In December 2019, we received the CE mark for these advancements in the EEA. &# The plan was implemented on July 6, 2020. There are three main ways to treat cancer: surgery, chemotherapy and radiation therapy. Chemotherapy uses drugs to kill cancer cells. Innovation is one of our greatest strengths as an organization. Other Image Guided therapy devices. We also purchase minor components and manufacture parts directly ourselves. Clinical data are sometimes required to support substantial equivalence. In this regard, we believe that the MRIdian Linac complies with applicable regulations. Such changes could result in reduced demand for MRIdian or additional pricing pressure. Our most recent recertification audit occurred in February 2021. 8226; Our ability to develop new products or enhance the capabilities of MRIdian. &# 8226; The effects of competition. &# 8226; Our ability to use our net operating losses to offset future taxable income. &# 8226; Risks associated with our international business. &# On July 6, 2020, we reduced our workforce by approximately 20%. At December 31, 2020, we had an accumulated deficit of $627.1 million. We are an early, commercial-stage company and have a limited operating history. Each MRIdian is a major capital equipment item and is subject to a lengthy sales cycle. Further, our backlog could be reduced due to cancellation of orders by customers. Nevertheless, we must carefully manage our introduction of new products. We anticipate growth in our business operations. In addition, we may be unable to obtain these licenses at a reasonable cost, if at all. These guidance documents replaced the 1997 guidance on the same topic. Certain policies of the Biden administration may impact our business and industry. Our 510(k) clearance from the FDA is based on current treatment guidelines. Any of these actions could significantly and negatively impact supply of MRIdian. These modifications may have an impact on the way we conduct our business in the EEA. Our relationships with providers and hospitals are subject to scrutiny under these laws. We expect our operating results to be subject to fluctuations.
