Markets

Entering the era of “Precision Cancer Surgery”

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 currently more than 69,000 cases of early-stage lung cancer in the U.S. potentially addressable by the NaviSci system, a number that is expected to grow to 92,000 by 2028. Although the total number of lung cancer patients has been decreasing, the number of early-stage diagnoses is growing annually.  In 2017, 40 percent of lung cancer cases diagnosed were Stage 1 and Stage 2. By 2028, it is estimated that nearly 60 percent of lung nodules diagnosed will be Stage 1.

The increase will be driven in part by expanded use of CT X-ray screening and favorable CMS reimbursement coverage for high-risk patients. In February 2022, CMS issued a national coverage determination that effectively expanded the number of individuals eligible to be reimbursed for CT lung cancer screening by 6.4 million, which would bring the total number of eligible screenings to 14.2 million per year. The coverage determination followed recommendations two years earlier by the U.S. Preventative Services Task Force.  Specifically, the recommendations lowered the age for screening from 55 to 50 years old and reduced the smoking history from 30 to 20 years. In 2021, a study by the American Lung Association found that screening was performed on only 5.8 percent of eligible patients. The screening numbers are in contrast to the proportion of diagnoses of other common cancers, e.g. prostate, breast, and colorectal, which have been in use for many years, and they suggest considerable opportunity for growth.

The increase in early-stage diagnoses is also contributing to growth in the use of minimally invasive techniques, such as Video-Assisted Thoracoscopic Surgery (VATS) used by the NaviSci System. These procedures can potentially reduce procedure time and length of stay and improve patient outcomes. The number of lung resections in the U.S. potentially addressable by the NaviSci System is expected to increase from 69,000 in 2023 to 92,000 in 2028.

The growth in tissue-sparing surgical approaches is being driven in part by clinical data supporting their use vs lobectomy, which has been the standard of care for early stage tumors.  For example, a study published the Feb. 9, 2023 issue of the New England Journal of Medicine found long-term survival in patients undergoing tissue sparing wedge resections or segmentectomies was comparable to patients who received full lobectomies. Similar results were reported recently in a large clinical trial in Japan, which compared lobectomy to segmentectomy. Declaring “the era of ‘precision’ surgery for NSCLC has arrived,” an editorial accompanying the NEJM study said, “these two landmark trials are practice-changing as they establish sublobar resection as the standard of care for a select group of patients with NSCLC.”

In the NEJM trial, which involved 697 patients with lung tumors 2 cm in size or less that had not spread to lymph nodes, after a median follow up of seven years, disease free survival in the sublobar group was similar (non-inferior) to lobectomy. Five-year overall survival was 80.3% (95% after sublobar resection and 78.9%  after lobar resection. In addition, six months post-surgery, there was a between group difference favoring the sublobar resection group of 2 percentage points in the predicted forced expiratory volume in one second, a standard measure of lung function.

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.