Transportation is primarily by commercial or charter airline. MACI may be implanted through a smaller incision or mini arthrotomy for focal defects. In the year ended December 31, 2020, MACI net revenues totaled $94.4 million. As a result, reaching target centers is feasible with a relatively small sales team. In addition, we and any provider that we retain will be subject to GCP requirements. This could result in a negative perception of our company or our products. Product development is a lengthy and expensive process, with an uncertain outcome. For example, Matricel is the sole supplier of the membrane for MACI. Biologics require BLA approval in the U.S. prior to being marketed. For example, the FDA approved Epicel as a HUD pursuant to an HDE application. Tissue based products are regulated differently in different countries. We have no issued patents or pending patent applications relating to Epicel. In the event of an intellectual property dispute, we may be forced to litigate. These proceedings can be expensive and time consuming. As a result, such claims could affect our earnings and financial condition. In the future, we may need to seek additional manufacturing and quality staff members.
