MINNEAPOLIS, May 14, 2026 (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, announced today that Humana has issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million Medicare Advantage members across 46 states. The new policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial, the landmark heart failure study evaluating Barostim in a significantly expanded patient population initiated earlier this year. “We are pleased to receive this Medicare Advantage coverage policy from Humana, which represents the first coverage policy for Barostim and marks an important milestone in our efforts to expand access to the therapy for patients living with heart failure,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Humana’s policy reflects continued progress in educating payers on the clinical outcomes and patient benefits of Barostim therapy. We believe this policy validates our commercial strategy, supports ongoing discussions with other regional and national payers, and will help accelerate adoption of Barostim through more consistent coverage.” This coverage policy follows two other positive reimbursement developments for Barostim this year. Effective Jan. 1, 2026, Category I CPT codes went into effect for the Barostim procedure. In addition, that same month, the Centers for Medicare & Medicaid Services (CMS) approved Category B IDE coverage for patients enrolled in the BENEFIT-HF trial. About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
Tag: CVRx
CVRx Reports First Quarter 2026 Financial and Operating Results
MINNEAPOLIS, May 11, 2026 (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 its financial and operating results for the first quarter of 2026. Recent Highlights Total revenue for the first quarter of 2026 was $14.8 million, an increase of approximately 20% over the prior year quarterU.S. revenue for the first quarter of 2026 was $13.7 million, an increase of 22% over the prior year quarterActive implanting centers in the U.S. grew to 257 as of March 31, 2026, as compared to 227 as of March 31, 2025First site activated and first patient enrolled in BENEFIT-HF clinical trial “We delivered a strong start to 2026, with U.S. revenue growing 22% as the investments we made in our team and programs throughout 2025 begin to translate into results,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are seeing continued progress from our sales organization and the successful activation of the first site and our first patient enrolled in our BENEFIT-HF clinical trial. Together, these developments reinforce our confidence in the path ahead and in our ability to make Barostim more accessible to heart failure patients.” First Quarter 2026 Financial and Operating Results Revenue was $14.8 million for the three months ended March 31, 2026, an increase of $2.4 million, or 20%, over the three months ended March 31, 2025. Revenue generated in the U.S. was $13.7 million for the three months ended March 31, 2026, an increase of $2.4 million, or 22%, over the three months ended March 31, 2025. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of March 31, 2026, the Company had a total of 257 active implanting centers in the U.S., as compared to 252 as of December 31, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 56 during the three months ended March 31, 2026. Revenue generated in Europe was $1.1 million for the three months ended March 31, 2026, a decrease of $27,000, or 2%, over the three months ended March 31, 2025. Total revenue units in Europe decreased to 56 for the three months ended March 31, 2026 from 59 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended March 31, 2026. Gross profit was $12.9 million for the three months ended March 31, 2026, an increase of $2.6 million, or 25%, over the three months ended March 31, 2025. Gross margin was 87% and 84% for the three months ended March 31, 2026 and March 31, 2025, respectively. R&D expenses increased $0.6 million, or 23%, to $3.1 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. This change was driven by a $0.4 million increase in consulting expenses, a $0.3 million increase in compensation expenses, and a $0.1 million increase in non-cash stock-based compensation expenses, partially offset by a $0.2 million decrease in clinical trial expenses. SG&A expenses increased $0.7 million, or 3%, to $22.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This change was primarily driven by a $1.0 million increase in compensation expenses and a $0.3 million increase in non-cash stock-based compensation expenses, partially offset by a $0.3 million decrease in consulting expenses and a $0.3 million decrease in advertising expenses. Interest expense increased $0.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, driven by the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 and $1.1 million for the three months ended March 31, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $13.1 million, or $0.50 per share, for the three months ended March 31, 2026, compared to a net loss of $13.8 million, or $0.53 per share, for the three months ended March 31, 2025. Net loss per share was based on 26.4 million weighted average shares outstanding for three months ended March 31, 2026 and 25.9 million weighted average shares outstanding for the three months ended March 31, 2025. As of March 31, 2026, cash and cash equivalents were $72.3 million. Net cash used in operating and investing activities was $12.3 million for the three months ended March 31, 2026 as compared to $12.9 million for the three months ended March 31, 2025. BENEFIT-HF Clinical Trial Update On March 31, 2026, the first site was activated in the BENEFIT-HF