HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced business updates and financial results for the first quarter ended March 31, 2025. Recent Business Highlights Soft Tissue Ablation Expanded direct commercial resources for the […]
Financial
CVRx Reports First Quarter 2025 Financial and Operating Results
MINNEAPOLIS, May 08, 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 its financial and operating results for the first quarter of 2025. Recent Highlights Total revenue for the first quarter 2025 was $12.3 million, an increase of 15% over the prior year quarterU.S. Heart Failure (HF) revenue for the first quarter of 2025 was $11.1 million, an increase of 14% over the prior year quarterActive implanting centers in the U.S. grew to 227, an increase of 19% since March 31, 2024Real-world evidence presented at the 2025 THT conference and published in the Journal of Cardiac Failure demonstrated large and statistically significant reductions in hospital visits for patients treated with Barostim “We’re encouraged about the momentum building in our business as we move into the second quarter,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “While revenue growth in the first quarter didn’t meet our expectations, we added a significant number of new sales representatives, and are very pleased with the talent we have attracted to the organization. As these reps are still in the early stages of building their territories, we expect their contributions to grow as the year progresses. We continue to support these commercial initiatives by advancing our growing body of clinical evidence, highlighted by our recently published hospitalization data from the Premier Healthcare Database, which further reinforced Barostim’s value proposition in the treatment of heart failure patients.” First Quarter 2025 Financial and Operating Results Revenue was $12.3 million for the three months ended March 31, 2025, an increase of $1.6 million, or 15%, over the three months ended March 31, 2024. Revenue generated in the U.S. was $11.2 million for the three months ended March 31, 2025, an increase of $1.4 million, or 14%, over the three months ended March 31, 2024. HF revenue in the U.S. totaled $11.1 million and $9.7 million for the three months ended March 31, 2025 and 2024, respectively. HF revenue units in the U.S. totaled 353 and 319 for the three months ended March 31, 2025 and 2024, 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, 2025, the Company had a total of 227 active implanting centers in the U.S., as compared to 223 as of December 31, 2024. 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. decreased by three to a total of 45 during the three months ended March 31, 2025. Revenue generated in Europe was $1.1 million for the three months ended March 31, 2025, an increase of $0.2 million, or 23%, over the three months ended March 31, 2024. Total revenue units in Europe increased to 59 for the three months ended March 31, 2025 from 44 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended March 31, 2025. Gross profit was $10.3 million for the three months ended March 31, 2025, an increase of $1.2 million, or 13%, over the three months ended March 31, 2024. Gross margin was 84% and 85% for the three months ended March 31, 2025 and March 31, 2024, respectively. R&D expenses decreased $0.5 million, or 18%, to $2.5 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This change was driven by a $0.4 million decrease in consulting expenses and a $0.1 million decrease in non-cash stock-based compensation expense. SG&A expenses decreased $7.1 million, or 25%, to $21.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This change was primarily driven by an $8.6 million decrease in non-cash stock-based compensation expense, partially offset by a $1.6 million increase in compensation expenses, mainly as a result of increased headcount. Approximately $8.4 million of the non-cash stock-based compensation expense for the three months ended March 31, 2024 was related to the previously disclosed modification of stock options held by the former Chief Executive Officer in connection with his retirement in the first quarter of 2024. Interest expense increased $0.5 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, driven by the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net increased $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This increase was primarily driven by increased interest income on our interest-bearing accounts. Net loss was $13.8 million, or $0.53 per share, for the three months ended March 31, 2025, compared to a net loss of $22.2 million, or $1.04 per share, for the three months ended March 31, 2024. Net loss per share was based on 25.9 million weighted average shares outstanding for three months ended March 31, 2025 and 21.2 million weighted average shares