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NEW YORK–(BUSINESS WIRE)–ACCESS, through its physician-led group purchasing organization, ACCESS GPO, today announced a multi-year preferred portfolio agreement with Johnson & Johnson to support the adoption of advanced cardiac electrophysiology technologies in ambulatory surgery centers (ASC) across the United States. The agreement encompasses an integrated portfolio of three-dimensional mapping, intracardiac imaging, radiofrequency ablation and pulsed field ablation technologies. The co
— Phase 2b PLATEAU clinical trial of enobosarm and semaglutide combination for high quality weight loss is fully enrolled with 239 patients – — Phase 2b PLATEAU clinical trial interim analysis and results on track for calendar Q1 2027– — In June 2026 Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical trial — — In August 2026 Company announced USPTO notice of allowance for key U.S. patent for enobosarm and semaglutide; when issued, U.S. patent protection until at least October 2044 — — Company to host conference call and webcast today at 8:00 a.m. ET – MIAMI, FL, Aug. 10, 2026 (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 2026 third quarter ended June 30, 2026, and provided an update on progress of its clinical development programs. “We are extremely pleased with the continued enobosarm progress during this past quarter,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044.” Dr. Steiner added: “We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027.” Obesity ProgramEvaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity Fully Enrolled Phase 2b PLATEAU Clinical StudyThe Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. During the past quarter, the Company exceeded its Phase 2b PLATEAU clinical trial targeted full enrollment of 200 patients by enrolling 239 patients. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. Completed Positive Phase 2b QUALITY Clinical StudyThe Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®**) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued. Recent Developments Regarding Enobosarm Intellectual PropertyRecently the Company received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued. The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide. When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications. In addition, the patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. Third Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses increased to $4.4 million from $3.0 millionGeneral and administrative expenses decreased to $3.4 million from $5.0 millionOperating loss from continuing operations increased to $7.7 million from $7.5 millionNet loss decreased to $7.0 million, or $0.30 per share, compared to $7.3 million, or $0.50 per share Year-to-Date Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $8.8 million from $12.7 millionGeneral and administrative expenses decreased to $11.5 million from $15.4 millionOperating loss from continuing operations decreased to $20.4 million from $25.9 millionNet loss decreased to $15.1 million, or $0.68 per share, compared to $24.2 million, or $1.65 per share Balance Sheet Information Cash, cash equivalents and restricted cash were $23.9 million as of June 30, 2026 versus $15.8 million as of September 30, 2025 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2565519, for one week. 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, an oral 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 to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to 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 planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; express or implied statements related to the issuance and scope of coverage, including allowed claims and treatment regimens, of a method of use patent from the Notice of Allowance for US Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss”, as well as other pending methods of use and formulation patents; whether the patent application meets requirements of patentability and, if and when the patent is issued, will provide patent protection until at least October 2044; whether new indications will be discovered or granted and whether the allowed claims under said Notice of Allowance, if and when issued, will add additional coverage and protection to new indications and the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, and other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs; whether the pending patent applications will be approved for claims that encompass a novel, oral, modified-release enobosarm formulation and if issued, will provide patent protection until at least May 2046; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass and the prevention of the regain of fat mass and total body weight loss, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether enobosarm will be the next generation combination therapy with GLP-1 receptor agonists for older patients with obesity that makes weight reduction more tissue selective for loss of fat, preservation of lean mass, physical function, improved body composition and maintaining or increasing bone mineral density, and demonstrating favorable HbA1c and insulin resistance results, all while maintaining a favorable safety profile; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or meet any unmet need for, obesity patients, including whether it will provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and inflammatory disease. 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: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future 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 patients in clinical studies or an inability to enroll patients in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; 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, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company’s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days’ prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; 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 obtain, protect and enforce its data, intellectual property and other proprietary rights; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property claims and challenges, securities litigation and litigation with the purchaser of the Company’s FC2 business; 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, 2025, 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. *During the past quarter the Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. Please see the Company’s SEC Form 8-K dated June 2, 2026 for further details. **Wegovy® is a registered trademark of Novo Nordisk A/S. FINANCIAL SCHEDULES FOLLOW Veru Inc.Condensed Consolidated Balance Sheets(unaudited) June 30, September 30, 2026 2025 Cash, cash equivalents, and restricted cash$23,880,142 $15,794,562 Investments in equity securities 1,911,386 2,525,305 Prepaid expenses and other current assets 1,436,799 595,251 Total current assets 27,228,327 18,915,118 Property and equipment, net 280,227 364,808 Operating lease right-of-use assets 2,342,186 2,746,014 Goodwill 6,878,932 6,878,932 Other assets 297,998 930,847 Total assets$37,027,670 $29,835,719 Accounts payable$1,709,689 $3,121,448 Accrued compensation 2,721,934 3,510,237 Accrued expenses and other current liabilities 949,092 394,529 Operating lease liability, short-term portion 775,157 758,946 Total current liabilities 6,155,872 7,785,160 Operating lease liability, long-term portion 1,907,735 2,358,018 Other liabilities 587,823 1,359,871 Total liabilities 8,651,430 11,503,049 Total stockholders’ equity 28,376,240 18,332,670 Total liabilities and stockholders’ equity$37,027,670 $29,835,719 Veru Inc.Condensed Consolidated Statements of Operations(unaudited) Three Months Ended Nine Months Ended June 30, June 30, 2026 2025 2026 2025 Operating expenses: Research and development$4,352,668 $3,020,563 $8,842,633 $12,669,495 General and administrative 3,361,013 5,010,528 11,514,031 15,402,074 Total operating expenses 7,713,681 8,031,091 20,356,664 28,071,569 Gain on sale of ENTADFI® assets — 484,615 — 2,154,134 Operating loss (7,713,681) (7,546,476) (20,356,664) (25,917,435) Non-operating income: Gain on extinguishment of debt — — — 8,624,778 Other non-operating income, net 725,331 223,375 4,943,185 307,260 Total non-operating income 725,331 223,375 4,943,185 8,932,038 Net loss from continuing operations (6,988,350) (7,323,101) (15,413,479) (16,985,397)Net (loss) income from discontinued operations, net of taxes — (9,719) 351,418 (7,194,389)Net loss$(6,988,350) $(7,332,820) $(15,062,061) $(24,179,786) Net loss from continuing operations per basic and diluted common shares and pre-funded warrants outstanding$(0.30) $(0.50) $(0.70) $(1.16)Net income (loss) from discontinued operations per basic and diluted common shares and pre-funded warrants outstanding$0.00 $(0.00) $0.02 $(0.49)Net loss per basic and diluted common shares and pre-funded warrants outstanding$(0.30) $(0.50) $(0.68) $(1.65) Basic and diluted weighted average common shares outstanding 23,050,320 14,657,777 22,127,243 14,644,927 Veru Inc.Condensed Consolidated Statements of Cash Flows(unaudited) Nine Months Ended June 30, 2026 2025 Net loss$(15,062,061) $(24,179,786) Adjustments to reconcile net loss to net cash used in operating activities (2,482,190) 3,920,100 Changes in operating assets and liabilities (3,007,404) (4,292,066) Net cash used in operating activities (20,551,655) (24,551,752) Net cash provided by investing activities 5,322,804 18,867,232 Net cash provided by (used in) financing activities 23,314,431 (4,221,611) Net increase (decrease) in cash, cash equivalents, and restricted cash 8,085,580 (9,906,131) Cash, cash equivalents and restricted cash at beginning of period 15,794,562 24,916,285 Cash, cash equivalents and restricted cash at end of period$23,880,142 $15,010,154 Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com
