Qiming Venture Partners’ Post

Going to CRT - Cardiovascular Research Technologies? Thomas E. Waggoner, DO, FACC, FSCAI, FSVM, RPVI will be presenting 30-day data from the DurAVR™ THV US Early Feasibility Study (EFS), and Rishi Puri will be presenting the latest DurAVR THV FIH study results and an analysis of the EFS data. Mark your calendars! #CRT2024 Can’t attend? Sign up for clinical data updates here: https://lnkd.in/gur9JPeX DurAVR™ INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE. EU: Exclusively for clinical investigations. US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.

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)   

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

🎉 We are thrilled to announce we have received Breakthrough Device Designation (BDD) from the US FDA for our investigational ARC-BCI™ System based on clinical data from two human feasibility studies. This makes us the FIRST company in the world to receive breakthrough designation for a BCI paired with therapeutic stimulation.    This BDD affords us: ⭐️ Priority FDA review ⭐️ Opportunities to interact with FDA experts throughout the pre-market regulatory review phase ⭐️ Potential to seek additional reimbursement   Brain-computer interface technology unlocks the transformative potential to enhance our ARC-IM® platform with thought-driven control of movement after paralysis. Our objective is not to control computer mice or keyboards, but instead to restore movement of the human body.    This brings our total number of BDDs to ten. Our previous nine BDDs were for multiple indications, including mobility and blood pressure regulation, with our ARC Therapy™ platforms.    To learn more about our commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.   *All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.   #EmpoweringMovement #SCI #BCI #BDD  

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

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

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

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）

We are pleased to share that the #FDA has granted Regenerative Medicine Advanced Therapy (#RMAT) designation to ATSN-101, our investigational #GeneTherapy for patients with GUCY2D-associated #LeberCongenitalAmaurosis (LCA1).   This designation was granted based on positive 6-month efficacy data from our ongoing Phase I/II clinical trial of ATSN-101. We look forward to reporting 12-month data from the trial before the end of this year.   Fewer than 100 RMAT designations have been granted by the FDA, underscoring the strength of our data and the potential of ATSN-101 to address the unmet medical needs of patients with LCA1.    Read more about the news in our press release: https://lnkd.in/eAfBHMzf

🖐Welcome to IVDR TALK 1! Join our experts Marta Carnielli and Andreas Stange as the delve into the certification of companion diagnostics (CDx). 🔬 CDx are key diagnostic tools to enhance the emerging field of personalised medicine. At the end of 2022 TÜV SÜD certified the world’s first CDx in accordance with the EU Regulation on in vitro diagnostic medical devices, IVDR (EU) 2017/746. What are your thoughts? Comment below! 💬 #companiondiagnostics #personalizedmedicine #healthcareinnovation #cdxcertification #ivdr