The ProSense system (IceCure Medical) is a minimally-invasive, imaging-guided, cryoablation system proposed for treatment of low-risk early-stage breast cancer in patients who are not suitable candidates for surgical alternatives.
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.
Donanemab (Eli Lilly and Co.) is an investigational, intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.
Nemolizumab (Galderma) is a subcutaneously injected interleukin-31 receptor alpha antagonist under investigation for the treatment of adult patients with prurigo nodularis.
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Marnetegragene autotemcel (Rocket Pharmaceuticals Inc.) is an investigational gene therapy administered by intravenous infusion for the treatment of severe leukocyte adhesion deficiency-I.
Human Acellular Vessel (HAV; Humacyte Inc.) is an investigational bioengineered vascular conduit proposed to establish arteriovenous access for hemodialysis in patients with end-stage renal disease.
Resamirigene bilparvovec is an investigational single-infusion gene therapy proposed for the treatment of X-linked myotubular myopathy.
Human Acellular Vessel (HAV; formerly Humacyl) (Humacyte Inc.) is an off-the-shelf bioengineered vascular conduit proposed for urgent arterial repair following extremity vascular trauma when a synthetic graft is not indicated, and when autologous vein use is not feasible.
COMS One (Piomic Medical AG) is a concurrent optical and magnetic stimulation device for use as an adjunct to standard wound care to aid in the healing of chronic diabetic foot ulcers.
The VenoValve is a porcine bioprosthetic venous valve under investigation for permanent implantation into the femoral vein for the treatment of deep vein reflux in chronic venous insufficiency.