Innovate Shares Gain After FDA Approves Kidney-Function Assessment Device

Dow Jones01-21
 

By Connor Hart

 

Shares of Innovate rose after the Food and Drug Administration approved the company's device to assess kidney function.

The stock was 43% higher, at $7.30, midday Tuesday, the first day of trading after the company received FDA approval after the bell Friday. Shares have gained 48% so far in 2025, though they are down 28% in the last 52 weeks.

MediBeacon, a medical-technology company under Innovation's portfolio of companies, said its Transdermal GFR system is a first-in-kind product that can assess kidney function in patients with normal or impaired kidney function. It works by measuring the clearance rate of an injected fluorescent agent as it leaves the body.

The system is validated for use in the assessment of glomerular filtration rate, or GFR, which is a measure of how well kidneys filter blood, in patients with stable kidney function at the point of care, the company said. It added that while the system requires an injection, it doesn't require blood draws or urine analysis, as is the case with many current practices.

Innovate said the Transdermal GFR system's approval was based on having met its primary efficacy endpoint.

MediBeacon Chief Executive Steve Hanley, said "the potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings."

 

Write to Connor Hart at connor.hart@wsj.com

 

(END) Dow Jones Newswires

January 21, 2025 12:41 ET (17:41 GMT)

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