Women's Health: Building Interventional Gynecology
This article was adapted from "Building Interventional Gynecology," which appeared in START-UP, June 2010.
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The sheer size of the stress urinary incontinence market and the potential for future growth have attracted the attention of a number of emerging companies. Although investor interest has waxed and waned over the years, it appears to be heating up once again. This renewed interest is being driven in part by the push to develop efffective nonsurgical treatments that will appeal to an increasingly health-savvy patient population.
Novasys Medical is using radio frequency (RF) energy to treat stress urinary incontinence in women. The company chose to adopt a much more rigorous and expensive clinical trials strategy than was needed to gain FDA approval of its device. This approach flummoxed the FDA,, slowing approval of the company's IRenessaI system. Novasys is betting that the enhanced data collected from its clinical study will result in the company gaining faster reimbursement that it hopes will drive adoption.