The Portable Neuromodulation Stimulator (PoNS) device is a portable neuromodulation stimulator for short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis for use by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older.
Horizon ScanningIt 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?
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Evrysdi (risdiplam; formerly RG7916) is an oral small molecule splicing modifier of the survival motor neuron 2 (SMN2) gene indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.
Amondys 45 (casimersen) is an intravenously administered antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
TissueGene-C is an injectable solution of normal and genetically modified allogeneic human chondrocytes in development for the treatment of knee osteoarthritis.
Beta thalassemia is blood disorder caused by sequent variants in the beta-globin (HBB) gene that threaten normal production of hemoglobin. Lentiviral Autologous Beta-Globin Gene Therapy (Proposed Name: Zynteglo, formerly LentiGlobin) aims to reduce or eliminate the need for regular blood transfusions in patients with transfusion-dependent beta-t…
Evkeeza (evinacumab-dgnb) is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).
The eXciteOSA Daytime Therapy Device (formerly known as Snoozeal) is a noninvasive electrical muscle stimulation device that delivers electrical pulses through a mouthpiece that sits around the tongue. The system consists of a mouthpiece, a rechargeable control unit that connects to the mouthpiece via a USB interface, and a mobile app that allows the user to control and track…
Lupkynis (voclosporin) is an oral calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
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.