Resamirigene bilparvovec is an investigational single-infusion gene therapy proposed for the treatment of X-linked myotubular myopathy.
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.
Human Acellular Vessel (HAV; Humacyte Inc.) for Vascular Trauma
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) Concurrent Optical and Magnetic Stimulation for Diabetic Foot Ulcers
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.
VenoValve (enVVeno Medical Inc.) for Chronic Venous Insufficiency
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.
Darvadstrocel (Takeda Pharmaceutical Co. Ltd.) for Perianal Fistula in Crohn Disease
Darvadstrocel is an injectable allogeneic, expanded, adipose-derived mesenchymal stem cell product. It is proposed as an adjunct to standard medical care for treatment-refractory complex perianal fistula in adults with Crohn disease. Darvadstrocel is in phase III clinical trial development for a future regulatory filing with the FDA. It is currently approved under the brand n…
Evoque Tricuspid Valve Replacement System (Edwards Lifesciences Corp.) for Tricuspid Regurgitation
The Evoque Tricuspid Valve Replacement System (Edwards Lifesciences Corp.) is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.
Farapulse Pulsed Field Ablation System (Boston Scientific Corporation) for Atrial Fibrillation
The Farapulse Pulsed Field Ablation System (Boston Scientific Corporation) is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
LuX-Valve Plus (Jenscare Scientific Co. Ltd.) Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation
LuX-Valve Plus (Jenscare Scientific Co. Ltd.) is an investigational transcatheter tricuspid valve replacement system for treatment of tricuspid regurgitation.
ProTractX3 Drug-Coated Balloon (GIE Medical Inc.) for Benign Esophageal Stricture
The ProTractX3 (GIE Medical Inc.) is an investigational drug-coated balloon for endoscopic dilation of symptomatic recurrent benign esophageal strictures in adults.
Exagamglogene Autotemcel (Casgevy; Vertex/CRISPR) for Transfusion-dependent Beta Thalassemia
Exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals and CRISPR Therapeutics) is an autologous genome-edited hematopoietic stem cell-based gene therapy indicated for the treatment of patients aged 12 years and older with transfusion-dependent beta thalassemia.