Regulatory

WallabyPhenox Announces First Patient Enrolled in PROMISE Study Evaluating Treatment of Medium Vessel Occlusion Stroke

Neuro Regulatory by 0 comments

IRVINE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) — WallabyPhenox today announced that the first patient has been enrolled in PROMISE (PROspective study on Management of Ischemic Stroke secondary to mEvo), an investigator initiated prospective study examining how medium vessel occlusion (MeVO) acute ischemic strokes are managed within the first 24 hours. The first subject was enrolled at Indiana University, Methodist Hospital. Dr. Devi Patra and Dr. Ann Jones are co-leads at Indiana University. Medium vessel occlusions account for a meaningful share of acute ischemic strokes, yet the field has not reached consensus on how best to treat them — mechanical thrombectomy versus medical management. PROMISE is designed to capture real-world practice across participating U.S. sites and to help characterize the current “equipoise” among treating physicians, enrolling patients managed with mechanical thrombectomy as well as those treated medically and following their outcomes over six months. “Management for MeVO related stroke is one of the next frontiers in advancing care for stroke patients. We planned this study to better understand the practice and challenges involved in management of these patients in a prospective, unbiased way. To achieve a higher level of nuanced understanding we planned the imaging to be core lab adjudicated. I thank WallabyPhenox for their support to this investigator-initiated project.” — Kaustubh Limaye, MD, Global Principal Investigator, Associate Professor at Indiana University Medical Center “This important study is expected to help answer a critical clinical question: whether revascularization attempt benefits patients with medium-vessel occlusion (MeVO). Current evidence remains largely equivocal, underscoring the need for clearer data to guide treatment decisions,” said Dr. Devi Patra, MD, a neuroendovascular surgeon at Indiana University Medical Center. Dr. Froehler, Director of Cerebrovascular Program at Vanderbilt University Medical Center said, “This study is important because it includes all MVO patients; not just those treated endovascularly. The results will help us to understand real-world MVO outcomes.” WallabyPhenox is supporting PROMISE as part of its commitment to advancing the evidence base behind stroke care. “Reaching first enrollment in PROMISE reflects WallabyPhenox’s commitment to advancing the science behind stroke care, not just the tools that support it. We’re proud to stand behind Dr. Limaye and the investigators as they generate the evidence the neurovascular community needs to make the best possible decisions for MeVO patients.” — Ruilin Zhao, Chief Executive Officer, WallabyPhenox The registry plans to enroll patients across 30 participating U.S. sites. The study is registered with Clinical Trials.gov https://clinicaltrials.gov/study/NCT07746947 CONTACT: CONTACT Ruilin Zhao
Chief Executive Officer
COMPANY WallabyPhenox
PHONE 1-844-674-3669
EMAIL cs@phenox.com
WEB https://www.phenox.com/

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Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter

Peripheral/Endo Regulatory by 0 comments

New device expands Vesalio’s pVasc platform with integrated clot-capture technology designed to retain clot fragments during retrieval. DALLAS, Aug. 13, 2026 /PRNewswire/ — Vesalio, a global leader in vascular intervention, today announced that the U.S. Food and Drug Administration (FDA)…

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Ventripoint Expands Subscription Access for FDA-Cleared AI Cardiac Imaging

