AMX0035 is an investigational co-formulation of sodium phenylbutyrate (PB) and taurursodiol (TURSO). PB is a prescription drug use to treat urea cycle disorders and TURSO (also known as tauroursodeoxycholic acid [TUDCA]) is a widely available non-prescription supplement. AMX0035 is proposed for the treatment of amyotrophic lateral sclerosis (ALS).
Horizon ScanningIt 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?
The HistoSonics System is an ultrasound histotripsy system intended for noninvasive mechanical destruction of malignant cells via acoustic cavitation. It is under investigation for the treatment of primary or metastatic hepatocellular tumors.
Lecanemab (BAN2401) is an investigational, intravenously administered anti-amyloid beta (Aβ) protofibril antibody proposed for the treatment of early Alzheimer disease.
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,…
The VenoValve is a porcine bioprosthetic venous valve under investigation for permanent implantation into the femoral vein for the treatment of deep vein reflux in 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.
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.
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).
The Agili-C is an aragonite scaffold implant indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
Zavegepant is an intranasal novel small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist (“gepant”) drug proposed for the acute treatment of migraine headache. CGRP is involved in vasodilation and sensory transmission and is a validated target for the treatment of migraine headache.