CureLeads’ Post

Important milestone for our company as we announced early completion of enrollment in LunAIRo, Apnimed’s Phase 3 #OSA #clinicaltrial examining the efficacy and safety of AD109 compared to placebo at six-months and one-year. We believe AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with obstructive #sleepapnea who are either intolerant of, or refuse to use, positive airway pressure therapy. We want to thank the patients who volunteered to participate in this study, extend our gratitude to the investigators for their support and give a shout out to our amazing clinical and medical colleagues who made this important step possible. Topline data expected mid-2025. Learn more about the study design and its presentation at #ATS2024: https://bit.ly/4draxhP #biotech #innovation

🌟 𝐌𝐚𝐣𝐨𝐫 𝐌𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞 𝐀𝐥𝐞𝐫𝐭! 🌟 We’re thrilled to announce that Bonus Biogroup has received official certification from the Israel Ministry of Health confirming that our two flagship products—#BonoFill (live human bone graft) and #MesenCure (advanced cellular therapy)—are produced in full compliance with Good Manufacturing Practices (GMP), in line with the recommendations of the World Health Organization! This certification not only reflects the highest quality standards but also paves the way for our journey toward industrial-scale production of these innovative therapies. 𝐖𝐡𝐚𝐭 𝐓𝐡𝐢𝐬 𝐌𝐞𝐚𝐧𝐬: 🔹 BonoFill and MesenCure production processes meet rigorous GMP standards for phase III clinical trials, opening new doors for advanced supply chain management and operational independence. 🔹 Our Haifa-based facility, designed for automated and sterile cell and tissue production, is now fully certified, ensuring consistent product quality and enhanced safety. Dr. Shai Meretzki, CEO, expressed it best: "𝐓𝐡𝐞𝐬𝐞 𝐆𝐌𝐏 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐧𝐨𝐭 𝐨𝐧𝐥𝐲 𝐯𝐚𝐥𝐢𝐝𝐚𝐭𝐞 𝐨𝐮𝐫 𝐡𝐢𝐠𝐡 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐛𝐮𝐭 𝐩𝐨𝐬𝐢𝐭𝐢𝐨𝐧 𝐮𝐬 𝐚𝐭 𝐭𝐡𝐞 𝐟𝐨𝐫𝐞𝐟𝐫𝐨𝐧𝐭 𝐨𝐟 𝐜𝐞𝐥𝐥 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐚𝐧𝐝 𝐭𝐢𝐬𝐬𝐮𝐞 𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 𝐰𝐨𝐫𝐥𝐝𝐰𝐢𝐝𝐞, 𝐩𝐨𝐢𝐬𝐞𝐝 𝐭𝐨 𝐫𝐞𝐯𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐢𝐳𝐞 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬 𝐟𝐨𝐫 𝐦𝐢𝐥𝐥𝐢𝐨𝐧𝐬." #MedicalInnovation #BiotechInnovation #Biotechnology #RegenerativeMedicine #GMP #CellTherapy #TissueEngineering #HealthcareInnovation #LifeSciences

RESISTANCE IS NOT AN OPTION

Are you at ISPOR to find a consultancy that can bring your data to life in a way that engages healthcare customers and supports conversations about the wider treatment pathway? If so, then look no further, pop by booth 125 (near theatre 2) and speak to our team! #ISPORannual #ISPORUS #ISPOR #customerengagement #valueproposition #datavisualisation #marketaccess #USA #Europe #Pharma #Medtech

Big changes are coming! Rose Pharma's rebranding is almost here, signaling a new chapter of cutting-edge innovation in aesthetic medicine. Are you ready to witness the evolution of Rose Pharma? Get ready for a fresh look, enhanced offerings, and the same trusted quality. The future of aesthetic medicine is about to get even brighter. ✨ Stay tuned for an unveiling that promises to redefine our commitment to quality, innovation, and the empowerment of professionals and patients alike. 🖤 #rosepharmalaboratoires #rosepharma #filler #aestheticmedicine #fillers #fillerinjections #fillersolutions #aesthetics #aestheticdoctor #rebranding

