Flyte device delivers mechanotherapy to the pelvic floor, thereby, stimulating tissue regeneration and the creation of neuromuscular memory all of which help to treat SUI and weakened pelvic floor muscles. Image Credit: bigshot01 / Shutterstock.

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.

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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.

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