LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that Sean Salmon has been appointed to its Board of Directors. Mr. Salmon will also serve on the Company’s Audit Committee and […]
Author: Ken Dropiewski
Kestra Medical Technologies Reports Second Quarter Fiscal 2026 Financial Results
KIRKLAND, Wash., Dec. 11, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today reported financial results for the second quarter fiscal 2026, which ended October 31, 2025. Financial Highlights Generated revenue of $22.6 million in Q2 FY26, an increase of 53% compared to the prior year period.Expanded gross margin to 50.6% in Q2 FY26 compared to 39.6% in the prior year period.Increased FY26 revenue guidance to $91 million, which would represent growth of 52% compared to FY25. “Kestra delivered another strong quarter of financial performance, generating revenue growth of 53% while expanding gross margin to over 50%, an important milestone for the company,” said Brian Webster, President and CEO. “We also continued to make progress on several key operational objectives, including growing the commercial organization, announcing compelling primary results from our post-approval study at the American Heart Association annual meeting, and fortifying our balance sheet with an equity offering earlier this month. As we progress on our journey to category leadership, our team remains focused on growing the wearable defibrillator market and executing on our commitments to patients and their prescribers.” Second Quarter Fiscal 2026 Financial Results Total revenue was $22.6 million, an increase of 53% compared to the prior year period. 4,696 prescriptions were written for the ASSURE® system, an increase of 54% compared to the prior year period.Revenue growth was driven by higher market share and continuing WCD market expansion. Revenue also benefited from a higher mix of in-network patients and continued improvements in revenue cycle management capabilities. Gross profit was $11.4 million compared to $5.8 million in the prior year period. Gross margin expanded to 50.6% compared to 39.6% in the prior year period, driven by volume leverage and a higher mix of in-network patients. GAAP operating expenses were $43.2 million and included $1.0 million of non-recurring costs. GAAP operating expenses were $25.0 million in the prior year period. Excluding non-recurring costs and share-based compensation expense, operating expenses were $33.5 million in Q2 FY26 compared to $23.8 million in Q2 FY25. The increase was attributable to growth in expenses related to commercial expansion and public company costs. GAAP net loss and comprehensive loss was $32.8 million compared to GAAP net loss and comprehensive loss of $20.6 million in the prior year period. Adjusted EBITDA* loss was $19.7 million compared to an adjusted EBITDA loss of $16.1 million in the prior year period. Cash and cash equivalents totaled $175 million as of October 31, 2025. The above cash and cash equivalents balance does not include the $148 million of net proceeds Kestra received from an underwritten public offering of 6.9 million common shares, which closed on December 4, 2025. *Adjusted EBITDA is a non-GAAP financial measure. See “Use of Non-GAAP Financial Measures” below for additional information. A reconciliation of Adjusted EBITDA to the most directly comparable GAAP measure is included in this press release. Fiscal Year 2026 Revenue GuidanceKestra is increasing its FY26 revenue guidance to $91 million, which would represent growth of 52% compared to FY25. This compares to prior FY26 revenue guidance of $88 million and initial FY26 guidance of $85 million. Webcast and Conference CallKestra will host a conference call today at 4:30 p.m. ET to discuss financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website. Use of Non-GAAP Financial MeasuresThis press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including Adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP. Adjusted EBITDA, which is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, share-based compensation expense, and non-recurring new public company costs, is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate the Company’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of Adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results. The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of Adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of December 11, 2025. