Nutromics landed FDA breakthrough device designation this week for its wearable patch that monitors vancomycin levels in real time.
Vancomycin is a widely used antibiotic for treating life-threatening infections like sepsis, but it’s notoriously difficult to dose correctly, with doctors typically relying on periodic blood draws to track it.
Nutromics was founded in 2017 with the goal of replacing these blood draws with continuous data for the roughly 2.9 million patients in the U.S. who receive vancomycin each year. The new designation gives the company faster, closer engagement with the FDA as it works toward an eventual commercial launch.
Peter Vranes, CEO and co-founder of Nutromics, noted that about 20% of patients in the intensive care unit suffer from vancomycin-induced acute kidney injury.
“Our objective is to make guideline-adherent dosing easier by providing doctors with real-time insights into vancomycin concentrations. Beyond that, we want to bring real-time, continuous molecular data to other indications, including sepsis monitoring and management, and cardiac monitoring,” he stated.
Nutromics’ patch contains microneedles, which are coated with synthetic DNA-based sensors that can identify the target they are sensing and bind with it by folding, Vranes explained. Once placed on the patient’s arm, the patch creates an electrical signal that is converted into a measurement delivered onto hospital screens via Bluetooth. Doctors can then use this data to make decisions about patient dosing and treatment.
Vranes noted that this approach is an improvement to the currently used methods to dose vancomycin.
“[These are] either trough-guided dosing, which relies heavily on repeated blood tests taken at specific times, or Bayesian dosing, which is guideline-compliant but incredibly expensive and complex to implement. By comparison, Nutromics’ patch intends to provide real-time vancomycin concentrations, while fitting within existing workflows,” he said.
Vranes also pointed out that the patch is easy to apply and its cost and form lends itself to scale.
Still, the device hasn’t been cleared for commercial use yet. Nutromics’ next step is generating the clinical evidence the FDA will need to grant approval, and Vranes said the company is working to launch further studies with U.S. hospitals this year.
“We hope to achieve a 74% reduction in acute kidney injuries with area under the curve-guided dosing while delivering a 15 times ROI to hospitals,” he declared.
He added that the company is preparing to raise its Series B funding round.
Nutromics is targeting next year for its U.S. commercial launch, assuming its upcoming studies go as planned and it secures FDA clearance.
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