Author: Ken Dropiewski

Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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– Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 – – Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Nov. 10, 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, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. “We are at an exciting point in our company’s history as we prepare for our NDA submission following pre-NDA feedback from the FDA last month. Our team has developed a fulsome data package consisting of multiple clinical trials which have demonstrated a well characterized efficacy and safety profile across distinct populations with uncontrolled and resistant hypertension. These findings for lorundrostat will provide the foundation for an NDA submission which we anticipate submitting near the end of 2025 or during the first quarter of 2026,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We continue to evaluate lorundrostat’s use in prevalent comorbidities of hypertension, for which normalizing aldosterone production may result in meaningful clinical benefit. Following positive topline data from our Phase 2 Explore-CKD trial, demonstrating successful results in the OSA patient population in our Phase 2 Explore-OSA trial would continue to expand the opportunity for lorundrostat in treating hypertension patients.” Recent Clinical Highlights and Upcoming Milestones Transform-HTN Open-Label Extension Trial – The Company’s open-label extension trial enables participants to continue to receive lorundrostat while allowing the Company to gather ongoing safety and efficacy data.Explore-OSA Phase 2 Trial – Enrollment is complete and topline data is anticipated in the first quarter of 2026. The trial is evaluating the safety and efficacy of lorundrostat in the treatment of overweight or obese participants with moderate-to-severe OSA and hypertension.Strengthened Balance Sheet – On September 4, 2025, the Company completed a public equity financing for gross proceeds of approximately $287.5 million, before deducting fees and expenses. Third Quarter 2025 Financial Highlights Cash, cash equivalents and investments were $593.6 million as of September 30, 2025, compared to $198.2 million as of December 31, 2024. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials and regulatory activities, as well as support corporate operations, into 2028. Research and Development (R&D) expenses for the quarter ended September 30, 2025 were $31.5 million, compared to $54.0 million for the quarter ended September 30, 2024. The decrease in R&D expenses was primarily due to a decrease of $26.8 million in preclinical and clinical costs primarily impacted by the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by increases of $3.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation and $1.1 million in higher clinical supply, manufacturing, regulatory and other costs. General and Administrative (G&A) expenses were $9.7 million for the quarter ended September 30, 2025, compared to $6.1 million for the quarter ended September 30, 2024. The increase in G&A expenses was primarily due to $2.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, $1.3 million in higher professional fees and $0.1 million in other administrative expenses. Total other income, net was $4.2 million for the quarter ended September 30, 2025, compared to $3.8 million for the quarter ended September 30, 2024. The increase was primarily attributable to increased interest earned on investments in money market funds and U.S. treasuries as a result of higher average cash balances invested during the quarter ended September 30, 2025. Net loss was $36.9 million for the quarter ended September 30, 2025, compared to $56.3 million for the quarter ended September 30, 2024. The decrease was primarily attributable to the factors impacting the Company’s expenses described above. Conference Call The Company’s management team will host a conference call at 4:30 p.m. ET today, November 10, 2025. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States. A live webcast of the conference call may be found here. A replay of the call will be available on the “News & Events” page in the Investor Relations section of the Mineralys Therapeutics website (click here). 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 Chronic Kidney Disease (CKD) CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 1-in-7 (approximately 37 million) U.S. adults have CKD, and approximately 22 million people in the United States are living with both hypertension and CKD. The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening BP control. When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly. Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation, and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk, and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation. About Obstructive Sleep Apnea (OSA) OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate to severe OSA is associated with increased production of aldosterone and increased nighttime BP; standard treatment with positive airway pressure is not sufficient for BP reduction. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2015, undiagnosed OSA is estimated to cost the United States approximately $149.6 billion annually from comorbid disease, workplace accidents, motor vehicle accidents and loss of workplace productivity. Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with rHTN. Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke. About Lorundrostat Lorundrostat 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 Mineralys Mineralys 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 Statements Mineralys 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  Mineralys Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share data)(unaudited)     Three Months Ended Nine Months Ended September 30, September 30,  2025   2024   2025   2024 Operating expenses:       Research and development$31,450  $53,985  $107,607  $124,012 General and administrative 9,681   6,121   24,717   16,624 Total operating expenses 41,131   60,106   132,324   140,636 Loss from operations (41,131)  (60,106)  (132,324)  (140,636)Interest income, net 4,195   3,774   9,908   11,779 Other income (expense) 4   (10)  (1)  (7)Total other income, net 4,199   3,764   9,907   11,772 Net loss$(36,932) $(56,342) $(122,417) $(128,864)Net loss per share attributable to common stockholders, basic and diluted$(0.52) $(1.13) $(1.94) $(2.68)Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 70,594,504   49,815,186   63,133,634   48,063,638   Mineralys Therapeutics, Inc.Selected Financial InformationCondensed Balance Sheet Data(amounts in thousands)(unaudited)  September 30, December 31, 2025 2024Cash, cash equivalents and investments$593,628 $198,187Total assets$599,947 $205,903Total liabilities$23,520 $14,646Total stockholders’ equity$576,427 $191,257

