Midomafetamine (MDMA; also 3,4-methylenedioxymethamphetamine; Lykos Therapeutics) is an oral synthetic entactogen under investigation in combination with psychological intervention for the treatment of adults with posttraumatic stress disorder (PTSD).
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.
Nemolizumab-ilto (Nemluvio; Galderma) for Prurigo Nodularis
Nemolizumab-ilto (Nemluvio; Galderma) is a subcutaneously injected interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis.
The SetPoint System (SetPoint Medical) for Rheumatoid Arthritis
The SetPoint System is an investigational implanted vagus nerve stimulation (VNS) device being developed for treatment of rheumatoid arthritis (RA).
ProSense System (IceCure Medical) for Low-Risk Early-Stage Breast Cancer
The ProSense system (IceCure Medical) is a minimally-invasive, imaging-guided, cryoablation system proposed for treatment of low-risk early-stage breast cancer in patients who are not suitable candidates for surgical alternatives.
AB-1002 (Asklepios and Bayer) Gene Therapy for Heart Failure
AB-1002 (Bayer AG) is an investigational one-time gene therapy administered via intracoronary artery infusion to reduce symptoms of advanced nonischemic heart failure.
Afamitresgene Autoleucel (Tecelra; Adaptimmune LLC) for Advanced Synovial Sarcoma
Afamitresgene autoleucel (afami-cel; Adaptimmune LLC) is an intravenously administered melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of select adults with previously treated, unresectable or metastatic synovial sarcoma.
UX111 (Ultragenyx Pharmaceutical Inc.) for Mucopolysaccharidosis Type IIIA
UX111 (Ultragenyx Pharmaceutical Inc.) is an investigational single-infusion gene therapy proposed for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA).
INO-1307 (Inovio Pharmaceuticals Inc.) for Recurrent Respiratory Papillomatosis
INO-3107 (Inovio Pharmaceuticals Inc.) is an injectable plasmid DNA immunotherapy under investigation in combination with electroporation for the treatment of recurrent respiratory papillomatosis in adults.
Verve Transurethral Renal Pelvic Denervation System (Verve Medical Inc.) for Uncontrolled Hypertension
The Verve Renal Pelvic Denervation System (formerly the Phoenix System; Verve Medical Inc.) is an investigational transurethral renal pelvic denervation system that uses a cystourethroscopic approach to perform radiofrequency ablation of the renal nerves for the treatment of uncontrolled hypertension.
CardiAMP Cell Therapy for Heart Failure
CardiAmp Cell Therapy is a cell harvesting, processing, and injection kit for transendocardial delivery of autologous bone marrow-derived cells to the heart for treatment of ischemic heart failure.