US start-up raises US$2.32m to address pelvic health concerns

The US women’s health start-up Pelvital has raised US$2.32m in funding to address “unanswered” pelvic health issues.

Minnesota-based Pelvital aims to restore pelvic health with its first product Flyte, an FDA-cleared intravaginal treatment for stress urinary incontinence (SUI) and weakened pelvic floor muscles.

The device, originally developed by physicians from the Arctic University of Norway, uses mechanotherapy, a treatment modality that when paired with an active pelvic floor contraction stimulates tissue regeneration and the creation of neuromuscular memory.

The company will use the funding to speed up the commercialisation of Flyte and raise awareness of pelvic health issues.

“Completing this round is an important step in continuing Pelvital’s unwavering dedication to provide women with innovative solutions for pelvic health, including the treatment of SUI,” said Lydia Zeller, president and CEO of Pelvital.

“This funding will play a crucial role in accelerating our commercialisation of Flyte with a strong emphasis on expanding payor coverage and enhancing clinical education and clinician awareness.”

With this final close, Zeller said, Pelvital would welcome new investors including Pier 70 Ventures, Life Science Angels, Tech Coast Angels Orange County, and Blue Pacific Fund.

Preetha Ram, managing partner at Pier 70 Ventures, would join the Pelvital board of directors.

“Joining Pelvital’s board alongside this investment round is truly an honour,” Ram shared.

“Pier 70 and I are thrilled to be part of this transformational opportunity, as Pelvital’s mission aligns beautifully with our dedication to support disruptive technologies that shake up the status quo in healthcare.

“Pelvital’s pioneering work is shaping a future where women’s health receives the attention and innovation it deserves with novel medical devices like Flyte.”

Oscar Moralez, founder and managing partner of Boomerang Ventures who led the investment round, said: “We are thrilled for the successful completion of this round as we aim to tackle the most pressing healthcare challenges.

“Our participation aims to address the chronic underfunding in women’s healthcare. Investing in Flyte, a truly groundbreaking treatment, addresses underserved pelvic health issues like SUI and contributes to raising vital awareness.”

Two published clinical trials have validated Flyte’s safety, efficacy and durability of treatment effect for women with SUI.

Most recently Pelvital published a paper in Therapeutic Advances in Urology, showing that 71 per cent of study participants achieved dry or near dry conditions as evidenced by a reduction in 24-hour pad weight after using Flyte for between two and 12 weeks.

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