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Intellia Therapeutics Presents Positive Longer-Term Phase 1 Data of Nexiguran Ziclumeran (nex-z) in Patients with Transthyretin (ATTR) Amyloidosis with Cardiomyopathy

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One-time treatment of nex-z led to consistently rapid, deep and durable reduction in serum TTR through three years of follow-upConsistent trend in disease stability or improvement in multiple measures of cardiomyopathy, regardless of NYHA Class, at 24 months compared to baselineLonger-term safety data consistent with previously reported Phase 1 data CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced positive follow-up data from the ongoing Phase 1 clinical trial of its investigational product nexiguran ziclumeran (nex-z) in patients with transthyretin (ATTR) amyloidosis with cardiomyopathy. Results were shared today in a late-breaking oral presentation at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans, Louisiana. “These longer-term data showed a consistent and durable reduction in TTR and stability or improvement in multiple markers of cardiomyopathy following a single dose of nex-z,” said Intellia President and Chief Executive Officer John Leonard, M.D. “It’s remarkable that even in patients with advanced heart failure, a population that declines rapidly, disease stabilization or improvement was observed out to 24 months in a majority of participants. We look forward to seeing how these data mature in longer-term follow up. In addition, we are working diligently to address the ongoing clinical hold the FDA placed on our MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials.” “ATTR amyloidosis is a progressive and fatal disease, often leaving patients with shortened lifespans and poor quality of life,” said Julian Gillmore, M.D., Ph.D., Professor of Medicine, National Amyloidosis Center, UCL Division of Medicine, Royal Free Hospital, U.K. “Today’s data support the potential benefit of nex-z and how persistently low levels of serum TTR may translate to improved outcomes and lowered rates of mortality.” The Phase 1 clinical trial is an open-label, two-part trial evaluating the safety and efficacy of nex-z in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). The trial enrolled 36 patients, a high proportion of whom had advanced disease at baseline (50% classified as New York Heart Association (NYHA) Class III and 31% with variant ATTR-CM). Data presented today were as of an August 23, 2025, data cut-off date. Continuation of Deep and Durable Serum TTR Reduction in Phase 1Across all patients, a one-time treatment of nex-z led to consistently rapid, deep and sustained serum TTR reduction, regardless of baseline levels, through the latest follow-up. All patients continued to show a sustained response with no evidence of a waning effect over time. Among the nine patients who reached 36 months of follow-up, the mean serum TTR reduction was 87% (mean absolute serum TTR level of 22.9 µg/mL [mean 95% CI, 16.0 to 29.8]), consistent with the overall cohort at month 24. Based on multiple studies in ATTR amyloidosis, low levels of serum TTR have been shown to lead to a meaningful clinical benefit. Evidence of Stability or Improvement on Clinical and Biomarker Measures in Phase 1Patients dosed with nex-z continued to show evidence of disease stabilization or improvement at month 24 compared to baseline. Evaluation was based on multiple markers of cardiomyopathy, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), high sensitivity Troponin T (hs-Troponin T), 6-minute walk test (6MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ) and echocardiographic measures. At 24 months, NT-proBNP and hs-Troponin T, which are markers known to be associated with disease progression, showed stability or improvement in 70% and 85% of patients, respectively. Preservation of functional status, as measured by 6MWT, was observed with 69% of patients either showing stability or improvement. Notably, 81% of patients were stable or improved in their NYHA classification at 24 months, including improvement in 83% of patients with NYHA Class III. There also was evidence of benefit in quality of life, regardless of NYHA Class at baseline as assessed by KCCQ. Assessment of cardiac structure with echocardiography showed a similar pattern of stability with limited progression of cardiac remodeling at 24 months. Post-Hoc Mortality Assessment of Phase 1 DataAdditionally, findings from a mortality assessment were presented. This post-hoc analysis was conducted on a cohort of 1,792 ATTR-CM patients from the National Amyloidosis Center (NAC) whose baseline characteristics were matched to those of the Phase 1 nex-z population. The analysis showed patients receiving a one-time treatment with nex-z had an all-cause mortality rate of 3.9 per 100 patient-years, while the matched cohort had an all-cause mortality rate of 12.7 per 100 patient-years (HR 0.27, p=0.009). Phase 1 SafetyNex-z was generally well tolerated across all patients in the Phase 1 clinical trial. The most commonly reported treatment-related