This federal Project Grant award from the National Institute of Child Health and Human Development (NICHD), under the Child Health and Human Development Extramural Research program (CFDA 93.865), is funding the development of an intravaginal, wearable medical device called "Violet" by Bold Type LLC. The Violet device is designed to provide pelvic floor muscle vibration and electrical nerve stimulation therapy for patients with high tone pelvic floor dysfunction, a major contributor to chronic pelvic pain affecting up to 15% of women in the United States. The $384,973 award, with a period of performance from September 1, 2024 to August 31, 2025, supports the following key objectives: 1) developing the Violet device to deliver on-demand intravaginal electrical stimulation and vibration therapy for pain relief, as well as measure and track intravaginal temperature, motion, and position; 2) developing the Violet software, including a mobile app and embedded systems, to track symptoms, wirelessly control the device, and extract data; and 3) conducting formative usability and preliminary validation testing with 15 healthy women. Successful completion of these aims will prepare the way for a future Phase 2 project to develop a commercial-grade system, obtain FDA clearance, and evaluate the device's efficacy in a longitudinal study.
Mod # | Description | Reason For Modification | Federal Obligation (Click to sort descending) | Date (Click to sort ascending) |
|---|---|---|---|---|
| Not listed | $385.0k | 8/28/24 |