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).
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?
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.