outstanding for the three months ended March 31, 2024. As of March 31, 2025, cash and cash equivalents were $102.7 million. Net cash used in operating and investing activities was $12.9 million for the three months ended March 31, 2025 as compared to $11.8 million for the three months ended March 31, 2024. For the three months ended March 31, 2025, the Company issued 543,462 shares of common stock for gross proceeds of $9.5 million under its at-the-market offering. Real-World Evidence Supporting Barostim In February 2025, CVRx announced compelling real-world evidence demonstrating significant healthcare utilization reductions with Barostim. Research presented at the Technology and Heart Failure Therapeutics (THT) conference and published simultaneously in the Journal of Cardiac Failure was conducted using data from the Premier Healthcare Database, a large all-payer database that includes information from more than 1,300 institutions. Comparisons were performed for the 306 Barostim patients identified in the data set for the 12 months prior to Barostim implant and for an average of almost two years post-implant. The analysis showed an 85% reduction in heart failure hospital visits, an 84% reduction in cardiovascular hospital visits, and an 86% reduction in all-cause hospital visits in patients following Barostim implantation. Business Outlook For the full year of 2025, the Company now expects: Total revenue between $55.0 million and $58.0 million;Gross margin between 83% and 84%;Operating expenses between $95.0 million and $98.0 million. For the second quarter of 2025, the Company expects to report total revenue between $13.0 million and $14.0 million. Webcast and Conference Call InformationThe 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 1-800-445-7795 for U.S. callers, or 1-785-424-1699 for international callers, approximately ten minutes prior to the start time. Please reference the following conference ID to access the call: CVRXQ125. 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 also received the CE Mark 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. 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 2025 results), our anticipated growth strategies, 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; 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, 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. 763-416-2853 emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) March 31, December 31, 2025 2024Assets Current assets: Cash and cash equivalents $102,668 $105,933 Accounts receivable, net of allowances of $810 and $780, respectively 9,012 9,268 Inventory 11,672 12,107 Prepaid expenses and other current assets 2,782 2,505 Total current assets 126,134 129,813 Property and equipment, net 2,435 2,505 Operating lease right-of-use asset 994 1,069 Other non-current assets 26 27 Total assets $129,589 $133,414 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $2,751 $2,582 Accrued expenses 5,757 8,180 Total current liabilities 8,508 10,762 Long-term debt 49,332 49,273 Operating lease liability, non-current portion 802 877 Other long-term liabilities 1,587 1,447 Total liabilities 60,229 62,359 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2025 and December 31, 2024; 26,051,992 and 25,324,684 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 261 253 Additional paid-in capital 620,416 608,354 Accumulated deficit (551,112) (537,346)Accumulated other comprehensive loss (205) (206)Total stockholders’ equity 69,360 71,055 Total liabilities and stockholders’ equity $129,589 $133,414 CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three months ended March 31, 2025 2024Revenue $12,348 $10,770 Cost of goods sold 2,036 1,615 Gross profit 10,312 9,155 Operating expenses: Research and development 2,517 3,057 Selling, general and administrative 21,232 28,330 Total operating expenses 23,749 31,387 Loss from operations (13,437) (22,232)Interest expense (1,457) (960)Other income, net 1,123 1,044 Loss before income taxes (13,771) (22,148)Benefit (provision) for income taxes 5 (38)Net loss (13,766) (22,186)Cumulative translation adjustment — (3)Comprehensive loss $(13,766) $(22,189)Net loss per share, basic and diluted $(0.53) $(1.04)Weighted-average common shares used to compute net loss per share, basic and diluted 25,876,062 21,232,009
Veru Reports Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress
–Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 — –Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 — –With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 meeting with FDA to discuss Phase 3 clinical program — –Company to host conference call and webcast today at 8:00 a.m. ET– MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2025 second quarter and provided an update on progress of its clinical development programs. “In addition to our previously disclosed robust and exciting topline efficacy data from the enobosarm Phase 2b QUALITY study, we are now looking forward to the near-term Company catalysts this calendar quarter including the unblinded safety data from the enobosarm Phase 2b QUALITY study as well as the topline efficacy and safety data from the Phase 2b extension maintenance study. The Phase 2b extension study should show us what happens to patients when they stop GLP-1 receptor agonist treatment but remain on enobosarm. The treatment objective is for patients to have a healthier option for choosing to stop GLP-1s without the fear of fat regain,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We also expect to submit our End of Phase 2 meeting request to FDA. We anticipate that the End of Phase 2 FDA meeting will provide regulatory clarity for the Phase 3 clinical program and should occur in the third quarter of calendar 2025.” Positive Phase 2b QUALITY clinical study: Enobosarm in combination with GLP-1 RA drugs makes weight reduction more tissue selective for fat loss while preserving lean mass and physical function. In January 2025, the Company announced positive topline results from the Phase 2b QUALITY clinical study which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in older (≥60 years of age) patients receiving semaglutide (Wegovy®) for chronic weight management. Topline ResultsIn the topline efficacy analysis, the trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks in total lean mass (71% relative reduction in lean mass loss, p=0.002). Notably, the enobosarm 3mg + semaglutide was the best dose with a >99% mean relative reduction in loss of lean mass (p
CorFlow Therapeutics Appoints Chris O’Connell as Chairman of the Board of Directors
BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (CorFlow) is pleased to announce the appointment of Chris O’Connell as Chairman of the Board of Directors, replacing Rick Geoffrion who remains as a Director on the Board. Chris is a highly regarded senior executive, board member and advisor across the medical devices, life sciences and global […]
Catheter Precision, Inc. Completes Acquisition of Cardionomic Heart Failure Assets
FORT MILL, S.C., May 06, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that its 82% owned subsidiary has acquired certain heart failure related assets of Cardionomic, Inc.
Angelini Ventures Co-Leads $45 Million Series B Financing of Nuevocor to Advance Transformative Treatment for Genetic Dilated Cardiomyopathy
Angelini Ventures marks its first investment in the cardiovascular and gene therapy space – and first in Asia, further diversifying its strong and growing portfolio Rome, Italy – 6 May 2025 – Angelini Ventures, the corporate venture firm of Angelini Industries focused on investing in companies developing innovative solutions in BioTech and Digital Health, today announces that it has co-led a $45 million Series B financing round in Nuevocor, an IND-stage biotechnology company specialized in the development of transformative therapies for patients with genetic cardiomyopathy, a largely unaddressed condition, by targeting the underlying mechanical defects. Founded in 2021, Nuevocor is pioneering a new generation of pathway-specific genetic medicines using its PrOSIA mechanobiology platform, with the potential to benefit patients across multiple cardiac genetic disorders. The company is dedicated to transforming the treatment of genetic cardiomyopathies by addressing the biomechanical root causes of the disease. Proceeds from the financing will be used to achieve clinical proof-of-concept for its lead candidate NVC-001 in patients with LMNA DCM, a rare genetic heart condition caused by mutations in the LMNA gene. Angelini Ventures co-led the financing with Kurma Partners and participation from Highlight Capital as well as continued significant support from existing investors Boehringer Ingelheim Venture Fund, ClavystBio, EDBI, SEEDS Capital and Xora Innovation. Dr. Elia Stupka, Managing Director at Angelini Ventures, will join Nuevocor’s Board of Directors as Board member, together with Dr. Lola Buono, Senior Associate, who will join as a Board Observer. Angelini Ventures has partnered with Nuevocor, reflecting its vision to support transformative global biotech companies with the potential to become the next generation of biopharma leaders. This collaboration marks Angelini Ventures first investment in the cardiovascular space and in gene therapy as well as the first investment in Asia – unlocking access to cutting edge innovation and transformative potential for patient outcomes. Dr. Elia Stupka, Managing Director at Angelini Ventures said, “This investment represents a significant strategic milestone for Angelini Ventures. It not only broadens our global footprint to a strategic Asian Life Sciences Hub