Neuspera's Nuvella system is said to be the first sacral neuromodulation (SNM) device to offer a minimally invasive approach, which could improve procedural flexibility in the treatment of overactive bladder
US-based medical device company Neuspera Medical is set to recruit patients for the second phase of its pivotal clinical trial (SANS-UUI) with its Nuvella system.
The single-arm study will enrol 145 patients at 25 sites around the world to study the safety and efficacy of the system in the treatment of patients with urinary urgency incontinence (UUI) symptoms.
Neuspera’s Nuvella system is said to be the first sacral neuromodulation (SNM) device to offer a minimally invasive approach, which could improve procedural flexibility in the treatment of overactive bladder (OAB).
Neuspera Medical founder and chief technology officer Alexander Yeh said: “We are very pleased the SANS-UUI trial has reached this important enrollment milestone, as we are now one step closer to bringing the life-changing benefits of this technology to patients.
“The Nuvella system is the smallest available SNM device designed to minimise post-procedure discomfort and has no visible external appearance of the implant.”
The feasibility phase results of SANS-UUI were presented at the American Urological Association (AUA) annual meeting in September last year and at the winter meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in February this year.
With two hours of daily stimulation, 90% of 34 patients implanted with the Nuvella device showed a 50% reduction in UUI symptoms at six and 12 months, while 52% were dry at the 12-month visit.
Neuspera Medical chief medical officer Steven Siegel said: “These results are very promising. In addition to the clinical benefits seen, Nuvella demonstrated safety consistent with other commercially available devices.”
Neuspera Medical develops implantable medical devices to improve the lives of patients battling chronic illnesses.
The Neuspera platform, which will feature the Nuvella technology, will offer patients and physicians new, less invasive, and customisable therapy alternatives.
The therapy options are intended to assist patients in regaining their health and well-being to improve their quality of life.
In July last year, Neuspera Medical secured $65m in Series C equity financing for the clinical trial of its miniaturised implantable neuromodulation technology platform.