INNOVATE Corp. (NYSE: VATE) announced that its Life Sciences subsidiary, MediBeacon, received FDA approval for the next‑generation Transdermal Glomerular Filtration Rate (TGFR) system on December 16, 2025. The approval covers a device that uses a reusable sensor to measure the clearance of the non‑radioactive fluorescent tracer Lumitrace, enabling real‑time, non‑invasive assessment of kidney function in both inpatient and outpatient settings.
The new system builds on an earlier FDA clearance granted in January 2025 for a first‑generation TGFR device. The addition of a reusable sensor improves patient comfort, reduces per‑use costs, and positions MediBeacon to capture a growing market for point‑of‑care kidney diagnostics.
Chronic kidney disease affects more than 800 million people worldwide, and clinicians increasingly seek rapid, bedside tools to monitor renal function. The TGFR system offers a non‑invasive alternative to blood draws, potentially accelerating clinical decision‑making and reducing hospital stays. While other companies develop continuous urine flow or radiation‑based monitoring, MediBeacon’s fluorescence‑based approach is the first to achieve FDA clearance for a reusable transdermal sensor.
INNOVATE Corp. has faced financial headwinds in recent quarters. Consolidated revenue fell 34.5 % to $236.6 million in Q4 2024, and adjusted EBITDA dropped to $7.2 million in Q1 2025, largely due to higher equity‑method losses from MediBeacon and a growing debt load. Interim CEO Paul Voigt said the company’s 2025 objective is to address its capital structure and meet near‑term debt maturities, underscoring the importance of new revenue streams such as the TGFR system.
The company plans to begin sales to select academic medical centers in the first quarter of 2026, with broader commercial availability later that year. The launch strategy aligns with MediBeacon’s focus on high‑volume, high‑margin point‑of‑care devices and leverages the company’s existing distribution network in the United States and China, where the device has also received regulatory approval.
Steven Hanley, CEO and co‑founder of MediBeacon, said the approval “is a major step toward improving kidney health by providing clinicians with a rapid, non‑invasive tool.” Dr. Melana Yuzefpolskaya, a cardiologist at New York Presbyterian Hospital‑Columbia, noted that incorporating transdermal GFR into heart‑failure studies could enhance patient monitoring. Voigt added that the approval “strengthens our portfolio and supports our strategy to improve cash flow while we restructure our balance sheet.”
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