In 2007, the total value of industry shipments for U.S. manufactured medical devices was $98 billion. The Company’s laparoscopic suturing tool is classified as a “Surgical and Medical Instrument,” a category that accounts for 26% of the medical device sales in the U.S. The medical device industry is very fragmented. In 2007, there were approximately 5,300 medical device companies in the U.S., mostly small and medium sized enterprises. Approximately 73% of these medical device companies had fewer than 20 employees, with 15% having as many as 100 employees.

The U.S. is the largest consumer of medical devices in the world and leads the world in production, accounting for roughly 42% of the world’s total. In 2008, U.S. exports of medical devices were valued at approximately $31.4 billion while imports were value at $33.6 billion. The majority of imports are low tech products such as surgical gloves and instruments. Exports of U.S. manufactured surgical and medical instruments grew by 61.54% from 2002 to 2007.