FEMSelect Information

FEMSelect® is the developer of EnPlace®, the FDA cleared and CE Marked system for suturing ligaments of the pelvic floor as an approach to minimally-invasive Pelvic Organ Prolapse (POP) procedures. The EnPlace® approach is much simpler to perform – and much easier to recover from - than the current standard of care dissection approach. The Problem: Pelvic Organ Prolapse (POP) is a painful, debilitating medical condition that occurs when the normal support of the vagina is lost, resulting in the “sagging” or dropping of the female pelvic organs. POP is a very common and bothersome condition facing many women. The Unmet Need: A Simple and Safe Pelvic Floor Repair System. The current standard of care includes hysterectomy or complicated mesh surgery. Mesh has been associated with pain, bleeding and other complications. In 2011, the FDA issued warnings regarding transvaginal mesh and many products were withdrawn from the market, leaving few good options. Many women believe they must live with the pain and discomfort due to the lack of simple, safe solutions. The Market: It is estimated that the lifetime prevalence for a woman is between 30-50%. The global market for the devices is $10 billion and is growing due to the aging population. Unique approach: FEMSelect’s EnPlace® is both FDA-cleared and CE Marked. EnPlace® is a truly minimally-invasive surgical system that is simpler than the current standard of care. The surgery is conducted with no deep dissection and no mesh. The device is a combination of a Nitinol-based anchor, surgical sutures and an innovative method of attachment. EnPlace® was tested in a large Post-Marketing Study in the US, Germany and Israel and is now available commercially in the US, Israel, Cyprus, Chile, Panama and soon in Mexico and Costa Rica. The EnPlace® technology is protected by global and US patents.