ARPA-H award supports development of magnetic robotic navigation technology designed to overcome the physical barriers limiting endovascular stroke therapy
SAN FRANCISCO, Aug. 07, 2026 (GLOBE NEWSWIRE) — Braveheart Bio, Inc. (Nasdaq: BRVE), a clinical-stage biopharmaceutical company developing next-generation therapeutics for hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases, today announced the closing of its upsized initial public offering of an aggregate of 24,437,500 shares of its common stock at an initial public offering price of $18.00 per share, including the full exercise by the underwriters of their option to purchase 3,187,500 additional shares. All shares of common stock were offered by Braveheart Bio. The shares began trading on the Nasdaq Global Market on August 6, 2026 under the ticker symbol “BRVE”. The gross proceeds from the initial public offering, including full exercise of the underwriters’ option to purchase additional shares, before deducting underwriting discounts and commissions and offering expenses payable by Braveheart Bio, were $439.9 million. Goldman Sachs & Co. LLC, Jefferies, TD Cowen, Stifel and Cantor acted as joint book-running managers for the offering. Registration statements relating to the shares being sold in the initial public offering have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on August 5, 2026. The offering was made only by means of a prospectus, forming part of the effective registration statement relating to these shares. Copies of the final prospectus may be obtained from the SEC’s website at www.sec.gov and may also be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at TDManualrequest@broadridge.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Braveheart BioBraveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Braveheart Bio’s lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart Bio’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity. Investor Relations ContactAlexander SharifNew Street Investor RelationsAlexander@NewStreetIR.com Media ContactFGS GlobalBraveheart-bio@fgsglobal.com
PALO ALTO, Calif.–(BUSINESS WIRE)– #BioPharma–Greenstone Biosciences, a biotechnology company advancing New Approach Methodologies (NAMs) for drug discovery, today announced that it has received a Catalyze R61 award from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH). The award funds a research program to discover novel drug candidates for myocardial fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy (DMD). DMD is a rare genet
– Operating expenses decline 16%, helping drive a 39% improvement in net loss – – Approximately $3.1 million of TULSA revenue recognition shifts into early Q3 due to shipment timing – – Strong clinical, commercial and reimbursement momentum continues – – Company reiterates full-year 2026 revenue guidance – – Announces first employer owned health plans to list the TULSA Procedure™ as a covered service – TORONTO, Aug. 06, 2026 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today announced financial results for the second quarter ended June 30, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP). “Commercial momentum continued to accelerate during the second quarter,” said Arun Menawat, Profound’s CEO and Chairman. “We received over $7.0 million in new purchase orders, a new quarterly record. Approximately $2.5 million of those orders were recognized as revenue during the quarter, while approximately $3.1 million was shipped in July and will be recognized in the third quarter. The shipment timing reflected a temporary logistics issue—not customer demand—and, absent the timing difference, second quarter revenue would have increased approximately 153% year-over-year. The logistics issue has since been resolved. Beyond top-line growth, our business model continued to demonstrate meaningful operating leverage. Gross margin remained above our long-term target of 70%, operating expenses declined 16%, and net loss improved by 39% year-over-year. Momentum has continued into the third quarter, including another monthly record for new order activity in July and exceptional physician engagement at SRS2026 that generated more than 160 qualified commercial opportunities over just four days. Based on continued payer coverage expansion, growing clinical validation, and a strengthening sales pipeline, we believe we are now in the strongest commercial position in the Company’s history. Based on this momentum and our improved visibility into the second half of the year, we are reiterating the $25.0 million bar we previously set for 2026 total revenue.” Business Highlights Clinical Momentum The post-market CAPTAIN Level 1 randomized clinical data continued to demonstrate statistically significant advantages of the TULSA Procedure™ over robotic radical prostatectomy, with new penile length preservation data presented in July 2026.Physician awareness of, and engagement with, the TULSA Procedure continued to expand through presentations at the 2026 meetings of the Society of Interventional Radiology (SIR), the American Urological Association (AUA), and the Society of Robotic Surgery (SRS). Reimbursement Expansion Payer coverage expanded by approximately 18.3 million covered lives during the second quarter, substantially broadening patient access to the TULSA Procedure. Most of the newly covered lives came through state Medicaid and managed Medicaid (Ambetter) programs.Today, Profound is pleased to announce that the Johns Hopkins Employee Health Plan and the Prime Healthcare Employee Health Plan, covering more than 50,000 and 55,000 employees, medical staff and family members, respectively, have become the first employer owned health plans to list the TULSA Procedure as a covered service. Commercial Execution & Adoption Profound’s TULSA-PRO® installed base increased to 84 at the end of Q2-2026.Profound estimates that the current aggregate total dollar value of its qualified sales pipeline (defined as within one of the “Verify, Negotiate and Contracting” stages) for TULSA-PRO and Sonalleve® is approximately $70.0 million.* Continuing Innovation Profound also launched an initiative to explore the potential of integrating PSMA PET molecular imaging technologies with the TULSA Procedure to support intention-to-treat decisions and patient monitoring. * There can be no assurance given with respect to the extent and/or timing of the Company’s qualified sales pipeline resulting in recognized revenue. Q2-2026 Clinical Utilization Trends Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the second quarter of 2026: Prostate Condition Ablation of malignant prostate tissueAblation of malignant and benign enlarged prostate tissueAblation of recurrent malignant prostate tissueAblation of benign enlarged prostate tissue71%(12% GG1, 58% GG2, 21% GG3, 9% GG4&5)14%11%4% Regional Ablation Whole-glandSub-total but more than half the glandHemi-ablationFocal therapy43%24%21%12% Prostate Size 100 cc8%39%31%17%5% TULSA INDEX20 Introduced by the Company in the first quarter of 2026, the following supplemental ‘same-store’ TULSA Procedure volume analysis is designed to track a fixed cohort (i.e. without any changes or substitutions) of 20 active commercial TULSA-PRO sites over time. The TULSA INDEX20 includes a representative variety of providers, including teaching hospitals and private-pay practices, all of which have been performing TULSA Procedures for at least 12 months. Geographically, 80% of the index sites are in the U.S. and 20% are international. TULSA INDEX20Q2-2025Q3-2025Q4-2025Q1-2026Q2-2026# TULSA Sites2020202020Average Procedures/Quarter8.28.610.311.310.0Average Procedures Annualized32.834.441.245.240.0Quarter-Over-Quarter Sequential Growth15%5%20%10%(12%)H1-2026 Over H1-2025 Growth 39%Quarterly Year-Over-Year Growth 22% Summary Second Quarter 2026 Results For the quarter ended June 30, 2026, Profound recorded total revenue of approximately $2.5 million, up 12% year-over-year, including $1.6 million of recurring non-capital revenue from single-use devices and services associated with extended warranties, and $871,000 from capital equipment sales. Approximately $3.1 million of TULSA product shipments originally anticipated in the final week of June were completed in July. The timing affected only the period of revenue recognition and did not reflect any change in customer demand or order activity. Excluding this shipment timing, second quarter revenue would have been approximately $5.6 million, representing 153% year-over-year growth. Gross margin expanded to 78% in Q2-2026 from 73% in the prior-year period, reflecting a favorable product mix, including multiple capital system sales that were previously under operating leases to customers. Operating