We're on a mission to help women treat bladder leaks.
Pelvital is a privately held medical technology company focused on women’s health. Founded in 2016 and headquartered in Minneapolis, Minnesota, our vision is to significantly improve the lives of people who suffer from pelvic floor disorders through novel, easy-to-use products backed by strong clinical evidence.
We are working to expand conservative treatment options that inspire women to treat conditions rather than cope with symptoms.
We believe that women deserve safe, effective, clinically proven products to treat common problems like urinary incontinence.
16 million American women suffer from stress urinary incontinence. Most are undiagnosed and untreated. This needs to change.
Our first product, Flyte™, is a simple, effective, affordable in-home treatment designed to treat weakened pelvic floor muscles to reduce bladder leaks and restore continence in women suffering from stress urinary incontinence.
Flyte uses a unique technology capable of delivering mechanotherapy, which is a proven method for healing and strengthening muscle systems. 1,2,3,4 Mechanotherapy has not been used to target pelvic floor muscles until now.
After a successful Pilot study in Norway, we sponsored the P-SUIT Trial, one of the largest multi-center randomized, double-blind study for an in-home product designed to treat incontinence. The P-SUIT trial was initiated in March 2017 and completed enrollment in September 2019. Flyte received FDA clearance in July 2020.
We're developing products that leverage the body's natural process to heal and restore the pelvic floor through mechanotherapy.
Flyte will be evaluated in additional pelvic floor disorders in the future.
Who We Are
Nissrine Nakib, MD
Director of Female Urology and Urodynamics, University of Minnesota
David Boulware, MD, MPH
Clinical Trial Specialist, University of Minnesota
Kevin Hallman, MD, FACOG, FPM-RS
Private Practice, Metro OBGYN, St. Paul, MN
Suzette Sutherland, MD
Director of Female Urology, University of Washington
Kristin Chrouser, MD
Associate Professor of Urology, University of Michigan
Annelise S. Swigert, MD
Private Practice, Southdale Obstetric and Gynecologic Consultants, Minneapolis, MN; Medical Director, Premier ObGyn of Minnesota
Scientific and Business Advisors
Gerald Timm, PhD
Entrepreneur, Professor of Urology, University of Minnesota
Paul Iaizzo, PhD
Professor of Surgery, Integrative Biology and Physiology, University of Minnesota
Mark Cook, PhD
Assistant Professor, Dept. of Integrative Biology and Physiology, University of Minnesota
Business Attorney, Gray, Plant, Mooty Law
Vice President of Business Operations, Optum
Pelvital announces FDA clearance of Flyte, in-home pelvic floor muscle treatment for stress urinary incontinence
August 20, 2020 – Pelvital, a medical technology company focused on women’s health, announced it has received U.S. Food and Drug Administration (FDA) clearance for Flyte™, a first-of-its-kind, non-invasive, intravaginal home-use device that is intended for strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.
According to the National Association for Incontinence, stress urinary incontinence (SUI) affects an estimated 16.6 million women in the United States. The condition often occurs because pelvic floor muscles and tissues have been weakened, preventing the urethra from closing adequately to hold urine in the bladder. Pelvital’s Flyte is the only product to use an expanding area of treatment called mechanotherapy (the treatment of disease by physical or mechanical means) to treat pelvic floor muscle weakness, the primary underlying cause of female SUI.
“Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbo charges Kegel exercises, the gold standard conservative treatment for SUI. Flyte amplifies the treatment impact of Kegels so women see results much sooner; days to weeks instead of months to years,” said Dale Wahlstrom, Co-Founder and Chief Executive Officer of Pelvital.
“Many women are just coping with SUI. Women with mild, moderate or severe SUI who want to avoid surgery, or a lengthy regimen of Kegel exercises now have a new option to treat their bladder leaks,” said Carrie Vollmer, Vice President of Marketing. “Flyte is an easy-to-use, 5-minute-per-day treatment that is backed by strong clinical evidence.”
Flyte was originally developed by physicians from the Arctic University of Norway and other experts in gynecology, muscle rehabilitation and urinary incontinence treatments. Two clinical trials studied the safety and effectiveness of Flyte in Norway and the United States. Between the two studies, more than 200 patients were treated using Flyte; most patients were dry or near dry after 2 – 12 weeks of treatment.
Flyte will be commercially available to consumers in the U.S. beginning in August, 2020.
