MELBOURNE, Australia & SAN DIEGO, Sept 11 — Nutromics is building a wearable lab-on-a-patch™ for continuous molecular monitoring. Today the company has announced that the FDA has granted Breakthrough Device Designation (BDD) for its first product in development – a wearable for vancomycin therapeutic drug monitoring.
The FDA’s Breakthrough Device Program is designed to bring promising new medical technologies to patients sooner by accelerating development and regulatory engagement and reviews. The designation is reserved for technologies that address life-threatening or irreversibly debilitating conditions and that have also demonstrated a likelihood of providing for more effective treatment or diagnosis. The patch is currently for investigational use only and has not been authorized for commercial distribution by the FDA.
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.
Emphasizing the importance of real-time monitoring for this indication, Dr George Chiampas, Emergency Medicine Physician at Northwestern Hospital said “Vancomycin dosing for individualized patients is incredibly challenging to get right. Access to real-time, continuous data about drug concentrations would meaningfully and positively impact our ability to make dosing decisions.”
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.
“Our team is thrilled that the FDA has recognized our patch as a breakthrough technology and has committed to work closely with us on our pivotal study design and submission”, CEO and co-founder Peter Vranes commented.
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.