuesday, April 30th, 2024. The Company will host a conference call to review its results at 5:00pm ...

BeAT-HF trial data published in the European Journal of Heart Failure and new abstracts presented at THT conference MINNEAPOLIS, Minn., April 15, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ:CVRX) ("CVRx"), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patien ...

Financial Performance - The company incurred net losses of $41.2 million and $41.4 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $477.4 million as of December 31, 2023[213]. - Total revenue for the year ended December 31, 2023, was $39,295,000, representing an increase of 75% compared to $22,469,000 in 2022[450]. - Gross profit for 2023 was $33,039,000, up from $17,470,000 in 2022, indicating a gross margin improvement[450]. - The net loss for 2023 was $41,199,000, slightly improved from a net loss of $41,428,000 in 2022[450]. - Cash and cash equivalents decreased to $90,569,000 as of December 31, 2023, down from $106,194,000 at the end of 2022[457]. - Long-term debt increased significantly to $29,222,000 in 2023 from $6,747,000 in 2022, reflecting increased financing activities[450]. - The company reported a net cash used in operating activities of $39,021,000 for 2023, compared to $42,677,000 in 2022, indicating a slight improvement in cash flow management[457]. - Total stockholders' equity decreased to $75,947,000 in 2023 from $109,180,000 in 2022, primarily due to the accumulated deficit increasing to $(477,381,000)[450]. Market and Competition - The company relies heavily on Barostim for revenue, which was first commercialized in the U.S. in 2020, and faces challenges in increasing market acceptance and brand recognition[216]. - The company faces intense competition from established medical device companies with greater resources, which could impact its market position and sales[222]. - Consolidation in the healthcare industry may lead to increased demands for price concessions, affecting the company's ability to sell Barostim at necessary prices[245]. - The company must effectively demonstrate the merits of Barostim to physicians and patients to drive sales, as acceptance is critical for revenue growth[218]. Operational Challenges - The company expects to continue incurring significant sales and marketing, research and development, and regulatory expenses as it grows its U.S. commercial sales force and expands marketing efforts for Barostim[213]. - The company plans to expand its U.S. direct sales and marketing organization to drive future revenue growth, which requires significant investment in hiring and training sales personnel[217]. - The company may encounter challenges in securing purchasing contracts with hospitals, which are necessary for physicians to use Barostim[227]. - The company is dependent on third-party manufacturers and suppliers, which poses risks related to supply shortages and performance degradation[228]. - The company’s manufacturing strategy is subject to risks that could affect its ability to meet consumer demand and maintain profitability[234]. - Manufacturing output must increase to meet expected customer demand, with potential difficulties in quality control and component supply posing risks to revenue generation[247]. - The company operates its only manufacturing facility in Minneapolis, Minnesota, which is critical for its operations and any disruption could significantly harm its business[238]. Regulatory and Compliance Risks - The medical device industry is heavily regulated, and non-compliance with FDA and foreign regulations could result in significant penalties, including product recalls and loss of regulatory approvals[313]. - The company must comply with the EU Medical Device Regulation (MDR) to continue selling Barostim in Europe, with its application currently under review[318]. - Regulatory requirements for product marketing and clinical studies can be lengthy and costly, potentially delaying the introduction of new products[319]. - The company faces potential penalties under various federal and state fraud and abuse laws, which could adversely affect its business operations and financial results[334]. - The company is subject to stringent FDA and European regulations regarding medical device reporting, which could lead to sanctions if adverse events are not reported timely[333]. Financial Strategy and Funding - The company anticipates that its existing cash, cash equivalents, short-term investments, and revenue will be sufficient to meet capital requirements for at least the next three years[299]. - The company may need to seek additional funds in the future if it cannot raise funds on favorable terms, which could negatively impact its commercialization efforts[299]. - The company has the option to draw down up to $20.0 million if trailing three months revenue reaches $9.0 million prior to June 30, 2024[480]. - The Loan Agreement requires interest-only payments through November 2027, followed by principal and interest payments starting in December 2027[480]. Intellectual Property and Legal Risks - The company may face significant costs and resource diversion due to potential intellectual property litigation, which could hinder commercialization efforts[276][283]. - Changes in patent law, such as the Leahy-Smith America Invents Act, could increase uncertainties and costs related to patent prosecution and enforcement[286]. - The company may need to indemnify customers and suppliers against intellectual property claims, which could lead to costly litigation[284]. - The company relies on trade secrets and proprietary information to maintain its competitive position, which may be difficult to protect[297]. - The company may not be able to prevent competitors from using its technologies in jurisdictions where it lacks patent protection[291]. Human Resources and Management - Retaining key executives and recruiting new employees is critical for the company's success, as turnover could delay business objectives[257]. - The company is undertaking various actions to maintain effective internal control over financial reporting, which may be time-consuming and costly[355]. - The company has not identified any material weaknesses in its internal control over financial reporting as of the latest evaluation[355]. Economic and Market Conditions - Economic conditions such as inflation, potential recession, and geopolitical uncertainty could adversely affect the business and financial results[264]. - Economic downturns could weaken demand for Barostim and strain relationships with manufacturers and suppliers, impacting overall business operations[265][266]. - The company expects revenue fluctuations due to seasonality and other factors, making it difficult to forecast financial results accurately[305]. Stock and Investment Considerations - The company's stock price is expected to be highly volatile, influenced by various factors including clinical trial results and regulatory actions[348]. - The company is classified as an "emerging growth company," which allows it to take advantage of reduced disclosure requirements, potentially affecting stock attractiveness[350]. - The company does not currently intend to pay cash dividends on its common stock for the foreseeable future, meaning returns on investment will depend on stock price appreciation[363].

Appointment effective February 12 following Nadim Yared's retirement Hykes currently serves as Augmedics' President and CEO, and has served on CVRx's Board of Directors since 2022 MINNEAPOLIS, Jan. 31, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ:CVRX) ("CVRx"), a commercial-stage medical device company, announced today the appointment of Kevin Hykes as the Company's new President and Chief Executive Officer, effective February 12. Hykes will continue to serve on the Company's Board of Directors. Yared will ...

Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:Warrior Met Coal, Inc. (HCC) : This metallurgical coal mining company has seen the Zacks Consensus Estimate for its current year earnings increasing 9.9% over the last 60 days.Eldorado Gold Corporation (EGO) : This mining and exploration company has seen the Zacks Consensus Estimate for its current year earnings increasing 11.5% over the last 60 days.World Acceptance Corporation (WRLD) : This consumer finance company has seen the Zacks ...

CVRx, Inc. (NASDAQ:CVRX) Q4 2023 Earnings Conference Call January 25, 2024 4:30 PM ET Company Participants Mike Vallie - IR Nadim Yared - President and CEO Jared Oasheim - CFO Conference Call Participants Margaret Andrew - William Blair Matthew O'Brien - Piper Sandler Robbie Marcus - JPMorgan Bill Plovanic - Canaccord Alex Nowak - Craig-Hallum Frank Takkinen - Lake Street Operator Greetings, and welcome to the CVRx Fourth Quarter 2023 Earnings Call. [Operator Instructions] As a reminder, this conference is ...

CVRx (CVRX) came out with a quarterly loss of $0.44 per share versus the Zacks Consensus Estimate of a loss of $0.55. This compares to loss of $0.51 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 20%. A quarter ago, it was expected that this medical device company would post a loss of $0.57 per share when it actually produced a loss of $0.43, delivering a surprise of 24.56%.Over the last four quarters, the company has surpass ...

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events ...