From: https://doi.org/10.1016/j.neurom.2025.01.013
My colleague Nicolás Barabino of Adcorpus called my attention to a recent publication by Nine Continents Medical reporting on Coloplast’s Intibia™ System, which is an implantable tibial nerve stimulator in subjects with urgency urinary incontinence.
Nine Continents Medical was founded in Livermore, CA in 2014. It was acquired in 2020 by ostomy company Coloplast acquired for $145M upfront cash payment and an additional contingent future milestone payment. The acquisition gave Coloplast an early-stage implantable tibial nerve stimulation treatment for over-active bladder.
The Intibia™ implantable tibial nerve stimulator (ITNS) is a miniaturized, self-powered unit placed in the lower leg under local anesthesia during a short, minimally invasive procedure. It is claimed to have long battery life, with no need for patient compliance in therapy.
Coloplast began pivotal studies in early 2022, with the ambition to obtain pre-market approval for a Class III device in the US and EU market.
The newly-published study was conducted on 10 patients with OAB, and provided preliminary data to inform the clinical program design to assess the safety and efficacy of the ITNS device in development for the treatment of patients with UUI symptoms.
According to the paper:
“Among the patients enrolled (mean age 68 years), seven were OAB-wet and three OAB-dry. After 13 weeks of therapy
delivery, a reduction in the number of daily voids during waking hours (8.5 ± 2.5 to 6.3 ± 1.9; p = 0.016), incontinence episodes (2.5 ± 1.8 to 0.3 ± 0.5; p < 0.001), and the daily voids associated with urgency (7.6 ± 3.1 to 3.0 ± 3.1; p < 0.001) was reported. Eight of the ten subjects were classified as responders for ≥one OAB component, with one patient reporting worsened symptoms of urgency (+6%). All ten patients reported global improvement in symptoms on the GRA with a median score of 6. Improvements in OAB severity and health-related quality-of-life scores were noted from pre- to posttreatment across participants (p < 0.001). No serious adverse effects were noted.”