Innovative device offers women more freedom

Flyte, the magic wand to cure stress incontinence

Michael Kleiner
Business & Sports Editor
The Norwegian American

When Shelly would go out with friends, she would have to note the location of the nearest bathroom.

All it took for Chris to experience urinary leakage was to laugh, sneeze, or cough.

Joan and Lori would experience leakage during exercise workouts.

Such is the “life” for women with stress urinary incontinence (SUI), which is a sudden urge to urinate. Women with SUI can experience mental health issues of embarrassment, depression, and isolation. SUI afflicts 17 million women in the United States, according to the Mayo Clinic, and is the most common form of incontinence. The Cleveland Clinic estimates 33% of people assigned female at birth (AFAB) will deal with SUI at some point in their lives. Seventy percent are undiagnosed.

The condition can last for years. Solutions can be certain exercises or surgery, but SUI can return.

Flyte (pronounced like flight), is a device developed by Dr. Gunnar Leivseth, a gynecologist at the Arctic University of Norway in Tromsø, and sports medicine specialist Ole Olsen.

“This is not a niche market at all. This is new mothers, athletic women, post-menopausal women, daughters, mothers, sisters, grandmothers, wives,” said Lydia Zeller, who became president and CEO of Flyte in April. “Historically, investment and

research into female health has lagged substantially behind investment in research into male health.

“But that is beginning to change. I truly believe tailwinds are behind women’s health. The attention paid to mental health in the last couple of years, precipitated by COVID, is going to be helpful to women’s health. Mental-health challenges were historically stigmatized.”

Flyte, taken from the Norwegian word “flytte,” meaning “movement or freedom of movement,” is an intravaginal wand-like device connected to a disc, providing mechanotherapy at the same time the woman contracts her pelvic floor muscles (kegels). The size of the wand is intended to provide a gentle therapeutic stretch while inserted.

One kegel equals one muscle contraction. It has to be done correctly to be effective. Flyte enhances that by 39 times–and tells the user if she is doing the kegel correctly–enabling the benefits to be experienced faster. The patient only needs to use it for five minutes a day for six weeks. Some women who have been suffering for decades have seen improvements within two weeks. Flyte was brought to the United States in 2016 and approved by the Food and Drug Administration (FDA) in 2020 as over-the-counter, meaning it could only be ordered directly from Flyte for $395 or a prescription from a doctor.

Shelly, Chris, Joan, and Lori have their lives back.

Geography was the mother of invention.

“We don’t have a hospital in every fjord,” said Leivseth. “The people living in Northern Norway travel a long distance for medical care. At that time, the (Arctic) university hospital had their own hotel so that the patient could live there while being treated.

“We saw the results and the compliance of the patient were not very good because they are away from home. We thought: Can we develop a method where the patient can treat themselves.”

Beginning in the 2000s, a partnership was established between Arctic University and Ergotest, a company that developed training equipment for professional athletes. Professionals in the fields of gynecology, muscle rehabilitation, and urinary incontinence treatments were also involved.

“I did my Ph.D. in physiology and was well aware of different measuring methods,” said Leivseth. “I saw that the common methods that they were using to investigate the function of the pelvic floor had major flaws in it. We examined how the force of the pelvic floor changes with respect to the length of the pelvic floor.”

Leivseth asked Olsen if he could develop a device.

“Ergotest developed sensory systems for optimization and training of the neuromuscular system,” explained Olsen in a video on the Flyte Therapy website. “Our products measured and quantified athletes’ ability to generate force and speed. Key elements in our training included biofeedback as well as strengthening and toning through mechanotherapy. Ergotest helped develop a whole body vibration machine. Its purpose was to generate forces that affected the muscles, nervous system, and circulation.

“When Gunnar asked if we could create a wand to treat the pelvic floor muscles, we simply adapted our existing concept into the new application. Together, the wand, the mechanical pulses, and the biofeedback significantly amplified the effects of a kegel.”

There were two clinical studies, one at Arctic University, and one at multiple locations in the United States. Subjects had to have endured SUI an average of nine years with surgery as the last option. Of the 60 women in the Norwegian study, 83% achieved continence at six weeks; 77% reported continence at the two-year follow-up. The American study involved 119 women with severe cases of SUI. After just two weeks, 37% related being dry or near dry. At 12 weeks, 71% reported the same. Over 90% said Flyte was easy to use. The “magic wand” could be used to treat mild, moderate, or severe SUI. None of the participants in either study needed surgery. Quality of life improved after two years.

“They experienced a better contraction on the pelvic floor and sensed the contraction in a better way,” said Leivseth.

BARN (Business Acceleration Resource Network) did not exist at the time that Pelvital, parent company of Flyte, first came to the United States in 2016. Leivseth contacted Ole Koppang, then president of the Norwegian American Chamber of Commerce North, and Minneapolis resident Dale Wahlstrom to be the first CEO.

“They asked me to help them figure out how to commercialize Flyte after they had clinical data,” said Wahlstrom, now chair of the Pelvital board and former board member of Norway House. “Minneapolis has a very large medical device setting. We also have a large urology-based group of companies that are interested in this type of technology. When they came to the United States, we created the company Pelvital USA. “

Zeller was brought in to take the venture to the next level.

“I have been an entrepreneur all of my life,” she said. “My most recent company was a digital health-care company (Kiio) in the muscular skeletal space. At that company, my most meaningful contributions were orchestrating a pivot in product and market to a digital solution that we sold to payers, health insurance companies, and large employers, and then deployed in their membership as a fully covered benefit. My relevant experience is in digital health care, consumer engagement, in B2B, to see value-based payer models, and in scaling and growing companies. I was brought in to hone our go-to-market strategy, tie into trends, and not only e-commerce health care, but also virtual and digital health care, and ramp up our commercialization.”

Pelvital’s arrival predated the creation of BARN by almost three and a half years. Wahlstrom, former interim chair of BARN, and Britt Ardakani, director of Business Outreach, BARN, are determining what lessons they can learn from the Pelvital experience.

One initiative, Membership Advertising, is a collaboration involving The Norwegian American.

“We want to have more companies join as advertising members of BARN like we’re doing with Flyte,” said Ardakani. “The company will buy 12 ads in The Norwegian American, advertising on our websites. Information about the product will be in two newsletters, on social media several times, and will be displayed on the TV screen in our cafeteria. There will also be printed material about the product available.”

“What we’re trying to do with BARN is to figure out how we can bring value to every company coming over by leveraging the capabilities and the infrastructure of Norway House,” said Wahlstrom. “Every company coming over is looking for people in the network of the Norway House to let them know that they’re here. They have a product. They have Norwegian history. Their roots are in Norway. How can we leverage these resources to provide benefit to them?

“That was a first piece. We’ve been working on BARN for two and a half years and Pelvital for six. Pelvital is way beyond in its development than most companies coming to the BARN today. The mechanism we’re developing is to expand our ability to support more mature companies, as well as young companies, through leverage. The work I did with Gunnar is the same thing we’re doing for the companies coming over now.”

This article originally appeared in the January 2023 issue of The Norwegian American. To subscribe, visit SUBSCRIBE or call us at (206) 784-4617.