Steven Kreuzer’s Post

Attralus has received Breakthrough Therapy Designation for our pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis from the US FDA. ✳ Read the press release – https://lnkd.in/egNHUjnT. ✳ 124I-evuzamitide (AT-01) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. ✳ FDA granted BTD for 124I-evuzamitide (AT-01) based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with cardiac amyloidosis, representing experience in more than 200 trial participants. #amyloidosis #rarediseases

🫀✨Positive momentum for the team at Amplitude Vascular Systems as they announce successful #IDE approval to begin their POWER-PAD-II pivotal trial toward their pulsatile intravascular #lithotripsy (IVL) therapy, the PULSE IVL system. Founded at the University of Michigan and now operating in the Boston seaport, Amplitude Vascular Systems has been aggressively developing a new standard in #coronary and #peripheral intravascsular low intensity, high-frequency balloon based lithotripsy attacking intimal and medial calcified vessels. With $28M+ in recent Series B financing alongside yesterday’s IDE approval, AVS looks to aggressively move closer toward successful FDA clearance and brining the PULSE IVL to the US market. “We are proud to be one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the USA. The IDE approval marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL system, which is designed to easily deliver therapy across complex calcified lesions and reduce overall procedural costs.” - Mark Toland, Amplitude Vascular Systems Board Chairman #medicalinnovation #vascularsolutions #interventionalmedicine #bioelectronics The Mullings Group Vascular News

🔬 Attention Healthcare Providers! Phase 2 Registration for DEX Z-Codes® Now Open Starting August 1, 2024, you can begin registering tests that fall within the scope of phase 2 of the DEX Z-Codes® for certain molecular diagnostic test services. As part of our recently updated Molecular Pathology Reimbursement Policy (Professional and Facility), which took effect on June 1, 2024, They are implementing this important requirement. 🔍 What’s New? Phase 2 Scope: Tests subject to phase 2open_in_new must include the appropriate Z-code on their claims. Effective Date: Claims with dates of service on or after November 1, 2024, will be considered for reimbursement if they comply with the Z-code requirement. Test Code Registration Phases: UHC send you timely reminders about each registration phase. You’ll receive notifications at least 30 days in advance of the start date. Phase 2 Registration: Get ahead by registering your tests starting August 01, 2024. 🔗 #HealthcareBilling #MolecularDiagnostics #ZCodes #Reimbursement Sonora Quest Laboratories/ Laboratory Sciences of Arizona Quest Diagnostics UHC Labcorp Palmetto GBA

🚀 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

Lung Imaging Breakthrough: FDA Clears Brainomix 360 e-Lung System for AI-Driven Respiratory Care The FDA has granted clearance to Brainomix's 360 e-Lung system, an AI-powered software designed to detect idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs) by analyzing CT scans. This clearance follows successful phase II clinical trial results, published in the American Journal of Respiratory and Critical Care Medicine, which demonstrated the system's superior performance in identifying high-risk IPF patients. Conducted in collaboration with AstraZeneca, the trial validated the system's accuracy in quantifying pulmonary fibrosis using proprietary imaging biomarkers. The Brainomix 360 e-Lung system promises to revolutionize lung disease diagnosis and management, offering a non-invasive, efficient alternative to traditional methods and setting a new standard in respiratory care. For more details please click the link! https://lnkd.in/dsgjEcuD #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

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

#News: Today at #AFSymposium2024 Biosense Webster unveiled 12-month data from the inspIRE clinical trial, which evaluated the safety and effectiveness of the investigational VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal #AFib in Europe and Canada. The results demonstrated 80% freedom from atrial recurrence at 12 months in patients with optimal PFA applications, with zero primary adverse events. The publication of this data is an exciting milestone for Biosense Webster as we work to bring forward a versatile, differentiated portfolio of PFA solutions designed to help #EPeeps deliver safe, effective and efficient cardiac ablation procedures. These encouraging results fuel our excitement as we continue to advance innovations to meet the diverse needs and ablation strategies required to successfully treat AFib. Learn more: https://lnkd.in/gSvtEd8h #mycompany #JNJMedTechProud

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

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