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; risks and uncertainties related to market conditions; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts)(unaudited) Three Months Ended October 31, Six Months Ended October 31, 2025 2024 2025 2024 Revenue$22,565 $14,710 $41,937 $27,492 Cost of revenue 11,141 8,880 21,661 17,462 Gross profit 11,424 5,830 20,276 10,030 Operating expenses: Research and development 4,878 3,509 8,878 6,913 Selling, general and administrative 38,301 21,455 72,029 40,682 Total operating expenses 43,179 24,964 80,907 47,595 Loss from operations (31,755) (19,134) (60,631) (37,565)Other expense (income): Interest expense 1,901 2,317 3,814 4,191 Interest income (1,796) (878) (3,962) (915)Other expense (income) 891 40 (1,939) 88 Net loss before provision for income taxes (32,751) (20,613) (58,544) (40,929)Provision for income taxes 34 8 67 15 Net loss and comprehensive loss (32,785) (20,621) (58,611) (40,944)Net loss attributable to non-controlling interest — (253) — (692)Net loss and comprehensive loss attributable to Kestra Medical Technologies, Ltd. (32,785) (20,368) (58,611) (40,252)Less: Undeclared preferred stock dividends — 3,323 — 5,706 Net loss attributable to common shareholders, basic and diluted$(32,785) $(23,691) $(58,611) $(45,958) Net loss per share attributable to common shareholders, basic and diluted$(0.64) $(1.19) $(1.14) $(2.31)Weighted-average shares of common shares outstanding, basic and diluted 51,376,278 19,885,382 51,340,438 19,885,382 RECONCILIATION OF GAAP NET LOSS AND COMPREHENSIVE LOSS TO ADJUSTED EBITDA (in thousands)(unaudited) Three Months Ended October 31, Six Months Ended October 31, 2025 2024 2025 2024 GAAP Net loss and comprehensive loss$(32,785) $(20,621) $(58,611) $(40,944)Non-GAAP Adjustments: Interest expense 1,901 2,317 3,814 4,191 Interest income (1,796) (878) (3,962) (915)Other expense (income) 891 40 (1,939) 88 Provision for income taxes 34 8 67 15 Depreciation expense 2,372 1,869 4,401 4,244 Share-based compensation expense 8,653 1,122 13,232 1,499 Non-recurring expenses 1,048 — 3,914 — Adjusted EBITDA$(19,682) $(16,143) $(39,084) $(31,822) KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)(unaudited) October 31, April 30, 2025 2025 Assets Current assets Cash and cash equivalents$175,424 $237,595 Accounts receivable, net 10,413 8,081 Disposable medical equipment supplies 6,918 6,572 Prepaid expenses and other current assets 2,659 3,080 Total current assets 195,414 255,328 Right-of-use assets 1,960 2,078 Deposits 1,858 2,021 Restricted cash 334 334 Property and equipment, net 45,932 34,830 Other long-term assets 1,203 1,153 Total assets$246,701 $295,744 Liabilities and Shareholders’ Equity Current liabilities Accounts payable$20,209 $23,961 Accrued liabilities 15,494 13,829 Operating lease liabilities, current portion 53 187 Total current liabilities 35,756 37,977 Operating lease liabilities, net of current portion 2,874 3,026 Warrant liabilities 1,977 8,097 Other long-term liabilities 140 140 Long-term debt, net 41,873 41,098 Total liabilities 82,620 90,338 Commitments and contingencies Shareholders’ equity Common shares, $1.00 par value; 100,000,000 shares authorized as of October 31, 2025 and April 30, 2025; 51,449,053 issued and outstanding as of October 31, 2025 and 51,348,656 shares issued and outstanding as of April 30, 2025 51,449 51,349 Additional paid-in capital 691,492 674,306 Accumulated deficit (578,860) (520,249)Total shareholders’ equity 164,081 205,406 Total liabilities and shareholders’ equity$246,701 $295,744 KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)(unaudited) Six Months Ended October 31, 2025 2024 Cash flows from operating activities Net loss$(58,611) $(40,944)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 4,401 4,244 Loss on disposal of property and equipment 560 580 Reserve for lost equipment and supplies 901 477 Provision for uncollectible accounts receivable 1,150 1,074 Interest paid-in-kind — 467 Amortization of debt discounts