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.

Vyvgart (Efgartigimod alfa-fcab) for Myasthenia Gravis

Vyvgart (efgartigimod alfa-fcab) is a first-in-class intravenously administered neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Tezspire (Tezepelumab-ekko) for Severe Asthma

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin blocker human monoclonal antibody indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Optilume Drug-Coated Balloon for Urethral Strictures

Optilume is drug-coated balloon indicated to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males with urethral strictures ≤ 3 cm in length.

Voxzogo (Vosoritide) for Achondroplasia

Vosoritide is a longer-acting C-type natriuretic peptide (CNP) analog that modulates activity of the fibroblast growth factor receptor 3 (FGFR3) by inhibiting a signaling pathway that mediates its effects, thereby stimulating endochondrial growth, resulting in enhanced growth velocity. It is indicated to increase linear growth in pediatric patients aged ≥ 5 years with achondr…

Balstilimab for Cervical Cancer

Balstilimab is an investigational intravenous immunotherapy. It inhibits the activity of programmed death-1 (PD-1), an immune checkpoint protein that helps restrain the immune system. Balstilimab is proposed for the second-line treatment of advanced cervical cancer in patients with disease progression or who experience a relapse during or after chemotherapy.

Lungpacer Diaphragm Pacing Therapy System

The Lungpacer Diaphragm Pacing Therapy (DPT) system is a temporary, minimally invasive, transvenous phrenic nerve pacing system intended for treatment of patients on mechanical ventilation to facilitate weaning from the ventilator.

Tavneos (Avacopan) for Anti-neutrophil Cytoplasmic Autoantibody-associated Vasculitis

Tavneos (avacopan) is an oral complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.

Tivdak (Tisotumab Vedotin-tftv) for Cervical Cancer

Tivdak (tisotumab vedotin-tftv) is an intravenously administered tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.