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 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?
TissueGene-C for Knee Osteoarthritis
TissueGene-C is an allogeneic cell and gene therapy delivered via intra-articular injection in development for the treatment of knee osteoarthritis.
Radiolabeled Omburtamab for Metastatic Neuroblastoma
Omburtamab is a radiolabeled monoclonal antibody targeting tumor antigen B7-H3 in development for intraventricular radioimmunotherapy for treatment of neuroblastoma central nervous system/leptomeningeal metastases.
Rebyota (Fecal Microbiota, Live-jslm) for Prevention of Recurrent Clostridioides Difficile Infection
Rebyota (fecal microbiota, live-jslm) is a ready-to-use enema product for fecal microbiota transplantation indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
FlowSense Device for Evaluation of Ventricular Shunt Function
The Flowsense device is a wireless, noninvasive thermal flow sensor in development for the detection of flow in implanted cerebrospinal fluid shunts in patients with hydrocephalus.
Teplizumab-mzwv (Tzield) for the Delay of Symptomatic Type 1 Diabetes
Teplizumab is an intravenously administered anti-CD3 monoclonal antibody indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with stage 2 T1D.
Revita Duodenal Mucosal Resurfacing for Type 2 Diabetes Mellitus
Revita DMR is an investigational endoscopic hydrothermal ablation device for duodenal mucosal resurfacing proposed for treatment of type 2 diabetes that is poorly controlled with oral medications and/or insulin.
CureSight for Amblyopia in Children
CureSight is a software-based prescription digital therapeutic for treatment of amblyopia that utilizes eye tracking technology to improve visual acuity and stereo acuity by training the visual system to use both eyes simultaneously.
AuroLase Therapy for Localized Prostate Cancer
AuroLase is a focal ablation therapy that uses gold nanoparticles and a near-infrared laser to thermally ablate localized prostate cancer.
Skysona (Elivaldogene Autotemcel) for Cerebral Adrenoleukodystrophy
Skysona (elivaldogene autotemcel; eli-cel) is lentiviral-based gene therapy indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).