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.

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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Zavegepant for Acute Treatment of Migraine

Zavegepant is an intranasal novel small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist (“gepant”) drug proposed for the acute treatment of migraine headache. CGRP is involved in vasodilation and sensory transmission and is a validated target for the treatment of migraine headache.

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