Pelvital
A Non-invasive Revolutionary Approach to Treating SUI

According to medical studies, one in every three women experiences stress urinary incontinence (SUI)—the leakage of urine due to the pressure on the bladder or urethra—at some point in her life. Of the 16.6 million American, women suffering from SUI, fewer than 30 percent are clinically diagnosed. Many simply cope using pads, unaware that conservative treatment options are available. Minneapolis-based pelvic health company, Pelvital, hopes to help change this. The company is working to commercialize FlyteTM, a simple in-home treatment for SUI, designed to treat weakened pelvic floor muscles and provide a good outcome at a fraction of the cost and risk of surgery.

Pelvital has recently completed enrollment in a 120-patient multicenter, randomized, double-blind controlled trial in the U.S. According to interim results, 80 percent of women using FlyteTM witnessed a reduction of at least one level of leakage severity (severe to moderate, moderate to mild, or severe to mild) with the majority of them achieving continence or mild levels of leakage. When it enters the market, the offering is expected to serve a large unmet clinical need as a conservative SUI treatment for the millions of women who are untreated today.

Vision and Humble Beginning

Pelvital began as an academic research project by a group of physicians in Norway who developed a prototype device and conducted a clinical study in Europe; early results were very promising. The team then partnered with medical industry veteran, and investor Dale Wahlstrom to establish Pelvital USA and launch FlyteTM in the U.S. market. “Our objective is to commercialize a clinically proven, in-home SUI treatment that has the potential to improve the quality of life of millions of women who are not being treated today, “said Dale Wahlstrom, Pelvital’s Co-Founder and CEO.

Key Differentiators

Pelvital’s FlyteTM is the only product to use mechanotherapy to treat pelvic floor muscle (PFM) disorders, the primary underlying cause of female SUI.

Mechanotherapy uses non-invasive mechanical stimuli to the surface of the pelvic floor to influence molecular, cellular and tissue structures and function via a process called mechanotransduction, ultimately leading to improved bladder control. “Mechanotherapy is a time efficient, effective therapy that essentially turbo charges gold standard Kegel exercises because it amplifies the treatment impact of Kegels by about 40 times,” said Wahlstrom. The product is designed to be used by women in the privacy of home for 5-minutes per day during a recommended 6-week treatment time.

Our objective is to commercialize a clinically proven, in-home SUI treatment that has the potential to improve the quality of life of millions of women who are not being treated today

“Unlike other intravaginal SUI devices on the market that are essentially mobile apps that teach women how to perform Kegel exercises, FlyteTM is a treatment with clinical outcomes backed by data, including the largest multicenter and double-blind study,” said Carrie Vollmer, VP of marketing at Pelvital. “We are excited about offering a non-surgical solution that has the potential to improve quality of life for woman at all levels of severity.” Flyte will be available through Ob-Gyns, urogynecologists, pelvic floor physical therapists and other clinicians who can diagnose, assess, and offer it as a first-line conservative treatment.

The Promising Potential

Early results are encouraging. During Pelvital’s first clinical study, a 38- year old woman was referred to the Department of Gynecology and Obstetrics at the University Hospital of Northern Norway, Tromso because of incontinence issues after two childbirths. After clinical and urodynamic examination, she was diagnosed with SUI. Stress tests showed a urine leakage of 66 grams. The patient was enrolled in Pelvital’s clinical study. After four weeks of treatment with FlyteTM, a significant improvement was observed, with almost 60 grams of leakage reduction (from 66 grams to 8 grams). In the randomized U.S. study the median 24 hour pad weight of patients dropped from 28.1 grams to 5.0 grams, or about 1 teaspoonful over 24 hours.

Backed by promising outcomes, upon FDA clearance, Pelvital is planning a limited market release for the duration of 2019 before a full release in 2020. In the upcoming days, the company’s main focus will be on broadening access to the treatment to serve a massive untreated population in a cost-effective and simple way.