such as Singapore but also accelerates our mission to back transformative science with the potential to impact patients worldwide. We’re excited by Nuevocor’s novel approach to treating genetic dilated cardiomyopathy by targeting mechanobiological pathways rather than simply replacing genes. This one-time therapy has the potential to transform patient outcomes and ease healthcare burdens. We’re proud to support Nuevocor’s mission and join the board – alongside Kurma Partners – as the company expands its global presence and advances clinical development in Europe.” “We are delighted to secure this significant financing milestone and build global collaborations with such an experienced syndicate of life sciences investors. Their support will enable Nuevocor to continue its strong momentum and advance NVC-001 into the clinic,” said Dr. Yann Chong Tan, PhD, CEO and Co-Founder of Nuevocor. “There exists a huge unmet need for patients suffering from cardiomyopathies, and with the help of our powerful mechanobiology platform, we continue to build our pipeline of targeted life-changing medicines for these patients.” Notes to EditorsAbout Angelini Ventures Angelini Ventures, the venture capital arm of Angelini Industries, is a Series A and Series B investment firm focused on accelerating disruptive innovations and trends in BioTech and Digital Health. Angelini Ventures will invest €300 million across a global portfolio in Europe and North America, drawing on a global team, strategic advisors and partners to help entrepreneurs scale their businesses into transformative category-leading companies. To date, Angelini Ventures has invested around €100 million into 18 companies covering a range of therapeutic areas and modalities. Angelini Ventures’ BioTech portfolio includes Neumirna, Cour Pharmaceuticals, Nouscom, Pretzel Therapeutics and Freya Biosciences. The Company’s Digital Health portfolio includes Vantis Health, Avation, Cadence Neuroscience, Nobi, Noctrix and Serenis. www.angeliniventures.com About Angelini Industries Angelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over two billion euros, generated in the health, industrial technology and consumer goods sectors. A targeted investment strategy for growth, constant commitment to research and development, deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates.www.angeliniindustries.com About Nuevocor Nuevocor is a biotechnology company pioneering innovative pathway-centric approaches to developing functional cures for heart conditions known as cardiomyopathies. Nuevocor designs life-changing medicines to target the biomechanical root-cause of these diseases by harnessing its PrOSIATM mechanobiology platform. Nuevocor’s approach surpasses the limitations of traditional gene therapy, which focuses on individual gene mutations, to treat defects within shared disease pathways across multiple cardiomyopathies. This enables us to expand our impact to broader patient populations. ContactsAngelini VenturesMartina Palmese, Communications Coordinatormartina.palmese@angeliniventures.com Media contacts for Italy – SEC Newgate ItaliaDaniele Pinosa, daniele.pinosa@secnewgate.it; Tel. +39 3357233872Fausta Tagliarini; fausta.tagliarini@secnewgate.it; Tel. +39 3476474513Daniele Murgia; daniele.murgia@secnewgate.it; Tel. +39 3384330031 Media contacts outside Italy – MEDiSTRAVA Sylvie Berrebi, Sandi Greenwood, Mark Swallowangeliniventures@medistrava.com
LeMaitre to Present at the Bank of America Securities 2025 Healthcare Conference
BURLINGTON, Mass., May 05, 2025 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that David Roberts, President, will present at the Bank of America Securities 2025 Healthcare Conference on Tuesday, May 13, 2024, at 5:00 PM PDT at the Encore at the Wynn Hotel in Las Vegas, NV.
Micro Medical Solutions Appoints George Quinoy as Chief Commercial Officer to Accelerate Global Growth
Seasoned Commercial Leader to Drive Strategic Expansion WOBURN, Mass., May 5, 2025 /PRNewswire/ — Micro Medical Solutions (MMS) an innovator in the development of microvascular intervention to improve clinical outcomes and quality of life in patients with CLI/CLTI, today announced the…
Butterfly Network Reports First Quarter 2025 Financial Results
Delivered on Quarterly Revenue and EBITDA Guidance Reiterate full year Revenue and Adjusted EBITDA guidance Quarterly Revenue of $21.2 million in Q1, representing 20% YoY growth Reduced Q1 Net Loss by 36% and Net Cash Used in Operations by 43% Raised $81.7 million of net proceeds through a public offering […]
LeMaitre Q1 2025 Financial Results
BURLINGTON, Mass., May 01, 2025 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (Nasdaq: LMAT), a provider of vascular devices, implants, and services, today reported Q1 2025 results, announced a quarterly dividend of $0.20/share, and provided guidance.