expenses declined 16% year over year to approximately $13.0 million, primarily reflecting lower personnel, commercial, travel, insurance and CAPTAIN clinical trial costs following completion of enrollment. These reductions were partially offset by higher R&D investments focused on product cost reduction, quality improvements and manufacturing efficiencies. Second quarter 2026 net loss was approximately $9.5 million, or $0.26 per common share, a 39% improvement from a net loss of approximately $15.7 million, or $0.52 per common share, in the three months ended June 30, 2025. Liquidity and Outstanding Share Capital As at June 30, 2026, Profound had cash of approximately $38.3 million. As at August 6, 2026, Profound had 36,532,594 common shares issued and outstanding. For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile at www.sedarplus.com, www.sec.gov and on Profound’s website under “SEC & SEDAR+ Filings.” Full Year 2026 Financial Outlook Based on record order activity, continued expansion of its commercial pipeline and improved visibility into second-half shipments, Profound continues to project total revenue for full-year 2026 to be approximately $25.0 million, which represents 56% growth compared to its prior year revenue. The Company also continues to expect full year 2026 gross margin to be 70% or higher. Conference Call Details Profound is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed. To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN. The call will also be broadcast live and archived on Profound’s website in the Investors section here. About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia. Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® and Sonalleve® system sales from its qualified sales pipeline; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO and Sonalleve. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. Financial Outlook This press release contains a financial outlook within the meaning of applicable securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company’s forecasted revenue for the 12 months to be ended December 31, 2026, and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions, including the assumptions discussed under the heading “Forward-Looking Statements” herein. The actual results of the Company’s operations for any period may vary from the amounts set forth in these projections, and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward-Looking Statements” herein, it should not be relied on as necessarily indicative of future results. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com T: 647.872.4849 Profound Medical Corp.CONDENSED CONSOLIDATED BALANCE SHEETS (USD in thousands, except per share data) (unaudited) June 30, 2026$ December 31, 2025$ Assets Current assets: Cash38,271 59,723 Trade and other receivables, net9,614 7,200 Inventory10,456 8,238 Prepaid expenses and deposits523 928 Total current assets58,864 76,089 Trade and other receivables, net- 300 Property and equipment, net556 698 Intangible assets, net121 138 Right-of-use assets, net2,763 184 Deferred tax assets, net81 66 Total assets62,385 77,475 Liabilities Current liabilities: Accounts payable955 1,563 Accrued expenses and other current liabilities3,127 3,815 Deferred revenue342 445 Long-term debt4,507 – Lease liabilities119 213 Income tax payable63 39 Total current liabilities9,113 6,075 Deferred revenue618 388 Long-term debt- 4,499 Lease liabilities2,754 – Other non-current liabilities92 79 Total liabilities12,577 11,041 Shareholders’ equity Common shares, no par value, unlimited shares authorized, 36,532,594 and 36,293,640 issued and outstanding at June 30, 2026 and December 31, 2025, respectively325,383 323,839 Additional paid-in capital25,688 25,310 Accumulated other comprehensive income3,070 5,025 Accumulated deficit(304,333)(287,740)Total shareholders’ equity49,808 66,434 Total liabilities and shareholders’ equity62,385 77,475 Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME(USD in thousands, except per share data) (unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2026$ 2025$ 2026$ 2025$ Revenue Recurring – non-capital1,612 1,561 4,086 3,362 Capital equipment871 650 3,734 1,470 2,483 2,211 7,820 4,832 Cost of sales536 593 2,041 1,361 Gross profit1,947 1,618 5,779 3,471 Operating expenses Research and development5,654 6,098 10,916 10,906 Selling, general and administrative7,359 9,326 13,950 17,537 Total operating expenses13,013 15,424 24,866 28,443 Operating loss11,066 13,806 19,087 24,972 Other (income) expenses Net finance income(336)(343)(713)(788)Net foreign exchange (gain) loss(1,245)2,168 (1,861)2,130 Total other (income) expenses(1,581)1,825 (2,574)1,342 Net loss before income taxes9,485 15,631 16,513 26,314 Income tax expense68 78 95 119 Deferred tax recovery(13)(14)(15)(14)Total income tax expense55 64 80 105 Net loss attributed to shareholders for the period9,540 15,695 16,593 26,419 Other comprehensive (income) loss Item that may be reclassified to (income) loss Foreign currency translation adjustment950 (2,713)1,955 (2,816) Net loss and other comprehensive loss for the period10,490 12,982 18,548 23,603 Loss per share Basic and diluted net loss per common share0.26 0.52 0.46 0.88 Basic and diluted weighted average common shares outstanding36,350,665 30,053,142 36,324,393 30,055,047 Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF CASHFLOWS(USD in thousands, except per share data) (unaudited) Six Months Ended June 30, 2026$ 2025$ Cash flows from operating activities Net loss for the period(16,593)(26,419)Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation of property and equipment219 218 Amortization of intangible assets16 86 Non-cash lease expense adjustment99 (19)Share-based compensation1,922 2,440 Interest and accretion expense9 51 Changes in operating assets and liabilities: Trade and other receivables(2,473)2,449 Inventory(2,686)(2,723)Prepaid expenses and deposits384 1,042 Accounts payable, accrued expenses and other liabilities(991)545 Deferred revenue164 317 Income taxes payable27 – Deferred tax assets(18)(14)Net cash used in operating activities(19,921)(22,027) Cash flows from financing activities Repayments of long-term debt- (290)Net cash provided by (used in) financing activities- (290) Net increase (decrease) in cash(19,921)(22,317)Effect of exchange rate changes on cash(1,531)2,600 Cash, beginning of period59,723 54,912 Cash, end of period38,271 35,195
MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the second quarter of 2026. Recent Highlights Total revenue for the second quarter of 2026 was $15.7 million, an increase of approximately 16% over the prior year quarterU.S. revenue for the second quarter of 2026 was $14.8 million, an increase of 21% over the prior year quarterActive implanting centers in the U.S. grew to 258 as of June 30, 2026, as compared to 240 as of June 30, 2025Humana issued a Medicare Advantage coverage policy, effective May 1, 2026 for Barostim therapy, which is the first coverage policy of its kind for Barostim “We are pleased with the strong revenue growth and margin performance in the second quarter along with the reimbursement progress we made, including the new Medicare Advantage coverage policy from Humana. However, we are not satisfied with our updated outlook for the balance of the year, driven by fewer sales territories than anticipated, lower sales force productivity and a prolonged challenge with one of our largest payers,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are taking direct action to address these headwinds, and our confidence in the long-term fundamentals of this business remains high, supported by strong growth observed in our most stable regions and encouraging early progress on the BENEFIT-HF trial and our broader clinical and reimbursement strategies.” Second Quarter 2026 Financial and Operating Results Revenue was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30, 2025. Revenue generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, over the three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of June 30, 2026, the Company had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30, 2026, the number of sales territories in the U.S. is 56 as compared to 47 sales territories as of June 30, 2025. Revenue generated in Europe was $0.9 million for the three months ended June 30, 2026, a decrease of $0.4 million, or 31%, compared to the three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, from 61 in the prior year period. The number of sales territories in Europe remained consistent at five as of June 30, 2026. Gross profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended June 30, 2025. Gross margin was 87% and 84% for the three months ended June 30, 2026 and June 30, 2025, respectively. R&D expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical trial expenses. SG&A expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease in travel expenses. Interest expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $14.0 million, or $0.53 per share, for the three months ended June 30, 2026, compared to a net loss of $14.7 million, or $0.57 per share, for the three months ended June 30, 2025. Net loss per share was based on 26.5 million weighted average shares outstanding for three months ended June 30, 2026 and 26.1 