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 RNA interference (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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Organ Care System (OCS) Heart

The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donor-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).

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Kerendia (Finerenone) for Diabetic Kidney Disease

Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.

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