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.

Inclisiran for Hypercholesterolemia

Inclisiran is a subcutaneously administered, investigational RNAi therapeutic that decreases hepatic synthesis of proprotein convertase subtilisin kexin type 9 (PCSK9), leading to increased low-density lipoprotein (LDL) receptor expression on the hepatocyte cell surface and subsequently to greater removal of LDL-C from circulation.

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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…

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Anifrolumab for Systemic Lupus Erythematosus

Anifrolumab is an investigational fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is proposed for the treatment of adults with moderately to severely active systemic lupus erythematosus (SLE) who are receiving standard care.

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Oxlumo (Lumasiran) for Primary Hyperoxaluria Type 1

Oxlumo (lumasiran) is a subcutaneously injected, HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Dosing is weight-based; for children weighing less than 10 kg, the recommended maintenance dose is 3 mg/kg once monthly. Dosing for individua…

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