Another estimated 40 million adults are reported to suffer from FI. Until we entered the market, it was serviced by Medtronic as a single participant. Our European study, RELAX-OAB, evaluated 51 patients that suffered from UUF and UUI. Approximately 16% of adult women suffer from SUI at some point in their lives. The graphic below demonstrates OAB prevalence by gender in the United States and Europe. OAB is associated with a significant economic burden to the society. Our r-SNM System allows for 1.5T and 3T full-body MRI scans under broad conditions. The temporary implantable lead has a single electrode. The therapy is not indicated for pregnant women, or pediatric use. In the United States, there are currently five sales professionals. We consider our primary competition to be implantable SNM devices offered by Medtronic. Investing in our securities involves a high degree of risk. We rely on third parties for the manufacture of our products. As of December 31, 2020, we had 416 employees. In addition, other unanticipated costs may arise. We bear the risk of warranty claims on our products. Any of the foregoing could harm our business. This is also known as "type approval." We will be responsible for deciding whether a modification requires approval by the FDA. The FDA, state and foreign regulatory authorities have broad enforcement powers. Any of these actions could significantly and negatively affect supply of our products. We refer to this matter as the Medtronic Litigation. We may also occasionally use these proceedings to challenge the patent rights of others. Item 1B. Unresolved Staff Comments.
