The Latest Cardiac and Vascular News
First and Only Liquid Embolic Approved for Hypervascular Tumor Embolization Supported by a Prospective, Randomized, Controlled, Clinical Trial BEDFORD, Mass., Aug. 7, 2025 /PRNewswire/ — Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular…
Heart Hospital of New Mexico is the First Hospital to Complete 200 Ventricular Ablation Procedures with the VIVO System
EP Lab Staff
The EP Lab staff celebrating the 200th procedure at Heart Hospital of New Mexico.
FORT MILL, S.C., Aug. 07, 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 the Heart Hospital of New Mexico is the first customer to complete 200 ventricular ablation procedures using its VIVO system. Heart Hospital of New Mexico is part of the Lovelace Health system which is made up of five hospitals, 33 health care clinics and seven outpatient therapy clinics with over 300 healthcare providers. The Heart Hospital of New Mexico at Lovelace Medical Center is New Mexico’s only hospital dedicated exclusively to cardiovascular care. David Jenkins, CEO of Catheter Precision said, “We are excited to congratulate the Heart Hospital of New Mexico on celebrating their 200th procedure utilizing VIVO. VIVO is a tool that is designed to help physicians and as one of the first users of VIVO, the physician team has fully embraced the technology. They have published their data and welcomed physicians for educational purposes and their partnership and support of the VIVO product line is invaluable. We look forward to their continued use and seeing what other milestone achievements they accomplish!” About VIVO™ Catheter Precision’s VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE Mark. About Catheter PrecisionCatheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Cautionary Note Regarding Forward-Looking StatementsStatements in this press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risk and uncertainties. Forward-looking statements can be identified by words such as “believe,” “anticipate,” “may,” “might,” “can,” “could,” “continue,” “depends,” “expect,” “expand,” “forecast,” “intend,” “predict,” “plan,” “rely,” “should,” “will,” “may,” “seek,” or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, statements regarding product evaluations at the hospital, and that the purchase order indicates that the hospital and its staff see the value and benefits that LockeT can bring and expectations regarding LockeT evaluations in the coming weeks. The Company’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties included under the caption “Risk Factors” in the Company’s Form 10-K filed with the SEC and available at www.sec.gov. The forward-looking statements included in this communication are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. CONTACTS: Investor Relations973-691-2000IR@catheterprecision.com # # #
Attachment
EP Lab Staff
MIAMI, FL, Aug. 06, 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 that it will effect a 1-for-10 reverse stock split of its shares of common stock. The reverse stock split will become effective at 11:59 pm CT on Friday, August 8, 2025. The Company’s common stock is expected to begin trading on the Nasdaq Capital Market under the same symbol (VERU) on a split-adjusted basis at the market open on August 11, 2025 with the new CUSIP number 92536C202. At the effective time, all outstanding stock options, stock appreciation rights, and equity incentive plans will be proportionally affected. Every 10 shares of issued and outstanding shares of the Company’s common stock will automatically be reclassified into one issued and outstanding share of common stock without any change in the par value of $0.01 per share. No fractional shares will be issued in connection with the reverse stock split and shareholders will be entitled to a cash payment in lieu of fractional shares. The reverse stock split will affect all shareholders uniformly and will not affect any shareholder’s ownership percentage of Veru’s shares, except for those shareholders receiving a cash payment in lieu of fractional shares. The Company is primarily implementing the reverse stock split to enable it to regain compliance with the Nasdaq $1.00 minimum bid price requirement. The reverse stock split was approved by the Company’s shareholders at the Special Meeting of Shareholders on July 25, 2025. Subsequently, the Board of Directors approved the reverse stock split at a ratio of 1-for-10. Computershare Inc. and its affiliate Computershare Trust Company, N.A., the Company’s transfer agent (collectively, “Computershare”), will act as the exchange agent for the reverse stock split. Shareholders of record holding certificates representing pre-split shares of the Company’s common stock will receive a letter of transmittal from Computershare with instructions on how to surrender certificates representing pre-split shares. Such shareholders should not send in their pre-split certificates until they receive a letter of transmittal from Computershare. Shareholders of record who held pre-split certificates will receive their post-split shares in book-entry form and will receive a statement from Computershare regarding their Company common stock ownership post-reverse stock split. Shareholders with book-entry shares or who hold their shares through a bank, broker, or other nominee will not need to take any action. Additional information about the reverse stock split can be found in the definitive proxy statement filed with the Securities and Exchange Commission (SEC) on June 10, 2025, which is available on the SEC’s website, www.sec.gov, and the Company’s website at www.verupharma.com. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the reverse stock split and expectations with respect to compliance with the minimum required bid price for continued listing on the Nasdaq Capital Market. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “opportunity,” “plan,” “predict,” “potential,” “estimate,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company’s current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: market conditions and their impact on the trading price of the Company’s common stock on the Nasdaq Capital Market; the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 3 program for enobosarm as a body composition drug and the number of Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the year ended September 30, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com
BEDFORD, Mass., Aug. 5, 2025 /PRNewswire/ — Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolization, has announced the appointment of Sean Boyle as Chief Executive Officer. I’m honored to join Instylla at such a crucial moment in…
— Management to host investor conference call today, August 5th, at 8:30am ET — MIAMI, Aug. 05, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced financial and operating results for the second quarter and six months ended June 30, 2025.
