Betibeglogene autotemcel (beti-cel; Zynteglo; formerly Lentiviral Autologous Beta-Globin Gene Therapy, LentiGlobin) is an autologous hematopoietic stem cell-based gene therapy for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions.
Horizon Scanning
It is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
iStent infinite Trabecular Micro-Bypass System for Open-Angle Glaucoma
The iStent infinite is a trabecular micro-bypass stent system intended to reduce intraocular pressure (IOP) as a stand-alone procedure for uncontrolled primary open-angle glaucoma (OAG). The device includes 3 heparin-coated titanium stents measuring one-third millimeter (mm) in length and width. The stents are preloaded into an auto-injection system that allows the surgeon to…
Pegzilarginase for Arginase 1 Deficiency
Pegzilarginase is an investigational recombinant form of the human enzyme arginase 1 (ARG1) proposed for the treatment of pediatric and adult patients with ARG1 deficiency. It is administered by intravenous infusion or subcutaneous injection.
Fexapotide Triflutate for Benign Prostatic Hyperplasia
Fexapotide triflutate is an investigational injectable apoptotic agent proposed for the treatment of benign prostatic hypertrophy (BPH).
Quell Wearable Neurostimulation Device for Fibromyalgia
Quell is a wearable transcutaneous electrical nerve stimulator (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity, including use during sleep.
GammaSense Stimulation System for Alzheimer Disease
The GammaSense Stimulation System is an investigational, home-use, wearable device that delivers auditory and visual stimulation to entrain gamma frequency neural activity in the brain. It is proposed for the treatment of mild to moderate Alzheimer disease (AD). Brainwave entrainment is a technique to prompt the brain’s neural activity to synchronize to the frequency of exter…
Organ Care System (OCS) Heart
The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donation-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time); and for the ex vivo reanimation,…
Mavacamten (Camzyos) for Obstructive Hypertrophic Cardiomyopathy
Mavacamten (Camzyos) is an oral cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
BlueLeaf Endovenous Valve Formation (EVF) System for Chronic Venous Insufficiency
The BlueLeaf Endovenous Valve Formation (EVF) System is an endovascular device intended to form autogenous tissue leaflets from femoral and popliteal vein walls that mimic a functional valve. It is under investigation for the treatment of deep vein reflux in chronic venous insufficiency.
Narsoplimab for Stem Cell Transplant-Associated Thrombotic Microangiopathy
Narsoplimab is an investigational, intravenous monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).