Angel- and venture-backed medtech start-ups are working to fill the tremendous unmet need for alternative device options for treating (not just managing) female urinary incontinence a condition that has a significant impact on quality of life for millions of women. In this issue we profile Floelle, InControl Medical, NexHand, and Solace Therapeutics.

Solace Therapeutics Inc.’s Solace Bladder Control System is a small, lightweight, polyurethane balloon device that fills with air once it is placed within the bladder, where it floats unobtrusively at the top of the organ, not blocking the urethra. The device is designed to eliminate or reduce involuntary urinary leakage by acting as a “shock absorber” to reduce the temporary peak pressure changes in the bladder that cause urinary leakage.

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.

For over three decades, medical device investors have accepted the Food and Drug Administration's crucial role as traffic cop for their start-ups. Yes, the agency could be tough, but a green light opened a lucrative road for device companies. But venture capitalists are increasingly worried that tighter controls on regulation could endanger innovation.