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.

Transpose RT System for Rotator Cuff Tendinopathy

The Transpose RT system (formerly known as Transpose Ultra) is a device for enzymatic isolation and preparation of uncultured unmodified autologous adipose-derived regenerative cells (UA-ADRCs) for injection therapy. This therapy is proposed for stand-alone point-of-care treatment of partial-thickness rotator cuff tears.

Exagamglogene Autotemcel (Casgevy; Vertex/CRISPR) for Sickle Cell Disease

Exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals and CRISPR Therapeutics) is an autologous, genome-edited, hematopoietic stem cell-based gene therapy indicated for the treatment of sickle cell disease (SCD) in patients aged 12 years and older with recurrent vaso-occlusive crises (VOCs).

Hepzato Kit (Melphalan/Hepatic Delivery System; Delcath Systems Inc.) Liver-Directed Therapy for Metastatic Uveal Melanoma

The Melphalan/Hepatic Delivery System (Hepzato Kit; Delcath Systems Inc.) is a melphalan drug pack and catheter-based chemofiltration delivery kit indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymp…