– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA editors – RADNOR, Pa., Dec. 12, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the manuscript highlighting the Company’s Phase 3 Launch-HTN clinical trial evaluating lorundrostat for the treatment of uncontrolled or treatment-resistant hypertension, was featured in JAMA’s inaugural “Research of the Year Roundup,” a curated collection of the most impactful studies published between October 2024 and September 2025. In introducing this first-ever “Research of the Year Roundup,” JAMA noted that its top editors were asked to nominate their favorite studies based on their importance and impact. The list of nine selected studies spans diverse topics – from hypertension, to dementia and the use of artificial intelligence (AI) – and, according to JAMA, reflects clinical conditions that are of great importance to patients, clinicians, and to the public health community. Among this select group, JAMA profiled Mineralys’ Launch-HTN trial under the banner “New Hope for Treatment-Resistant Hypertension.” The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor (ASI), when added to existing background antihypertensive treatment in 1,083 participants with uncontrolled or treatment-resistant hypertension. The trial demonstrated that lorundrostat significantly reduced systolic blood pressure (BP) with a favorable safety and tolerability profile. Launch-HTN recruited a diverse population as reflected in the high proportion of female, Black or African American and elderly participants in the trial. JAMA highlighted several key findings from the Launch-HTN trial: Lorundrostat’s mechanism targets excess aldosterone production, a root cause of hypertension. Unlike existing aldosterone blockers that obstruct the hormone receptor, lorundrostat inhibits the enzyme that produces aldosterone itself, offering a novel mechanism of action.When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful, statistically significant mean reductions in automated office blood pressure (AOBP) with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) that was sustained with a reduction of 19.0 mmHg at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across age, sex, race, body mass index, and baseline medication regimen.Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial, noting that while hyponatremia, hyperkalemia, and reduced kidney function occurred more frequently in the treatment arm, discontinuation rates due to adverse events remained below 1%. In the “Research of the Year” article, JAMA’s Executive Editor Gregory Curfman, MD, emphasized the importance of advancing care for the large segment of patients whose hypertension remains uncontrolled despite being on multiple medications, noting that lorundrostat “opens a new approach to the treatment of uncontrolled hypertension, which may affect up to 40% of patients.” The article also points out that, until now, patients have had limited options despite facing heightened cardiovascular risks, including myocardial infarction, stroke, or chronic kidney disease. “We are honored that JAMA has recognized Launch-HTN as one of its Research of the Year studies,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “This acknowledgment underscores the significant clinical need faced by millions of people living with uncontrolled or treatment-resistant hypertension. The results of Launch-HTN reflect the dedication of our investigators, participants, and team, and reinforce our commitment to bringing forward a differentiated therapy to address a root cause of hypertension.” The manuscript titled, “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension” was featured in JAMA’s June 30, 2025 issue. Lorundrostat continues to be evaluated in the ongoing Transform-HTN open-label extension trial, which is assessing long-term safety and durability of response. The Company also completed enrollment in Explore-OSA, the first trial to evaluate lorundrostat in participants with hypertension and moderate-to-severe OSA. Lorundrostat is the only ASI being studied to address both apnea-hypopnea index (AHI) and nighttime systolic blood pressure in this population, with data anticipated in the first quarter of 2026. About Launch-HTNLaunch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring. About Hypertension Having sustained, elevated blood pressure (or hypertension) (BP) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About MineralysMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking StatementsMineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and the FDA’s review of the same; the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; any delays in the FDA’s review of our planned NDA submission, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com
Author: Ken Dropiewski
United Imaging Intelligence at RSNA 2025: Reshaping Medicine with AI Agents
SHANGHAI, Dec. 12, 2025 /PRNewswire/ — Under the theme “Imaging the Individual”, RSNA 2025 challenged the radiology community to push into new frontiers and close the gap between personalized care and global health disparities. This year, United Imaging Intelligence (UII), the AI-focused…
Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Final Decision from European Commission Expected in Q1 2026 SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026. “We are pleased with CHMP’s positive recommendation based on the robust clinical evidence from SEQUOIA-HCM that demonstrated the safety and efficacy of MYQORZO in patients with oHCM, and we are accelerating commercial readiness activities accordingly,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Given the urgency to bring new treatment options to the European oHCM patient community, pending the final European Commission decision, we look forward to making MYQORZO available to patients in Europe.” “This positive opinion from the CHMP is an important milestone toward bringing a new treatment option with distinct attributes to patients with oHCM,” said Iacopo Olivotto, M.D., Head of the Cardiomyopathy Center and Professor of Cardiovascular Medicine at the University of Florence, Italy. Aficamten is currently under regulatory review in the U.S., where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Additionally, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) is reviewing an NDA for aficamten with Priority Review. About SEQUOIA-HCM The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.1 The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 ml/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 ml/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002). The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low left ventricular ejection fraction (LVEF). Treatment emergent serious adverse events occurred in 5.6% and 9.3% of patients on MYQORZO and placebo, respectively. Core lab echocardiographic LVEF was observed to be
Peijia Medical Receives NMPA Approval for TaurusTrio Transcatheter Aortic Valve System, Pioneering Treatment for Aortic Regurgitation in China
HONG KONG, Dec. 12, 2025 /PRNewswire/ — Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its TaurusTrio Transcatheter Aortic Valve (TAV) system received approval from…
Adagio Medical Appoints Industry Veteran Sean Salmon to Board of Directors
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 […]
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
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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 […]