million weighted average shares outstanding for the three months ended June 30, 2025. As of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million for the three months ended June 30, 2026, compared to $8.0 million for the three months ended June 30, 2025. Humana Medicare Advantage Coverage Policy In May 2026, Humana issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million Medicare Advantage members across 46 states. The policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial. This is now the third significant reimbursement development for Barostim this year, following the transition to Category I CPT codes and CMS approval of Category B IDE coverage for BENEFIT-HF patients, each of which took effect in the first quarter of 2026. Business Outlook For the full year of 2026, the Company now expects: Total revenue between $58.0 million and $60.0 million;Gross margin between 86% and 87%;Operating expenses between $99.0 million and $101.0 million. For the third quarter of 2026, the Company expects to report total revenue between $13.5 million and $14.5 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and third quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) June 30,2026 December 31,2025Assets Current assets: Cash and cash equivalents$64,586 $75,708 Accounts receivable, net of allowances of $869 and $871, respectively 9,401 10,665 Inventory 13,028 12,205 Prepaid expenses and other current assets 2,473 3,069 Total current assets 89,488 101,647 Property and equipment, net 2,061 2,243 Operating lease right-of-use asset 708 878 Other non-current assets 26 26 Total assets$92,283 $104,794 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$3,874 $3,833 Accrued expenses 7,250 9,484 Total current liabilities 11,124 13,317 Long-term debt 58,571 49,514 Operating lease liability, non-current portion 448 638 Other long-term liabilities 2,187 2,001 Total liabilities 72,330 65,470 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2026 and December 31, 2025; 26,641,597 and 26,311,607 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 266 263 Additional paid-in capital 637,707 629,916 Accumulated deficit (617,816) (590,652)Accumulated other comprehensive loss (204) (203)Total stockholders’ equity 19,953 39,324 Total liabilities and stockholders’ equity$92,283 $104,794 CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three months endedJune 30, Six months endedJune 30, 2026 2025 2026 2025 Revenue$15,705 $13,589 $30,474 $25,937 Cost of goods sold 1,981 2,139 3,869 4,175 Gross profit 13,724 11,450 26,605 21,762 Operating expenses: Research and development 3,130 2,469 6,214 4,986 Selling, general and administrative 23,617 23,357 45,575 44,589 Total operating expenses 26,747 25,826 51,789 49,575 Loss from operations (13,023) (14,376) (25,184) (27,813)Interest expense (1,578) (1,473) (3,129) (2,930)Other income, net 560 1,110 1,153 2,233 Loss before income taxes (14,041) (14,739) (27,160) (28,510)Benefit (provision) for income taxes (3) 3 (4) 8 Net loss (14,044) (14,736) (27,164) (28,502)Cumulative translation adjustment — 3 — 3 Comprehensive loss$(14,044) $(14,733) $(27,164) $(28,499)Net loss per share, basic and diluted$(0.53) $(0.57) $(1.03) $(1.10)Weighted-average common shares used to compute net loss per share, basic and diluted 26,515,442 26,071,316 26,435,958 25,974,229
Enrollment completed in TX45 APEX Phase 2 clinical trial in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”) with topline results anticipated in early Q1 2027TX45 APEX Phase 2 clinical trial Independent Data Monitoring Committee (“IDMC”) met in July 2026 and recommended continuation of the study without modificationTX2100, a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”), completed dosing of the six single dose healthy volunteer cohorts in the Phase 1a clinical trial, with topline results anticipated by end of Q3 2026Cash and cash equivalents were $227.1 million as of June 30, 2026, including approximately $11.7 million in net proceeds raised from an at-the-market offering for the three months ended June 30, 2026, is expected to provide cash runway into Q1 2029 WATERTOWN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the second quarter ended June 30, 2026, and provided an overview of recent business highlights. “In the second quarter, we completed enrollment in our global APEX Phase 2 trial in PH-HFpEF, a critical milestone for TX45, and we look forward to topline results in early Q1 2027,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. “We also completed dosing of the single dose cohorts in the TX2100 Phase 1a clinical trial in healthy volunteers. Subject to favorable safety, tolerability and pharmacokinetic results, we plan to advance TX2100 into a Phase 1b trial in patients with hematologic-support dependent HHT and a Phase 2 trial in moderate to severe HHT patients, bringing us one step closer to a first-in-class therapy for a disease with no approved treatments.” Recent Business Highlights Completed Enrollment of TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients: In June 2026, the Company completed enrollment for the APEX trial, a global, randomized, placebo-controlled 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with PH-HFpEF. In July 2026, the Independent Data Monitoring Committee (“IDMC”) met to review unblinded safety and efficacy data from the TX45 APEX Phase 2 clinical trial, including approximately 80% of the expected patient exposure. The IDMC recommended the continuation of the trial without modification. The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”) >3 Wood Units (“WU”) at baseline. The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR >3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. The mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR >3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Completed Dosing of Single Dose Cohorts in Phase 1a Clinical Trial of TX2100 in Healthy Volunteers: In July 2026, the Company completed dosing of the six single dose cohorts in the Phase 1a clinical trial of TX2100 in healthy volunteers. The randomized, placebo-controlled, double-blind, single ascending-dose trial is intended to characterize safety and tolerability, with pharmacokinetics assessed as a secondary endpoint. TX2100 is a VHH-Fc antagonist of the APJ (apelin) receptor, a GPCR involved in pro-angiogenic signaling, and is being developed as a potential treatment for Hereditary Hemorrhagic Telangiectasia (HHT). Upcoming Milestones TX2100 Phase 1a Topline Results Expected by End of Q3 2026 with Phase 2 Planned in Early 2027: The Company expects to report topline results for the TX2100 Phase 1a clinical trial in healthy volunteers by the end of Q3 2026, with detailed data planned to be subsequently presented at a scientific meeting. Subject to favorable safety, tolerability and pharmacokinetic results, Tectonic plans to advance TX2100 into an open-label Phase 1b clinical trial in patients with hematologic-support dependent HHT and a placebo-controlled, Phase 2 clinical trial in moderate-to-severe HHT patients, with endpoints expected to include epistaxis, hemoglobin, hematologic support, and other endpoints relevant to HHT. Phase 1b and Phase 2 trials are planned to run in parallel, with the Phase 2 trial anticipated to begin in early 2027.TX45 APEX Phase 2 Trial Ongoing with Topline Results Expected Early Q1 2027: The global, randomized, placebo-controlled 24-week APEX Phase 2 trial is ongoing, evaluating subcutaneous TX45 in patients with PH-HFpEF, including an enriched population with combined pre- and post-capillary pulmonary hypertension (CpcPH). The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline in the CpcPH subgroup (PVR ≥3 Wood Units). APEX patient enrollment is complete with topline results expected early Q1 2027. Overview of Financial and Operating Results Cash Position: As of June 30, 2026, cash and cash equivalents were $227.1 million, compared to $236.9 million as of March 31, 2026. Tectonic anticipates that, based on current operating assumptions, its current cash and cash equivalents will provide a cash runway into Q1 2029, including through the Phase 2 topline readouts of TX45 in PH-HFpEF and PH-ILD, and through significant clinical milestones in the TX2100 development program.Research and Development Expenses: Research and development expenses were $18.0 million for the three months ended June 30, 2026, as compared to $17.2 million for the three months ended June 30, 2025. The increase was primarily the result of contract research and contract development and manufacturing organizations costs related to the ongoing Phase 2 clinical trials of TX45 and employee-related expenses due to an increase in non-cash, stock-based compensation expense and increase in headcount.General and Administrative Expenses: General and administrative expenses were $6.2 million for the three months ended June 30, 2026, as compared to $5.2 million for the three months ended June 30, 2025. The increase was primarily the result of higher employee-related expenses driven by higher non-cash, stock-based compensation.Net Loss: For the three months ended June 30, 2026, the Company had a net loss of $22.3 million compared to a net loss of $20.0 million for the three months ended June 30, 2025. ¹ Baseline characteristics are preliminary and subjective