Neurotech Firms Flock to Urological Disorders Market

by James Cavuoto, editor

June, 2015 issue

The neurotech market for treating urological and bladder disorders has become more crowded recently as several new firms have introduced new sacral nerve or tibial nerve stimulation systems.

At the recent meeting of the International Neuromodulation Society in Montreal [see conference report, p7], several new players were on hand. Axonics Modulation Technologies of Irvine CA, a spinoff from the Alfred Mann Foundation, displayed a sacral nerve neuromodulation system for the treatment of urinary and fecal incontinence. The device uses a rechargeable IPG, a user-friendly patient remote, and implanted leads. An Israeli firm, BlueWind Medical Ltd., showed an injectable wireless tibial nerve stimulation system that includes a wearable control and recording unit. FemPulse LLC showed a noninvasive stimulation system for overactive bladder in women.

Sacral nerve stimulation market leader Medtronic has sold more than 150,000 InterStim systems. Publicly traded Cogentix Medical (formerly Uroplasty Inc.) is the current market leader in tibial nerve stimulation systems. Its Urgent PC neuromodulation system consists of a percutaneous needle electrode and a handheld stimulator. The device received FDA clearance for overactive bladder in 2005. Urgent PC sales amounted to $18 million last year, an increase of 17 percent. Nuviant Medical, Inc., a Dallas, TX startup launched by MicroTransponder founder Will Rosselini, plans to offer an implantable wireless tibial nerve stimulation system to treat OAB. Nuviant recently added Uroplasty’s former CEO to its board.

StimGuard LLC, a spinoff of Stimwave Technologies in Miami Beach, FL, recently announced positive results for long-term patients using its wireless injectable tibial nerve stimulator system for treatment of OAB. The device was placed last year in Zurich, Switzerland by urology pioneer Karl-Dietrich Sievert, chairman of urology at the University of Salzburg. Patient outcomes showed reduction of voiding episodes and more than 80 percent relief with a therapy that is administered only at night.

The StimGuard technology, developed by scientists and engineers led by co-inventor and StimGuard chairman Laura Tyler Perryman, uses an injectable microchip device placed through a small needle that delivers small pulses of energy to electrodes near surrounding nerves, triggering a reaction that enables the brain to remap specific urge signals.

“The therapy is utilized for just eight hours a day, so it can be conveniently administered using only a sock worn during the evening or overnight,” said StimGuard director James McGivern. “Chronic tibial stimulation affects multiple afferent paths to the micturition centers, possibly better serving patients than classic sacral neurostimulation over the long term.”

Sievert conducted the procedures live at the 2014 Swiss Continence Foundation Conference in Zurich last August. “I am pleased to report that our two patients who presented with OAB and a variety of other medical complications had long term positive outcomes and a reduction in incontinence episodes of greater than 80 percent on average, positively affecting their quality of life,” said Sievert.

StimGuard plans to complete regulatory studies for CE Mark in 2015 and to seek FDA approval in 2016.