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.
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.
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.