to change. About Group 2 Pulmonary Hypertension in HFpEFThe World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About Group 3 Pulmonary Hypertension and PH-ILDGroup 3 is PH due to chronic lung disease and Tectonic is focused on a Group 3 subtype, called PH-ILD where PH develops in patients who have ILD. ILD is a group of rare conditions causing inflammation and scarring in the lungs. It is believed that a combination of factors leads to the formation of PH-ILD, including lung fibrosis, chronic hypoxia, vascular remodeling and other factors that lead to worsening exercise capacity. PH-ILD has worse survival than ILD without PH. There are currently two approved treatments for PH-ILD, both of which contain the active ingredient treprostinil administered via nebulizer or dry powder inhaler. About TX45, a long-acting Fc-relaxin fusion proteinTX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About Hereditary Hemorrhagic Telangiectasia (HHT)HHT is a rare, inherited vascular disorder affecting an estimated 75,000 people in the United States. HHT is the second most common inherited bleeding disorder and a disease for which there are currently no approved therapies. It is characterized by fragile, abnormal blood vessels that lead to recurrent bleeding, which can reduce quality of life, result in emergency room visits and hospitalizations, as well as chronic anemia requiring frequent iron infusions and/or blood transfusions. Many patients with HHT also develop arteriovenous malformations (AVMs) in vital organs such as the lungs, brain, and liver that, if left untreated, are at risk of rupturing and can result in serious and potentially life-threatening complications including lung or brain hemorrhage, stroke, heart failure, or death. Despite being a rare disease and the second most common inherited bleeding disorder, there are currently no approved therapies. About TX2100, a VHH-Fc fusion antagonist antibodyTX2100, is a VHH-Fc fusion antagonist antibody that binds to the APJ receptor (also known as the apelin receptor; APLNR), a GPCR that mediates signaling by the pro-angiogenic peptide hormone apelin. APJ represents a differentiated approach for the potential treatment of HHT. APJ is a selective anti-angiogenic target that is primarily expressed in endothelial cells and is generally quiescent under normal physiological conditions, but is upregulated during pathologic angiogenesis, including in HHT preclinical models. TX2100 is designed as a selective APJ antagonist intended to inhibit disease-associated angiogenic signaling with the goal of providing a more favorable safety profile compared to less selective anti-angiogenic approaches. Anti-angiogenic agents have demonstrated activity in HHT preclinical models and in patients, and APJ antagonism has shown activity in multiple HHT preclinical models, supporting development of TX2100 for this indication. About TectonicTectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit https://tectonictx.com/ and follow @TectonicTx on X (formerly Twitter) and LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of Tectonic’s product candidates, including the ongoing Phase 2 clinical trials for its lead product candidate, TX45, in Group 2 PH-HFpEF and in Group 3 PH-ILD and the ongoing Phase 1 clinical trial for TX2100; and the Company’s expected cash runway. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed for the quarter ended June 30, 2026 and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts: Investors:Dan FerryLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576 Media:Kathryn MorrisThe Yates Networkkathryn@theyatesnetwork.com(914) 204-6412 Tectonic Therapeutic, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except per share data)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $18,048 $17,185 $38,919 $30,221 General and administrative 6,170 5,147 12,600 10,409 Total operating expenses 24,218 22,332 51,519 40,630 Loss from operations (24,218) (22,332) (51,519) (40,630)Other income (expense), net: Interest income 2,021 3,389 4,202 5,833 Interest expense (6) (17) (14) (37)Other expense (5) (48) (118) (80)Total other income, net 2,010 3,324 4,070 5,716 Loss before income tax (22,208) (19,008) (47,449) (34,914)Income tax expense (77) (976) (77) (976)Net loss (22,285) (19,984) (47,526) (35,890)Other comprehensive (loss) income: Foreign currency translation adjustment — (51) 37 (58)Comprehensive loss $(22,285) $(20,035) $(47,489) $(35,948)Net loss per share, basic and diluted $(1.18) $(1.07) $(2.52) $(2.00)Weighted-average common shares outstanding, basic and diluted 18,964,008 18,680,042 18,867,044 17,923,056 Tectonic Therapeutic, Inc.Select Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) June 30, 2026 December 31, 2025 Cash and cash equivalents $227,068 $253,798Working capital* 220,729 247,693Total assets 237,034 261,038Total stockholders’ equity 223,846 251,329 *Working capital is defined as current assets less current liabilities
COLUMBIA, Md., Aug. 4, 2026 /PRNewswire/ — MedStar Health is celebrating high praise for its hospitals in U.S. News & World Report’s Best Hospitals rankings for 2026-27, including prestigious national and regional recognition for exceptional patient care. Each year, U.S. News ranks…
Financial Highlights† Reported revenue of $418.8 million, up 10%Constant currency revenue* and constant currency revenue, organic* up 9% and up 9%, respectivelyGAAP operating margin of 14.4%, compared to 12.3% in prior year periodNon-GAAP operating margin* of 22.6%, compared to 21.2% in prior year periodGAAP EPS $0.65, up 20%Non-GAAP EPS* $1.19, up 18%Cash flow from operations of $110.0 million year-to-date, down 11%Free cash flow* generation of $76.6 million year-to-date, down 14% † Comparisons above are calculated for the current quarter compared with the second quarter of 2025, unless otherwise specified. Amounts stated in this release are rounded, while percentages are calculated from the underlying amounts. * Constant currency revenue; constant currency revenue, organic; non-GAAP gross profit and margin; non-GAAP operating income and margin; non-GAAP net income; non-GAAP EPS; and free cash flow figures (used here and below) are non-GAAP financial measures. A reconciliation of these financial measures to their most directly comparable GAAP financial measures is included under the heading “Non-GAAP Financial Measures” below. SOUTH JORDAN, Utah, July 30, 2026 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced financial results for the three and six-month periods ended June 30, 2026. “Merit delivered second quarter financial results that exceeded the high end of our expectations, driven primarily by 9% organic, constant currency revenue growth, excluding the impact of a strategic divestiture,” said Martha G. Aronson, Merit’s President and CEO. “We experienced improving revenue growth trends across our global business in Q2, as expected, with notable strength in sales to customers in the U.S. which increased 10% year-over-year, well ahead of our expectations. We also delivered improvement in both our non-GAAP operating margin and our non-GAAP earnings per share, which increased by 140 basis points and 18%, respectively, year-over-year.” Ms. Aronson continued: “We have increased our 2026 revenue and non-GAAP earnings per share guidance to reflect the stronger-than-expected results over the first half of 2026 and remain confident in our team’s ability to execute, with attractive constant currency growth, improving profitability, and solid cash flow generation this year. Our team remains focused on delivering our Continued Growth Initiative financial targets for the three-year period ending December 31, 2026, and, in parallel, we are developing our longer-term strategic plan focused on identifying opportunities to better position the company for sustainable growth, enhanced profitability and value creation for our shareholders.” Merit’s revenue by product category for the three and six-month periods ended June 30, 2026 and 2025 was as follows (unaudited; in thousands, except for percentages): Three Months Ended Reported Constant Currency* June 30, Impact of foreign June 30, 2026 2025 % Change exchange 2026 % ChangeFoundational Access $161,786 $152,122 6 % $(2,340) $159,446 5 %OEM 48,338 43,218 12 % (29) 48,309 12 %Procedural Solutions 27,949 31,741 (12)% 140 28,089 (12)%Vascular Intervention 41,652 34,955 19 % (409) 41,243 18 %Other 1,236 346 257 % 1,102 2,338 576 %Total Foundational 280,961 262,382 7 % (1,536) 279,425 6 % Therapeutic Cardiac Therapies 28,510 22,930 24 % (479) 28,031 22 %Endoscopy 23,647 18,400 29 % 37 23,684 29 %OEM 12,797 9,735 31 % (20) 12,777 31 %Oncology 25,774 23,943 8 % (171) 25,603 7 %Renal Therapies 12,713 12,817 (1)% (164) 12,549 (2)%Vascular Intervention 34,441 32,255 7 % (654) 33,787 5 %Total Therapeutic 137,882 120,080 15 % (1,451) 136,431 14 % Total $418,843 $382,462 10 % $(2,987) $415,856 9 % Six Months Ended Reported Constant Currency * June 30, Impact of foreign June 30, 2026 2025 % Change exchange 2026 % ChangeFoundational Access $312,910 $286,520 9 % $(7,520) $305,390 7 %OEM 87,878 86,641 1 % (264) 87,614 1 %Procedural Solutions 54,437 60,310 (10)% (18) 54,419 (10)%Vascular Intervention 80,690 67,804 19 % (1,472) 79,218 17 %Other 525 1,489 (65)% 2,749 3,274 120 %Total Foundational 536,440 