MELBOURNE, Australia & SAN DIEGO: 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.

About Nutromics: Nutromics is an Australian-founded advanced monitoring company that has built a wearable, DNA-based platform for continuous molecular monitoring. Its DNA-based sensors, integrated with minimally invasive microneedles, are designed to sense multiple proteins, drugs, metabolites, and hormones in real time. Nutromics is advancing toward regulatory clearance and commercial launch of its first product, with operations in Australia and the United States. The company’s vision is a world with zero preventable deaths due to a lack of continuous molecular monitoring.

Disclaimer:
This release contains forward-looking statements regarding the development and potential future regulatory status of the Nutromics patch. These statements are based on the Company’s current assumptions, estimates and expectations and involve known and unknown risks and uncertainties. Actual results and the timing or outcome of development and regulatory activities may differ materially from those expressed or implied in these statements. The Nutromics patch is investigational and has not received FDA marketing authorization. Nothing in this release should be construed as a representation that FDA has determined the patch to be safe or effective. The patch is not available for commercial supply.

Disclosure: Dr George Chiampas is a consultant to Nutromics.

Fonte: Business Wire