$56.2 million in proceeds from completed public offering and concurrent private equity purchase by Medtronic and Ligand$55 million in proceeds and funding commitments from royalty-based, non-dilutive investments from Medtronic and LigandProceeds extend expected cash runway into the second half of 2027 and expected to fund completion of enrollment and follow up for the primary endpoint of the BACKBEAT study, as well as substantial enrollment of the Virtue Trial NEW HOPE, Pa., Aug. 05, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the successful completion of strategic transactions and concurrent public and private equity offerings totaling an expected $111.2 million in gross proceeds to support continued advancement of the Company’s late-stage atrioventricular interval modulation (“AVIM”) therapy and Virtue Sirolimus AngioInfusion Balloon (“SAB”) clinical programs. The aggregate $111.2 million in expected gross proceeds from transactions that formally closed or were committed to on August 4, 2025, is comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc. (NYSE: MDT, “Medtronic”) Ligand committed $35 million in exchange for a tiered revenue interest in Orchestra BioMed’s future royalties from AVIM therapy and Virtue SABMedtronic committed $20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share $56.2 million received from a $40 million underwritten public offering of common stock and prefunded warrants (the “Public Offering”) and $11.2 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively (collectively, the “Private Placement”) “We are very proud to have secured significant long-term capital from strategic transactions with Medtronic and Ligand and the completion of our first underwritten public equity offering. We believe the success of these financing transactions reflects confidence from strategic partners and shareholders in the transformative potential of our two high impact, late-stage therapeutic programs,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “With Ligand, an established royalty investor, joining us as a strategic capital partner and Medtronic, the global market leader in cardiac rhythm management, expanding their commitment to our existing collaboration, this new capital strongly positions us to advance our core technologies, AVIM therapy and Virtue SAB, toward fundamental clinical and regulatory milestones that have the potential to create significant value for all stakeholders.” Orchestra BioMed currently intends to use the net proceeds from these transactions to fund potential significant value-creating catalysts, including: Full enrollment of the BACKBEAT global pivotal study (“BACKBEAT study”) evaluating AVIM therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemakerCompletion of follow-up for the BACKBEAT study primary endpointsCompletion or near-completion of enrollment of the Virtue Trial evaluating Virtue SAB in the treatment of Coronary in-stent restenosis (ISR) In the Public Offering, which closed on August 4, 2025, Orchestra BioMed sold 9,413,637 shares of its common stock at a price of $2.75 per share, and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 5,136,363 shares of common stock at a price of $2.7499 per pre-funded warrant. Medtronic purchased 4,077,427 shares, and Ligand purchased 1,818,181 shares also at $2.75 per share in the Private Placement. The gross proceeds from the Public Offering and Private Placement combined were approximately $56.2 million, with net proceeds of approximately $51.8 million after deducting underwriting discounts, commissions, placement fees and offering expenses. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of uncontrolled hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SABVirtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to receipt of committed capital , the use of proceeds from the transactions, the Company’s expected cash runway, the enrollment, implementation and design of the Company’s planned and ongoing pivotal trials, realizing the clinical and commercial value of the Company’s product candidates, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Contacts For Orchestra BioMed:Investors:Silas NewcombSnewcomb@orchestrabiomed.com Media: Kelsey Kirk-EllisKkirkellis@orchestrabiomed.com