trial and the first patient was enrolled in the second quarter of 2026. This trial, as previously disclosed, is a landmark randomized controlled trial designed to evaluate Barostim’s impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL. If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times, significantly broadening access to this proven neuromodulation-based approach to heart failure management. Business Outlook For the full year of 2026, the Company maintained its revenue and expense guidance, and updated its guidance range for gross margin, as follows: Total revenue between $63.0 million and $67.0 million;Gross margin between 85% and 87%, compared to prior guidance of 84% and 86%;Operating expenses between $103.0 million and $107.0 million. For the second quarter of 2026, the Company expects to report total revenue between $15.1 million and $16.1 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and second quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. 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, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) March 31, December 31, 2026 2025Assets Current assets: Cash and cash equivalents $72,303 $75,708 Accounts receivable, net of allowances of $869 and $871, respectively 9,104 10,665 Inventory 12,403 12,205 Prepaid expenses and other current assets 2,940 3,069 Total current assets 96,750 101,647 Property and equipment, net 2,159 2,243 Operating lease right-of-use asset 793 878 Other non-current assets 26 26 Total assets $99,728 $104,794 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $2,998 $3,833 Accrued expenses 6,488 9,484 Total current liabilities 9,486 13,317 Long-term debt 58,490 49,514 Operating lease liability, non-current portion 544 638 Other long-term liabilities 2,099 2,001 Total liabilities 70,619 65,470 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2026 and December 31, 2025; 26,428,767 and 26,311,607 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively 264 263 Additional paid-in capital 632,820 629,916 Accumulated deficit (603,772) (590,652)Accumulated other comprehensive loss (203) (203)Total stockholders’ equity 29,109 39,324 Total liabilities and stockholders’ equity $99,728 $104,794 CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three months ended March 31, 2026 2025Revenue $14,769 $12,348 Cost of goods sold 1,888 2,036 Gross profit 12,881 10,312 Operating expenses: Research and development 3,084 2,517 Selling, general and administrative 21,958 21,232 Total operating expenses 25,042 23,749 Loss from operations (12,161) (13,437)Interest expense (1,551) (1,457)Other income, net 593 1,123 Loss before income taxes (13,119) (13,771)Benefit (provision) for income taxes (1) 5 Net loss (13,120) (13,766)Cumulative translation adjustment — — Comprehensive loss $(13,120) $(13,766)Net loss per share, basic and diluted $(0.50) $(0.53)Weighted-average common shares used to compute net loss per share, basic and diluted 26,355,591 25,876,062
CVRx Announces First Patient Enrollment in BENEFIT-HF, a Landmark Heart Failure Trial Evaluating Barostim in Significantly Expanded Population
MINNEAPOLIS, May 04, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced the enrollment of the first patient in the landmark BENEFIT-HF trial at North Central Heart – a division of the Avera Heart Hospital, in Sioux Falls, S.D. by Dr. Orvar Jonsson. BENEFIT-HF is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, enrolling 2,500 patients at approximately 150 centers in the United States and Germany. The prospective, randomized, controlled, multicenter trial is supported by CMS Category B IDE coverage and designed to evaluate all-cause mortality and heart failure decompensation events in a significantly expanded heart failure population. “We are honored to enroll the first patient in the BENEFIT-HF trial,” said Dr. Orvar Jonsson, North Central Heart – a division of the Avera Heart Hospital. “This study will evaluate Barostim therapy in a broader population of patients who remain symptomatic despite optimized guideline-directed medical therapy, generating important data that will further define Barostim’s position in the heart failure continuum.” “Achievement of this early milestone reflects tremendous excitement in the healthcare community regarding this landmark trial, and strong execution by the CVRx team in partnership with BENEFIT-HF investigators,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are proud to collaborate with leading physicians in development of such meaningful clinical evidence, and excited to further characterize the patient benefits of Barostim therapy that we believe will drive long-term adoption.” The BENEFIT-HF trial is expected to continue through 2032. If successful, the Trial could expand the indicated patient population for Barostim by approximately three times, significantly broadening access to the therapy. About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the expected timing, enrollment, scope, and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment; the resulting impact on our addressable market; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF clinical trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. 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, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
CVRx Announces Nomination of Michael Dale for Election to the Board of Directors
MINNEAPOLIS, April 20, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, announced today the nomination of Michael Dale to serve on its Board of Directors. Mr. Dale will stand for election at the annual meeting of stockholders scheduled for June 1, 2026.
