As of 10:10 a.m. Eastern Time on Tuesday upon the announcement by Innovate Corp. (VATE, Financials) that the U.S. Food and Drug Administration authorized MediBeacon's Transdermal Glomerular Filtration Rate System, shares jumped 63% to $8.31. The gadget is meant to evaluate renal functioning in individuals either with normal or damaged kidneys. The details were revealed in a corporate statement.
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The system comprises a Lumitrace injectable fluorescent tracer agent sensor and monitor. According to the business, the device tracks Lumitrace fluorescence's clearance rate over a sensor on the skin to gauge kidney function. Real time processing of the data is shown at the patient's bedside or outpatient clinic.
Innovate said the technology does away with the requirement for urine samples, blood tests, and sophisticated lab testing required in conventional techniques. It immediately gauges kidney performance and eliminates the need for estimating formulae used in traditional evaluations.
The business said that clinical studies revealed the system attained a P30 value of 94%, meaning that 94% of kidney function estimations came within 30% of recorded glomerular filtration rate values. There were participants in the studies ranging in kidney function levels and with varying skin tones; no serious side effects were recorded.
Steve Hanley, CEO of MediBeacon, noted in the release that approximately 800 million individuals globally suffer from chronic renal disease, so it is a major international health problem. He further said that FDA clearance offers a fresh approach to handle this problem.
The clearance aligns with previous studies by MediBeacon's Chief Scientific Officer, Dr. Richard Dorshow, in a peer-reviewed medical publication endorsing the use of the Lumitrace agent in kidney function evaluations.
This article first appeared on GuruFocus.
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