We introduced iFuse-3D, our second-generation implant, in 2017. The iFuse procedure involves a 1- to 2-inch incision and is much less invasive. Our implants are made of titanium and have a porous surface. Three of our implants are typically used in each procedure. SIFI is a single-arm study conducted in the United States. Patient satisfaction remained high for patients treated with the iFuse Implant. These clinical studies demonstrate the iFuse procedure to be safe and effective. However, the new code did not immediately lead to positive coverage decisions by payors. In most cases, the payors who are not covering are reevaluating coverage. However, this consequence cannot be excluded. We also compete against non-hardware products, such as allograft bone implants. We have focused the majority of our foreign patent efforts in China, Europe, and Japan. The FDA classifies medical devices into one of three classes. The PMA process is much more demanding than the 510(k) premarket notification process. A showing of substantial equivalence sometimes, but not always, requires clinical data. The FDA inspected our facilities again in December 2016. We are currently collecting information to determine our regulatory strategy in Japan. We may experience similar issues in future quarters due to the COVID-19 pandemic. Our products are used in situations in which there is a risk of serious injury or death. Corporate Information We were incorporated in March 2008 in Delaware. Payors could also abandon their decisions to cover iFuse exclusively for other reasons. Federal Food, Drug, and Cosmetic Act ("FDCA"), or are exempt from premarket review. The sacroiliac joint fusion market has attracted numerous new companies and technologies. We are subject to risks associated with our non-U.S. operations. The Medical Devices Regulation became effective on May 25, 2017. We updated our Section 382 ownership change analysis through December 31, 2020.