Tegsedi (inotersen) is an antisense oligonucleotide (ASO) that inhibits production of transthyretin that is intended for the treatment of polyneuropathy due to hereditary transthyretin (TTR) amyloidosis. Inotersen is administered weekly via subcutaneous injection.
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?
OTX-TP (Travoprost Insert)
OTX-TP is an eye insert that delivers travoprost to the ocular surface for up to 90 days. It is proposed as an alternative to daily eye drops for lowering intraocular pressure in patients with glaucoma or ocular hypertension.
OTX-TP (Travoprost Insert)
OTX-TP is an eye insert that delivers travoprost to the ocular surface for up to 90 days. It is proposed as an alternative to daily eye drops for lowering intraocular pressure in patients with glaucoma or ocular hypertension.
WiSE Cardiac Resynchronization Therapy System
The WiSE CRT system (formerly the WiCS-LV) is a wireless left ventricular pacing system that works with a conventional pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated. The WiSE CRT system is comprised of an ultrasonic transmitter attached to a battery unit and a tiny wireless receiver which acts as a pacing electrode. T…
Elzonris (Tagraxofusp-erzs) for Blastic Plasmacytoid Dendritic Cell Neoplasm
Elzonris is a recombinant protein consisting of human interleukin-3 (IL-3) conjugated with diphtheria toxin that is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm. This protein binds to the IL-3 receptor subunit alpha chain (CD123), preventing protein synthesis and prompting cell death.
Elzonris (Tagraxofusp-erzs) for Blastic Plasmacytoid Dendritic Cell Neoplasm
Elzonris is a recombinant protein consisting of human interleukin-3 (IL-3) conjugated with diphtheria toxin that is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm. This protein binds to the IL-3 receptor subunit alpha chain (CD123), preventing protein synthesis and prompting cell death.
Humacyl Acellular Vessel
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…
Transpyloric Shuttle Device
The TransPyloric Shuttle Device is an endoscopically placed gastric-occupying device for weight reduction in adult patients with a BMI of 35.0 kg/m2 to 40.0 kg/m2 or a BMI of 30.0 kg/m2 to 34.9 kg/m2 with at least 1 obesity-related comorbidit…
Transpyloric Shuttle Device
The TransPyloric Shuttle Device is an endoscopically placed gastric-occupying device for weight reduction in adult patients with a BMI of 35.0 kg/m2 to 40.0 kg/m2 or a BMI of 30.0 kg/m2 to 34.9 kg/m2 with at least 1 obesity-related comorbidit…
Plenity (Gelesis100) for Weight Loss
Plenity (formerly Gelesis100 and GSP3) is an oral, non-systemic, superabsorbent hydrogel intended as an aid in weight management in overweight and obese adults with a body mass index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise.