Medical Device Network

Pelvital raises $2.3m to advance commercialisation of Flyte device

Pelvital’s Flyte device is approved by the US FDA to treat stress urinary incontinence (SUI) and weakened pelvic floor muscles.

US-based women’s health medtech company, Pelvital, has closed an additional $2.32m in seed plus funding to commercialise its Flyte device.

The additional funding brings the total funding raised to $5m and exceeds the initial target by $500,000. The financiers included US-based venture capital fund Boomerang Ventures, Pier 70 Ventures, Life Science Angels, Tech Coast Angels Orange County, and Blue Pacific Fund.

Pelvital plans to use the funds to accelerate the commercialisation of its US Food and Drug Administration (FDA) approved Flyte device. The US FDA cleared the Flyte device for intravaginal home use as a treatment for stress urinary incontinence (SUI) and weakened pelvic floor muscles in 2020.

The device delivers mechanical therapy, which is aimed at stimulating tissue regeneration and the creation of neuromuscular memory, while women contract their pelvic floor muscles. The therapy is delivered for five minutes per-day over six weeks. Clinical trials for the device show that 77% of participants using the Flyte device remained continent after two years.

Concurrent with the funding, Preetha Ram, PhD, managing partner at Pier 70 Ventures also joined Pevital’s board of directors.

There has been an increased interest and investment in women’s health in recent months. Big data and artificial intelligence (AI) are expected to be major trends in the field. To that end, GE HealthCare launched the US FDA-approved AI-assisted breast cancer screening platform, MyBreastAI suite, in November 2023.

Last year, US-based women’s healthcare company Gynesonics raised $42.5m in financing to help further commercialise its FDA-approved Sonata technology. The system uses radiofrequency ablation with intrauterine ultrasound guidance to treat symptomatic uterine fibroids.

In January, the US FDA cleared Q-Pad’s Qvin menstrual pad for collecting blood samples for the A1c haemoglobin test to monitor blood sugar levels. The Qpad comes with a single removable strip which after use can then be sent to a laboratory for clinical testing, with users receiving results via a proprietary phone app.