adverse events were infusion-related reactions (IRRs) and transaminase elevations. In this Phase 1 population, liver enzyme elevations did not exceed Grade 2. Through the long-term follow-up evaluation, including patients who reached 44 months, any event leading to death (n=4) was related to the progression of the patients’ underlying cardiovascular disease, consistent with what is expected for this patient population. The AHA data presentation will be available on the Scientific Publications & Presentations section of intelliatx.com. About nex-zBased on Nobel Prize-winning CRISPR/Cas9 gene editing technology, nex-z has the potential to become the first one-time treatment for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) and/or polyneuropathy (ATTRv-PN). Nex-z is designed to inactivate the TTR gene that encodes for the transthyretin (TTR) protein. Interim Phase 1 clinical data showed the administration of nex-z led to consistent, deep and long-lasting TTR reduction. This investigational product is being investigated in the ongoing MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials in ATTR-CM and ATTRv-PN, respectively, which are currently on clinical hold by the U.S. Food and Drug Administration (FDA). Further information about the clinical hold can be found here. Nex-z has received Orphan Drug and RMAT Designations from the FDA and an Orphan Drug Designation (ODD) from the European Commission. Intellia leads development and commercialization of nex-z as part of a multi-target discovery, development and commercialization collaboration with Regeneron Pharmaceuticals, Inc.  About Transthyretin (ATTR) AmyloidosisTransthyretin amyloidosis, or ATTR amyloidosis, is a rare, progressive and fatal disease. Hereditary ATTR (ATTRv) amyloidosis occurs when a person is born with mutations in the TTR gene, which causes the liver to produce structurally abnormal transthyretin (TTR) protein with a propensity to misfold. These damaged proteins build up as amyloid in the body, causing serious complications in multiple tissues, including the heart, nerves and digestive system. ATTRv amyloidosis predominantly manifests as polyneuropathy (ATTRv-PN), which can lead to nerve damage, or cardiomyopathy (ATTRv-CM), which can lead to heart failure. Some individuals without the genetic mutation produce non-mutated, or wild-type TTR proteins that become unstable over time, misfolding and aggregating in disease-causing amyloid deposits. This condition, called wild-type ATTR (ATTRwt) amyloidosis, primarily affects the heart. There are an estimated 50,000 people worldwide living with ATTRv amyloidosis and between 200,000 and 500,000 people with ATTRwt amyloidosis. There is no known cure for ATTR amyloidosis and currently available medications are limited to slowing accumulation of misfolded TTR protein. About Intellia TherapeuticsIntellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. The company’s in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body. Intellia’s ex vivo programs use CRISPR to engineer human cells outside the body for the treatment of cancer and autoimmune diseases. Intellia’s deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at intelliatx.com and follow us @intelliatx. Forward-Looking Statements This press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding: the safety, efficacy, success and advancement of its clinical programs for nexiguran ziclumeran or “nex-z” (f/k/a NTLA-2001), for transthyretin (“ATTR”) amyloidosis, including the ability to address the clinical hold that the United States Food and Drug Administration (“FDA”) placed on the investigational new drug (“IND”) applications for our global Phase 3 MAGNITUDE study for ATTR amyloidosis with cardiomyopathy (“ATTR-CM”) and our global Phase 3 MAGNITUDE-2 study for hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”), and to resume those clinical trials; and its belief that greater TTR reduction may lead to greater clinical benefit. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies’ evaluation of regulatory filings and other information related to our product candidates, including nex-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including risks related to our ability to address the clinical hold that the FDA placed on the IND applications for the MAGNITUDE Phase 3 study for ATTR-CM and the MAGNITUDE-2 Phase 3 study for ATTRv-PN and to resume those clinical trials; the risk that any one or more of Intellia’s product candidates, including nex-z, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia’s other product candidates; and risks related to Intellia’s reliance on collaborations, including that its collaboration with Regeneron will not continue or will not be successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K and quarterly form on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Intellia Contacts: Investors:Jason FredetteVice President, Investor Relations and Corporate CommunicationsIntellia Therapeutics, Inc.jason.fredette@intelliatx.com Media:Matt CrensonTen Bridge Communicationsmedia@intelliatx.com mcrenson@tenbridgecommunications.com