CVRx Reports Preliminary First Quarter 2026 Financial Results
Delivered strong topline performance with first quarter revenue expected to be $14.7 million to $14.8 million, approximately 20% growth compared to first quarter of 2025Early data in 2026 shows an increase in the 30-day approval rate for Medicare Advantage prior authorizations managed by our market access teamFirst site activated in BENEFIT-HF clinical trial MINNEAPOLIS, April 13, 2026 (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 certain preliminary unaudited first quarter 2026 financial and operating results. “The investments we made in our team and programs in 2025 are beginning to pay off, allowing us to deliver strong revenue growth in the first quarter,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are also starting to observe positive effects from the Category I CPT Code that took effect at the beginning of the year, as early data shows improved 30-day prior authorization approval rates compared to what we saw in 2025. Our continued progress in reducing the barriers to adoption for Barostim have enabled us to start the year off with positive momentum, and we are excited about what that means for the balance of 2026 and beyond.” First Quarter 2026 Total revenue for the first quarter of 2026 is expected to be in the range of $14.7 million to $14.8 million compared to revenue for the first quarter of 2025 of $12.3 million, representing growth of approximately 20%. Gross margin for the first quarter of 2026 is expected to be approximately 87% compared to 84% in the first quarter of 2025. Total operating expenses for the first quarter of 2026 are expected to be approximately $25 million compared to $23.7 million in the first quarter of 2025. As of March 31, 2026, the Company had a total of 257 U.S. active implanting centers, as compared to 252 as of December 31, 2025. The number of sales territories in the U.S. increased by three to a total of 56 during the three months ended March 31, 2026. As of March 31, 2026, cash and cash equivalents were approximately $72.3 million. Reimbursement Update As previously disclosed, the Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using the Company’s Barostim device replaced Category III codes as of Jan. 1, 2026, which eliminates the automatic denials regularly seen with Category III codes and improves prior authorization predictability to fairly pay physicians for the procedure. Early data in 2026 shows an increase in the 30-day approval rate for Medicare Advantage prior authorizations managed by the Company’s in-house market access team, which has increased from 31% in 2024 to 44% in 2025 and to 50% for the first two months of 2026. First Site Activated in BENEFIT-HF Clinical Trial On March 31, 2026, the first site was activated in the BENEFIT-HF trial and enrollment is expected to begin in the second quarter of 2026. This trial, as previously disclosed, is a landmark randomized controlled trial designed to evaluate Barostim’s impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL. If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times, significantly broadening access to this proven neuromodulation-based approach to heart failure management. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance, our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; the constant growth and development of technology, including artificial intelligence; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF clinical trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. 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, changed circumstances or otherwise. Preliminary First Quarter 2026 Results This press release includes estimated financial results for the first quarter of 2026, which are preliminary, unaudited and represent the most recent current information available to Company management. The Company’s actual results may differ from these estimated financial results, including due to the completion of its financial closing procedures and final adjustments. The Company expects to issue full financial results for the first quarter of 2026 in mid-May. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
CVRx Announces Late-Breaking Data and Scientific Presentations Highlighting Barostim Outcomes at the THT 2026 Annual Meeting