and issuance costs 937 861 Share-based compensation expense 13,232 1,499 Non-cash lease expense 148 242 Change in fair value of warrant liabilities (2,065) — Changes in operating assets and liabilities: Disposable medical equipment supplies (596) (1,117)Prepaid expenses and other current assets 953 (53)Accounts receivable (3,482) (4,470)Accounts payable (2,372) (345)Accrued liabilities 520 1,786 Operating lease liabilities (313) 124 Other long-term assets 20 20 Net cash used in operating activities (44,617) (35,555)Cash flows from investing activities Purchases of property and equipment (15,431) (11,484)Deposits for medical rental equipment (338) (197)Refund of deposits for medical rental equipment: 117 227 Net cash used in investing activities (15,652) (11,454)Cash flows from financing activities Proceeds from issuance of redeemable preferred stock — 103,400 Proceeds from issuance of stock to non-controlling interest — 17,100 Deemed dividend for payments to third party on behalf of shareholder — (1,598)Payment of equity issuance costs: (1,902) (3,224)Net cash provided by (used in) financing activities (1,902) 115,678 Net increase (decrease) in cash, cash equivalents and restricted cash (62,171) 68,669 Cash, cash equivalents and restricted cash Beginning of period 237,929 8,583 End of period$175,758 $77,252 Reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets Cash and cash equivalents$175,424 $76,918 Restricted cash: 334 334 Cash, cash equivalents and restricted cash$175,758 $77,252 Non-cash investing and financing activities: Purchases of property and equipment in accrued liabilities and accounts payable$8,313 7,914 Exercise of liability classified warrant 4,055 — Supplemental disclosure of cash flow information Income taxes paid (refunds received)$(18) $43 Interest paid 2,846 2,451 CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
HeartSciences Announces Major Upgrade to User Features of MyoVista Insights Platform with Commercial Launch Version 1.1
Version 1.1 Designed to Provide Best Usability of any ECG System Version 1.1 Designed to Provide Best Usability of any ECG System
Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology
The FDA clearance of enVast redefines coronary thrombectomy treatment and further expands Vesalio’s commercial platform. PLANO, Texas, Dec. 11, 2025 /PRNewswire/ — Vesalio, a leader in thrombectomy solutions, today announced FDA 510(k) clearance and the upcoming U.S. commercial launch of…
Heartflow FFRCT Analysis Delivers Prognostic Power and Significant Cost Savings in New Analyses of Over 90,000 Patients with Coronary Artery Disease
Lesion-specific FFRCT predicts individual cardiovascular outcomes and delivers greater-than-modeled cost savings for real-world population in FISH&CHIPS analyses from England’s National Health ServiceMOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced two new analyses from FISH&CHIPS, a real-world, multicenter, retrospective study of more than 90,000 patients conducted by the National Health Service (NHS) in England, representing the largest fractional flow reserve (FFRCT) study ever conducted. The data, presented today at the European Society of Cardiology’s European Association of Cardiovascular Imaging (EACVI) conference in Vienna, provide the strongest real-world evidence to date that Heartflow FFRCT Analysis derived from coronary computed tomography angiography (CTA) improves diagnostic decision-making, predicts future cardiovascular events, and delivers substantial, system-wide cost savings. “These real-world data show that coronary CTA plus Heartflow FFRCT Analysis brings both clinical and economic value when utilized in a large health system,” said Timothy Fairbairn, Ph.