Nutromics is building a wearable lab-on-a-patch for continuous molecular monitoring. Today the company announced that the FDA has granted Breakthrough Device Designation (BDD) for its first product in development - a wearable for vancomycin therapeutic drug monitoring.
Nutromics’ first product in development is a patch designed to support vancomycin therapeutic drug monitoring. Approximately 2.9 million patients in the US receive vancomycin therapy every year. This antibiotic is used to treat life-threatening conditions like sepsis. In 2020, vancomycin dosing guidelines were published that recommended area under the curve dosing over trough monitoring.
In granting the designation, the FDA determined that Nutromics’ Vancomycin TDM Patch represents a breakthrough technology with the potential to lead to clinical improvement. In reaching its determination on clinical success, the FDA specifically considered the device's workflow improvements, increased accessibility, and expected ability to return actionable results and facilitate modified vancomycin dosing sooner than the current standard of care.
Vancomycin is the first of several planned sensors the company is pursuing with its unique DNA-based sensing platform. Nutromics views multi-analyte sensing to be the next product evolution. The company’s future targets for planned sensors include molecules for the diagnosis and management of sepsis and cardiovascular disease.
In February this year, Nutromics published first-in-human data relating to its molecular monitoring platform in Nature Biotechnology. The company has since conducted ICU clinical studies in Australia and is preparing for further studies in the United States. The company is targeting a potential US launch in 2027, subject to obtaining the necessary regulatory authorization.
