INNOVATE Corp. announced that its portfolio company, MediBeacon Inc., has received U.S. Food and Drug Administration (FDA) approval for its MediBeacon TGFR System. This system is approved for the assessment of kidney function in adult patients with normal or impaired renal function, marking a significant advancement in nephrology.
The TGFR system, comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace (relmapirazin) injection, offers a non-radioactive, non-iodinated fluorescent GFR tracer agent. This innovative approach allows for the assessment of kidney function by measuring the clearance rate of the fluorescent agent transdermally, eliminating the need for traditional blood draws or urine analysis.
Clinical studies demonstrated the TGFR system met its primary efficacy endpoint, achieving a P30 value of 94%, indicating high accuracy in GFR estimation. No serious or severe adverse events were observed during these trials. This FDA approval positions MediBeacon to address a critical public health crisis, as chronic kidney disease causes more deaths annually than breast cancer or prostate cancer.
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