Pelex’s New Device Uses Biofeedback to Make Pelvic Floor Rehab Accessible and Affordable
Leveraging a powerful combination of a non-invasive medical device and virtual pelvic floor physical therapy, Pelex offers personalized, home-based treatments for a broad range of pelvic floor disorders. With successful clinical tests and ongoing studies, Pelex is committed to fostering a cultural shift, empowering women to prioritize their pelvic health.
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The Challenge
Nearly a decade ago, Jeremy Wiygul, MD, a pediatric and reconstructive urologist, decided to find a solution for a health condition he frequently dealt with at work – urinary leakage. One of the primary treatments for this condition is pelvic floor rehabilitation. The procedure usually involved a massive, six-foot-tall device that showed the patients Kegel exercises on a screen – basically a form of biofeedback – and tracked their muscle activity as they performed the exercises.
While the procedure was effective, it had to be conducted at the doctor’s office, which often wasn’t accessible in non-urban areas. So Dr. Wiygul started looking for ways to make the huge device compact and inexpensive.
Meanwhile, Dr. Wiygul’s wife, like every other mother out there, was also struggling with pelvic floor strength problems post-childbirth. These issues could be treated through the same type of biofeedback device that Dr. Wiygul was attempting to build for children. So, she asked him, “Why not make this available for women?” All of a sudden, an enormous market opened up.
“My wife used to complain about her symptoms. And I was like, let's have you seen by someone, let's get you treated,” says Dr. Wiygul. “But we had a hard time finding someone. If a urologist's wife has a hard time getting access to this kind of care, I can't imagine how hard it is for everyone else.” His wife was one of the first people to use the device successfully, and the positive response in her symptoms told him they were on the right track.
Origin Story
Dr. Wiygul began exploring the market for women in the postnatal period and found numerous products in the market designed to strengthen the pelvic floor but none that came with proper guidance.
“If people have never been shown how to use the device, they could end up hurting themselves because not all pelvic floor disorders are the same,” says Dr. Wiygul. “Sometimes, you need the pelvic floor relaxed, while other times, it requires strengthening.”
This prompted Dr. Wiygul to modify his solution and make it a combination of technology and personalized treatment, the first of its kind in the market. He wanted to recreate the clinical experience at home for his users. So he added a pelvic floor physical therapist to the equation (through a virtual clinic model), who would provide coaching and guidance to complement the patient's self-guided device use at home.
Once the guidance part was taken care of, Dr. Wiygul started looking at the other gaps in the market and addressing them one by one. He found that similar devices and treatment options available to women in the postnatal period were invasive. This made a lot of women put off treatment. So, he made his product non-invasive.
Dr. Wiygul also realized that a form of treatment called neurostimulation could be performed through the same patient interface. Most other devices that offered stimulation targeted muscle, but the muscular stimulation wasn’t as effective as the neuro stim. So Dr. Wiygul decided to leverage neurostimulation and target a novel nerve for certain disorders of the pelvic floor, like chronic pelvic pain and dyspareunia (painful intercourse). These were conditions that no one had been able to successfully target before non-invasively, and with this new approach, Pelex could treat up to 90% of all pelvic floor disorders.
After numerous trials, Dr. Wiygul and his team successfully developed a beta prototype that implemented the biofeedback technology, featuring a patient interface resembling a saddle, a specific sensor array (fully patented part of their intellectual property), and a smartphone application where the interactions happen. They successfully ran a round of clinical trials using their beta prototype and the biofeedback technology. They were able to amass overwhelmingly positive feedback, with close to an average of 50% reduction in symptoms across all subjects.
“We have had users tell us if they could have access to this all the time, they would use it all the time. I remember a couple of study participants saying they didn’t want to give the device back and asking me if they could keep it. Participants liked the idea, and they found the smartphone application to be very good at explaining how to set the whole thing up. Also, it made perfect sense to people that this is something that is built to be used in the privacy and comfort of your home rather than during an appointment with a specialist,” says Dr. Wiygul.
Under the Hood
Pelex took a basic technology that has been around for decades – biofeedback – and modified it by integrating neurostimulation. They also made treatment non-invasive and more accessible for people suffering from pelvic floor disorders.
There are two parts to their device. The first is a saddle with electrodes embedded in it, and the second is a smartphone app connected to the saddle via Bluetooth. For the biofeedback component, when a user sits on the saddle, the electrodes capture the signals and deliver them to the app, which shows the user their own muscle contractions and guides the user in performing the exercises properly. For the neurostimulation therapy, electrical impulses are delivered to the pudendal nerve via an array of stimulation electrodes. These sessions are also set and controlled by the smartphone app and are performed separate from the biofeedback therapy.
All the data generated through the device is gathered and stored in a HIPAA-compliant manner on a third-party cloud platform. Over time, this data can be used to analyze how a specific treatment plan works for a specific user and tailor regimens based on individual needs, creating a personalized pelvic floor care plan.
Pelex has successfully run clinical tests on the device with the biofeedback technology, demonstrating the device’s intuitive usability. The signal capture was also found to be highly efficient, ensuring accurate data collection and analysis.
Currently, Team Pelex has begun the second round of clinical investigation: a three-arm study comparing the device alone, the device with virtual pelvic floor physical therapy, and the virtual pelvic floor physical therapy alone. The anticipated results are expected to highlight the superior effectiveness of Pelex’s device in conjunction with physical therapy as opposed to either alone.
“There have been multiple studies comparing people who are taught pelvic floor exercise by a trained professional and people who were given the same training along with an in-office device and asked to follow the same regimen for four weeks. Those given the device consistently got better outcomes as compared to those receiving pelvic floor physical therapy alone, with a substantial improvement of around 30%,” says Dr. Wiygul. “There is also a significant added benefit to using a device than just doing Kegel exercises alone. This goes to the very basis of biofeedback, where somehow representing your own body processes allows you to control those processes better than not seeing them represented in one form or fashion.”
After the study concludes, Pelex will be poised for FDA submission and approval. The FDA Class II designation would set Pelex apart in a market flooded with wellness devices. It allows them to make specific claims about treatment that others cannot. This clinical differentiation is crucial in the market where consumers seek evidence-based solutions and guidance from their physicians. Hence, Pelex's primary sales channel will be through doctors' offices, in contrast to generic devices available through mainstream online platforms.
Last Words
Pelex is committed to reshaping the narrative around women’s health. For Dr. Wiygul and his team, improving the lives of mothers post-birth is personal.
“The stigma around something like leakage is that it's not that big of a deal. But these pelvic floor issues can snowball into situations that keep a woman from being able to be confident at work, pursue her dreams, and can affect her overall quality of life,” says Dr. Wiygul. “We also know, through the testimony of our study participants, that women with these conditions feel very vulnerable even talking about it. Our goal is to make getting treatment as easy as flipping a switch.”
With their novel device and platform – which bring the clinical standard of care into the home – Pelex aspires to foster a cultural shift where women are encouraged to prioritize their pelvic health. Their goal is to empower women to receive the care they deserve without compromising their priorities. And we’re proud to support Pelex as a member of the StartUp Health community.
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Published: Apr 10, 2024