502,764 7 % (6,525) 529,915 5 % Therapeutic Cardiac Therapies 55,914 43,489 29 % (1,694) 54,220 25 %Endoscopy 45,339 34,951 30 % 20 45,359 30 %OEM 20,276 20,877 (3)% (50) 20,226 (3)%Oncology 49,282 45,994 7 % (526) 48,756 6 %Renal Therapies 24,225 26,206 (8)% (392) 23,833 (9)%Vascular Intervention 69,244 63,532 9 % (1,756) 67,488 6 %Total Therapeutic 264,280 235,049 12 % (4,398) 259,882 11 % Total $800,720 $737,813 9 % $(10,923) $789,797 7 % Financial Summary: GAAP gross margin was 51.4%, compared to 48.2% for the second quarter of 2025. Non-GAAP gross margin* was 55.8%, compared to 53.2% for the second quarter of 2025. GAAP operating margin was 14.4%, compared to 12.3% for the second quarter of 2025. Non-GAAP operating margin* was 22.6%, compared to 21.2% for the second quarter of 2025. GAAP net income was $38.8 million, or $0.65 per share, compared to $32.6 million, or $0.54 per share, for the second quarter of 2025. Non-GAAP net income* was $71.3 million, or $1.19 per share, compared to $61.0 million, or $1.01 per share, for the second quarter of 2025. As of June 30, 2026, Merit had cash and cash equivalents of $448.7 million and total debt obligations of $747.5 million, compared to cash and cash equivalents of $446.4 million and total debt obligations of $747.5 million as of December 31, 2025. Merit had available borrowing capacity of approximately $697 million as of June 30, 2026. Fiscal Year 2026 Financial Guidance Based upon the information currently available to Merit’s management, for the twelve-month period ending December 31, 2026, absent the potential impact of trade policies and related actions implemented by the U.S. and other countries subsequent to today’s date, material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit anticipates the following financial results: Revenue and Earnings Guidance* Updated GuidancePrior Guidance(2) Year Ending% ChangeYear Ending% ChangeFinancial Measure December 31, 2026Y/YDecember 31, 2026Y/YTotal Revenue $1.631 – $1.643 billion8% – 8%$1.612 – $1.634 billion6% – 8% Non-GAAP Earnings Per Share(1) $4.25 – $4.3511% – 14%$4.01 – $4.155% – 8% *Percentage figures approximated; dollar figures may not foot due to rounding. (1) Merit’s non-GAAP earnings per share reflect the dilutive impact of its 3.00% Convertible Senior Notes due 2029 (the “Convertible Notes”) calculated using the if-converted method of approximately $0.03 per share for the year ending December 31, 2026. Any offsetting impacts of the capped call associated with the Convertible Notes are not considered. (2) “Prior Guidance” reflects Merit’s full-year 2026 financial guidance, previously introduced on April 30, 2026. Merit does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of various items which could impact Merit’s future financial results, such as expenses attributable to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reasonably predict the amount and impact of these items and Merit believes inclusion of the most comparable GAAP financial measure, and a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance. Merit’s financial guidance for the year ending December 31, 2026 is subject to risks and uncertainties identified in this release and Merit’s filings with the SEC. This guidance is based on information and estimates available to Merit as of July 30, 2026. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results will likely vary, and could vary materially, from past results and those anticipated, estimated or projected. CONFERENCE CALL As previously announced, Merit will hold its investor conference call today, Thursday, July 30, 2026, at 4:30 p.m., Eastern Time, to discuss its results for the second quarter and provide an operational update. To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck will also be available at merit.com. CONSOLIDATED BALANCE SHEETS(in thousands) June 30, December 31, 2026 2025ASSETS (Unaudited) Current Assets Cash and cash equivalents $448,699 $446,404 Trade receivables, net 224,237 203,710 Other receivables 23,960 17,773 Inventories 374,112 333,705 Prepaid expenses and other assets 33,496 31,493 Prepaid income taxes 5,033 4,941 Income tax refund receivables 2,701 2,128 Total current assets 1,112,238 1,040,154 Property and equipment, net 436,749 428,401 Intangible assets, net 612,026 537,654 Goodwill 539,772 506,837 Deferred income tax assets 7,200 7,049 Operating lease right-of-use assets 83,776 87,600 Other assets 71,859 78,227 Total Assets $2,863,620 $2,685,922 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Trade payables $70,737 $60,551 Accrued expenses 172,185 159,486 Current operating lease liabilities 10,921 10,876 Income taxes payable 11,090 8,851 Total current liabilities 264,933 239,764 Long-term debt 736,258 734,038 Deferred income tax liabilities 39,704 19,665 Liabilities related to unrecognized tax benefits 2,248 2,248 Deferred compensation payable 19,297 17,542 Deferred credits 1,347 1,398 Long-term operating lease liabilities 72,942 76,658 Other long-term obligations 47,087 10,306 Total liabilities 1,183,816 1,101,619 Stockholders’ Equity Common stock 783,892 763,909 Retained earnings 903,828 824,030 Accumulated other comprehensive loss (7,916) (3,636)Total stockholders’ equity 1,679,804 1,584,303 Total Liabilities and Stockholders’ Equity $2,863,620 $2,685,922 CONSOLIDATED STATEMENTS OF INCOME(Unaudited, in thousands except per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Net sales $418,843 $382,462 $800,720 $737,813 Cost of sales 203,677 197,975 400,757 381,306 Gross profit 215,166 184,487 399,963 356,507 Operating expenses: Selling, general and administrative 129,229 113,097 247,439 220,583 Research and development 25,389 24,367 47,998 46,845 Contingent consideration expense (benefit) 145 143 (34) 1,166 Total operating expenses 154,763 137,607 295,403 268,594 Income from operations 60,403 46,880 104,560 87,913 Other income (expense): Interest income 3,752 3,761 7,652 7,551 Interest expense (12,118) (6,775) (18,644) (13,343)Other (expense) income — net (723) (487) 11,292 (784)Total other (expense) income — net (9,089) (3,501) 300 (6,576) Income before income taxes 51,314 43,379 104,860 81,337 Income tax expense 12,511 10,798 25,062 18,609 Net income $38,803 $32,581 $79,798 $62,728 Earnings per common share Basic $0.65 $0.55 $1.34 $1.06 Diluted $0.65 $0.54 $1.33 $1.03 Weighted average shares outstanding Basic 59,679 59,140 59,595 59,019 Diluted 60,006 60,611 60,010 60,945 CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited, in thousands) Six Months Ended June 30, 2026 2025 CASH FLOWS FROM OPERATING ACTIVITIES: Net income $79,798 $62,728 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 61,538 60,313 Gain on disposition of a business (12,557) (249)Amortization of right-of-use operating lease assets 5,779 5,766 Fair value adjustments related to contingent consideration liabilities (34) 1,166 Stock-based compensation expense 21,876 19,951 Other adjustments 4,388 3,173 Changes in operating assets and liabilities, net of acquisitions and divestitures (50,831) (28,969)Total adjustments 30,159 61,151 Net cash, cash equivalents, and restricted cash provided by operating activities 109,957 123,879 CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures for property and equipment (33,340) (34,812)Proceeds from asset and business dispositions 25,555 294 Cash paid for notes receivable and other investments — (14,617)Cash paid in acquisitions, net of cash acquired (92,997) (122,555)Other investing, net (1,617) (1,296)Net cash, cash equivalents, and restricted cash used in investing activities (102,399) (172,986) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock 4,623 20,014 Contingent payments related to acquisitions (2,991) (2,567)Payment of taxes related to an exchange of common stock (6,973) (6,145)Net cash, cash equivalents, and restricted cash (used in) provided by financing activities (5,341) 11,302 Effect of exchange rates on cash 140 2,953 Net increase (decrease) in cash, cash equivalents and restricted cash 2,357 (34,852) CASH, CASH EQUIVALENTS AND RESTRICTED CASH: Beginning of period 448,549 378,767 End of period $450,906 $343,915 RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: Cash and cash equivalents 448,699 341,819 Restricted cash reported in prepaid expenses and other current assets 2,207 2,096 Total cash, cash equivalents and restricted cash $450,906 $343,915 Non-GAAP Financial Measures Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), Merit’s management believes that the non-GAAP financial measures referenced in this release may provide investors with useful information regarding the underlying business trends and performance of Merit’s ongoing operations and can be useful for period-over-period comparisons of such operations. Non-GAAP financial measures used in this release include: constant currency revenue;constant currency revenue, organic;non-GAAP gross profit and margin;non-GAAP operating income and margin;non-GAAP net income;non-GAAP earnings per share; andfree cash flow. Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating and financial results to prior periods, to evaluate changes in the results of its operating segments, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to measures determined in accordance with GAAP. Readers should consider non-GAAP measures used in this release in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures generally exclude some, but not all, items that may affect Merit’s net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such items in the calculation of non-GAAP gross profit and margin, non-GAAP operating income and margin, non-GAAP net income, and non-GAAP earnings per share (in each case, as further illustrated in the reconciliation tables below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as acquisition or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings or changes in tax or industry regulations, gains or losses on disposal of certain assets, equity method investment loss (income) from equity investees, and debt issuance costs. Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this release should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures used in this release may not be comparable with similarly titled measures of other companies. Merit urges readers to review the reconciliations of its non-GAAP financial measures to their most directly comparable GAAP financial measures included herein, and not to rely on any single financial measure to evaluate Merit’s business or results of operations. Constant Currency Revenue Merit’s constant currency revenue is prepared by converting the current-period reported revenue of subsidiaries whose functional currency is a currency other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period and adjusting for the effects of hedging transactions on reported revenue, which are recorded in the U.S. dollar. The constant currency revenue adjustment of $(3.0) million and $(10.9) million to reported revenue for the three and six-month periods ended June 30, 2026 was calculated using the applicable average foreign exchange rates for the three and six-month periods ended June 30, 2025. Constant Currency Revenue, Organic Merit’s constant currency revenue, organic, is defined, with respect to prior fiscal year periods, as GAAP revenue less revenue from certain divestitures. For the three and six-month periods ended June 30, 2025, Merit’s constant currency revenue, organic, excludes revenues attributable to the DualCap® product line which Merit sold to Health Line International Corporation (“Health Line”) on February 17, 2026 (the “DualCap Divestiture”). With respect to current fiscal year periods, constant currency revenue, organic, is defined as constant currency revenue (as defined above), less revenue from certain acquisitions and divestitures. For the three and six-month periods ended June 30, 2026, Merit’s constant currency revenue, organic, excludes revenues attributable to products acquired in connection with (i) Merit’s acquisition of View Point Medical, Inc. (“View Point”) in April 2026 (the “View Point Merger”), (ii) the assets acquired from Pentax of America, Inc. related to the C2 CryoBalloon™ device in November 2025 (the “C2 Acquisition”) and (iii) Merit’s acquisition of Biolife Delaware, L.L.C. (“Biolife”) in May 2025 (the “Biolife Merger”). For the six-month period ended June 30, 2026, Merit’s constant currency revenue, organic, excludes revenues attributable to the DualCap Divestiture. Non-GAAP Gross Profit and Margin Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets and inventory mark-up related to acquisitions. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales. Non-GAAP Operating Income and Margin Non-GAAP operating income is calculated by adjusting GAAP operating income for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations, as well as other items referenced in the tables below. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales. Non-GAAP Net Income Non-GAAP net income is calculated by adjusting GAAP net income for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to Merit’s long-term debt, gains or losses on disposal of certain assets, equity method investment loss (income) from equity investees, and other items set forth in the tables below. Non-GAAP EPS Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period. Free Cash Flow Free cash flow is defined as cash flow from operations calculated in accordance with GAAP, less capital expenditures for property and equipment calculated in accordance with GAAP, as set forth in the consolidated statement of cash flows. Other Non-GAAP Financial Measure Reconciliations The following tables set forth supplemental financial data and corresponding reconciliations of non-GAAP financial measures to Merit’s corresponding financial measures prepared in accordance with GAAP, in each case, for the three and six-month periods ended June 30, 2026 and 2025. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of $6.3 million and $5.0 million for the three-month periods ended June 30, 2026 and 2025, respectively, and $9.5 million and $9.3 million for the six-month periods ended June 30, 2026 and 2025, respectively. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Three Months Ended June 30, 2026 Pre-Tax Tax Impact After-Tax Per Share Impact GAAP net income $51,314 $(12,511) $38,803 $0.65 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 18,718 (4,419) 14,299 0.24 Operating Expenses Contingent consideration expense 145 (33) 112 0.00 Amortization of intangibles 2,496 (589) 1,907 0.03 Performance-based share-based compensation (a) 6,621 (756) 5,865 0.10 Corporate restructuring (b) 2,159 (510) 1,649 0.03 Acquisition-related 2,568 (194) 2,374 0.04 Medical Device Regulation expenses (c) 1,452 (342) 1,110 0.02 Other (Income) Expense Long-term debt costs (e) 6,477 (1,529) 4,948 0.08 Other non-operating loss (f) 294 (82) 212 0.00 Non-GAAP net income $92,244 $(20,965) $71,279 $1.19 Diluted shares 60,006 Three Months Ended June 30, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income $43,379 $(10,798) $32,581 $0.54 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 18,980 (4,485) 14,495 0.24 Inventory mark-up related to acquisitions 67 (16) 51 0.00 Operating Expenses Contingent consideration expense 143 25 168 0.00 Amortization of intangibles 2,543 (601) 1,942 0.03 Performance-based share-based compensation (a) 5,879 (345) 5,534 0.09 Corporate restructuring (b) 2,587 (611) 1,976 0.03 Acquisition-related 2,140 (14) 2,126 0.04 Medical Device Regulation expenses (c) 1,634 (385) 1,249 0.02 Other (d) 50 (12) 38 0.00 Other (Income) Expense Long-term debt costs (e) 1,414 (334) 1,080 0.02 Gain on disposal of business unit (249) — (249) (0.00) Non-GAAP net income $78,567 $(17,576) $60,991 $1.01 Diluted shares 60,611 Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Six Months Ended June 30, 2026 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income $104,860 $(25,062) $79,798 $1.33 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 36,945 (8,722) 28,223 0.47 Operating Expenses Contingent consideration benefit (34) 5 (29) (0.00)Amortization of intangibles 4,950 (1,168) 3,782 0.06 Performance-based share-based compensation (a) 12,429 (1,062) 11,367 0.19 Corporate restructuring (b) 2,159 (510) 1,649 0.03 Acquisition-related 6,811 (905) 5,906 0.10 Medical Device Regulation expenses (c) 2,070 (488) 1,582 0.03 Other (Income) Expense Long-term debt costs (e) 7,891 (1,863) 6,028 0.10 Gain on disposal of business unit (12,502) 1,520 (10,982) (0.18)Other non-operating loss (f) 825 (207) 618 0.01 Non-GAAP net income $166,404 $(38,462) $127,942 $2.13 Diluted shares 60,010 Six Months Ended June 30, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income $81,337 $(18,609) $62,728 $1.03 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 36,586 (8,645) 27,941 0.46 Inventory mark-up related to acquisitions 67 (16) 51 0.00 Operating Expenses Contingent consideration expense 1,166 34 1,200 0.02 Amortization of intangibles 4,937 (1,167) 3,770 0.06 Performance-based share-based compensation (a) 10,653 (931) 9,722 0.16 Corporate restructuring (b) 2,587 (611) 1,976 0.03 Acquisition-related 2,156 (18) 2,138 0.04 Medical Device Regulation expenses (c) 3,228 (762) 2,466 0.04 Other (d) 29 (7) 22 0.00 Other (Income) Expense Long-term debt costs (e) 2,828 (668) 2,160 0.04 Gain on disposal of business unit (249) — (249) (0.00) Non-GAAP net income $145,325 $(31,400) $113,925 $1.87 Diluted shares 60,945 Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of Reported Operating Income to Non-GAAP Operating Income (Unaudited, in thousands except percentages) Three Months Ended Three Months Ended Six Months Ended Six Months Ended June 30, 2026 June 30, 2025 June 30, 2026 June 30, 2025 Amounts % Sales Amounts % Sales Amounts % Sales Amounts % SalesNet Sales as Reported $418,843 $382,462 $800,720 $737,813 GAAP Operating Income 60,403 14.4% 46,880 12.3% 104,560 13.1 % 87,913 11.9%Cost of Sales Amortization of intangibles 18,718 4.5% 18,980 5.0% 36,945 4.6 % 36,586 5.0%Inventory mark-up related to acquisitions — — 67 0.0% — — 67 0.0%Operating Expenses Contingent consideration expense (benefit) 145 0.0% 143 0.0% (34) (0.0)% 1,166 0.2%Amortization of intangibles 2,496 0.6% 2,543 0.7% 4,950 0.6 % 4,937 0.7%Performance-based share-based compensation (a) 6,621 1.6% 5,879 1.5% 12,429 1.6 % 10,653 1.4%Corporate restructuring (b) 2,159 0.5% 2,587 0.7% 2,159 0.3 % 2,587 0.4%Acquisition-related 2,568 0.6% 2,140 0.6% 6,811 0.9 % 2,156 0.3%Medical Device Regulation expenses (c) 1,452 0.3% 1,634 0.4% 2,070 0.3 % 3,228 0.4%Other (d) — — 50 