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool, UK. “The introduction of Heartflow FFRCT Analysis into the NHS resulted in fewer avoidable tests, lower inpatient and outpatient costs, and substantial overall savings for both the hospitals and patients. It’s a compelling example of how noninvasive AI-powered technology can reshape care pathways at scale.” Lesion-Specific Heartflow FFRCT Analysis Predicts Individual Cardiovascular OutcomesIn a nationwide analysis of 7,836 patients who underwent FFRCT in the FISH&CHIPS study, investigators evaluated the prognostic value of Heartflow FFRCT Analysis across individual outcomes, including myocardial infarction (MI), cardiovascular mortality, all-cause mortality, and revascularization. Key findings include:1 The lower the FFRCT values, the higher the risk of MI, revascularization, cardiovascular death, and all-cause death, independent of traditional cardiovascular risk factors.Patients with the lowest FFRCT values faced a four-fold increased risk of heart attack and a three-fold increased risk of cardiovascular death.Lesion-specific FFRCT (measured just beyond a specific stenosis) was the strongest predictor in the study of MI and revascularization, compared to distal vessel FFRCT (measured at the end of the artery). Heartflow FFRCT Analysis Delivers Greater-Than-Expected Cost SavingsA separate analysis of FISH&CHIPS data evaluated the cost-effectiveness of incorporating Heartflow FFRCT Analysis into the diagnostic pathway for stable CAD. The findings showed that the national program:2 Reduced downstream cardiovascular testing, including invasive coronary angiography.Increased appropriate revascularization and improved revascularization ratios.Produced £1,042 GBP ($1,394 USD) in per-patient cost savings at two years, substantially exceeding the cost savings modeled by NHS and the National Institute for Health and Care Excellence (NICE) during initial assessment and adoption. This suggests a potential £25 million GBP ($33.45 million USD) cost savings per year for the health system.Demonstrated cost savings beginning in the first year, with benefits persisting in lifetime modeling. “These data provide compelling real-world evidence underscoring the clinical value of lesion-specific Heartflow FFRCT Analysis to provide precise, localized physiological assessments,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “We now see that lesion-specific FFRCT insights can also help predict which patients are most likely to experience future events, enabling clinicians to tailor care earlier with greater precision and reduce costs.” These analyses are the latest to demonstrate the prognostic power of the Heartflow One platform, the most accurate noninvasive AI-enabled CAD assessment technology, including RoadMap™ Analysis, FFRCT Analysis and Plaque Analysis. Insights from FISH&CHIPS add to a growing body of evidence demonstrating the clinical and economic value of the Heartflow One platform providing superior patient outcomes in patients with confirmed CAD.3,4 A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025 provided strong validation of total plaque volume-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death.5 Heartflow One provides an integrated workflow that empowers physicians to improve care by enabling a faster, more optimal diagnosis to avoid unnecessary tests. About FISH&CHIPSFISH&CHIPS, the largest FFRCT study conducted to date, is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFRCT to a coronary CTA-first diagnostic paradigm for CAD at a national level. The study analyzed data from 27 NHS hospital sites in England, including 90,553 patients followed for at least two years. The primary objective was to determine whether introducing a coronary CTA+FFRCT diagnostic pathway was clinically useful and safe compared to a standard-of-care diagnostic chest pain pathway using coronary CTA alone. Two-year data were published in May 2025 in Nature Medicine, showing improved care efficiency with a reduction in unnecessary invasive and noninvasive cardiac tests using coronary CTA and Heartflow FFRCT versus coronary CTA alone. The study was funded by the UK Medical Research Council (MRC) and supported by the National Institute for Health and Care Research (NIHR) Research Delivery Network. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include: Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com ‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾1 Bell et al. AHA 2025.2 Fairbairn et al. EACVI 2025. 3 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 20244 Douglas PS, et al. The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023;8(10):904–914. doi:10.1001/jamacardio.2023.25955 Fairbairn et al. AHA 2025.
