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Stuart Edwards: Tale of a Serial Entrepreneur

This article was originally published in Start Up

Executive Summary

Few individuals can successfully combine an inventor's creativity with an entrepreneur's business acumen to launch a device start-up company. Doing that nearly a dozen times, as Stuart Edwards has, is quite a feat, particularly in today's hostile environment for device company creation. Edwards has a unique formula, relying on a common technology base (radio frequency or RF energy) which he applies to untapped markets, such as sleep and gastrointestinal disorders. Critics of his unorthodox approach claim Edwards fails to maximize value, creating separate companies rather than building a single company with greater critical mass. But Edwards has yet to have a company fail and investors are returning for more.

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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.

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.

Rita Medical: Can a Device Pure Play Compete in Oncology?

In interventional oncology, what makes RITA Medical's path particularly challenging is that the company needs to break new ground on at least a couple of levels simultaneously with its radiofrequency ablation (RFA) technology for treating solid tumors. This is not simply a case of convincing customers to substitute a next-generation device for a longstanding favorite product. The company must convince a group of physician customers-medical oncologists, who control these patients-that devices, specifically RFA technology, can play a role in oncology therapy. This when the only treatment regimens these physicians are accustomed to using are drugs and surgery.

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