0.0% — — 29 0.0% Non-GAAP Operating Income $94,562 22.6% $80,903 21.2% $169,890 21.2 % $149,322 20.2% Note: Certain percentages may not sum to totals due to rounding. (a) Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards. (b) Includes employee termination benefits associated with activities related to corporate restructuring initiatives and costs to terminate certain distribution contracts from the Biolife Merger. (c) Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation. (d) Represents costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice. (e) Represents costs associated with the Convertible Notes including the amortization of debt issuance costs and a one-time charge for additional interest incurred pursuant to Merit’s obligation to remove restrictive legends. (f) Includes equity method investment loss from equity investees. Reconciliation of Reported Revenue to Constant Currency Revenue (Non-GAAP), and Constant Currency Revenue, Organic (Non-GAAP)(Unaudited, in thousands except percentages) Three Months Ended Six Months Ended June30, June30, % Change 2026 2025 % Change 2026 2025 Reported Revenue 9.5%$418,843 $382,462 8.5%$800,720 $737,813 Add: Impact of foreign exchange (2,987) — (10,923) — Constant Currency Revenue (a) 8.7%$415,856 $382,462 7.0%$789,797 $737,813 Less: Revenue from certain acquisitions (4,660) — (13,704) — Less: Revenue from divestitures (b) — (5,296) (1,644) (10,212) Constant Currency Revenue, Organic (a) 9.0%$411,196 $377,166 6.4%$774,449 $727,601 (a) A non-GAAP financial measure. For a definition of this and other non-GAAP financial measures, see the section of this release entitled “Non-GAAP Financial Measures.” (b) On February 17, 2026, Merit sold certain assets relating to the DualCap product line to Health Line for $28 million, of which $25.5 million was paid to Merit at closing. Reconciliation of Reported Gross Margin to Non-GAAP Gross Margin (Non-GAAP)(Unaudited, as a percentage of reported revenue) Three Months Ended Six Months Ended June30, June30, 2026 2025 2026 2025 Reported Gross Margin 51.4% 48.2% 50.0% 48.3% Add back impact of: Amortization of intangibles 4.5% 5.0% 4.6% 5.0%Inventory mark-up related to acquisitions —% 0.0% —% 0.0% Non-GAAP Gross Margin 55.8% 53.2% 54.6% 53.3% Note: Certain percentages may not sum to totals due to rounding. Reconciliation of Reported Cash Flow from Operations to Free Cash Flow (Non-GAAP) (Unaudited, in thousands) Six Months Ended June30, 2026 2025 Reported Cash Flow from Operations $109,957 $123,879 Less: Capital Expenditures (33,340) (34,812) Free Cash Flow $76,617 $89,067 Reconciliation of 2026 Net Sales Guidance – % Change from Prior Year (Constant Currency) Updated Guidance Prior Guidance(1) Low High Low High2026 Net Sales Guidance – % Change from Prior Year (GAAP) 7.6% 8.4% 6.3% 7.8%Estimated impact of foreign currency exchange rate fluctuations (0.8%) (0.8%) (0.8%) (0.8%)2026 Net Sales Guidance – % Change from Prior Year (Constant Currency) 6.8% 7.6% 5.6% 7.0% Note: Certain percentages may not sum to totals due to rounding. (1) “Prior Guidance” reflects Merit’s full-year 2026 financial guidance, previously introduced on April 30, 2026. ABOUT MERIT Founded in 1987, Merit 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 customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,500 people worldwide. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others: statements preceded or followed by, or that include the words, “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “projects,” “forecasts,” “potential,” “target,” “continue,” “upcoming,” “optimistic” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology;statements that address Merit’s future operating performance or events or developments that Merit’s management expects or anticipates will occur, including, without limitation, any statements regarding Merit’s projected revenues, earnings or other future financial measures, Merit’s plans and objectives for future operations, Merit’s proposed new products or services, the integration, development or commercialization of the business or any assets acquired from other parties, future economic conditions or performance, the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives Program or other business optimization initiatives, and any statements of assumptions underlying any of the foregoing; andstatements regarding Merit’s past performance, efforts, or results about which inferences or assumptions may be made, including statements proceeded or followed by the words “preliminary,” “initial,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications” or “early feedback” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. The forward-looking statements contained in this release are based on Merit management’s current expectations and assumptions regarding future events or outcomes. If underlying expectations or assumptions prove inaccurate, or risks or uncertainties materialize, actual results will likely differ, and may differ materially, from Merit’s expectations reflected in any forward-looking statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Investors are cautioned not to unduly rely on any such forward-looking statements. The following are some of the important risks and uncertainties that could cause Merit’s actual results to differ from management’s expectations in any forward-looking statements: risks and uncertainties arising from the conflict among the United States, Israel and Iran and related geopolitical instability; risks and uncertainties associated with Merit’s acquisition of View Point and the OneMark® Detection Imaging System and related technology; risks and uncertainties associated with Merit’s integration of the View Point business, assets and operations into its operations and its ability to achieve anticipated financial results, product development and other anticipated benefits of the acquisition; uncertainties as to whether Merit will achieve revenue or other financial performance consistent with its forecasts projected for the View Point Merger; risks and uncertainties associated with Merit’s executive succession planning activities and leadership transition; risks and uncertainties regarding trade policies or related actions implemented by the U.S. or other countries, including existing, proposed, prospective or invalidated tariffs, duties or other measures; risks and uncertainties associated with Merit’s integration of businesses or assets acquired from third parties, including View Point in April 2026, the business and assets acquired in the C2 Acquisition in November 2025 and Biolife in May 2025, and Merit’s ability to achieve the anticipated financial results, product development and other anticipated benefits of such acquisitions; effects of the Convertible Notes on Merit’s net income and earnings per share performance; restrictions and limitations set forth in the Convertible Notes and Indenture, which could affect Merit’s ability to operate its business as well as its liquidity; disruptions in Merit’s supply chain, manufacturing or sterilization processes; U.S. and global political, economic, competitive, reimbursement and regulatory conditions; modification or limitation of, or policies and procedures associated with, governmental or private insurance reimbursement policies; reduced availability of, and price increases associated with, components and other raw materials; increases in transportation expenses; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; prospective financial obligations or other uncertainties associated with the DualCap Divestiture completed in February 2026; fluctuations in interest or foreign currency exchange rates and inflation; cybersecurity events; government scrutiny and regulation of the medical device industry; difficulties relating to development, testing and regulatory approval, clearance and maintenance of Merit’s products; the safety, efficacy and patient and physician adoption of Merit’s products; the ability to fully enroll and the outcomes of ongoing and future clinical trials and market studies relating to Merit’s products; litigation and other legal proceedings affecting Merit; risks and possible effects of Merit’s failure to comply with U.S. and foreign laws and regulations; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other jurisdictions or exposure to additional tax liabilities which may adversely affect Merit’s effective tax rate; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; failure to comply with applicable environmental laws; changes in key personnel; labor shortages and increases in labor costs; price and product competition; extreme weather events; and geopolitical events. For a further discussion of the risks and uncertainties and other factors that 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, 2025 filed with the SEC, which Merit updated in Part II, Item 1A. “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for each of the quarters ended March 31, 2026 and June 30, 2026. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. 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. Contacts: PR/Media Inquiries:Investor Inquiries: Sarah ComstockMike Piccinino, CFA, IRC Merit MedicalICR Healthcare +1-801-432-2864+1-443-213-0509 sarah.comstock@merit.com mike.piccinino@icrhealthcare.com
