The Reducer (Shockwave Medical Inc.) is a catheter-delivered, hourglass-shaped, stainless steel mesh device implanted into the coronary sinus to improve blood flow to ischemic myocardial tissue in patients with refractory angina pectoris who are unsuitable for revascularization by coronary artery bypass grafting or percutaneous coronary intervention.
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.
VE303 (Vedanta Biosciences Inc.) for Prevention of Recurrent Clostridioides Difficile Infection
VE303 is an investigational oral microbiome restoration therapy proposed to prevent recurrent Clostridioides difficile infection (CDI) in adults following antibacterial treatment for CDI.
Fezolinetant (Veozah; Astellas Pharma) for Vasomotor Symptoms Due to Menopause
Veozah is an NK3 receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Respiratory Syncytial Virus Vaccine, Adjuvanted (Arexvy; GSK plc) for Prevention of Lower Respiratory Tract Disease due to Respiratory Syncytial Virus in Older Adults
Arexvy (respiratory syncytial virus vaccine, adjuvanted; GSK plc) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.
Atrial Flow Regulator (Occlutech) for Heart Failure
The Atrial Flow Regulator (Occlutech) is a transcatheter interatrial shunt under investigation for the treatment of heart failure with preserved or reduced ejection fraction.
Vowst (Fecal Microbiota Spores, Live-brpk; Seres Therapeutics Inc.) for Prevention of Recurrent Clostridioides Difficile Infection
Vowst (fecal microbiota spores, live-brpk; Seres Therapeutics Inc.) is an oral capsule containing fecal microbiota spores indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
Pentosan Polysulfate Sodium (Paradigm Biopharmaceuticals Ltd.) for Knee Osteoarthritis
Pentosan polysulfate sodium (proposed name, Zilosul) is a subcutaneously injected semisynthetic glucosaminoglycan under investigation for treatment of knee osteoarthritis.
Tofersen (Qalsody; Biogen) for Amyotrophic Lateral Sclerosis
Tofersen (Qalsody; Biogen) is an intrathecally administered antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS).
Blarcamesine for Rett Syndrome
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.
Lenire Device (Neuromod Devices Ltd.) for Tinnitus
Lenire is a bimodal neuromodulation device combining sound and transmucosal electrical tongue stimulation to temporarily relieve the symptoms of tinnitus in patients ≥ 18 years of age with at least moderate tinnitus. Lenire therapy is intended to be self-administered by the patient following prescription by a healthcare professional who is experienced in the evaluation and ma…