Pelex is a new start up that is bringing the best in class clinical therapies to your home. We are transforming the treatment and prevention of pelvic floor disorders (PFDs) such as urinary incontinence by creating at-home pelvic floor strengthening and therapeutic devices that are easy to use and clinically effective.
WHAT ARE PFDs?
Pelvic floor disorders (PFDs) are a variety of conditions that are associated with weakened pelvic floor muscle and nerve function. PFDs affecting most people fall into four categories: Bladder Control Problems, Bowel Control Problems, Pelvic Organ Prolapse, and Sexual Dysfunction.
WHAT IS THE PELVIC FLOOR?
The pelvic floor is a group of muscles, ligaments and connective tissue and nerves in the lowest part of the pelvis. It supports a host of organs such as the bladder and rectum. The pelvic floor also supports sexual and reproductive organs such as the prostate in men and the uterus and vagina in women. The pelvic floor is vital to proper sensation and function of these organs, and requires all of its parts to work together.
ABOUT THE PELEX PLATFORM
The Pelex platform is designed to be an effective at-home medical device uniquely designed to strengthen both the muscles and nerves of the pelvic floor. We have applied technologies that are already widely used and proven effective as a standard of care in urology clinics, as well as novel therapy designed for particularly difficult to treat symptoms, all in a convenient format.
Our devices are designed to help strengthen pelvic floor muscles and nerves to help patients reduce their symptoms associated with a weak or dysfunctional pelvic floor. Our devices will have two modes that can be used individually or together. The muscle training mode is designed to train users to properly tone their pelvic floor muscle without stretching and creating additional sag in the pelvic floor. Our neurostimulation mode is designed to stimulate the nerves in the pelvic floor to further strengthen the network of neurons that control muscle activity and sensations of pelvic organs.
As a urologist at Cornell Weill with 20 years of clinical experience, Dr. Jeremy Wiygul has experienced the complexities of pelvic floor disorders across a diverse patient population. Realizing that available products for treatments, such as Kegel balls, internal stimulators and sensors, were either too invasive or did not offer therapy for a wide range of pelvic floor disorders, he decided to create a technology that could help his patients with these issues.
Pelex brings proven best-in-class clinical therapies for pelvic floor disorders into an easy to use, non-invasive, at-home device. Early use of our system will be designed to prevent symptoms from getting worse or requiring the use of medication or surgery. Pelex is currently preparing for clinical trials and plans to achieve FDA clearance by end of 2021.
In addition to his clinical experience, Dr. Wiygul is a proven inventor, having successfully developed and licensed an FDA-approved urinary catheter technology. He also developed the first prototype for the Pelex device platform, and is currently developing another catheter technology as well.
Dr. Wiygul has recruited a diverse leadership team that possesses the experience to successfully commercialize the Pelex device.
HOW IT WORKS
The user sits on a cushion that is arrayed with sensors and electrodes. The Pelex device detects levels of muscle activity and let the user know if the pelvic exercises are being done correctly through a hand-held app. The device will also gently stimulate the nerves in the pelvic floor. This bio-feedback type of exercises and neurostimulation have proven to be the most effective in-office methods to improve pelvic floor health without creating further damage. Our goal is to have these best-in-class methods be available for home use.
Director of Pediatric Urology at New York-Presbyterian Queens
Commercial Insights and Marketing
Innovation Strategy & Commercialization for Colgate, Unilever, Abbott, Janssen
Product Development and Engineering
New York, NY
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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.