NiNA

NiNA Companion App — your non-invasive neurostimulation companion for managing overactive bladder at home. Simple, effective, and designed for daily use.

NiNA is the companion app for EBT Medical's non-invasive neurostimulator, designed to help manage overactive bladder (OAB) from the comfort of your home.

Connect to your NiNA device via Bluetooth, follow guided therapy sessions, and track your treatment progress — all in one app.

LIMITED AVAILABILITY

This app is not available to the general public. NiNA is distributed exclusively to enrolled participants in an authorized clinical study. Access requires a clinical invitation link and credentials provided by the study site. The app cannot be used without a prescribed NiNA device and an active study enrollment.

NiNA is an investigational device, used solely under an authorized clinical investigation in accordance with FDA 21 CFR Part 812. The IRB has issued a Non-Significant Risk (NSR) determination for this device (see attached letter, IRB Protocol #[00094048]). The approval of the protocol is done by Advarra IRB which is registered with OHRP and FDA under IRB#00000971.The app is restricted to participants enrolled in the study; access requires a protocol-issued invitation link. The app is not available to the general public and does not provide diagnoses or treatment advice outside the supervised study.

KEY FEATURES

• Device Pairing: Seamlessly connect to your NiNA neurostimulator via Bluetooth Low Energy
• Guided Therapy Sessions: 30-minute guided sessions with real-time intensity adjustment and feedback.
• Structured Treatment Programs: Follow the RESTORE program (28 days of daily sessions) then transition to MAINTAIN for ongoing care.
• Treatment Tracking: Monitor your weekly progress, session history, and treatment consistency.
• Device Monitoring: Real-time battery level, electrode status, and pad connection diagnostics.
• Firmware Updates: Keep your device up to date with over-the-air firmware updates.
• Educational Content: Access in-app tutorials and treatment guidance videos.

HOW IT WORKS

1. Pair your NiNA device using Bluetooth.
2. Begin your prescribed treatment program.
3. Adjust stimulation intensity during each 30-minute session until you feel the correct sensation.
4. Track your progress and stay consistent for the best results.

IMPORTANT MEDICAL DISCLAIMER

This app is intended for use only under the direction and supervision of a qualified healthcare professional as part of an authorized clinical investigation by SPRIM Pro and Obvio Health. NiNA is an investigational device and has not received FDA clearance or approval. It is being studied under a clinical trial to evaluate its safety and effectiveness. Do not use this app as a substitute for professional medical advice, diagnosis, or treatment. Always consult your doctor before making any medical decisions or changes to your treatment plan. A enrolment in the trail by SPRIM/Obvio Health and NiNA device are required.

INVESTIGATIONAL DEVICE - JURISDICTION The NiNA neurostimulator is an investigational device that an Institutional Review Board (IRB) has determined to be a Non-Significant Risk (NSR) device. It is authorized for use only by participants enrolled in IRB/ethics-approved clinical studies conducted in the United States and Australia, and is made available to authorized testers in Canada. It is not a cleared or approved commercial medical device and is not for general sale or use.