ENDRA Life Sciences Inc. announced it will build on the content of its completed 510(k) application and pursue the De Novo pathway for its TAEUS System, which is intended to characterize fatty liver tissue as a means to non-invasively assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA's updated regulatory strategy is the result of a tremendous amount of productive dialogue with the U.S. Food and Drug Administration (FDA), which led to a clearer understanding of the path forward to achieve ENDRA's U.S. market claims for the TAEUS System. While ENDRA could continue to pursue its 510(k) application, ENDRA now believes that the potential resulting 510(k) market claims may understate the TAEUS System's clinical and commercial value.

This is particularly so when ENDRA considers the remaining effort to demonstrate 510(k) predicate equivalency compared with the effort involved in the De Novo pathway. For a similar investment of time and effort, ENDRA believes it can achieve a stronger market position through the De Novo process with TAEUS-optimized market claims compared with the 510(k) approach. Unlike a 510(k) clearance in which FDA determines “substantial equivalence” between a new product and another commercially available product with the same intended use and safety and efficacy profile (e.g., Ultrasonic imaging systems), the De Novo process provides a pathway for ENDRA to set the bar for an entirely new product classification.

Further, this regulatory path will showcase TAEUS' distinctive capabilities and will highlight TAEUS as being unique and novel, thereby strengthening TAEUS' competitive position when it becomes available for sale in the U.S. ENDRA's De Novo submission will involve the following key steps: Leveraging substantial portions of ENDRA's completed 510(k) submission, which encompasses many of the same elements as the intended De Novo submission, including safety and efficacy data. Customizing TAEUS' proprietary testing methods into “special controls,” which will become requirements for future product submissions. This is expected to accelerate 510(k) submissions of future generations of TAEUS products while creating market-entry barriers for competitive products.

Adding limited confirmatory clinical data from a subset of ENDRA's existing clinical evaluation sites, which is expected to be available in 2022.