Radiology Regulatory by 0 comments

Commercial initiative aims to make VMS+ easier for hospitals to evaluate and adoptTORONTO, Aug. 12, 2026 (GLOBE NEWSWIRE) — Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”) (TSXV: VPT; OTC: VPTDF), a leader in AI-assisted cardiac imaging, today announced the next phase of its commercial strategy for VMS+™ 4.0, its FDA-cleared platform that turns standard heart-ultrasound images into three-dimensional cardiac measurements. The Company is expanding subscription-based access, hospital demonstrations, and customer-engagement programs to help more hospitals evaluate and adopt VMS+. The objective is straightforward: expand access to advanced heart imaging using ultrasound systems hospitals already have. Hospitals, cardiac programs, distributors and strategic partners interested in evaluating VMS+, requesting a demonstration, or learning more about subscription access are invited to visit www.ventripoint.com or contact the Company directly. VMS+ uses artificial intelligence and Ventripoint’s proprietary Knowledge Based Reconstruction technology to create 3D models and quantitative measurements of all four chambers of the heart. The system is designed to provide MRI-comparable volumetric cardiac measurements while fitting into the more widely available heart-ultrasound workflow. Addressing a Common Hospital Barrier One of the primary barriers to adoption of new medical technology is often not clinical interest, but the capital-budget and procurement process. To help address that, Ventripoint is expanding its Device-as-a-Service (“DaaS”) model. This gives qualified hospitals and cardiac programs the option to access VMS+ through an annual subscription instead of relying solely on a traditional upfront capital purchase. The Company is targeting an approximately 80/20 weighting toward subscription-based access, while continuing to support capital-purchase options for institutions that prefer them. Subscription arrangements are designed to include: installationonboardingclinical trainingsoftware updatestechnical support “Hospitals can recognize the value of a technology long before it fits neatly into a capital budget,” said Hugh MacNaught, President and Chief Executive Officer of Ventripoint Diagnostics. “Our subscription model is designed to reduce that friction. It gives qualified hospitals another path to evaluate and implement VMS+ without relying solely on a large upfront equipment purchase.” What VMS+ Does Heart ultrasound is among the most widely used tools in cardiac care. But measuring complex heart anatomy—especially the right ventricle—can still be difficult using conventional two-dimensional imaging alone. VMS+ is designed to enhance that process by adding AI-assisted, three-dimensional analysis to standard heart-ultrasound exams. VMS+ 4.0: creates 3D models and measurements of all four heart chambersprovides ventricular volumes and ejection-fraction measurementsworks alongside supported ultrasound systems already used in hospitalsis designed to provide MRI-comparable volumetric measurementsincludes AI-assisted point placementdoes not require hospitals to replace their existing ultrasound systems VMS+ 4.0 received U.S. FDA 510(k) clearance in 2025. The platform also holds regulatory approvals in Canada, the European Union and the United Kingdom and received a 2026 Gold Edison Award in Precision Health Technologies. Momentum Across Real-World Care Settings Ventripoint’s commercial expansion comes as VMS+ continues gaining traction across a range of healthcare settings. In July, VMS+ was selected for the AIRES – Artificial Intelligence Reconstruction of Echocardiography Study, led by The Royal Wolverhampton NHS Trust in the United Kingdom. The NHS describes AIRES as the world’s first study evaluating AI-enabled heart ultrasound specifically in oncology patients. The study focuses on patients receiving chemotherapy for breast cancer and is expected to involve more than 500 echocardiography scans. Researchers will study whether AI can improve the accuracy, speed and efficiency of cardiac monitoring. AIRES is ongoing, and no clinical outcome should be inferred at this stage. Separately, Ventripoint recently signed an MOU with UniDoc Health Corp. to evaluate the potential integration of VMS+ into connected-care infrastructure for remote cardiac assessment and cardiovascular screening. The proposed model could support imaging access in remote, rural, Indigenous and other underserved communities, subject to further agreements. “What is exciting is not just the technology itself, but where it can be used,” MacNaught added. “We are seeing interest in settings that range from specialist cardiac care to oncology research to remote-health models. That suggests the need for better, more accessible cardiac information is much broader than one single use case.” Designed for Workflow and Adoption Commercial adoption is driven by usability, not solely technical capability. In a formal