Attralus ’s Post

While the big news out of Boston Scientific Q4 earnings was obviously the approval of Farapulse*, the company also announced a (hopefully slight) delay to the approval of its ACURATE neo2 TAVR based on interim readout of their ongoing ACURATE IDE study. As an ongoing trial the company is unable to comment on details, but CEO Mike Mahoney noted that the company expects a readout of full results in the second half of 2024. The trial is designed with 1500 patients in the main randomized cohort, with a 1:1 split to a control group of currently available TAVR valves (Edwards' SAPIEN 3 and Medtronics CoreValve). Primary endpoints are a 1-year look at clinical outcomes (all-cause mortality, all stroke, and rehospitalization). ACURATE neo2 has apparently done great in Europe (where it has had CE mark since 2020), with the company noting it sold 70,000 valves last year. Trial results (including post-market follow ups) from Europe have been strong.

More exciting news for Humacyte!!

Ophthopedia Update:Drug Approval for the Treatment of Geographic Atrophy: How We Got Here and Where We Need to Go: To discuss the clinical trial results leading to the FDA approval of anti-complement therapies for geographic atrophy (GA), perspectives on functional data from the GA clinical trials, and how lessons from the FDA approval may guide future directions for basic and clinical research in AMD. #Ophthalmology #Ophthotwitter #Scicomm

https://lnkd.in/eXJSG6sy We’re thrilled to announce that our investigational Acellular Tissue Engineered Vessel (ATEV™) has received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for advanced Peripheral Artery Disease (PAD) treatment. This marks our third RMAT designation, a testament to our commitment to innovation and patient care. Our previous RMAT designations were for vascular trauma repair and arteriovenous (AV) access in hemodialysis. What does this mean?  The RMAT designation has the potential to accelerate the development and review process, allowing us to work closely with the FDA and potentially an expedited/priority review of a Biologics License Application (BLA). Our ATEV is designed to be a universally implantable vascular conduit, offering a potential option for PAD patients who lack other treatment options.  Stay tuned as we continue to advance this exciting technology, with the goal of improving outcomes for PAD patients worldwide. #Humacyte #Innovation #Healthcare #Biotech #FDA #RMAT #PAD #VascularHealth

US fast track drug development news from Market Scope: Priovant Therapeutics, of Durham, North Carolina, reported Sept. 23 that the US FDA had granted fast track designation for #brepocitinib in non-infectious intermediate or posterior uveitis or panuveitis. Brepocitinib is a potential first-in-class dual selective inhibitor of TYK2 and JAK1 under evaluation for multiple autoimmune diseases. It is administered as a once-daily oral therapy. #uveitis #retina #developmentpipeline #fasttrack

Trust the unique formulation of IN.PACT™ for precise drug delivery, ensuring a sustained anti-restenotic effect¹. See the difference in the results. https://bit.ly/3S7JfEu

The US FDA Clears HARBOUR BIOMED’s IND Application of HBM9027 for Solid Tumors #harbour #hbm9027 #solidtumors #regulatory #clinicaltrial #preclinicalstudy #treatment #safety #efficacy #tolerability #pk #pharmacokinetics #antitumoractivity #patients

🚀 Exciting News from Auxilius Pharma! 🚀 We're thrilled to announce that Auxilius Pharma is set to revolutionize the treatment of chronic stable angina pectoris (CSAP) with their latest innovation, AUX-001! 🌟 AUX-001 is a groundbreaking, once-daily version of nicorandil, developed to enhance patient convenience and adherence. With a successful Phase Ia trial already under our belt, they are gearing up to submit an IND application and kick off a Phase Ib trial in Q4 2024 or early Q1 2025. 📅 Their Phase Ib study aims to demonstrate the bioequivalence of AUX-001, setting the stage for a pivotal Phase III trial in H2 2025. This could be a game-changer in the management of CSAP, offering a simpler, more effective treatment option for patients. 💡 Stay tuned for more updates on our journey to transform cardiovascular care! 💖 #Auxilius #AUX001 #ChronicStableAngina #CSAP #CardiovascularHealth #PhaseIbTrial #ClinicalTrials #FDA #INDApplication #PharmaceuticalInnovation #Nicorandil #Bioequivalence #PhaseIII #PatientCare #HealthcareInnovation #DrugDevelopment #PharmaIndustry #MedicalResearch #Cardiology #HeartHealth #AnginaTreatment #PharmaNews #LifeSciences #Biotech #HealthTech #ClinicalResearch #biotech #innovation #news

Learn more about developing new lead indications for SM-020 with Dermbiont's latest announcement. #HealthTech

The evolution continues...one of, if not the first report, of a phase I clinical trial with a bispecific ADC (HER3-EGFR directed) https://lnkd.in/e_DquMPZ