MINNEAPOLIS, March 02, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, announced today the schedule of scientific presentations reviewing the science and outcomes of Barostim therapy at the Technology and Heart Failure Therapeutics 2026 (THT) meeting. THT, the annual conference organized by the Cardiovascular Research Foundation® (CRF®), will be held March 2-4, 2026, in Boston, Massachusetts. The presentations include late-breaking clinical data, oral sessions and posters highlighting real-world outcomes, cardiac energetics, hospitalization impact, left ventricular ejection fraction (LVEF) improvements and changes in advanced hemodynamic, respectively. Late-Breaking REBALANCE Registry Data In a late-breaking presentation on Monday, March 2, Dr. Dmitry Yaranov will share, for the first time, data from the REBALANCE Registry, a post-market observational study designed to evaluate real-world data on the safety and benefit of Barostim therapy in the commercial setting. Dr. Yaranov will present the six-month outcomes in over 400 patients enrolled in the registry. Scientific Presentations Featuring Barostim Monday, March 2: Late-Breaking Clinical Science Session 1: Initial Six-Month Outcomes with Baroreflex Activation Therapy from the REBALANCE Registry (Dr. Dmitry Yaranov)Unmasking the Energetic Response Following Acute Titration of Baroreflex Activation Therapy Through Patient-Specific Modeling and Simulation (Dr. Rohan Goswami)Impact of Baroreflex Activation Therapy on Hospitalizations: A Single Center Retrospective Analysis (Dr. Joel Joseph) Tuesday, March 3: Electrical Therapies for Heart Failure: Barostimulation for HFrEF (Dr. Philip Adamson)Abstract Session 8: Heart Failure Reduced Ejection Fraction I Real-World Outcomes of Barostim Baroreflex Activation Therapy in Heart Failure: Analysis of a Large Multi-Institutional Database (Dr. Arvind Bhimaraj)LVEF and Functional Improvement Observed in a Post-Market Registry of Barostim Baroreflex Activation Therapy (Dr. Dmitry Yaranov) CVRx Sponsored Satellite Program CVRx will also host a satellite program on Tuesday, March 3 from 12:15-1:30 p.m. ET in Ensemble CD South, which will include the following presentations: Advances in Evidence with Baroreflex Activation Therapy (Dr. Philip Adamson)Outcomes from the REBALANCE Registry (Dr. Dmitry Yaranov)BREATHE-HF: Impact of Barostim Therapy on Cardiac Hemodynamics (Dr. Gabriel T. Sayer)BENEFIT-HF: Broadening Access to Barostim Therapy (Dr. Farooq Sheikh) During the satellite program, faculty will provide updates on the REBALANCE Registry, the BREATHE-HF trial, and the BENEFIT-HF trial. BREATHE-HF, a large physician-initiated study, is evaluating the impact of Barostim on cardiac hemodynamics. In January, CVRx announced the initiation of the BENEFIT-HF trial, a landmark randomized study supported by CMS Category B IDE coverage. The trial is designed to evaluate the impact of Barostim in a significantly expanded heart failure population, with the primary endpoint as a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. “We are excited by the new data supporting Barostim being featured at THT 2026,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are encouraged by the increasing adoption of Barostim by the heart failure community. The accelerating cadence of publications evaluating Barostim’s impact is proof of the positive patient impact and increasing acceptance of Barostim in the heart failure treatment continuum.” About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the expected enrollment of the BENEFIT-HF clinical trial and anticipated benefits of Barostim therapy. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment, the resulting impact of our addressable market and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. 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, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.comMedia Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
CVRx Reports Fourth Quarter and Full Year 2025 Financial and Operating Results
MINNEAPOLIS, Feb. 12, 2026 (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 its financial and operating results for the fourth quarter and full year of 2025. Recent Highlights Total revenue for the fourth quarter 2025 was $16.0 million, an increase of 4% over the prior year quarterU.S. revenue for the fourth quarter of 2025 was $14.9 million, an increase of 4% over the prior year quarterTotal revenue for 2025 was $56.7 million, an increase of 10% over the prior yearActive implanting centers in the U.S. grew to 252 in 2025, as compared to 223 in the prior yearInitiated the BENEFIT-HF trial with first enrollments expected in the second quarter of 2026Category I CPT codes and the related favorable physician fee payment levels took effect on Jan. 1, 2026 “We achieved key foundational goals in 2025, and we’re heading into 2026 with increasing momentum. Our sales team is building experience and becoming more effective, and we’re seeing strong support at high-potential centers. Additionally, the new Category I CPT codes, effective January 1st, remove automatic prior authorization denials. Finally, the initiation of the landmark BENEFIT-HF trial under CMS Category B IDE coverage is a major step that could allow us to triple our addressable market,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We’re confident that these developments will support our accelerated growth and make Barostim therapy more accessible for heart failure patients in the coming year.” Fourth Quarter 2025 Financial and Operating Results Revenue was $16.0 