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Women's Health: Building Interventional Gynecology

Executive Summary

This article was adapted from "Building Interventional Gynecology," which appeared in START-UP, June 2010.

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Building Interventional Gynecology

Once a sluggish category for clinical innovation, gynecology is drawing new venture-backed companies eager to build upon the lead created by first-generation companies operating in minimally-invasive endometrial ablation and female sterilization. First generation companies had the difficult task of creating paths to early adopters of minimally invasive procedures. These now exist, and the clinical specialty appears to be also evolving in ways that encourage the growth of in-office procedures.

Emerging Competitors in the SUI Market

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: Using Clinical Trials to Drive Adoption for Incontinence

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.

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