Enhance Diagnostics, announced today that it has been awarded a $307,000 Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH). The grant will support development of a novel, non-invasive breath diagnostic tool to improve monitoring and care for individuals living with urea cycle disorders (UCDs).
UCDs are rare inherited metabolic conditions caused by defects in the liver’s urea cycle, which normally clears ammonia generated during protein metabolism. When the urea cycle does not function properly, ammonia can build up in the bloodstream to life-threatening neurotoxic levels. While patients often manage their condition through diet and medication, common triggers such as illness or stress can lead to elevated ammonia levels (hyperammonemia), requiring emergency room visits for blood testing and treatment. Because symptoms of hyperammonemia, such as nausea, fatigue, and headache, can resemble common illnesses, patients are often advised to seek urgent care even when ammonia levels may not actually be elevated.
Enhance Diagnostics aims to change this paradigm by providing patients and clinicians with a quick, low-cost, non-invasive way to measure blood ammonia through a simple exhaled breath test. Preliminary clinical studies with UCD patients have demonstrated strong correlation between breath ammonia and blood ammonia levels, suggesting the potential for a point-of-care or at-home test to reduce unnecessary ER visits, lower costs, and improve patient quality of life.
“We are thrilled that the NIH has chosen to support our work through this Phase I SBIR award. This grant is a strong validation of both the scientific promise of our technology and the urgent need for better tools to support patients living with urea cycle disorders,” said Matthew Leming, PhD, Chief Scientific Officer of Enhance Diagnostics. “With NIH’s support, we can advance development of our at-home device to provide patients and families with more accessible, timely insights into their health. This is an exciting step not just for our team, but for the entire UCD community, as we work toward solutions that can meaningfully improve care and quality of life.”
The Phase I project will focus on refining the sensitivity of the ammonia-sensing discs specifically for UCD applications, evaluating performance under real-world conditions, and developing a dedicated sensor-reading instrument capable of delivering quantitative digital readouts of breath ammonia levels. Success in this stage will position the technology for larger-scale clinical studies under a subsequent Phase II SBIR program.
To learn more about Enhance Diagnostics, visit enhancediagnostics.com
About VIC Tech
Enhance Diagnostics is part of the portfolio of VIC Tech, a venture studio focused on creating companies from innovative academic research. Breeze is the third device from a VIC Tech portfolio company to receive Breakthrough Device Designation from the FDA, highlighting VIC’s consistent track record of advancing impactful health technologies toward clinical and commercial success.