Any of these competitive disadvantages could materially, adversely affect us. A variety of tissues and synthetic materials are implanted in these cardiac procedures. This new indication was, and still is, unique to the On-X aortic valve. Left untreated, an aortic dissection often results in a ruptured aorta, leading to death. The E-liac competes with products from Gore and Cook. We began limited distribution of NEXUS in the fourth quarter of 2019 in EMEA. This can result in poor circulation, pain, and sores that do not heal. TMR is typically performed with a CO2 or Holmium: YAG laser. We are approved to distribute SMI's PerClot in approximately 70 countries. We anticipate PMA submission to the FDA during the third quarter of 2021. Supplies of materials are discussed for each of our main products and services below. On January 21, 2021 we received notice that the FDA had approved our PMA supplement. All of these factors subject us to risk of supply interruption. Processes are validated to review whether products manufactured meet our specifications. This study is ongoing, and enrollment was completed in 2019. The contamination was identified by our routine quality controls. 30 Table of Contents We are dependent on our key personnel. We may not realize all the anticipated benefits of our business development activities. Item 1B. Unresolved Staff Comments.