Two-Year Cardiac Study Published in JHLT Reveals Long-Term Survival Benefits with Advanced Heart Preservation
Study published in the Journal of Heart and Lung Transplantation investigating the use of the Paragonix SherpaPak marks the first time a preservation device has demonstrated significant improvements in survival following heart transplantation. WALTHAM, MA. December 9, 2025 – Paragonix Technologies, a pioneer in organ transplant technologies and services, announced […]
Impulse Dynamics Completes $158M Financing Round
nvestment to Fuel Strategic Growth and Future Product Commercialization MARLTON, N.J., DEC 10th, 2025 (GLOBE NEWSWIRE) — Impulse Dynamics®, a global medical device company committed to improving the lives of people with heart failure (HF), announced today that it raised more than $158 million in financing to enhance commercialization and […]
Proven AI Gains in Radiology Lead WellSpan Health To Expand Aidoc aiOS™Across Enterprise
Expansion positions WellSpan as a leading AI-enabled health system, accelerating safer, faster and more effective care for patients NEW YORK, Dec. 10, 2025 /PRNewswire/ — Aidoc, the global leader in clinical AI with the most FDA-cleared CAD solutions*, announced today an expanded…
Veru to Report Fiscal Year 2025 Financial Results on December 17th
MIAMI, FL, Dec. 10, 2025 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced it will host a conference call and audio webcast on Wednesday, December 17, 2025, at 8:00 a.m. ET to discuss its fiscal year 2025 financial results and to provide a business update. The 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 2225332, 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, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass leading to improved body composition and physical function with expected clinically meaningful incremental weight reduction versus GLP-1 RA monotherapy. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.Enobosarm Obesity Program – Enobosarm is a next generation drug that in combination with GLP-1 RA results in higher quality weight reduction The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial ended at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg 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 preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period for a higher quality weight reduction compared to the placebo group. While weight loss was similar across treatment groups in this short 16 week study, we anticipate that preservation of lean mass and function will lead to increased energy expenditure, and this effect coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer clinical study in patients who have obesity. Phase 2b PLATEAU clinical studyVeru’s planned Phase 2b PLATEAU clinical study will evaluate the effect of enobosarm 3mg on total body weight, physical function, and safety in approximately 200 patients who have obesity (BMI ≥ 35) and are initiating GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 72 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DEXA scans. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), bone mineral density, and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function). The Phase 2b PLATEAU clinical 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 to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 72 weeks. The clinical study is expected to begin in calendar Q1 2026. 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 and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the planned PLATEAU Phase 2b study; whether clinically meaningful incremental weight loss in the PLATEAU Phase 2b study will continue to be seen as an acceptable primary endpoint by the FDA to support potential approval; whether the FDA will continue to accept 3mg as an acceptable dosage for enobosarm in the planned PLATEAU Phase 2b study or in any other studies; whether the FDA will further evolve its position on the acceptable patient population for the PLATEAU Phase 2b study or any other future studies; whether the Company will be able to partner with any other company in the development of enobosarm; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and function, will be replicated to the same or any degree in the planned PLATEAU Phase 2b study or in any future Phase 3 studies; whether patients treated with enobosarm in the planned PLATEAU Phase 2B study will exhibit increased energy and whether such effects will result in incremental weight reduction; whether patients treated with enobosarm in the planned PLATEAU Phase 2B study will exhibit higher quality weight reduction; the expected costs, timing, patient population, design, endpoints and results of the planned PLATEAU Phase 2b study or any future Phase 3 studies of enobosarm in patients with obesity; whether the Company will be able to raise sufficient capital, dilutive or otherwise, to fund the PLATEAU Phase 2b study of enobosarm in patients with obesity or any other studies; whether the Company will be able to recruit a sufficient number of patients in a timely manner for the PLATEAU Phase 2b study; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned PLATEAU Phase 2b study or any future Phase 3 studies; whether the Company will be able to engage clinical research organizations and recruit patients for the PLATEAU Phase 2b program and in a timely or cost-effective manner; whether enobosarm will cause weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will cause weight loss in the planned PLATEAU Phase 2b study or any future Phase 3 studies or, if approved and commercialized, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will experience weight loss or have a greater loss of adiposity or greater weight loss than with GLP-1 RA drug alone; whether and when enobosarm will be approved by the FDA as a weight loss drug or a body composition drug or any other type of drug; and whether and when the Company will be able to further advance the development of sabizabulin in atherosclerotic 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 possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from FDA on the designs of its clinical trials and intends to continue to do so, FDA may ultimately disagree that the Company’s 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 subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, 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 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; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property, 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, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.Wegovy® is a registered trademark of Novo Nordisk A/S. Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com
CathVision Announces Appointment of Eric Thepaut as Independent Chairman of the Board and Releases ECGenius® System Version 3.5
COPENHAGEN, Denmark, Dec. 10, 2025 /PRNewswire/ — CathVision, a medical technology company dedicated to improving clinical outcomes in cardiac electrophysiology through high-fidelity signal acquisition and intelligent software, today announced two major milestones: the appointment of…



