Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, today announced the completion of the 100th implant of its Neuspera System as part of the SANS-UUI Phase II clinical trial. SANS-UUI is an international study that’s evaluating the safety and efficacy of the Neuspera System, a discreet, minimally invasive implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB).
“I’m always looking for the most advanced and effective treatment methods to offer my patients suffering from overactive bladder that will provide them relief and help them get back to living their lives as normally as possible,” said Dr. Derrick Sanderson, D.O. Urogynecology at Women’s Health Advantage in Fort Wayne, IN. “I’m excited to be a part of this clinical trial and the potential of this minimally invasive and discreet sacral neuromodulation therapy option.”
OAB is a common medical disorder affecting roughly 1 in 6 adults. OAB symptoms include a sudden, uncontrolled need or urge to urinate, urine leakage, and/or the need to pass urine many times during the night and day. These symptoms can make it difficult to work, socialize, exercise and lead a normal, active life which can lead to depression, self-esteem and social stigma issues.
Neuspera’s unique system is designed to provide patients who have failed medication management a minimally invasive, more approachable way of benefitting from sacral neuromodulation, a clinically proven effective treatment that’s been used for more than 30 years to treat UUI associated with OAB.
The system is comprised of a minimally invasive, ultra-miniaturized pulse generator that is 100 times smaller than the smallest commercially available sacral neuromodulation pulse generator. It is designed to be discreet, to provide patients with freedom from inconvenient and visible batteries, and to empower them to regain control of their quality of life. The device works together with a convenient external wearable to activate the system that is designed to fit into patients’ lifestyles and give them the personal control and relief from their symptoms that have been controlling them and their life for some time.
“We’re grateful to all of the physicians and patients for their enthusiastic participation in this study,” said Steffen Hovard, CEO of Neuspera Medical. “We have positive feasibility data from phase one of SANS-UUI, and this phase two pivotal study is an important step in getting closer to being able to potentially fill a gap in the sacral and tibial neuromodulation market that meets patient demand for a discreet, effective solution.”
The Neuspera System has FDA approval for peripheral nerve stimulation (PNS) and is undergoing clinical trials as an investigational device for the use of treating UUI, a symptom associated with OAB.