Neuspera Medical has implanted the neuromodulation device in the patients treated in SANS-UUI two-stage seamless clinical trial
Neuspera Medical, a clinical stage medical device company, has completed the first chronic clinical implants of the Neuspera Neuromodulation System on the sacral nerve.
The company has implanted its ultra-miniaturised device in the first set of patients treated in the SANS-UUI clinical trial that evaluates approximately 200 patients around the world.
SANS-UUI trial is a multi-centre, single-arm, open-label, two-stage study to support FDA approval for Urinary Urgency Incontinence (UUI), a symptom of overactive bladder.
Rebecca McCrery urogynecologist from Omaha, Nebraska, has performed the first implantation.
McCrery said: “It is exciting to see continued innovation in the sacral nerve stimulation space resulting in more options for patients and physicians. I was impressed that the implant procedure was very straight forward and importantly, placement of the implant does not require pocket formation, blunt dissection, or tunnelling, making this procedure less invasive for both patients and physicians.”
The first phase of the clinical trial is planned to be conducted at up to 14 sites in the US and Europe to assess the usage of the system and determine the time required for daily stimulation.
The second phase of the trial will assess the safety and efficacy of the Neuspera Neuromodulation System for the primary efficacy endpoint and for secondary safety and efficacy endpoints.
SANS-UUI trial principal investigator Steven Siegel said: “Neuspera’s system may broaden the appeal of sacral Neuromodulation for urinary urge incontinence patients who are reluctant to try implantable therapy because of the invasiveness of the options currently available.”
Neuspera Neuromodulation System is a wirelessly powered sacral nerve stimulator
The Neuspera Neuromodulation System is a wirelessly powered implant, and is the smallest known sacral nerve stimulator, more than 100 times smaller than the available systems, said the company.
The company’s patented Mid-Field Powering technology will enable the implant to be wirelessly powered by a lifestyle-integrated, wearable, external transmitter.
The technology platform is said to provide physicians with the first catheter-delivered sacral Neuromodulation device that prevents need for tunneling or forming pocket for an implanted battery.
Furthermore, the features will enable patients to benefit from a less invasive implant procedure, resulting in potentially lesser complications and post-surgical adverse effects.
Neuspera Medical president and CEO Milton Morris said: “The start of the SANS-UUI trial brings us a step closer to our goal of delivering the benefits of sacral Neuromodulation to patients who have struggled with urinary urge incontinence and have yet to find an acceptable stimulation therapy option.
“We are thankful for the support of our investigators who are delivering this important therapy to deserving patients in a safe and responsible manner consistent with the new environment of COVID-19 and associated FDA guidance on clinical trials.”