GE HealthCare (GEHC) Begins Phase 2/3 Trial for Innovative MRI Contrast Agent [Yahoo! Finance]
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Source: Yahoo! Finance
reached a clinical milestone with the first patient dosed in the Phase 2/3 LUMINA trial for mangaciclanol, an innovative manganese-based MRI contrast agent. The trial, currently underway at the Mayo Clinic, evaluates the agent under an FDA Fast Track designation, which is intended to accelerate the development of products addressing significant unmet medical needs. Mangaciclanol is designed for both adult and pediatric patients to help clinicians visualize lesions with abnormal vascularity in the central nervous system and other parts of the body. If approved, mangaciclanol has the potential to transform the medical imaging market by serving as a viable alternative to (or even a replacement for) gadolinium-based contrast agents/GBCAs, which are the current global standard. Unlike gadolinium, a rare-earth metal that has raised medical concerns regarding long-term retention in the body, manganese is a naturally occurring element that is autoregulated by the human system. Early clini
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