Neuspera Medical® announces first successful implant of the Nuvella™ System in the second phase of its sans-UUI IDE Clinical Trial
Study to support U.S. FDA approval of sacral neuromodulation device in patients with urinary urgency incontinence symptoms
SAN JOSE, Calif., Oct. 10, 2022 /PRNewswire/ — Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms.
Photo (left to right): Alex Yeh, Neuspera Founder & CTO, Dr. Jodi Michaels of Minnesota Urology and Steven Siegel, Neuspera CMO
“I am excited to be a part of the initial cases and for the potential of this innovative technology to treat my OAB patients in a less invasive and more adaptable way than current devices,” stated Dr. Jodi Michaels. “This system has the ability to treat UUI symptoms with the smallest available implant, significantly improving the patient experience.”
The prospective, multi-center, single-arm study will enroll 145 patients globally. The feasibility phase results of SANS-UUI were first presented at the annual meeting of the American Urological Association (AUA) in September 2021 and again at the winter meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in 2022. In 34 patients implanted with the Nuvella system, 90% of subjects demonstrated a 50% improvement in UUI symptoms at 6 and 12 months with two hours of daily stimulation, while 52% were completely dry at the 12-month visit.
Sacral neuromodulation is a proven therapy for the treatment of UUI that can significantly improve quality of life in patients suffering from this condition. The Nuvella system delivers neuromodulation therapy through a wireless, less invasive, and more versatile platform than commercially available technology. Nuvella is the first sacral neuromodulation device that offers this ultra-miniaturized option, which may allow for a better patient experience and greater procedural flexibility.
“We are pleased to enroll the first patients in our pivotal SANS-UUI trial, an important milestone for the company. Kicking off enrollment builds on the strong momentum from our feasibility experience,” commented Steffen Hovard, CEO of Neuspera Medical. “This technology has the potential to revolutionize the way physicians utilize SNM therapy to treat patients battling chronic conditions, while restoring patients’ health and quality of life.”
Overactive bladder (OAB) is a common medical disorder affecting roughly 1 in 6 adults.1 Symptoms of OAB include sudden, uncontrolled need or urge to urinate (most common), urine leakage, and need to pass urine many times during the night. The worldwide OAB treatment market size was 1,192.5M in 2020 and is experiencing tremendous growth due to increasing prevalence of chronic conditions.2
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1. MedTech Monitor: The Next Growth Opportunity For Neuromodulation: OAB Piper Sandler Investment Research
SOURCE Neuspera Medical Inc.