million for the three months ended December 31, 2025, an increase of $0.7 million, or 4%, over the three months ended December 31, 2024. Revenue generated in the U.S. was $14.9 million for the three months ended December 31, 2025, an increase of $0.6 million, or 4%, over the three months ended December 31, 2024. Revenue units in the U.S. totaled 478 and 460 for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily driven by continued growth as a result of the expansion into new sales territories and new accounts, as well as increased physician and patient awareness of Barostim. As of December 31, 2025, the Company had a total of 252 active implanting centers, as compared to 250 as of September 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 53 during the three months ended December 31, 2025. Revenue generated in Europe was $1.1 million for the three months ended December 31, 2025, an increase of $0.1 million, or 10%, over the three months ended December 31, 2024. Total revenue units in Europe increased to 49 for the three months ended December 31, 2025 from 41 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended December 31, 2025. Gross profit was $13.8 million for the three months ended December 31, 2025, an increase of $1.1 million, or 8%, over the three months ended December 31, 2024. Gross margin increased to 86% for the three months ended December 31, 2025, compared to 83% for the three months ended December 31, 2024. Gross margin for the three months ended December 31, 2025 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily resulting from an increase in manufacturing efficiencies. R&D expenses increased $0.2 million, or 7%, to $3.0 million for the three months ended December 31, 2025 compared to the three months ended December 31, 2024. This change was primarily driven by a $0.3 million increase in compensation expenses, mainly as a result of increased headcount, partially offset by a $0.1 million decrease in clinical study expenses. SG&A expenses increased $1.8 million, or 9%, to $22.0 million for the three months ended December 31, 2025 compared to the three months ended December 31, 2024. This change was driven by a $1.3 million increase in compensation expenses, mainly as a result of increased headcount, a $0.5 million increase in advertising expense, and a $0.3 million increase in travel expense, partially offset by a $0.3 million decrease in consulting expense. Interest expense decreased $0.1 million to $1.4 million for the three months ended December 31, 2025 compared to the three months ended December 31, 2024. This decrease was driven by the lower interest rate on the levels of borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.7 million for the three months ended December 31, 2025, compared to $1.1 million for the three months ended December 31, 2024. This decrease was primarily driven by less interest income on our interest-bearing accounts. Net loss was $11.9 million, or $0.46 per share, for the three months ended December 31, 2025, compared to a net loss of $10.7 million, or $0.43 per share, for the three months ended December 31, 2024. Net loss per share was based on 26.2 million weighted average shares outstanding for three months ended December 31, 2025 and 24.7 million weighted average shares outstanding for the three months ended December 31, 2024. Full Year 2025 Financial and Operating Results Revenue was $56.7 million for the year ended December 31, 2025, an increase of $5.4 million, or 10%, over the year ended December 31, 2024. Revenue generated in the U.S. was $51.9 million for the year ended December 31, 2025, an increase of $4.7 million, or 10%, over the year ended December 31, 2024. Revenue units in the U.S. totaled 1,648 and 1,522 for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, the Company had a total of 252 active implanting centers, as compared to 223 as of December 31, 2024. As of December 31, 2025, we had 53 sales territories in the U.S. as compared to 48 sales territories as of December 31, 2024. Revenue generated in Europe was $4.8 million for the year ended December 31, 2025, an increase of $0.6 million, or 16%, over the year ended December 31, 2024. Total revenue units in Europe increased to 219 for the year ended December 31, 2025, from 204 for the prior year period. The number of sales territories in Europe remained consistent at five for each of the years ended December 31, 2025 and December 31, 2024. Gross profit was $48.3 million for the year ended December 31, 2025, an increase of $5.4 million, or 13%, over the year ended December 31, 2024. Gross margin increased to 85% for the year ended December 31, 2025 compared to 84% for the year ended December 31, 2024. Gross margin for the year ended December 31, 2025 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies. R&D expenses were $11.1 million for the years ended December 31, 2025 and December 31, 2024, respectively. R&D expense for the