Fidanacogene elaparvovec-dzkt (Beqvez; Pfizer Inc.) is a single-infusion gene therapy for the treatment of adults with moderate to severe hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated vi…
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?
Ventura Interatrial Shunt (V-Wave Ltd.) for Heart Failure
The Ventura Interatrial Shunt (V-Wave Ltd.) is an investigational transcatheter interatrial shunt proposed for treatment of chronic heart failure.
Rusfertide (Protagonist Therapeutics Inc./Takeda Pharmaceutical Co. Ltd.) for Polycythemia Vera
Rusfertide (formerly PTG-300; Protagonist Therapeutics Inc./Takeda Pharmaceutical Co. Ltd.) is a subcutaneously injected hepcidin mimetic for the treatment of erythrocytosis associated with polycythemia vera.
Varipulse Pulsed Field Ablation (Biosense Webster Inc.) for Atrial Fibrillation
Varipulse is an investigational pulsed-field ablation system in development for treatment of paroxysmal atrial fibrillation.
Letetresgene Autoleucel (Adaptimmune Therapeutics PLC) for Advanced Synovial Sarcoma
Letetresgene autoleucel is an investigational autologous engineered T-cell therapy for the treatment of HLA-A*02 positive patients with advanced synovial sarcoma expressing the NY-ESO-1 antigen.
ReCET (Endogenex Inc.) Duodenal Mucosal Regeneration for Type 2 Diabetes
ReCET (Endogenex Inc.) is an investigational endoscopic procedure that uses pulsed electric fields to promote duodenal mucosal regeneration for treatment of type 2 diabetes that is poorly controlled with oral medications and/or insulin.
Relyvrio (Sodium Phenylbutyrate/Taurursodiol; Amylyx Pharmaceuticals Inc.) for Amyotrophic Lateral Sclerosis (ALS)
Relyvrio (sodium phenylbutyrate/taurursodiol, formerly AMX0035; Amylyx Pharmaceuticals Inc.) is an oral fixed-dose combination drug indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults. As of April 4, 2024, Relyvrio has been withdrawn from the market.
TriClip G4 System (Abbott Medical) Transcatheter Tricuspid Valve Repair for Tricuspid Regurgitation
The TriClip G4 System (Abbott Medical) is a transcatheter tricuspid valve repair system indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and i…
Eko Low Ejection Fraction Tool (ELEFT; Eko Health Inc.) for Artificial Intelligence (AI)-based Stethoscope Detection of Low Ejection Fraction
The Eko Low Ejection Fraction Tool (ELEFT; Eko Health Inc.) is an artificial intelligence (AI)-based algorithm that analyzes single-lead electrocardiogram (ECG) data collected via a compatible Eko digital stethoscope as an aid in the detection of low left ventricular ejection fraction in adult patients during a routine physical examination. It is not intended as a sole means …
Remestemcel-L (Mesoblast Ltd.) for Acute Graft-Versus-Host Disease
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.