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…
Horizon ScanningIt is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.
The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
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.
Etripamil is an investigational, self-administered, calcium-channel blocker, nasal spray for rapid termination of paroxysmal supraventricular tachycardia outside of the healthcare setting.
Sotatercept is a first-in-class activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein under investigation for the treatment of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) in adult patients on stable background therapy.
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.
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 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.
The automated low-flow ascites pump (alfapump; Sequana Medical NV) is an implantable wireless battery-powered pump for treatment of recurrent or refractory ascites due to liver cirrhosis.
The Edison System (HistoSonics) is a nonthermal focused ultrasound system with real-time image guidance under investigation for the noninvasive mechanical destruction of stage I primary solid renal tumors via histotripsy.