Confidence Medical develops device to strengthen pelvic floor muscles

Fecal incontinence, the involuntary loss of stool, affects an estimated 7 to 12 percent of adults globally, with rates rising sharply with age. One study found prevalence increasing from 7 percent in women under 30 to 22 percent in women in their 70s. Despite its wide reach, the condition remains underdiagnosed and undertreated, leaving millions without effective options.

A Milwaukee-based startup is working to change that. Confidence Medical, founded in 2023, is developing a low-cost, pelvic floor strengthening device designed to help women manage fecal incontinence by building internal muscle strength. The device, now in development, aims to serve as a first-line, non-invasive option that could be used in clinical settings and at home.

The company is led by three clinical innovators with deep ties to the region’s major health systems: Dr. Matthew Lee, inventor Dr. Reza Shaker, and medical device entrepreneur Dr. Adam Kadlec. Their collaboration reflects what Lee describes as Milwaukee’s growing culture of cross-institutional innovation.

“Milwaukee is set for tech innovation. You do not have to go somewhere else,” Lee said. “We are finding seed funding here, and we have been introduced to venture funds. There is a lot of activity in this area.”

A device focused on strengthening, not surgery

The company’s continence-training device, known as cRED, uses progressive resistance to strengthen the circular pelvic muscles involved in continence. Lee, a longtime OB-GYN who spent more than 20 years at Ascension St. Joseph, has worked closely with pelvic floor physical therapists throughout his career and saw firsthand the need for more tools that fit between conservative therapy and surgery.

In describing the concept, he compares the device to a resistance band used in physical therapy routines. “How do you exercise a circular muscle? You squeeze against compressible resistance,” he said. “We are really looking at resistance exercise for the pelvic floor.”

The idea is simple: physical therapists would use the device in the clinic to teach patients proper technique, and many patients would bring a device home to continue strengthening exercises. Affordability is a key design factor. Confidence Medical aims to produce a device at an accessible price point for most patients.

Collaborative roots in Milwaukee’s innovation ecosystem

The startup’s origin story is rooted in Milwaukee’s academic and clinical networks. After retiring from surgical practice, Lee joined Concordia University as a faculty member and was encouraged by colleague Dan Sem to connect with Shaker, inventor of the device. He soon met Kadlec, who brought experience in medical device commercialization.

From there, the team worked closely with tech transfer experts, entrepreneurial training programs, and regional mentors. Lee credits the support and openness of Milwaukee’s institutions for much of the company’s early momentum.

In working with MCW tech transfer director Kevin Boggs, Lee said the process felt like a true partnership. “It is much less a transaction and more a partnership. Kevin is one of our partners. He is a cheerleader for our success,” he said.

The company has also drawn on resources from UWM’s entrepreneurial programs and seed-stage funders. “People are very willing to introduce you to others,” Lee said. “A lot of connections are helpful.”

Early traction and a long road ahead

Confidence Medical earned first place in the Healthcare Track at the Wisconsin HIP Innovation Showcase in October, receiving $25,000 in cash and in-kind support. The award validates the clinical need and gives the founders early resources as they advance product development and begin regulatory strategy toward an anticipated FDA 510(k) pathway.

As with any medical device, commercialization will take time. Based on guidance from mentors with experience in continence-related devices, Lee anticipates a five- to seven-year timeline to market entry. One of the company’s priorities is determining a viable commercialization path early, shaping decisions around cost, design, and distribution.

“The commercialization pathway drives everything,” Lee said. “Even if the device is safe and effective, we need to make sure there is a reasonable path to getting it in the hands of patients.”

Confidence Medical is currently in discussions with seed-round investors as it prepares for its next phase of development. The founders say the device presents an opportunity to expand conservative treatment options for a condition that is both common and widely misunderstood.

As the company moves through its next milestones, Lee hopes readers will see Confidence Medical as a product of Milwaukee’s increasingly connected health innovation landscape.