MINNEAPOLIS, Aug. 04, 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 second quarter of 2025. Recent Highlights Total revenue for the second quarter 2025 was $13.6 million, an increase of 15% over the prior year quarterU.S. Heart Failure (HF) revenue for the second quarter of 2025 was $12.1 million, an increase of 15% over the prior year quarterActive implanting centers in the U.S. grew to 240, an increase of 27% since June 30, 2024CMS proposed to keep Barostim implant procedure in New Technology APC 1580 for 2026 with a payment of approximately $45,000 for outpatient proceduresCMS proposed favorable physician fee payment levels in connection with the Category I CPT codes set to take effect in 2026Brent Binkowski appointed to newly created Chief Operating Officer role “We delivered solid second quarter results and continued to build momentum across our business,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Our sales force transformation is gaining traction, and we’re building sustainable Barostim programs with high potential centers. We continue to make progress on multiple fronts by advancing our clinical evidence strategy and strengthening our reimbursement position, including CMS’ proposal to keep Barostim in APC 1580 with appropriate payment for the implant procedure. The fundamentals of our business remain strong, and our maturing commercial organization positions us well for continued growth.” Second Quarter 2025 Financial and Operating ResultsRevenue was $13.6 million for the three months ended June 30, 2025, an increase of $1.8 million, or 15%, over the three months ended June 30, 2024. Revenue generated in the U.S. was $12.2 million for the three months ended June 30, 2025, an increase of $1.6 million, or 15%, over the three months ended June 30, 2024. HF revenue in the U.S. totaled $12.1 million and $10.5 million for the three months ended June 30, 2025 and 2024, respectively. HF revenue units in the U.S. totaled 387 and 339 for the three months ended June 30, 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 June 30, 2025, the Company had a total of 240 active implanting centers in the U.S., compared to 227 as of March 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 two to a total of 47 during the three months ended June 30, 2025. Revenue generated in Europe was $1.3 million for the three months ended June 30, 2025, an increase of $0.2 million, or 19%, over the three months ended June 30, 2024. Total revenue units in Europe decreased to 61 for the three months ended June 30, 2025, compared to 63 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended June 30, 2025. Gross profit was $11.5 million for the three months ended June 30, 2025, an increase of $1.5 million, or 16%, over the three months ended June 30, 2024. Gross margin was 84% for each of the three months ended June 30, 2025 and 2024. R&D expenses decreased $0.3 million, or 11%, to $2.5 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This change was driven by a $0.3 million decrease in compensation expenses. SG&A expenses increased $2.2 million, or 11%, to $23.4 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This change was primarily driven by a $1.4 million increase in compensation expenses, a $0.8 million increase in travel expenses, and a $0.4 million increase in non-cash stock-based compensation expense, partially offset by a $0.5 million decrease in advertising expenses. Interest expense increased $0.5 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net increased $0.2 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This increase was primarily driven by more interest income on our interest-bearing accounts. Net loss was $14.7 million, or $0.57 per share, for the three months ended June 30, 2025, compared to a net loss of $14.0 million, or $0.65 per share, for the three months ended June 30, 2024. Net loss per share was based on 26.1 million weighted average shares outstanding for three months ended June 30, 2025 and 21.6 million weighted average shares outstanding for the three months ended June 30, 2024. As of June 30, 2025, cash and cash equivalents were $95.0 million. Net cash used in operating and investing activities was $8.0 million for the three months ended June 30, 2025 compared to $10.2 million for the three months ended June 30, 2024. Reimbursement Updates2026 OPPS Rule Progress: CMS has proposed to keep the Barostim implant procedure as part of the New Technology Ambulatory Payment Classification (APC) 1580 for 2026, with an associated payment of approximately $45,000 for procedures performed in the outpatient setting. CMS is also soliciting comments about the need for a Level 6 Neurostimulator APC. CVRx expects CMS to publish the 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule in November, which is expected to take effect on January 1, 2026. Category I CPT Codes: The transition to Category I CPT codes in January 2026 represents a significant milestone that will directly benefit commercial efforts. The proposed Medicare Physician Fee Schedule, released July 15, specified 11 relative value units (RVUs) for the implant procedure, translating to a national average physician payment of approximately $550, consistent with the Company’s expectations. Overall, the transition to Category I will eliminate the automatic denials regularly seen with Category III codes and improve prior authorization predictability to fairly