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.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
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 As of April 4, 2024, Relyvrio has been withdrawn from the market.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.