Pelvital raises $2.32M to commercialize its urinary incontinence device

Flyte delivers mechanotherapy transvaginally to the pelvic floor

The majority of adult women in the US suffer urinary incontinence (UI), with the most common form of UI being Stress Urinary Incontinence (SUI), which is often caused by weak pelvic floor muscles. SUI often presents post-partum and generally does not resolve without treatment.

Among the barriers to care include stigmatization, with UI beibg highly stigmatized, and patients being often embarrassed to bring it up with their healthcare provider, as well as normalization, Lydia Zeller, President and CEO of women's health medical device company Pelvital, told VatorNews.

"Women have historically been led to believe that UI is a normal part of being a mom, and a normal part of aging. This has led to the majority of UI being untreated – with women coping with pads rather than treating. UI is very, very common – but it is not normal, and a woman does not have to live with it," she said. 

There's also lack of access to conservative care, a lack of screening for UI, lack of information, lack of time, lack of paid time off, and lack of childcare, all of which create additional barriers.

Pelvital's first product, Flyte, uses novel technology to deliver mechanotherapy transvaginally to the pelvic floor. While it has already been used thousands of patients, the company wants to get it into the hands of as many patients as possible, and so it announced it raised $2.32 million, bringing its seed-plus funding round to $5 million, in order to expedite the commercialization of Flyte.

Flyte is an intravaginal wand, covered in smooth medical grade silicone, that is inserted into the vagina similar to inserting a tampon, delivering mechanotherapy treatment while guiding the user through a series of contractions and relaxations of her pelvic floor. The typical treatment time is five minutes per day for six weeks, with some women benefiting from 12 weeks. 

"For patients and clinicians with questions, we provide support staffed by Doctors of Physical Therapy further certified in pelvic health. That level of expert support is something you do not see elsewhere," said Zeller. 

The typical user presents with mild to severe SUI that is negatively impacting her quality of life, and they can range from new moms to athletes to women in menopause to women in their eighties. For example, it might be used by a postpartum woman who has resolved many of her symptoms through pelvic floor physical therapy but hit a plateau and is still not able to run without leaking or a woman who received surgery several years prior which resolved her incontinence at the time but has now been referred to surgery again when her incontinence returned.

Other examples include a woman in her 50s experiencing embarrassing leaks while at work and wanting to avoid surgery or a woman in her 40s using multiple pads a day and suffering related recurrent UTIs.

Nearly half, 40%, of Flyte users have been suffering for two to five years, while 24% have had issues for six to ten years, and 17% for over 10 years. 

"Our data indicates that prior to Flyte our users have been coping with leaks by using pads, avoiding exercise, staying close to a bathroom, changing their clothes often, and socializing less. Many have also tried other interventions without success," said Zeller.

"For a woman, we fill the gap by allowing her to get surgical-level results in an easy-to-use, at-home treatment, without the need to take time of work for repeated clinical visits, and without the risks associated with surgery."

The company also helps clinicians, providing them with a first-line, conservative treatment option to offer their patients. Flyte is typically prescribed as an alternative to in-person treatments, bulking agents, and surgery.

So far, Flyte has been proven in two published trials to deliver both continence rates and durability of treatment effect similar to surgery.

"It is hard to describe how powerful of an impact we make when we successfully treat a woman’s incontinence. UI is highly stigmatizing and embarrassing; many women decrease their social activities and interactions – and a third stop exercising, but it goes beyond that," said Zeller.

"UI is linked to more than double the rate of severe depression, to significantly higher rate of UTI, and is ranked just behind Alzeheimer’s and stroke in the three conditions that most negatively impact quality of life. Eliminating UI has a profoundly positive impact both on a woman’s health and on her emotional wellbeing. It is truly lifechanging." 

While some women find Flyte on their own, increasingly the majority are prescribed Flyte by their healthcare provider, and the company plans to use this funding primarily around expanding insurance coverage, along with clinical education, increasing clinician awareness of conservative treatment options for their patients, and advocating for routine screening for UI in primary care/family practice and OB/GYN. 

In conjunction with the funding, it was also announced that Preetha Ram, PhD, Managing Partner at Pier 70 Ventures, has joined the Board of Directors at Pelvital.

"We are fortunate to have a strong and diverse Board and are delighted to welcome Preetha Ram, Managing Partner at Pier 70 Ventures to the Board. Dr. Ram brings experience and a broad network in venture investment and entrepreneurship, as well as operator experience in a successful high growth company," said Zeller.

"A former Associate Dean for Science at Emory, she also brings a career-long commitment to innovation, high tech, STEM programs, and helping bridge the gender gap through mentoring and access to capital."

The ultimate goal at Pelvital is for Flyte is to dramatically decrease what is currently an unacceptable percentage of women suffering with unresolved urinary incontinence.

"We will know that we have been successful when Flyte is available to all clinicians and women as a gold standard of conservative care for UI and is covered as a first-line treatment by all insurance plans."