human-factors and usability study of VMS+ 3.0 involving 13 cardiac sonographers and healthcare professionals, Ventripoint reported: 98% task completionno critical errorsan average workflow completed within 15 minutes Participants completed acquisition, analysis, 3D visualization and reporting tasks in a simulated hospital environment. VMS+ 4.0 later added AI-assisted point placement intended to further support workflow efficiency. “Clinicians need tools that are practical, not just powerful,” said MacNaught. “The usability data showed that trained professionals were able to complete the workflow quickly and successfully. That matters because adoption depends on how a technology fits into real clinical practice.” From Validation to Broader Adoption Ventripoint is now focused on turning years of development, research, and regulatory work into broader commercial adoption. Current priorities include: expanding hospital evaluations and product demonstrationsincreasing subscription-based access in approved marketssupporting onboarding, training and implementationexpanding distributor, clinical and strategic relationshipsincreasing awareness among healthcare systems, cardiologists and patient organizations Current and previous generations of Ventripoint technology are used by hospitals in North America and Europe. The Company has also submitted VMS+ 4.0 for regulatory approval in China through strategic partner Lishman Global, which qualified for the NMPA’s expedited “green channel” review pathway. Frequently Asked Questions What is VMS+?VMS+ is Ventripoint’s AI-assisted cardiac imaging platform. It uses standard heart-ultrasound images to create 3D models and quantitative measurements of all four chambers of the heart. Does VMS+ replace cardiac MRI?No. Cardiac MRI remains an important clinical reference standard. VMS+ is designed to provide MRI-comparable volumetric cardiac measurements through the more widely available heart-ultrasound workflow. What problem does the subscription model solve?Many hospitals face long capital-budget and procurement cycles when buying new technology. Ventripoint’s subscription model gives qualified institutions another way to access VMS+. What is included in subscription access?Subscription access is designed to include installation, onboarding, clinical training, software updates and technical support. Is Ventripoint using AI to detect breast cancer?No. In the AIRES study, VMS+ is being evaluated to monitor heart function in patients receiving breast cancer treatment. It does not detect or diagnose breast cancer. How can a hospital evaluate VMS+?Hospitals and cardiac programs can contact Ventripoint to request a demonstration, discuss an evaluation or learn more about subscription-based access. About Ventripoint Diagnostics Ltd. Ventripoint Diagnostics Ltd. (TSXV: VPT; OTC: VPTDF) is a leader in the application of artificial intelligence to echocardiography. Ventripoint’s VMS+™ platform is powered by its proprietary Knowledge Based Reconstruction technology, developed over more than a decade and designed to provide accurate volumetric cardiac measurements equivalent to MRI for all four chambers of the heart. VMS+ is compatible with leading ultrasound systems from major vendors and designed for deployment across hospital, community, and remote-care settings. The platform delivers advanced cardiac imaging and longitudinal ventricular function analysis without requiring additional imaging hardware, supporting broader access to specialist-quality cardiac assessment. For more information, visit www.ventripoint.com. Contact Ventripoint Diagnostics Ltd.Hugh MacNaughthmacnaught@ventripoint.com(604) 671-4201 Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release. Forward-Looking Statements This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends” and similar expressions are intended to identify forward-looking information or statements. The forward-looking statements and information are based on certain key expectations and assumptions made by the Company. Although the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward-looking statements and information because the Company can give no assurance that they will prove to be correct. Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to several factors and risks. Factors which could materially affect such forward-looking information are described in the risk factors in the Company’s most recent annual management’s discussion and analysis that is available on the Company’s profile on SEDAR at www.sedar.com. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements included in this news release are expressly qualified by this cautionary statement. The forward-looking statements and information contained in this news release are made as of the date hereof and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, whether because of new information, future events or otherwise, unless so required by applicable securities laws