year ended December 31, 2025 included a $0.4 million increase in compensation expenses, mainly as a result of increased headcount, offset by a $0.5 million decrease in clinical study expenses. SG&A expenses decreased $2.8 million, or 3%, to $88.5 million for the year ended December 31, 2025, compared to the year ended December 31, 2024. This change was driven by a $7.9 million decrease in non-cash stock-based compensation expense, a $0.2 million decrease in insurance expenses, and a $0.2 million decrease in bad debt expense, partially offset by a $4.0 million increase in compensation expenses, mainly as a result of increased headcount and a $1.5 million increase in travel expenses. Approximately $8.4 million of the decrease in non-cash stock-based compensation expense is related to the modification of stock options held by our former Chief Executive Officer in connection with his retirement in the first quarter of 2024. Interest expense increased $1.4 million to $5.8 million for the year ended December 31, 2025, compared to the year ended December 31, 2024. This increase was driven by the interest expense on borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $3.8 million for the year ended December 31, 2025, compared to $4.0 million for the year ended December 31, 2024. This decrease was primarily driven by less interest income on our interest-bearing accounts. Net loss was $53.3 million, or $2.04 per share, for the year ended December 31, 2025, compared to a net loss of $60.0 million, or $2.65 per share, for the year ended December 31, 2024. Net loss per share was based on 26.1 million weighted average shares outstanding for year ended December 31, 2025 and 22.6 million weighted average shares outstanding for the year ended December 31, 2024. As of December 31, 2025, cash and cash equivalents were $75.7 million. Net cash used in operating and investing activities was $40.8 million for the year ended December 31, 2025, compared to $40.5 million for the year ended December 31, 2024. BENEFIT-HF Clinical Trial In January 2026, the Company announced the initiation of the BENEFIT-HF trial, a landmark randomized controlled trial designed to evaluate Barostim’s impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL. If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times, significantly broadening access to this proven neuromodulation-based approach to heart failure management. The trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients at approximately 150 centers across the U.S. and Germany. The Centers for Medicare & Medicaid Services (“CMS”) has approved Category B IDE coverage for the trial, and enrollment is expected to begin in the second quarter of 2026. The net trial costs are expected to be $20 million to $30 million spread over the next five to seven years. Debt Facility On January 9, 2026, the Company amended its term loan agreement with an affiliate of Innovatus Capital Partners, LLC, to increase the existing facility by $50 million, to an aggregate principal amount of up to $100 million, subject to the Company’s achievement of certain milestones. Also on the closing date, the Company borrowed an additional $10 million under the term loan agreement, bringing the total outstanding principal amount of term loans to $60 million. The initial interest rate under the amended term loan agreement is equal to the greater of 9.40% or prime plus 2.65%. The interest-only period is extended four years from the closing date and is extendable to five years from the closing date upon achieving certain revenue milestones. The term loans mature in May 2031 and continue to be secured by substantially all of the Company’s assets. Business Outlook For the full year of 2026, the Company continues to expect: Total revenue between $63.0 million and $67.0 million;Gross margin between 84% and 86%;Operating expenses between $103.0 million and $107.0 million. For the first quarter of 2026, the Company expects to report total revenue between $13.7 million and $14.7 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and first quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and “Part II, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. 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, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Consolidated Balance Sheets(In thousands, except share and per share data) December 31, December 31, 2025 2024Assets Current assets: Cash and cash equivalents $75,708 $105,933 Accounts receivable, net of allowances of $871 and $780, respectively 10,665 9,268 Inventory 12,205 12,107 Prepaid expenses and other current assets 3,069 2,505 Total current assets 101,647 129,813 Property and equipment, net 2,243 2,505 Operating lease right-of-use asset 878 1,069 Other non-current assets 26 27 Total assets $104,794 $133,414 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $3,833 $2,582 Accrued expenses 9,484 8,180 Total current liabilities 13,317 10,762 Long-term debt 49,514 49,273 Operating lease liability, non-current portion 638 877 Other long-term liabilities 2,001 1,447 Total liabilities 65,470 62,359 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of December 31, 2025 and 2024; 26,311,607 and 25,324,684 shares issued and outstanding as of December 31, 2025 and 2024, respectively 263 253 Additional paid-in capital 629,916 608,354 Accumulated deficit (590,652) (537,346) Accumulated other comprehensive loss (203) (206) Total stockholders’ equity 39,324 71,055 Total liabilities and stockholders’ equity $104,794 $133,414 CVRx, INC.Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data) Three months ended Year ended December 31, December 31, 2025 2024 2025 2024 Revenue $16,024 $15,342 $56,651 $51,292 Cost of goods sold 2,199 2,571 8,311 8,334 Gross profit 13,825 12,771 48,340 42,958 Operating expenses: Research and development 3,000 2,805 11,132 11,131 Selling, general and administrative 22,009 20,240 88,473 91,317 Total operating expenses 25,009 23,045 99,605 102,448 Loss from operations (11,184) (10,274) (51,265) (59,490) Interest expense (1,417) (1,520) (5,827) (4,397) Other income, net 660 1,072 3,768 3,977 Loss before income taxes (11,941) (10,722) (53,324) (59,910) Benefit (provision) for income taxes 7 71 18 (55) Net loss (11,934) (10,651) (53,306) (59,965) Cumulative translation adjustment – 2 2 1 Comprehensive loss $(11,934) $(10,649) $(53,304) $(59,964) Net loss per share, basic and diluted $(0.46) $(0.43) $(2.04) $(2.65) Weighted-average common shares used to compute net loss per share, basic and diluted 26,218,215 24,715,681 26,084,709 22,596,229
CVRx Announces Initiation of BENEFIT-HF, a Landmark Heart Failure Trial Evaluating Barostim in Significantly Expanded Population
Study is Expected to Be One of the Largest Therapeutic Cardiac Device Trials in Heart Failure Ever Performed, and is Supported by CMS Category B IDE CoverageMINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim™ in a significantly expanded heart failure population. Barostim™ is an implantable device that delivers electrical signals to baroreceptors located on the carotid artery, increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure symptoms. Barostim™ received FDA approval in 2019 following its designation under the FDA’s Breakthrough Devices Program and is now commercially available in both the U.S. and Europe. The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. The BENEFIT-HF trial is designed to evaluate Barostim in patients with heart failure who: Remain symptomatic after receiving optimized guideline-directed medical and device therapies (GDMT)Have a left ventricular ejection fraction (LVEF)
CVRx Announces Implementation of New Category I CPT Codes for Barostim Therapy
MINNEAPOLIS, Jan. 06, 2026 (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, confirmed today that Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using its Barostim device replaced the Category III codes as of Jan. 1, 2026. In the U.S. healthcare system, Category I CPT codes signify established procedures, supporting adoption, coverage, and reimbursement nationwide. The new CPT codes for use with Barostim procedures are available in the reimbursement guide here, and on CVRx’s website. U.S. hospitals and physicians performing Barostim procedures should update their billing systems and start using these new codes for all procedures performed on or after Jan. 1, 2026. “We believe the new Category I CPT codes will enable more predictable and consistent reimbursement for Barostim patients and healthcare professionals,” said Kevin Hykes, President and Chief Executive Officer of CVRx, “and validate the important role of Barostim therapy in the heart failure treatment continuum.” About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding the anticipated effect the new codes will have on Barostim’s adoption are forward-looking statements. These statements speak only as of the date of this press release and are based on our current expectations and projections about the future and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause actual results to differ from our expectations, including the actual impact the new codes have on reimbursement and patient access. 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, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
CVRx to Present at the 44th Annual J.P. Morgan Healthcare Conference
MINNEAPOLIS, Dec. 22, 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 the management team will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, Jan. 14, 2026. The Company’s presentation will begin at 3:45 p.m. (PT). A live webcast of the event can be found at ir.cvrx.com. An archived version of the presentation will be available following the live event and can be accessed at the same location for a limited time.About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com



