Researched and Curated by Clinical and Scientific Experts.

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 for Hemophilia A

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…

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GammaSense Stimulation System for Alzheimer Disease

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…

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AMX0035 for Amyotrophic Lateral Sclerosis (ALS)

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).

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Organ Care System (OCS) Heart

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,…

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External Female Catheters

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).

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