MINNEAPOLIS, July 21, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that it plans to release second quarter 2025 financial and operating results after market close on Monday, August 4, 2025. The Company will host a conference call to review its results at 4:30pm Eastern Time the same day.A live webcas ...

Company Overview - CVRx shares experienced a significant increase of 19% to $8.45 in the last trading session, with a trading volume higher than average, contributing to a total gain of 25.4% over the past four weeks [1][2] Financial Performance - The company is projected to report a quarterly loss of $0.52 per share, reflecting a year-over-year improvement of 20%. Expected revenues are $13.46 million, which is a 14% increase compared to the same quarter last year [3] Market Sentiment - Investor optimism surged following the proposal from the Centers for Medicare and Medicaid Services (CMS) to include the Barostim implant procedure in the New Technology Ambulatory Payment Classification (APC) 1580, with an associated payment of approximately $45,000 for outpatient procedures [2] Earnings Estimates - The consensus EPS estimate for CVRx has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - CVRx operates within the Zacks Medical - Instruments industry, where another company, InspireMD, Inc., has shown a decline of 4.6% over the past month, closing at $2.34 [4]

Core Insights - CVRx, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) proposed to maintain the Barostim implant procedure under the New Technology Ambulatory Payment Classification (APC) 1580, with an outpatient payment of approximately $45,000 [1] - The proposal follows positive reimbursement developments, including Barostim's assignment to a higher paying MS-DRG for inpatient procedures and its transition from Category III to Category I CPT codes for physician payments starting January 1, 2026 [2] - The updates in reimbursement are expected to enhance access to Barostim for patients with heart failure, supporting its broader market adoption and long-term growth [3] Company Overview - CVRx is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [4] - Barostim is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients, delivering electrical pulses to baroreceptors in the carotid artery [4] - Barostim has received FDA Breakthrough Device designation and is compliant with EU Medical Device Regulation, holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [4]

Barostim Device & Clinical Trial Results - Barostim improves exercise capacity in HFrEF patients, showing a 19%-20% improvement versus the control arm in clinical trials[19, 37] - The BeAT-HF pivotal trial demonstrated a clinically meaningful improvement of 60 meters in exercise capacity and a -14 point change in quality of life for Barostim patients[27, 28] - The BeAT-HF pivotal trial showed a 25% reduction in NT-proBNP levels with Barostim, which is considered clinically meaningful[34] Market Opportunity & Patient Identification - The initial annual market opportunity for Barostim in the U S and the five largest EU countries is estimated at $2 9 billion[44] - The U S market consists of 6 3 million patients, while the 5 EU countries have 8 6 million patients[42] - The initial addressable patient incidence rate is 55,000 patients per year in the U S and 61,000 patients per year in the 5 EU countries[42] - Patient identification for Barostim is straightforward, based on NYHA II/III symptoms, LVEF ≤ 35%, and NT-proBNP < 1600pg/ml[47] Commercial Strategy & Financial Performance - The company aims to add 3 new account managers every quarter to create new territories and activate implanting centers[58] - The goal is to have 5 active implanting centers per territory, with each center implanting 12 Barostim units per year[58] - Full year 2022 revenue was $7 0 million - $7 1 million, with US HF revenue at $5 9 million (+118%)[67] - The company projects total revenue between $35 0 million and $38 0 million for the full year of 2023[68]

Market Opportunity & Disease Burden - Heart failure affects over 6 million people in the U S [9], leading to over 1 1 million hospital discharges and over 1 3 million emergency room visits annually [11] - The annual costs associated with heart failure are expected to reach $70 billion by 2030 in the U S [11] - The U S annual net addressable market for Barostim is estimated at $2 2 billion, assuming an average selling price (ASP) of $29,000 [37] Barostim Therapy & Clinical Evidence - Barostim is presented as a neuromodulation therapy designed to improve heart failure symptoms [8] - Barostim implantation is a 60-minute procedure with a 97% freedom from major complications [46, 48] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months) [67] Financial Performance & Guidance - Worldwide revenue for 2024 was $51 3 million, representing 31% growth [87, 88] - The gross margin for 2024 was 84% [87, 88] - The company's revenue guidance for full year 2025 is $55 0 – $58 0 million, with a gross margin of 83% – 84% and operating expenses of $95 0 – $98 0 million [90]

Core Insights - CVRx is a pioneering medical device company focused on treating advanced heart failure with its FDA-approved therapy [1] - The company is currently unprofitable due to significant investments in US sales and support infrastructure [1] Company Overview - CVRx operates in the medical device industry, specifically targeting advanced heart failure treatment [1] - The company has received FDA approval for its therapy, indicating regulatory validation of its product [1] Financial Performance - Despite its innovative approach, CVRx has not yet achieved profitability [1] - Heavy investments in infrastructure are a key factor contributing to the company's current financial status [1]

