Amvuttra (vutrisiran) is an injectable RNA interference (RNAi) therapeutic agent indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
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?
Lecanemab (Leqembi) is an intravenously administered anti-amyloid beta (Aβ) protofibril antibody indicated for the treatment of Alzheimer disease.
The LimiFlex Dynamic Sagittal Tether is a minimally invasive spinal implant designed to stabilize the spine, without fusing it, and maintain motion after spinal decompression in patients with grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.
Eladocagene exuparvovec is an investigational gene replacement therapy administered by bilateral intraputaminal infusion for the treatment of aromatic L-amino acid decarboxylase deficiency.
Avasopasem manganese is an investigational intravenously administered superoxide dismutase mimetic intended to reduce the incidence and severity of radiation-induced oral mucositis in patients undergoing radiotherapy for head and neck cancer.
Omecamtiv mecarbil is a first-in-class oral cardiac myosin activator under investigation for the treatment of heart failure with reduced ejection fraction (HFrEF).
TissueGene-C is an allogeneic cell and gene therapy delivered via intra-articular injection in development for the treatment of knee osteoarthritis.
Remestemcel-L is an investigational allogeneic liquid cell suspension of ex-vivo cultured adult human mesenchymal stem cells derived from healthy donor bone marrow proposed for the treatment of pediatric patients with acute graft-versus-host-disease (aGVHD) refractory to standard first-line steroid therapy.
The Detour System is an endovascular device for catheter-based femoropopliteal bypass for the treatment of long occlusions of the superficial femoral artery in patients with moderate to severe peripheral artery disease.
The Medtronic Extravascular Implantable Cardioverter Defibrillator is an implantable cardioverter-defibrillator (ICD) with a substernal lead and subcutaneously implanted generator proposed to treat patients with a class I or IIa indication for an ICD for primary or secondary prevention of sudden cardiac arrest and sudden cardiac death.