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Kaneka Expands Global Reach with i-ED COIL™ Launch in Europe

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TOKYO–(BUSINESS WIRE)–Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO:4118) has begun sales of its i-ED COIL™, a brain aneurysm embolization coil (*1), in Europe as of October. The product obtained EC certification (*2) under an EU Medical Device Regulation (*3) in July and will be distributed primarily in Europe […]

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AHA 2025 Late-Breaking Science: Cleerly’s AI Atherosclerosis Quantification Outperforms Traditional Risk Scoring

Coronary/Structural Heart by 0 comments

DENVER–(BUSINESS WIRE)–Cleerly, a leader in AI-based cardiovascular imaging, presented new, late-breaking science from the international CONFIRM2 Registry at the American Heart Association (AHA) Scientific Sessions 2025 at the Ernest N. Morial Convention Center in New Orleans, LA. “This is another step towards earlier identification and treatment for patients,” said Ibrahim Danad, MD, […]

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TriSalus Life Sciences to Host Virtual KOL Event to Discuss the TriNav Infusion System for the Treatment of Uterine Fibroids on November 12, 2025

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WESTMINSTER, Colo.–(BUSINESS WIRE)–TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (“TriSalus” or the “Company”), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, announced today that it will host a virtual key opinion leader (KOL) event on Wednesday, November 12, 2025 […]

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Kardigan Presents Positive Phase 2 Data on Ataciguat in Patients with Moderate Calcific Aortic Valve Stenosis at American Heart Association Scientific Sessions 2025

Coronary/Structural Heart by 0 comments

Results presented in oral session demonstrated that treatment with ataciguat reduced aortic valve calcium and improved cardiac function and output compared to placebo Download Press Release PDF SOUTH SAN FRANCISCO, Calif., and PRINCETON, N.J., November 7, 2025 — Kardigan, a heart health company modernizing cardiovascular drug development, announced positive Phase 2 […]

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AHA 2025: New study from Genomics shows polygenic risk scores improve the accuracy of cardiovascular disease risk prediction

Coronary/Structural Heart by 0 comments

The addition of polygenic risk scores (PRS) improved the accuracy of the cardiovascular disease (CVD) risk prediction tool PREVENT across all groups studied, across ancestries. Over 3 million people aged 40-70 in the U.S. are at high risk of CVD but are currently invisible to the system,…

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Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra’s ASSURE Device