pay physicians for the procedure. This proposal is also expected to be finalized in November. Chief Operating Officer Appointment CVRx is pleased to announce that Brent Binkowski will join as Chief Operating Officer in August, and will be responsible for the research and development, operations, regulatory affairs and quality functions. Binkowski brings over 20 years of leadership experience in medical devices, with expertise in implantable devices covering interventional cardiology, radiology, and urology. His experience building world-class teams and scaling businesses will be of great value to the Company. Business OutlookFor the full year of 2025, the Company narrowed its revenue and operating expense guidance ranges and now expects: Total revenue between $55.0 million and $57.0 million, compared to prior guidance of $55.0 million and $58.0 million;Gross margin between 83% and 84%;Operating expenses between $96.0 million and $98.0 million, compared to prior guidance of $95.0 million and $98.0 million. For the third quarter of 2025, the Company expects to report total revenue between $13.7 million and $14.7 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: CVRXQ225. 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. 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 third quarter 2025 results), our anticipated growth strategies (including statements about the proposal to maintain the APC for the Barostim implant procedure and progress toward expanded access to Barostim), 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; the final OPPS rule, which could differ from the proposed rule, following the public comment period; the actual impact of the APC on actual reimbursement and patient access; 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. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) June 30, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $95,025 $105,933 Accounts receivable, net of allowances of $871 and $780, respectively 7,153 9,268 Inventory 11,720 12,107 Prepaid expenses and other current assets 2,247 2,505 Total current assets 116,145 129,813 Property and equipment, net 2,345 2,505 Operating lease right-of-use asset 1,048 1,069 Other non-current assets 26 27 Total assets $119,564 $133,414 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $3,032 $2,582 Accrued expenses 6,657 8,180 Total current liabilities 9,689 10,762 Long-term debt 49,392 49,273 Operating lease liability, non-current portion 819 877 Other long-term liabilities 1,730 1,447 Total liabilities 61,630 62,359 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2025 and December 31, 2024; 26,145,951 and 25,324,684 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively 261 253 Additional paid-in capital 623,724 608,354 Accumulated deficit (565,848) (537,346)Accumulated other comprehensive loss (203) (206)Total stockholders’ equity 57,934 71,055 Total liabilities and stockholders’ equity $119,564 $133,414 CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three months ended Six months ended June 30, June 30, 2025 2024 2025 2024 Revenue $13,589 $11,807 $25,937 $22,577 Cost of goods sold 2,139 1,900 4,175 3,515 Gross profit 11,450 9,907 21,762 19,062 Operating expenses: Research and development 2,469 2,765 4,986 5,822 Selling, general and administrative 23,357 21,115 44,589 49,445 Total operating expenses 25,826 23,880 49,575 55,267 Loss from operations (14,376) (13,973) (27,813) (36,205)Interest expense (1,473) (959) (2,930) (1,919)Other income, net 1,110 944 2,233 1,988 Loss before income taxes (14,739) (13,988) (28,510) (36,136)Benefit (provision) for income taxes 3 (41) 8 (79)Net loss (14,736) (14,029) (28,502) (36,215)Cumulative translation adjustment 3 — 3 (3)Comprehensive loss $(14,733) $(14,029) $(28,499) $(36,218)Net loss per share, basic and diluted $(0.57) $(0.65) $(1.10) $(1.69)Weighted-average common shares used to compute net loss per share, basic and diluted 26,071,316 21,628,542 25,974,229 21,430,276
SHENZHEN, China, Aug. 4, 2025 /PRNewswire/ — Pulsecare Medical, a pioneer in cardiovascular intervention technologies, announced that its innovative NxPFA™ nanosecond pulsed field ablation (ns-PFA) systemhas received marketing approval from China’s National Medical Products…
