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.
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.
EB-101 is an autologous gene-corrected skin graft under investigation for the treatment of chronic open wounds in patients with recessive dystrophic epidermolysis bullosa.
Etranacogene dezaparvovec (Hemgenix; formerly AMT-061) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with hemophilia B (congenital factor IX deficiency) who currently use factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Blarcamesine (ANAVEX 2-73) is an investigational oral drug that targets sigma-1 and muscarinic receptors. It is in development for the treatment of Rett syndrome as well as for a number of other central nervous system disorders.
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 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.
Bulevirtide is an investigational, first-in-class subcutaneously injected virion entry inhibitor proposed for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Humacyl is an off-the-shelf bioengineered human acellular vessel proposed for use as a hemodialysis access graft in patients with end stage renal disease (ESRD). This technology uses a process to decellularize donated human vascular smooth muscle cells, while preserving extracellular matrix proteins. This results in a tubular scaffold that is acellular at the time of implanta…
A radiolabeled monoclonal antibody targeting tumor antigen B7-H3 in development for intraventricular radioimmunotherapy for treatment of neuroblastoma central nervous system/leptomeningeal metastases.
SER-109 is an investigational oral microbiota-based product for fecal microbiota transplantation (FMT) proposed to prevent recurrent Clostridioides (formerly Clostridium) difficile infection (CDI) in adults with a history of 3 or more CDI episodes within a 12-month period.