CVRx (CVRX) FY Conference Summary Company Overview - **Company**: CVRx - **Industry**: Medical Devices, specifically focusing on heart failure treatment - **Product**: Barostim, a neuromodulation therapy for heart failure Key Points and Arguments Market Opportunity - CVRx has developed the world's first neuromodulation therapy for heart failure, representing a **$2.2 billion** annual market opportunity with a defined patient population that has limited treatment options [3][10] - Heart failure affects over **6 million** Americans, leading to significant healthcare utilization, including **over 1 million** hospital discharges and **8 million** physician visits annually [4] Treatment Paradigm - Current treatment options primarily involve a regimen of four drugs (quad therapy), which have shown limited impact on quality of life, with only **1%** of patients reaching optimal doses [6][8] - The majority of heart failure patients (approximately **98%**) are not eligible for advanced therapies like LVAD or cardiac transplants, leading to a significant unmet need [5] Barostim Therapy - Barostim therapy addresses the unmet need in heart failure treatment by improving quality of life and exercise capacity, with **68%** of patients showing improvement in their New York Heart Association class status [16] - The therapy has demonstrated a **97%** freedom from major complications in clinical trials [13] - Real-world evidence shows an **85%** reduction in hospitalizations for patients receiving Barostim therapy [18] Commercial Strategy - CVRx aims to drive Barostim to become the standard of care through a focused commercial strategy that includes building a world-class sales team and developing sustainable adoption programs [19][20] - The company is targeting approximately **3,000 to 4,000** hospitals in the U.S. that have the potential for Barostim therapy adoption [23] Financial Performance - In 2024, CVRx reported worldwide revenue of **$51.3 million**, representing a **31%** growth, with U.S. heart failure revenue at **$46 million** and gross margins of **84%** [35] - For Q1 2025, the company reported revenue of **$12.3 million**, with a full-year guidance of **$55 million to $58 million** [36][37] Future Growth Potential - CVRx anticipates a sequential growth rate of **8% to 10%** from Q1 to Q4 2025, with long-term growth potential projected at **mid to high 20%** as the market opportunity expands [60][61] Additional Important Insights - The company is focusing on increasing awareness and evidence for Barostim therapy among healthcare providers, including advanced practice providers who frequently manage heart failure patients [26][29] - Significant changes in reimbursement policies are expected to improve patient access, including a proposed permanent outpatient code that could enhance the economic viability of the therapy [32][34] - The sales team has undergone significant changes, with **26%** of the team hired in 2025, indicating a focus on attracting experienced therapy development representatives [22][40] This summary encapsulates the critical aspects of CVRx's conference, highlighting the company's strategic direction, market potential, and financial outlook in the heart failure treatment landscape.

Company Overview - CVRx, Inc. is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3] - The company's flagship product, Barostim™, is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Recent Developments - CVRx management will present at the William Blair 45 Annual Growth Stock Conference on June 4, 2025, at 10:00 am Central Time via webcast [1] - A live audio webcast of the conference presentation will be accessible on the investor relations page of the company's website [2] Regulatory Approvals - Barostim has received FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. [3] - The device has also obtained the CE Mark for heart failure and resistant hypertension in the European Economic Area [3]

Group 1 - The company reported revenue of $12.3 million for Q1 2025, reflecting a 15% growth compared to the same quarter last year, aligning with preliminary results shared earlier [5] - The company aims to establish Barostim as the standard of care in its field [5] Group 2 - The earnings call included forward-looking statements regarding financial guidance, which are subject to change based on various risks and uncertainties [4] - The call featured participation from key executives, including the President and CEO, Kevin Hykes, and CFO, Jared Oasheim [3]

Revenue and Sales Performance - Revenue for the three months ended March 31, 2025, was $12.3 million, an increase of $1.6 million, or 15%, compared to the same period in 2024[84]. - U.S. sales accounted for $11.2 million, reflecting a 14% increase from $9.8 million in the prior year, driven by growth in the U.S. heart failure business[88]. - The number of active implanting centers in the U.S. increased to 227 as of March 31, 2025, up from 190 a year earlier[89]. Profitability and Expenses - Gross profit for the three months ended March 31, 2025, was $10.3 million, a 13% increase from $9.2 million in the same period in 2024, with a gross margin of 84%[91]. - Research and development expenses decreased by $0.5 million, or 18%, to $2.5 million for the three months ended March 31, 2025[92]. - Selling, general and administrative expenses decreased by $7.1 million, or 25%, to $21.2 million for the three months ended March 31, 2025[93]. - For the three months ended March 31, 2025, the net loss was $13.8 million, a decrease from a net loss of $22.2 million for the same period in 2024, representing a 37.9% improvement[98]. Cash Flow and Liquidity - Cash and cash equivalents as of March 31, 2025, were $102.7 million, down from $105.9 million as of December 31, 2024[98]. - Net cash used in operating activities for the three months ended March 31, 2025, was $12.8 million, compared to $10.9 million for the same period in 2024, indicating a 17.4% increase in cash outflow[104]. - Cash used in investing activities was $0.1 million for the three months ended March 31, 2025, down from $0.9 million in the same period in 2024[107]. - Net cash provided by financing activities for the three months ended March 31, 2025, was $9.6 million, a significant increase from $1.4 million in the same period in 2024[109]. Future Outlook and Funding - The company expects to continue incurring net losses for the next several years, which may require additional funding[71]. - Future liquidity and capital funding requirements will depend on factors including market acceptance of Barostim and costs of commercialization activities[101]. - The company has $50.0 million in outstanding Term Loans under the Loan Agreement as of March 31, 2025[99]. - The company raised $9.5 million through the issuance of 543,462 shares of common stock under the ATM offering during the three months ended March 31, 2025[100]. - The company has remaining capacity to issue and sell up to $6.7 million of additional shares of common stock under the ATM offering[100]. - The company anticipates incurring significant losses for at least the next several years[98]. Cost of Goods Sold and Interest Expense - Cost of goods sold increased by $0.4 million, or 26%, to $2.0 million for the three months ended March 31, 2025, driven by higher sales of Barostim[91]. - Interest expense increased by $0.5 million for the three months ended March 31, 2025, due to higher levels of borrowings under the Loan Agreement[95]. Commercial Strategy - The company plans to expand its U.S. commercial infrastructure by increasing its sales force and enhancing physician education on Barostim[67].