Other News

BiVACOR Total Artificial Heart Accepted into FDA’s Total Product Life Cycle (TAP) Program

Milestone Deepens Strategic Partnership with FDA Following Breakthrough Device Designation HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–BiVACOR, Inc., a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH), today announced that its TAH System has been accepted into the U.S. Food and Drug Administration’s (FDA) prestigious Total Product Life […]

Merit Medical Launches the Prelude Wave Hydrophilic Sheath Introducer with SnapFix Technology

Thin-wall design with superior insertion and unique sheath-securement solution to support successful radial access procedures and may aid in reducing arterial spasm and occlusionSOUTH JORDAN, Utah, Aug. 07, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced the US commercial release of the Prelude Wave™ Hydrophilic Sheath Introducer with SnapFix™ Securement Technology. The Prelude Wave is the latest innovation in Merit’s comprehensive Access portfolio, which includes a wide range of dilators, micro-access systems, sheath introducers, and guide sheaths. A low-profile, hydrophilic sheath with best-in-class insertion and sheath retention, the Prelude Wave with SnapFix technology is designed with features which may aid in the reduction of arterial spasm and occlusion as physicians perform radial access procedures. Radial access offers many well-documented benefits compared to the femoral approach,1 but there remain opportunities to improve patient outcomes, as radial artery spasm (narrowing) and occlusion (blockage) can still occur. Radial artery spasm is reported in up to 20% of patients,2 and approximately 4.6% will have a radial artery occlusion,3 both of which can lead to patient discomfort and other complications.4,5 Sheath features, such as a hydrophilic coating, a low profile, and tapered transitions have been shown to help reduce the risks of radial artery spasm and occlusion as well as improve patient comfort.1,6 In addition, securement devices utilized to stabilize hydrophilic sheaths during procedures have been linked to reported issues in 30% of cases, leading to procedural inefficiency.7 A securement device specifically developed for sheaths may help alleviate the challenges physicians face. To meet these clinical needs, Merit innovated the Prelude Wave, a next-generation sheath with a unique securement feature. Compared to the leading competitor, the Prelude Wave offers twice the lubricity, twice the resistance to buckling and kinking, and requires 40% less insertion force.8 A first of its kind, SnapFix technology provides twice the adhesive strength, with physicians rating its performance and ease of use superior to the leading competitor.8 Learn more about the Prelude Wave with SnapFix Technology. “Prelude Wave addresses challenges interventionalists see when performing radial procedures,” said Morton Kern, MD, MSCAI, FACC, FAHA, Interventional Cardiologist at Veterans Administration Long Beach Health Care System in Long Beach, CA, and a consultant of Merit. “A sheath and securement solution that may help minimize these risks, while also offering strong radial access performance, provides physicians with a meaningful product option that creates a better treatment experience for patients.” To further support a radial-first approach, Merit has tailored its portfolio with solutions that complement existing products, designed to address physicians’ toughest clinical challenges. A recent example of this was Merit’s acquisition of StatSeal®, a patented hemostatic sealant used to protect access sites, as seen in radial procedures. “Whether by design or acquisition, we always strive to advance innovation in our Access portfolio, providing our healthcare partners with solutions that support data-driven approaches to treatment,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “The Prelude Wave with SnapFix Technology is a superior product built to champion radial procedures, manufactured with features designed to aid in minimizing common vascular access challenges. We’re proud to continue offering radial technology advancements for physicians and their patients.” ABOUT MERIT MEDICAL Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit’s filings with the U. S. Securities and Exchange Commission (“SEC”). For a further discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the SEC and Merit’s other filings with the SEC. Actual results will likely differ, and may differ materially, from anticipated results. CONTACTS PR/Media InquiriesSarah ComstockMerit Medical+1-801-432-2864 | sarah.comstock@merit.com  INVESTOR INQUIRIES Mike Piccinino, CFA, IRCWestwicke – ICR+1-443-213-0509 | mike.piccinino@westwicke.com References Rathore et al. 2010. “Impact of Length and Hydrophilic Coating of the Introducer Sheath on Radial Artery Spasm during Transradial Coronary Intervention.” JACC Cardiovasc Interv 3, no. 5 (May): 475 ̶ 83. doi: 10.1016/j.jcin.2010.03.009.Randall and Boudoulas. “Reducing Radial Spasm.” Society for Cardiovascular Angiography & Interventions (2024 Sep 19).Pitta, Sharma, and Boudoulas. “Newer Emerging Strategies to Reduce Radial Artery Occlusion: Post-Transradial Catheterization.” Society for Cardiovascular Angiography & Interventions (2025 Jun 19).Zus et al. 2024. “Radial Artery Spasm—A Review on Incidence, Prevention and Treatment.” Diagnostics (Basal) 14, no 17 (Aug 29): 1897. doi: 10.3390/diagnostics14171897.Tsigkas et al. 2023. “Preventing and Managing Radial Artery Occlusion Following Transradial Procedures: Strategies and Considerations.” J Cardiovasc. Dev Dis. 10, no. 7 (Jun 30): 283. doi: 10.3390/jcdd10070283.Mason et al. 2018. “An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement from the American Heart Association.” Cir Cardiovasc Interv 11, no. 9 (Sept): e000035. doi: 10.1161/HCV.0000000000000035.Kern et al. 2020. “Securing the Radial Sheath: An Update on a Pesky but Persistent Little Problem.” Cath Lab Digest (Nov).Data on File.

BDC Laboratories Partners with Newly Launched Dilawri Cardiovascular Institute to Advance Clinically Relevant Cardiovascular Device Testing

Strategic collaboration supports cutting-edge translational research, combining regulatory-grade bench testing with clinical insight to improve outcomes for patients. WHEAT RIDGE, Colo. and VANCOUVER, BC, Aug. 7, 2025 /PRNewswire/ — BDC Laboratories, a leader in cardiovascular device…

Milestone Achievement for Hospital Using Catheter Precision’s VIVO System

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 # # #
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EP Lab Staff

Veru Announces Reverse Stock Split

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