Investing.com -- Shares of Innovate Corp. (NYSE:VATE) surged 60% following the announcement that the U.S. Food and Drug Administration (FDA) has approved the company's MediBeacon Transdermal GFR System for assessing kidney function. This significant regulatory milestone was shared by the company on Friday.
The FDA's green light for the MediBeacon TGFR, which includes the TGFR Sensor, TGFR Monitor, and Lumitrace injection, marks a pivotal advancement in kidney health management. The TGFR system measures the clearance rate of a fluorescent tracer agent, Lumitrace, without the need for traditional blood draws or urine samples. This new method provides a more convenient and immediate assessment of kidney function directly at the patient's bedside or in an outpatient setting.
The TGFR has demonstrated its primary efficacy endpoint in clinical studies, achieving a P30 value of 94%, indicating that the GFR estimation falls within +/- 30% of measured GFR values across a diverse patient population, including various GFR ranges and skin tones.
Innovate's announcement emphasized the system's potential to revolutionize the nephrology field by offering a non-invasive and accurate method for evaluating kidney function, a process that has historically relied on less patient-friendly techniques. The company also highlighted the alignment of the FDA approval with the recent publication in Kidney International, which supports the utility of MediBeacon's patented Lumitrace agent.
The approval has been lauded by medical professionals, including Dr. Mitchell Rosner and Dr. Pierre Galichon, who recognized the TGFR's significance in improving kidney function assessment and its potential clinical applications. Steve Hanley, CEO of MediBeacon, commented on the public health impact of chronic kidney disease (CKD) and expressed optimism about the TGFR's role in addressing this challenge.
The clinical studies reported no serious or severe adverse events associated with the TGFR system. For more detailed safety and effectiveness data, the company directs interested parties to the FDA's official website.
Investors have responded positively to the news, as reflected in the stock's significant price movement, underscoring the market's confidence in the potential commercial success of the TGFR system.
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