US start-up secures US$2.68m to address pelvic health concerns

The US women’s health start-up Pelvital has raised US$2.68m in seed funding to address stress urinary incontinence and pelvic health concerns.

The Minnesota-based company aims to restore pelvic health with its first product Flyte, an at-home intravaginal device that treats stress urinary incontinence and strengthens pelvic floor muscles.

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

New figures suggest that six in ten women are living with at least one symptom of poor pelvic floor health, such as urinary incontinence or pelvic organ prolapse — yet 69 per cent have never mentioned these to an NHS professional, according to a recent survey by the Royal College of Obstetricians and Gynaecologists (RCOG).

In the US, around 25 per cent of women reported one or more pelvic floor disorder, with urinary incontinence being the most common disorder reported.

“Pelvital is committed to empowering both women and clinicians with transformative products backed by strong clinical evidence,” said Lydia Zeller, president and CEO of Pelvital.

“We are excited to partner with Boomerang as we execute on our vision to be the gold standard of care for treatment of urinary incontinence, an issue that impacts one in two women.

“In the context of significant gaps in health equity – and in particular for issues that disproportionately impact peri-menopausal and menopausal women – increasing access to clinically proven, patient-centric treatments is vitally important.”

The investment round, led by Boomerang Ventures, will be used to complete the development of the company’s product and accelerate commercialisation.

Oscar Moralez, founder and managing partner of Boomerang Ventures, said, “Boomerang Ventures is driven to solve the biggest challenges in healthcare which is why we’re so excited about this investment in Flyte by Pelvital.

“Their commitment to innovation, science-backed results, research and development, and user experience is making a significant impact on lives and on the cost of care.

“We have understood for a long time both the opportunity and the historic underfunding in women’s health care, and we’re beginning to understand how largely neglected the menopause segment is. We are incredibly proud to be part of the contingent addressing this gap.”

Two clinical trials studied the safety, efficacy, and durability of Flyte in women with stress urinary incontinence. The studies, Pelvital says, demonstrated that Flyte can deliver continence rates and durability comparable to surgery, yet with a fast and convenient treatment.

Typical treatment is only five minutes per day for a total of six weeks. The device is FDA-cleared for both over-the-counter and prescription use.