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KIRKLAND, Wash., Nov. 10, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced primary results from the ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS), presented as a late-breaking science session at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans. ACE-PAS, the largest prospective real-world study of wearable defibrillators to date, confirmed the strong safety and effectiveness of the ASSURE WCD in clinical practice. “ACE-PAS delivers robust, real-world evidence on how the ASSURE WCD performs in routine care and provides contemporary data describing the risk of life-threatening ventricular tachycardia and fibrillation in diverse populations with reduced cardiac function,” said Jeanne E. Poole, MD, Professor of Medicine at the University of Washington and Principal Investigator. “Life-threatening arrhythmias can occur early in patients with low ejection fraction who have recently experienced a myocardial infarction, undergone coronary revascularization, or have been newly diagnosed with heart failure. These patients may have significant recovery of heart function during a waiting period of one to six months, such that a permanently implanted defibrillator is not indicated. The ASSURE WCD should be considered to protect patients at elevated risk of sudden cardiac death during this vulnerable time.” The study enrolled 21,612 patients across the United States. Key findings demonstrate consistent safety, effectiveness, and compliance in real-world use: Proven effectiveness The primary effectiveness endpoint was achieved, with 100% successful conversion for ventricular tachycardia and fibrillation (VT/VF) events, surpassing the prespecified performance goal. Validated safety The study met its primary safety endpoint, with an inappropriate-shock rate of 0.0065 per patient-month, below the prespecified performance goal and confirming a strong safety profile. Minimal false alarms 94% of patients experienced no false positive shock alarms, ensuring confidence and comfort during wear. Critical protection 2.6% of patients experienced at least one life-threatening VT/VF event within only a few months, highlighting the importance of protection in this vulnerable population. Additional clinically relevant arrhythmias revealed The ASSURE system facilitated detection of high-rate atrial fibrillation in 4.2% of patients (35% previously undiagnosed) and severe bradycardia/asystole in 0.3%, enabling the potential of timely intervention. High compliance Patients wore the device for a median of more than 23 hours per day, and one-third continued use beyond 90 days—highlighting its practicality in real-world, long-term care. “These results reinforce the critical role wearable device monitoring and therapy can play in protecting patients during periods of elevated risk,” said Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies. “As the largest and most contemporary study of its kind, ACE-PAS provides compelling evidence that may help inform future updates to clinical practice—particularly around how physicians identify and protect patients at early risk of sudden cardiac death. By pairing proven performance with connected, data-driven insight, Kestra is redefining what’s possible in wearable protection and advancing evidence-based innovation.” The ACE-PAS results represent a significant step forward in understanding and managing sudden cardiac arrest risk. Additional analyses from the study will be shared in forthcoming scientific forums. A recorded panel discussion featuring ACE-PAS investigators and other leading clinical experts, hosted by MedAxiom, offers further perspective on the study’s design, outcomes, and implications for patient care. The full discussion can be viewed here: https://na2.hubs.ly/H01ZZM90 About ACE-PASThe ASSURE WCD Clinical Evaluation Post-Approval Study (ACE-PAS) is a prospective, multicenter registry evaluating the use, safety, and effectiveness of the ASSURE Wearable Cardioverter Defibrillator in the prevention of sudden cardiac death. The study enrolled 21,612 patients from November 2021 through July 2025 across the U.S. Primary endpoints were overall VT/VF shock conversion and inappropriate-shock rate. About Kestra Kestra 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, please visit www.kestramedical.com.  Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of November 10, 2025. Statements in this press release 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, we undertake 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, the Company’s goals and prospects, the ACE-PAS study, the potential uses and benefits of the evidence collected therefrom and additional analyses that may be shared from the ACE-PAS study in the future. 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. 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; and other risks and uncertainties, including those described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) on July 17, 2025, and in other periodic reports filed by the Company with the 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/. CONTACT: Media contact 
Rhiannon Pickus 
rhiannon.pickus@kestramedical.com 

Investor contact 
Neil Bhalodkar 
neil.bhalodkar@kestramedical.com 

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