There are approximately 450,000 soft tissue cancer cases per year in the U.S., where Navigation’s technology may provide benefit. These cancers include lung, liver, head and neck, thyroid, and brain, as well as breast cancer. The addressable U.S. market for Navigation’s technology, including both systems and consumables is estimated at approximately $1.26 billion. The company’s lead application is lung cancer, where the potential to improve outcomes with early-stage detection and removal is particularly high, and the impact of delayed treatment on morbidity and mortality is severe. There are more than 76,000 cases of early-stage lung cancer in the U.S. annually. Although the total number of lung cancer patients has been decreasing, the number of early-stage diagnoses is growing annually and is expected to increase further because of expanded use of CT X-ray screening and favorable CMS reimbursement coverage for high-risk patients. In March 2020, the U.S. Preventative Services Task Force issued recommendations, published in JAMA, for a major expansion of free annual CT screening. The report recommended screening be provided to 6.4 million additional individuals, which would total 14.5 million screening per year. The recommendations lowered the age for screening from 55 to 50 years old and reduced the smoking history from 30 to 20 years.
Beyond the U.S. the clinical and commercial opportunities in major European markets and China, are significant. In these European markets the addressable opportunity for Navigation Science’s technology is nearly 486,000 patients and the market potential is comparable to the U.S. There are more than China 1.4 million soft tissue cancers annually in China, where the addressable market is nearly $2 billion.