Every Hayes clinical evidence report is developed by experienced teams that have been trusted by healthcare decision makers since 1989. Here is a sampling of our content that is being used every day to inform defensible, evidence-based decisions by payers and providers.
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Valoctocogene roxaparvovec (AAV5-hFVIII-SQ; proposed name: Valrox) is a single-administration hemophilia A gene therapy that combines a viral capsid (adeno-associated virus type 5 [AAV5]) with a factor VIII (FVIII) gene. The therapeutic viral vector delivers FVIII DNA to patient cells, where it can be expressed as FVIII protein. Valoctocogene roxaparvovec has the potential to…
The GammaSense Stimulation System is an investigational, home-use, wearable device that delivers auditory and visual stimulation to entrain gamma frequency neural activity in the brain. It is proposed for the treatment of mild to moderate Alzheimer disease (AD). Brainwave entrainment is a technique to prompt the brain’s neural activity to synchronize to the frequency of exter…
This report addresses whether full-text clinical studies, systematic reviews, and clinical practice guidelines and position statements support the use of the Podimetrics Remote Temperature Monitoring System (Podimetrics Inc.) for the prediction of diabetic foot ulcers.
This report addresses whether full-text clinical studies, systematic reviews, and clinical practice guidelines and position statements support the use of the ReActiv8 Implantable Neurostimulation System for mechanical chronic low back pain due to lumbar multifidus muscle weakness for improvements in pain, disability, quality of life, and change in opioid intake.
AMX0035 is an investigational co-formulation of sodium phenylbutyrate (PB) and taurursodiol (TURSO). PB is a prescription drug use to treat urea cycle disorders and TURSO (also known as tauroursodeoxycholic acid [TUDCA]) is a widely available non-prescription supplement. AMX0035 is proposed for the treatment of amyotrophic lateral sclerosis (ALS).
The HistoSonics System is an ultrasound histotripsy system intended for noninvasive mechanical destruction of malignant cells via acoustic cavitation. It is under investigation for the treatment of primary or metastatic hepatocellular tumors.
Lecanemab (BAN2401) is an investigational, intravenously administered anti-amyloid beta (Aβ) protofibril antibody proposed for the treatment of early Alzheimer disease.
The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donation-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time); and for the ex vivo reanimation,…
This report addresses whether full-text clinical studies, systematic reviews, and clinical practice guidelines and position statements support the use of external urinary catheters in inpatient hospital or residential care settings to reduce the incidence of catheter-associated urinary tract infection (CAUTI) in patients with female genitalia and urinary incontinence (UI).
This report addresses whether full-text clinical studies, systematic reviews, and clinical practice guidelines and position statements support the use of the OverStitch suturing system to perform endoscopic sleeve gastroplasty for weight loss in patients with obesity.