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FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System

Peripheral/Endo Regulatory by 0 comments

The U.S. pivotal study will evaluate FastWave’s electric IVL system in patients with peripheral artery disease. MINNEAPOLIS, Aug. 11, 2026 /PRNewswire/ — FastWave Medical, which is developing next-generation intravascular lithotripsy (IVL) technology, has received FDA approval of its Investigational Device Exemption (IDE) application, which clears the company to begin a U.S. pivotal trial of its ArteroTM electric IVL […]

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Arch Biopartners to Expand Phase II Cardiac Surgery-Associated Acute Kidney Injury Trial to the United States

Regulatory by 0 comments

TORONTO, Aug. 11, 2026 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (TSX Venture: ARCH and OTCQB: ACHFF) today announced that the Company will expand its ongoing Phase II trial of LSALT peptide targeting cardiac surgery-associated acute kidney injury (“CS-AKI”) into the United States, following interest from clinicians at five leading U.S. institutions. The planned U.S. expansion builds on progress at the four Canadian clinical sites currently participating in the trial and patient data collected from the five sites in Turkey that were the first to recruit patients to the study. Patient recruitment has maintained momentum; there have been no adverse events related to the study drug, and AKI has occurred consistently among enrolled patients, validating trial design. These factors support the Company’s decision to expand the study with additional sites. Expanding the trial to the U.S. is intended to increase access to eligible patients and support continued recruitment. The Company is also continuing to grow the trial in Canada as one additional Canadian site moves through the activation process. “We are seeing strong interest from American clinicians to join our CS-AKI trial for LSALT peptide to protect patients from cardiac surgery-related acute kidney injury. Establishing a U.S. arm of the study will increase awareness of LSALT peptide and our Phase II trial among kidney care specialists, the pharmaceutical industry and potential partners,” said Richard Muruve, Chief Executive Officer of Arch Biopartners. The Company expects new U.S. clinical sites to require approximately four to six months to complete site preparation, contracting, regulatory review, training and other start-up activities before dosing their first patients. Timing will vary by institution and is subject to the completion of all applicable approvals. The Company will provide further updates as U.S. clinical sites complete the steps required to join and begin recruiting patients in the trial. About the CS-AKI Phase II Trial Cardiac surgery-associated acute kidney injury is a common complication following on-pump (heart-lung machine) cardiac surgery and can lead to longer hospital stays and worse outcomes. The trial is designed to evaluate whether LSALT peptide can reduce the rate of AKI in this setting. The CS-AKI Phase II trial is a multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Details of the Phase II trial can be viewed at ClinicalTrials.gov: NCT05879432. About Arch Biopartners Arch Biopartners Inc. is a therapeutic biotechnology company developing novel drugs for acute kidney injury (AKI) and chronic kidney disease (CKD). The Company is advancing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury. Arch’s development pipeline includes: LSALT peptide: in a Phase II trial targeting cardiac surgery-associated AKI.Cilastatin: a repurposed drug in a Phase II trial targeting toxin-induced AKI.CKD Platform: next-generation therapeutics targeting chronic kidney disease. These assets represent distinct, mechanism-based approaches focused on protecting the kidney from different causes of damage. Chronic kidney disease affects more than 800 million people worldwide,1 while acute kidney injury adds a further significant burden. Together, Arch’s programs target unmet needs across both acute and chronic kidney disease. Both Phase II programs are currently enrolling patients at Canadian clinical sites, with an additional Canadian site in development and a U.S. expansion of the CS-AKI trial underway. For more details about the Company’s science and ongoing clinical trials, please visit www.archbiopartners.com/our-science Follow Arch on LinkedIn, Bluesky, and X (formerly Twitter) for company updates and scientific content. The Company has 67,933,289 common shares outstanding. For more information, please contact: Aaron BensonDirector of CommunicationsArch Biopartners Inc.647-428-7031 Send a message or subscribe for updates at www.archbiopartners.com/contact-us Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of the Company’s future performance, liquidity, and capital resources, as well as the ongoing development of its drug candidates targeting chronic kidney disease and the dipeptidase-1 (DPEP1) pathway, including the outcomes of its clinical trials relating to LSALT peptide (Metablok) and cilastatin, the successful commercialization and marketing of its drug candidates, whether the Company will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe, and other countries, its ability to raise capital to fund its business plans, the efficacy of its drug candidates compared to the drug candidates developed by competitors, its ability to retain and attract key management personnel, and the breadth of, and its ability to protect, its intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in the Company’s most recent annual audited financial statements and related management’s discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company undertakes no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including the Company’s most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR+”) website at www.sedarplus.ca. References: Mark, Patrick B., et al. Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023. The Lancet, 2025;406(10518), 2461–2482. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01853-7/fulltext Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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AQUAPASS Completes Enrollment in REFORM-HF Pivotal Trial, Results to Be Presented at Major Heart Failure Conference This Fall

Coronary/Structural Heart Regulatory by 0 comments

NEWTON, Mass. and SHEFAYIM, Israel, Aug. 10, 2026 /PRNewswire/ — AQUAPASS, developer of a noninvasive, kidney-independent therapy for fluid overload management in patients experiencing heart failure and chronic or end-stage kidney disease, announced completion of enrollment in its FDA…

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Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint

Regulatory by 0 comments

ORION CORPORATION STOCK EXCHANGE RELEASE – INSIDE INFORMATION 10 AUGUST 2026 at 14.05 EEST         Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint Orion Corporation’s license partner Tenax Therapeutics, Inc., today announced that the Phase 3 LEVEL clinical trial evaluating oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score. According to Tenax, prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results of the LEVEL trial, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss revisions to the ongoing registrational development of levosimendan for the treatment of PH-HFpEF, and to seek parallel scientific consultation from the European Medicines Agency. Further details on the Phase 3 LEVEL clinical trial topline results can be found on Tenax Therapeutics’ website at https://www.tenaxthera.com. Orion Corporation Liisa HurmePresident and CEO    Mikko KemppainenGeneral Counsel   Contact person:Tuukka Hirvonen, Head of Investor Relations, Orion Corporation tel. +358 10 426 2721                                                   Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandhttp://www.orionpharma.com Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.

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Kardium Receives Health Canada Approval for the Globe® Pulsed Field System

Regulatory Rhythm by 0 comments

VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced today that Health Canada has granted a Medical Device Licence for the Globe® Pulsed Field System. Building on the successful U.S. launch of the Globe System following FDA approval in 2025, Health Canada approval marks the next major milestone in expanding access to Kardium’s integrated mapping and pulsed field ablation platfor

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Implicity’s Next-Generation ILR ECG Analyzer Earns FDA Clearance

Regulatory Rhythm by 0 comments

Cloud-based AI algorithm supports implantable cardiac monitors from all major manufacturers, reducing false-positive alerts by up to 76% while maintaining high sensitivity for true events Cambridge, Mass., July 28, 2026 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced that the U.S. Food and […]

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