Inventor says medical device stops leaks to give women active lifestyle back
EDMOND — Allison Conti is one of 88 million women globally who experience involuntary urine leakage. She's the one who decided to do something about it.
Conti, 38, invented a medical device to stop the leaking, then raised nearly $2 million to develop it and get a patent.
The device, Yoni.Fit, is undergoing a 12-week clinical trial at New York University to satisfy the Food and Drug Administration's requirements for quality, safety and effectiveness.
"It wasn't my goal to be the urine leakage lady," said Conti, who worked in marketing and advertising before becoming an entrepreneur.
But the problem she first experienced at age 29 became much worse after she gave birth to an 11-pound baby. She stopped going to her workout classes because of the embarrassment before realizing that wasn't the solution. Neither were pads or surgery.
"You feel like you're in prison when it's that bad," Conti said.
She started researching the issue and learned she wasn't alone. One in three women 18 or older experiences episodes of involuntary urine leakage during normal, daily activities like lifting something heavy, laughing, coughing or sneezing. It can be more than embarrassing.
Doctors say incontinence negatively affects quality of life. Women who experience it report more depression and loss of self-esteem. They may avoid sex and social functions, and be absent from work more often.
"There's got to be a way to intercept this," Conti decided, and the idea for her invention was born.
'Suffering in silence'
Tackling the design, production and FDA approval of a medical device didn't deter Conti.
"I just grew up in an entrepreneurial environment," she said. "I learned without even knowing I was learning at a very young age."
She also got a lot of good advice, including help from i2E Inc., which mentors technology-based startup companies, and Gina Ferriere, whose expertise is in the quality and regulatory sector of medical devices. Conti's brother, Ross Watkins, took charge of the meetings with private investors, and Francis Tuttle Business Innovation Center leased office space to her and continues to provide business support.
A 2016 feasibility study conducted at the University of Oklahoma Health Sciences Center found the product worked in 87.6% of the women tested and showed the product needed to be offered in multiple sizes. After that, it was full steam ahead.
The intravaginal product works by applying a painless amount of pressure on the urinary sphincter.
Conti knows Yoni.Fit works because she uses it. The device can give women the confidence to participate in a workout or take a flight to New York. It can be used as needed for 30 minutes or up to 12 hours.
Following FDA approval, she hopes to sell the patent to a company for production of an easy-to-use, discrete, affordable, over-the-counter product. Or her company might go to market with it, which would require raising another $20 million. Conti said that's doable because would-be investors already are calling.
“This is a product that will empower millions of American women to start to take control of their lives," said Dr. Benjamin Brucker, the adviser for clinical development and operation. "Many active women develop urinary incontinence, and for years have been suffering in silence because the treatments can be perceived as intimidating or invasive."
Conti said women often keep quiet for six or seven years before they go to a doctor. Meanwhile, the problem becomes progressively worse.
"We don't talk about it. Not everybody knows," she said. "The more women talk about it, the more women will be comfortable talking about it."