At home monitoring of kidney disease is challenging and prevents optimal care. Enhance Diagnostic’s simple, inexpensive, fast, and accurate home breath test can monitor Urea Cycle Disorders, Chronic Kidney Disease, and more, thereby improving health and reducing healthcare costs.
The Problem: Proper management of metabolic waste is critical to maintaining good health. Chronic kidney disease (CKD) affects hundreds of thousands of Americans every year and at home monitoring of this and similar diseases is challenging. This prevents optimal care for these patients by increasing morbidity and decreasing clinician touchpoints along the patient journey. Urea cycle disorders (UCD) are rare diseases that result in the inability of the metabolic system to convert ammonia into urea. As a result, these patients are at risk of hyperammonemia and must closely manage and monitor their ammonia levels. There is presently no reliable option other than in-clinic blood tests to check for ammonia levels.
The Solution: At Enhance Diagnostics we have developed a platform, at home, breath test for ammonia. Clinical data indicates strong correlation between breath ammonia and blood urea nitrogen (BUN) in patients with CKD, as well as direct correlation to blood ammonia levels in patients with UCDs. Our test significantly enhances patient monitoring in the home without necessitating more frequent in-person visit.
Market Opportunity: The beachhead UCD market opportunity is small, estimated at about $23M/year in the U.S. However, due to the compelling need market adoption rate should be high. Also, market penetration is expected to be rapid as the customer base is easy to access. The CKD market opportunity is larger, about $100M in U.S. for CKD Stage 4 where the need for the device is greatest, and about $1.3B for Stage 3. However, market penetration for Stage 3 is less certain. Other future market opportunities include diabetes (Acetone / Isoprene), asthma (Nitric Oxide / H2S), respiratory diseases (viral particles), and more.
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