NeuGuide™ FDA – Cleared in 2016 from a woman-led company with innovation in women’s health.
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 yet quite painful and bothersome condition facing many women.
It is estimated that the lifetime prevalence for a woman is between 30-50%. The global market for the devices is $1 billion and is growing due to the aging population.
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 In 2011, the FDA issued warnings regarding transvaginal mesh and many products were withdrawn from the market, leaving few good options.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.
POP Medical’s NeuGuide™.FDA-cleared NeuGuide™ is a truly minimally-invasive surgical system that is much safer and simpler than the current standard of care. The surgery is conducted with no dissection and no mesh. The device is a combination of a Nitinol-based anchor, surgical sutures and an innovative method of attachment. NeuGuide was tested in a human trial in Israel with 100% success and is protected by global and US patents.