Reveal’s gadolinium-free MRI contrast agent will be a direct substitute for GBCAs for use in all patients.
Our agent, RVP-001, was invented by Peter Caravan and Eric Gale at Massachusetts General Hospital / Harvard Medical School. Their research was driven by the need for safe contrast enhanced imaging of renally impaired patients. These very sick patients frequently need medical imaging for diagnosis and disease management, but currently have no safe contrast agent options. Gadolinium based contrast agents (GBCAs) carry an FDA boxed warning because they trigger nephrogenic systemic fibrosis in this patient population, while CT contrast agents are contraindicated for these patients due to the risk of acute kidney failure.
Since 2013 concerns with GBCAs have escalated and expanded to include all patients. GBCAs have been shown to cause deposition of gadolinium in the brain, bone, and other organs of all patients, including those with normal renal function. Gadolinium deposition disease (GDD) has emerged as a debilitating condition afflicting some patients with normal renal function, while the long term consequences of brain and bone deposition of gadolinium remain unknown. In 2017 the European Medicines Agency suspended four of the current seven general purpose GBCAs due to their potential risks. There is grave and increasing concern among regulators and physicians about the safety of all GBCAs. All patients need safe gadolinium-free MRI contrast agents.
Reveal’s agent, RVP-001, was designed to solve these challenges. RVP-001 is based on biocompatible manganese, an essential element vital for life. RVP-001 is functionally equivalent to current gadolinium based contrast agents. It is administered at the same dose and volume as GBCAs. RVP-001 provides equivalent MRI signal, has the same distribution within the body, and enables imaging of the same disease indications as GBCAs. RVP-001 does not require any change to established radiology workflows and existing MRI protocols. RVP-001 produces equivalent images to GBCAs and can be used for all patients.
RVP-001 is the gadolinium-free MRI contrast agent.