Founded in 2016, Pelvital is a privately held medical technology company focused on women’s health. Pelvital’s vision is to significantly improve the lives of people who suffer from pelvic floor disorders through novel, easy-to-use products backed by strong clinical evidence. The company is focused on expanding conservative treatment options to inspire consumers to treat conditions rather than cope with symptoms.
Their first product, Flyte, is a simple, effective in-home treatment for incontinence, designed to treat weakened pelvic floor muscles to reduce bladder leaks and restore continence. For more information visit pelvital.com.
Pelvital appoints healthcare marketing veteran to lead the launch of Flyte
January 23, 2020 – Pelvital, a privately held medical device company that has developed Flyte™, a conservative and clinically proven treatment for female stress urinary incontinence, publicly announced today that Carrie Vollmer has been appointed VP of Marketing and Customer Experience. In this role, Vollmer will be responsible for all marketing, branding and consumer experiences for the company. She will also be responsible for establishing and leading a team to build and manage Pelvital’s ecommerce platform.
“Carrie has been working with Pelvital on a contract basis for over a year,” said Dale Wahlstrom Co-Founder and CEO of Pelvital. “During that time frame she has demonstrated her strong leadership capability, and knowledge of both the prescription and direct to consumer marketing and distribution channels. Now that we have received FDA clearance, we are very fortunate and excited to have Carrie guiding us through the launch of Flyte.”
Vollmer’s 20+ years of experience driving healthcare consumer awareness and engagement within organizations like American Medical Systems, Medtronic and St. Jude Medical, positively positions the Pelvital team to address the market from a customer-centric perspective.
Vollmer’s core competencies include leading teams in consumer-driven businesses, developing research-driven marketing strategies, creating innovative brand experiences, managing digital strategy, marketing campaigns, social media, and mobile applications. "All of Carrie’s experiences are exactly the skill sets we need to successfully launch Flyte”, added Wahlstrom.
“I joined the Pelvital team because I believe Flyte will serve a large unmet clinical need as a simple, safe and effective conservative SUI treatment for the millions of women who are untreated today,” said Vollmer. “I am excited to be part of a team offering a clinically proven non-surgical solution that has the potential to improve the quality of life for woman at all levels of severity," Vollmer said.
Founded in 2016, Pelvital’s vision is to significantly improve the lives of people who suffer from pelvic floor disorders through novel, easy-to-use products backed by strong clinical evidence. The company is focused on expanding conservative treatment options to inspire consumers to treat conditions rather than cope with symptoms.
Their first product, Flyte, is a simple, effective in-home treatment for stress urinary incontinence, designed to treat weakened pelvic floor muscles to reduce bladder leaks and restore continence.
Pelvital USA, Inc. announced that Cathy Barr joined its Board of Directors
January 1, 2019 - Pelvital USA, Inc. announced that Cathy Barr joined its Board of Directors. Cathy brings more than 30 years of operational, strategic planning, and senior leadership expertise to Pelvital. In her previous roles as Regional President, Chief Operating Officer, and Senior Vice President at Fairview Health Services of Minnesota and HealthEast Care System in St. Paul, MN, Cathy led multi-disciplined care delivery operations for a 2.7-billion-dollar integrated health care system that served over 248,000 patients and had 7,500 employees.
“Pelvic floor dysfunction, and specifically stress urinary incontinence is a large unmet clinical need affecting millions of women. From what I have seen from the clinical results, Pelvital’s technology holds great promise to provide a solution to most women who suffer from this condition.” Ms. Barr said. “I am very pleased to be joining the Pelvital board of directors and I am excited to help bring this new technology to patients.”
Cathy started her career as a nurse in a neurology step-down unit in Philadelphia, PA. That experience developed her sensitivity to the very personal issues that affect patients and their families. In addition, her role as the senior leader of major health care systems was instrumental in creating an understanding of the pressures and complexities of the evolving health care profession. We look forward to Cathy providing guidance to the Pelvital team as we bring the Flyte™ incontinence product to market,” said Dale Wahlstrom, CEO of Pelvital.
Cathy is a former president of the Women’s Health Leadership Trust, a past member of its board of directors, and the 2013 recipient of its Jean Harris Award. She was named a “Woman to Watch” by the Minneapolis/St. Paul Business Journal and has been included on Becker’s Hospital Review list of “Hospital and Health System Leaders to Know.” Cathy held a director role on the board of Cerenity Senior Care as well as vice chair and was a member of the Board of Directors for CLUES, and Community Health Charities.
Cathy holds an MBA from the University of St. Thomas in St. Paul, Minnesota and a Bachelor of Science degree in Nursing from Niagara University in New York.