Neuspera Medical has announced plans to begin the second phase of its SANS-UUI pivotal clinical trial of the Nuvella system.
The company plans to start enrolling 145 subjects at 25 sites across the world.
The single-arm clinical study has been designed to assess the Nuvella system’s safety and efficacy for the treatment of overactive bladder (OAB) in patients who have urinary urgency incontinence (UUI) symptoms.
It is said to be the first sacral neuromodulation (SNM) device designed to provide a minimally invasive option, which could allow better procedural versatility and patient experience.
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 have no visible external appearance of the implant.”
In the feasibility phase of the SANS-UUI study, 34 subjects were implanted with the Nuvella system.
According to the findings, 90% of subjects showed an improvement of 50% in UUI symptoms at six and 12 months with two hours of daily stimulation.
At the 12-month visit, 52% of the subjects were completely dry, said the company.
Neuspera Medical chief medical officer Steven Siegel said: “In addition to the clinical benefits seen, Nuvella demonstrated safety consistent with other commercially available devices.”
The company is committed to developing implantable medical devices to improve the lives of patients with chronic diseases.
Including the Nuvella system, the Neuspera platform will provide patients and physicians with new and potentially earlier treatment options that are less invasive and more adaptable.