We developed the OCS to comprehensively address the major limitations of cold storage. However, organ preservation remains primarily limited to cold storage. The donor organ is then placed in a sterile plastic bag and stored on ice in a cooler. Expect FDA Advisory Committee meeting on April 6, 2021. We have submitted additional PMA applications for the OCS Heart and OCS Liver. & &# We generate a significant amount of our net revenue from a limited number of customers. This has established multiple years of billing precedent. 24 & We have received FDA approval for a CAP for the OCS Heart EXPAND Trial.& & As of February 28, 2021, we have enrolled 74 patients in this trial. EU laws in relation to CE marking also apply in Norway, Lichtenstein and Iceland. Each of our OCS products is a Class III device. The PMA process is more demanding than the 510(k) premarket notification process. The FDA has broad regulatory compliance and enforcement powers. A product may be recalled in one country but not in others. The fiscal year ended December 28, 2019 included 52 weeks.& & The risks and uncertainties described below are not the only ones we face. Under the FDA's analysis, the patent term extension would be until November 6, 2021. In these countries, patents may provide limited or no benefit. This process can be expensive and lengthy and entail significant costs. The COVID-19 pandemic may result in delayed review and approval timelines. The notified body will assess the proposed change. These modifications may have an effect on the way we conduct our business in the EEA. Our actual or perceived failure to comply with such obligations could harm our business. Item 1B. Unresolved Staff Comments.
