Our BRAVO study was fully enrolled at 92 patients. Our business has been impacted by the COVID-19 pandemic. As of December 31, 2020, we had an accumulated deficit of $196.7 million. This leads to increased risk of bulging of the material or hernia recurrence. Additionally, biologic matrices are typically expensive to source. In addition, we continue to pursue contracts with additional GPOs and IDNs. Increasing product permeability encourages a more-natural healing response. None required a surgical intervention. Most Class II devices are subject to premarket review and clearance by the FDA. There are many potential bases for liability under the False Claims Act. 8203;COVID-19 has and may continue to have an impact on ports and trade globally. Our long-term growth depends on our ability to enhance our product offerings. We may fail to obtain any of these licenses on commercially reasonable terms, if at all. Our issued U.S. patents will expire between 2035 and 2038. Third parties may assert ownership or commercial rights to inventions we develop. Intellectual property rights do not necessarily address all potential threats. In addition, a PMA generally requires the performance of one or more clinical trials. In the EEA, we have obtained the CE mark for our OviTex products. Any of these actions could significantly and negatively affect supply of our products. There is additional uncertainty in light of the new Presidential administration. We do not have redundant facilities. We are subject to the periodic reporting requirements of the Exchange Act.
