Avation Medical

The Vivally System by Avation Medical is supported by two multicenter clinical studies. The FreeOAB study (96 patients, FDA 510(k) K220454) demonstrated that 63.8% of patients had significant reduction in incontinence or void symptoms (p=0.007), with daily improvements of 2.84 voids, 1.91 leaks, and 3.09 urgency episodes after 12 weeks. Quality of life improvements exceeded 200% of the minimally clinically important difference. Benefits were sustained after 1 year with zero device-related serious adverse events.

The ReduceOAB sham-controlled study (125 patients, 1:1 randomized) showed 83.6% response rate in the active arm (p=0.0031), with daily improvements of 3.73 voids, 2.61 leaks, and 3.76 urgency episodes. 49.1% of patients returned to normal in one or more symptoms. Patient satisfaction was 98.9%, ease of use 98.9%, and 95.6% said they were likely to continue using Vivally.

Vivally costs approximately $4,995 for a 3-year treatment period, compared to medications ($17,000), BOTOX ($6,500–$12,500), PTNS ($5,445–$13,995), sacral/tibial implants (over $23,000), and catheters ($12,405–$22,995).

Clinical Evidence

Vivally Clinical Evidence

We conducted several successful multi-site randomized clinical studies to generate robust clinical evidence for Vivally effectiveness, safety and usability.

ReduceOAB — Sham-Controlled Study, 12-weeks, 125 patients

  • Vivally Active users had 83.6% success (5 of 6 patients were responders)
  • Responder defined by significant reduction in incontinence (≥ 50%) or voids (≥ 30%)
  • 49.1% of patients became asymptomatic in one or more symptoms
  • Notable daily symptom improvements — 3.73 (Voids) | 2.61 (Leaks) | 3.76 (Urgency)
  • Study successful showing Active arm superior to sham (p-value 0.0031)

Patient Perspectives from clinical trials:

  • Quality of Life (OAB-q and I-QoL) improvement > 200% over benchmark MCID
  • Very high therapy compliance at 92.7%
  • Confirmed long-term sustenance of effectiveness with 12 months of clinical data
  • Vivally is inherently safe with no device-related serious adverse events
100%

Easy to fit in their daily routine

98.9%

Satisfaction

98.9%

Easy to use

95.6%

Likely to use Vivally to treat OAB

Journal Publications

Posters and Presentations

Additionally, Avation has conducted multiple Feasibility Studies, Human Factor Trials, Bench-top Testing and an ongoing real-world registry to validate the technology features, ensure ease of use by patients, system durability and robust Vivally operation under all operating conditions.