SUNNYVALE, Calif., Aug. 04, 2025 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provides the anticipated timing of regulatory activities seeking FDA and Japan PMDA approvals of its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter. Q3 2025 Helix application for approval to FDA The Company intends to submit for approval of the Helix Transendocardial Delivery System (Helix) to FDA as a DeNovo 510(k) application based on its safety and performance in twelve cell and gene therapy clinical studies. The clinical performance of the Helix system sets a high safety standard with more than 4,000 intramyocardial deliveries including studies under CE-mark in Europe. Therapeutic agent retention in the heart has also been shown to be superior using Helix compared to other catheter and surgical delivery approaches.1 Q4 2025 CardiAMP Cell Therapy for Heart Failure meeting request on approval pathway to FDA BioCardia expects to complete a submission to FDA and meeting request to discuss the approvability of CardiAMP Cell Therapy for treatment of ischemic heart failure based on the available clinical data. The FDA has previously approved a number of important high-risk cardiovascular therapeutic medical devices where safety and benefit were demonstrated but which did not meet pivotal study primary endpoints.2 The following are expected to be helpful in this discussion: FDA’s previous granting of the CardiAMP Cell Therapy system Breakthrough Designation based on the significant unmet need that exists for these patients and the previously available clinical results from the Phase I TABMMI clinical trial, the Phase II TAC-HFT clinical trial, and the roll-in cohort results from the CardiAMP HF clinical trial, totaling 63 patients.The longer term CardiAMP HF follow-up in the 10-patient roll-in cohort patients as well as the outcomes of the 115-patient randomized procedure placebo controlled double blind cohort with two-year follow-up.The status of the submissions of the primary components of CardiAMP Cell Therapy: FDA’s 510(k) approval of the point of care CardiAMP cell processing platform used under the trade name Marrowstim for other indications, which BioCardia holds exclusive rights to for cardiac indications.Helix DeNovo 510(k) submission planned in Q3 2025. The confirmatory CardiAMP HF II trial is actively enrolling in the USA with five most active centers being Baycare Hospital in Clearwater, University of Wisconsin at Madison, Emory University in Atlanta, Henry Ford Health System in Detroit, and the Cleveland Clinic. Q4 2025 CardiAMP Cell Therapy for Heart Failure Clinical Consultation with Japan PMDA. It is expected that the in-person meeting on the clinical consultation with PMDA requested in July 2025 will take place mid Q4 2025. If the parties are aligned, this could enable BioCardia to submit for approval of the CardiAMP system for market entry in Japan. This discussion may be influenced by other sponsor’s applications to PMDA for allogeneic cell therapies to treat the same clinical indication expected to require chronic immunosuppression and open chest surgical delivery of cells. Such laboratory manufactured therapies may receive early conditional approval under Japan’s adaptive framework for the approval of regenerative medical products with a post marketing study. The CardiAMP Cell Therapy is regulated as a medical device as the autologous cells are processed at point of care. The point of care CardiAMP cell processing platform is already approved and in clinical use in Japan for orthopedic applications by Zimmer Biomet Japan under the trade name BioCUE. PMDA has provided advice to BioCardia that should CardiAMP Cell Therapy be approved with Helix, other developers of biologic therapies in Japan would be enabled to use Helix from a regulatory perspective by reference. About CardiAMP Cell Therapy Granted FDA Breakthrough designation, the proprietary CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The Phase IIIB CardiAMP HF II Trial (NCT06258447) is actively enrolling in the United States. The principal outcomes from the 125-patient randomized procedure controlled double blind CardiAMP HF Trial (NCT02438306) were presented at the late breaking clinical trial sessions of the American College of Cardiology on March 29th, 2025. Results of the CardiAMP HF Trial showed reduction in all cause death, reduced major adverse cardiac events, and improved quality of life, whose composite endpoint was statistically significant in patients having elevated NTproBNP, a marker of active heart stress. This was preceded by the Phase II 33-patient randomized placebo controlled Transendocardial Autologous Cells in heart Failure Trial (NCT 00768066) and the open label 20-patient Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction Trial (NCT 00507468), both of which demonstrated enhanced exercise ability and heart function in patients who received therapy. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. References 1 Mitsutake Y, Pyun WB, Rouy D, Foo CWP, Stertzer SH, Altman P, Ikeno F. Improvement of Local Cell Delivery Using Helix Transendocardial Delivery Catheter in a Porcine Heart. Int Heart J. 2017 May 31;58(3):435-440. doi: 10.1536/ihj.16-179. Epub 2017 May 23. PMID: 28539564. 2 Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020, JAMA Intern Med, 2021;181;(10):1409-1412. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.com Phone: 650-226-0120
