NeuSpera Medical is a medical device company focused on developing implantable neuromodulation devices to treat patients suffering from chronic illnesses. The company's flagship product, the Nuvella system, is an ultra-miniaturized sacral neuromodulation (SNM) device designed to treat overactive bladder (OAB) with urinary urgency incontinence (UUI) symptoms.
The Nuvella system delivers neuromodulation therapy wirelessly through a micro-implant that is 75 times smaller than the smallest commercial implantable pulse generator. This miniaturized design allows for a less invasive and more adaptable treatment approach, potentially enhancing the patient experience and procedural flexibility for physicians. The system includes a wearable transmitter and an iPad-based clinician programmer.
In May 2023, the company received FDA clearance for its next-generation Neuspera ultra-miniaturized system, designed for peripheral nerve stimulation (PNS) in managing chronic peripheral nerve pain. This system operates on a similar wireless platform as the Nuvella device.
NeuSpera Medical has conducted clinical trials to evaluate the safety and efficacy of the Nuvella system. In the feasibility phase of the SANS-UUI study, involving 34 patients implanted with the device, 90% demonstrated at least a 50% improvement in UUI symptoms at six and 12 months with two hours of daily stimulation, while 52% were completely dry at the 12-month visit. The company completed enrollment and implant procedures for the pivotal phase of the SANS-UUI trial in December 2023, with final results expected in the first half of 2024.
By using this site, you agree to allow SPEEDA Edge and our partners to use cookies for analytics and personalization. Visit our privacy policy for more information about our data collection practices.