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.
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?
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 As of April 4, 2024, Relyvrio has been withdrawn from the market.
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.
Sotatercept-csrk (Winrevair; Merck & Co. Inc.) for Pulmonary Arterial Hypertension
Sotatercept-csrk (Winrevair; Merck &Co. Inc.) is an activin signaling inhibitor indicated for the treatment of adults with World Health Organization (WHO) Group 1 pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
Atidarsagene Autotemcel (Lenmeldy; Orchard Therapeutics) for Metachromatic Leukodystrophy
Atidarsagene autotemcel (Lenmeldy; Orchard Therapeutics) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of children with presymptomatic late infantile, presymptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy (MLD).
Blarcamesine (Anavex 2-73; Anavex Life Sciences Corp.) for Alzheimer Disease
Blarcamesine (Anavex 2-73; Anavex Life Sciences Corp.) is an investigational oral small molecule sigma-1 receptor agonist for treatment of early Alzheimer disease.
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) for Advanced Melanoma
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Marnetegragene Autotemcel (Rocket Pharmaceuticals Inc.) for Severe Leukocyte Adhesion Deficiency-I
Marnetegragene autotemcel (Rocket Pharmaceuticals Inc.) is an investigational gene therapy administered by intravenous infusion for the treatment of severe leukocyte adhesion deficiency-I.
Human Acellular Vessel (HAV; Humacyte Inc.) for Dialysis Access
Human Acellular Vessel (HAV; Humacyte Inc.) is an investigational bioengineered vascular conduit proposed to establish arteriovenous access for hemodialysis in patients with end-stage renal disease.