Anteris Technologies’ Post

We're excited to share that Venus Medtech's self-developed Transcatheter Pulmonary Valve Replacement (TPVR) system, VenusP-Valve, has successfully held its kick-off meeting at the University of Virginia School of Medicine (UVA) for the PROTEUS IDE clinical study. This marks another significant step forward since the product received IDE approval from the US FDA last year, marking the official commencement of the crucial clinical trial enrollment in the United States. The PROTEUS clinical study is a prospective, multi-center, non-randomized, interventional study for patients with moderate to severe pulmonary regurgitation accompanied by native Right Ventricular Outflow Tract (RVOT) dysfunction. The study will enroll 60 patients, and its data will support registration applications with both the US FDA and Japan's PMDA. Stay tuned for further updates! #QMportfolio #QMhealthcare #medtech #VenusP #clinicalstudy #VenusMedtech #PROTEUS #ClinicalTrials #VenusPValve

Exciting news for the medical community! Thrombolytic Science's novel dual fibrinolytic treatment with mutant prourokinase (mproUK) is set to undergo a clinical trial later this year. The British Regulatory Agency, the MHRA, has accepted TSI's request for a clinical trial authorization, paving the way for an open label, randomized pilot clinical Phase II study. This study will explore the safety of mproUK preceded by tissue plasminogen activator and resulting early epicardial and microvessel patency in patients presenting with an ST-elevation myocardial infarction (STEMI). Stay tuned for updates! #CTA #MHRA #STEMI #clinicaltrial #ThrombolyticScience #mproUK #dualfibrinolytic

Exciting news for the medical community! Thrombolytic Science's novel dual fibrinolytic treatment with mutant prourokinase (mproUK) is set to undergo a clinical trial later this year. The British Regulatory Agency, the MHRA, has accepted TSI's request for a clinical trial authorization, paving the way for an open label, randomized pilot clinical Phase II study. This study will explore the safety of mproUK preceded by tissue plasminogen activator and resulting early epicardial and microvessel patency in patients presenting with an ST-elevation myocardial infarction (STEMI). Stay tuned for updates on this exciting development in the field of medical research! #CTA #MHRA #STEMI#clinicaltrial #ThrombolyticScience #mproUK #dualfibrinolytic

Attending ACC 2024? Seeking conference coverage support in the cardiometabolic realm? CVrg is all set to analyze the latest data, especially in HF, DYS/ATH, and other CVM indications. Curious about our year-round conference plans? Reach out to Brooke Blackwelder for details into how CVrg can support your needs! Let's navigate the cardiometabolic landscape together! #ACC24 #Cardiometabolic #cardiovascular #pharmaCI #competitveintelligence #pipelinestrategy

This week, we reaffirmed our 2024 strategic priorities, and we have an exciting 2H ahead! Our top priority remains preparing for commercialization, and we look forward to bringing the investigational ARC-EX® System to the Spinal Cord Injury (SCI) Community in the US later this year. *   Here’s more detail:  ➡️ ARC-EX® commercial launch. We intend to launch our ARC-EX Therapy for people with SCI in the US in Q4 2024, pending Food and Drug Administration (FDA) clearance.   ➡️ ARC-IM ® interim data publication. We expect a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI. ➡️ ARC-IM pivotal study commencement. We are preparing to launch our global pivotal study, called Empower BP, for investigational ARC-IM Therapy to address blood pressure instability after SCI, pending FDA Investigational Device Exemption approval.  ➡️ ARC-BCI™ Therapy advancement. Clinical and development activities for our investigational ARC-BCI System continue and several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and @CEA-Clinatec.  Here are our unaudited Q2 2024 financial highlights: ✅ We plan to publish our Half Year 2024 financial statements on September 10, 2024.  ✅ The net cash balance on June 30, 2024, was EUR 32.1 million.   To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit www.ONWD.com    *All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.  #EmpoweringMovement #SCI #StrategicPriorities d4871b2d-3d8c-4e4b-99fd-2774a1714fb6 (onwd.com)   

ON-DEMAND // View the second installment of our webinar series with Precision For Medicine, focusing on optimizing immunohistochemistry (IHC) validation and regulatory strategies. This session explores in-depth the essential validation and regulatory strategies for IHC, providing crucial insights into the regulatory landscape and validation processes necessary for successful clinical trials. Watch it here: https://lnkd.in/gS3WemA9

Join us at HRS2024! Booth 453    Session Title: PO-484335 Poster Session VI – Ablation Session Date and Time: May 19, 2024 from 9:30 AM to 11:30 AM  Presentation: Paroxysmal Atrial Fibrillation Treated by A Pulsed- Field Ablation System Using ACircular Catheter with Variable Diameter  （One-Year Outcome of PF-Beat-AF Clinical Trial）

Are you attending ASCPT? Reach out to Cody Mann to explore how Certara can best support and accelerate your drug development process or needs.

💗 AngioDynamics launches RECOVER-AV study of AlphaVac F18⁸⁵ System for PE treatment According to the US-based medical technology company, the prospective, multicentre, multinational study will assess the efficacy, safety, and long-term functional outcomes of the system in treating the condition. The trial will evaluate the device’s ability to treat intermediate-risk PE through percutaneous mechanical aspiration thrombectomy, with the aim of facilitating its adoption in Europe. The RECOVER-AV study follows the completion of the APEX-AV (Acute Pulmonary Extraction Trial with AlphaVac), a previous single-arm trial conducted in the US under an Investigational Device Exemption. Read more online: https://lnkd.in/e9pneeBN 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

This is so exciting! What other therapies from similar diseases, combinations of existing medications, and new innovations are in discovery that could improve the lives of those living with T1D? How can we support new diagnosis and those not yet insulin-dependent? I can't wait to see and hear about the progress that will be made from these breakthroughs.