Humacyte released third quarter financial results with a business update, highlighting progress in our bioengineered human tissue projects. Key updates include: - Ongoing FDA review of the ATEV™ for vascular trauma. - Phase 3 trial results for ATEV in hemodialysis patients presented at Kidney Week 2024. - Long-term data of ATEV in treating vascular injuries from the Ukraine conflict, presented at MHSRS, a major U.S. Department of Defense meeting. - Application for an NTAP reimbursement to CMS was submitted in October For more details, read the full press release here: https://lnkd.in/esriRwPG The BioVascular Pancreas and the Acellular Tissue Engineered Vessel (ATEV) are investigational and have not been approved by the FDA or any regulatory agency. #Biotech #Humacyte #EarningsCall #Innovation #investors

𝗡𝗶𝘁𝗶𝗻𝗼𝘁𝗲𝘀 𝗦𝘂𝗿𝗴𝗶𝗰𝗮𝗹 𝗮𝘁 𝗟𝗦𝗜 𝗘𝘂𝗿𝗼𝗽𝗲 ‘24 We’re excited to announce that our CEO, Lloyd Diamond has been selected to present Nitinotes at LSI Europe ‘24 this September 16-20th in Sintra, Portugal. Join us to learn more about how EndoZip™ is setting new standards in the treatment of obesity and discover opportunities for collaboration in advancing healthcare solutions. If you’re attending, make sure to connect with us! 📩 Reach out to schedule a meeting with us 📍 Location: Sintra, Portugal 📅 September 16-20, 2024 — --- — --- — 𝗔𝗯𝗼𝘂𝘁 𝘂𝘀: EndoZip™ - our flagship product, is a fully automated endoscopic suturing system, offers a minimally invasive approach for obesity class I & II patients, ensuring consistent, safe suturing with the press of a button. Our solution is intended to overcome the limitations of current bariatric treatments, including invasiveness, irreversibility, procedural complexity, and poor outcomes due to technique limitations. Exciting Developments: • Raised a $10.1 Million Series B Funding Round in September 2023 • Awaiting European market authorization and scaling up manufacturing capabilities in anticipation of commercial launch in Europe. • Preparing for a pivotal U.S. trial next year in support of FDA approval. LSI Europe #LSIEurope24 #NitinotesSurgical  #EndoZip #HealthTech #Innovation #ObesityTreatment

Are you at ISPOR to find a consultancy that can bring your data to life in a way that engages healthcare customers and supports conversations about the wider treatment pathway? If so, then look no further, pop by booth 125 (near theatre 2) and speak to our team! #ISPORannual #ISPORUS #ISPOR #customerengagement #valueproposition #datavisualisation #marketaccess #USA #Europe #Pharma #Medtech

Are you at ISPOR to find a consultancy that can bring your data to life in a way that engages healthcare customers and supports conversations about the wider treatment pathway? If so, then look no further, pop by booth 125 (near theatre 2) and speak to our team! #ISPORannual #ISPORUS #ISPOR #customerengagement #valueproposition #datavisualisation #marketaccess #USA #Europe #Pharma #Medtech

📣 We are thrilled to announce the launch of our new Cilia Beat Frequency analysis assay for lung small airway epithelium cells (SAEC). This cutting-edge software enables researchers to assess the effect of drugs and chemicals on the function of cilia. The new, functionally-validated assay generates reliable and predictive in vitro data on the activity of the beating cilia of the airways. It allows the assessment of dosing on mucus clearance, the function of cilia, and evaluation of drug efficacy in reversing disease-like conditions. Unlock a comprehensive, high-sensitivity set of data that accurately measures the effect of your compound, including fast-acting ones, on mucociliary clearance. Dr Dr Mike Nicholds, CEO and Co-Founder, Newcells Biotech, commented: “CiliaBeat complements our existing capabilities, giving customers more options to gain physiologically-relevant insights into this crucial organ type.” Amy Mawdesley, Account Manager, is on hand at the European Respiratory Society in Vienna to answer your questions about CiliaBeat! Find out more here: https://lnkd.in/extRdN2R #Newcells #LungAssay #Cilia #SAEC