The AGENT Drug-Coated Balloon (Boston Scientific Corp.) is a paclitaxel-coated balloon catheter indicated for treatment of coronary in-stent restenosis (ISR). It is intended to be used after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 millimeters (mm) to 4.0 mm in diameter and lesions up to 26 m…
Horizon Scanning
It 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?
dNerva Lung Denervation System (Nuvaira Inc.) for Chronic Obstructive Pulmonary Disease
The dNerva Lung Denervation System (Nuvaira Inc.) is an investigational, bronchoscopic catheter-based pulmonary nerve ablation system proposed to reduce the frequency and severity of chronic obstructive pulmonary disease (COPD) exacerbations.
aXess Vascular Conduit (Xeltis) for Dialysis Access
The aXess graft (Xeltis) is a synthetic bioresorbable vascular conduit under investigation to establish arteriovenous access for hemodialysis in patients with end-stage renal disease.
Prademagene Zamikeracel (Abeona Therapeutics Inc.) for Recessive Dystrophic Epidermolysis Bullosa
Prademagene zamikeracel (pz-cel; formerly EB-101) (Abeona Therapeutics Inc.) is a gene-corrected epidermal sheet under investigation for the treatment recessive dystrophic epidermolysis bullosa.
CYB003 (Cybin Inc.) Deuterated Psilocybin Analogue for Major Depressive Disorder
CYB003 (Cybin Inc.) is an oral deuterated psilocybin analogue proposed for use in conjunction with supportive psychotherapy for treatment of patients with moderate to severe major depressive disorder who have had an inadequate response to an antidepressant medication.
Fidanacogene Elaparvovec-dzkt (Beqvez; Pfizer Inc.) for Hemophilia B
Fidanacogene elaparvovec-dzkt (Beqvez; Pfizer Inc.) is a single-infusion gene therapy for the treatment of adults with moderate to severe hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated vi…
Ventura Interatrial Shunt (V-Wave Ltd.) for Heart Failure
The Ventura Interatrial Shunt (V-Wave Ltd.) is an investigational transcatheter interatrial shunt proposed for treatment of chronic heart failure.
Rusfertide (Protagonist Therapeutics Inc./Takeda Pharmaceutical Co. Ltd.) for Polycythemia Vera
Rusfertide (formerly PTG-300; Protagonist Therapeutics Inc./Takeda Pharmaceutical Co. Ltd.) is a subcutaneously injected hepcidin mimetic for the treatment of erythrocytosis associated with polycythemia vera.
Varipulse Pulsed Field Ablation (Biosense Webster Inc.) for Atrial Fibrillation
Varipulse is an investigational pulsed-field ablation system in development for treatment of paroxysmal atrial fibrillation.
Letetresgene Autoleucel (Adaptimmune Therapeutics PLC) for Advanced Synovial Sarcoma
Letetresgene autoleucel is an investigational autologous engineered T-cell therapy for the treatment of HLA-A*02 positive patients with advanced synovial sarcoma expressing the NY-ESO-1 antigen.