Neuspera Medical has concluded enrolment of patients and implant procedures for the SANS-UUI pivotal clinical study of its minimally invasive implant, Neuspera System.
The implant has been designed to offer personal control and relief to patients from the overactive bladder (OAB) symptom called urinary urge incontinence (UUI).
OAB is a common medical disorder that impacts approximately one in six adults.
The single-arm and multi-centre trial is intended to assess the efficacy and safety of the Neuspera System.
It involved screening and implanting the device in patients at 26 centres in Europe and the US.
The data from the trial will be used to receive approval from the FDA for the system.
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Neuspera Medical CEO Steffen Hovard said: “We are pleased to have reached the target patient enrollment in our pivotal SANS-UUI trial.
“The completion of patient implants builds on the progress and strong momentum from our previously reported positive clinical outcomes.”
Neuspera has developed this system to offer patients who have not found success with medication management a less invasive and more accessible means of benefiting from sacral neuromodulation.
Featuring an ultra-miniaturised pulse generator attached to an electrode array, the Neuspera System is claimed to be the least invasive sacral neuromodulation device.
The system already received approval from the FDA to treat chronic pain of peripheral nerve origin.
In April 2023, Neuspera Medical obtained approval from the FDA for its next-generation ultra-miniaturised system for peripheral nerve stimulation.
Designed for chronic peripheral nerve pain management, the leadless micro-implant provides neurostimulation therapy through a wireless platform, powered by a wearable transmitter.