Overview

Pelvital is a privately held company founded in 2016 and headquartered in Minneapolis, Minn. Our vision is to significantly improve the lives of people who suffer from pelvic floor disorders.

The company is evaluating the FlyteTM System which is an investigational device that is designed to strengthen and potentially heal the pelvic floor muscle system. It uses a unique technology capable of delivering “Mechanotherapy”. Mechanotherapy  is a proven method for healing and strengthening muscle systems, but has not been used to target pelvic floor muscles until now.1,2,3,4

The Flyte System was developed by physicians who are experts in gynecology, muscle rehabilitation, and urinary incontinence treatments. In their first clinical study, a high percentage of the study patients suffering from stress urinary incontinence were cured of their condition.5 Flyte is designed with features that allow it to be used in the privacy of the home and also provides visual guidance on how to properly contract pelvic floor muscles.

The Flyte System is currently being evaluated in a randomized blinded study in the United States for the treatment of stress urinary incontinence. The Flyte System will be evaluated in additional pelvic floor disorders in the future.

References

  1. Engber DE. Cellular mechanotransduction: putting all pieces together again. FASEB J 2006; 20: 811-827.
  2. Iskratsch T, Wolfenson H, Sheetz MP. Appreciating force and shape – the rise of mechanotransduction in cell biology. Molecular Cell Biology 2014; 15: 825-833.
  3. Paulch EP, Nelson CM, Biais N, Fabry B, Moeller J, Pruitt BL et al. Mechanotransduction: use the force(s). BMC Biology 2015: 13-47.
  4. Salanova M, Gelfi C, Moriggi M, Vasso M, Viganò A. et al. Disuse deterioration of human skeletal muscle challenged by resistive exercise superimposed with vibration: evidence from structural and proteomic analysis. FASEB J 2014 Nov; 28(11):4748-63.
  5. Nilsen I, Rebolledo G, Acharya G, Leivseth G. Mechanical oscillations superimposed on the pelvic floor muscles during Kegel exercises reduce urine leakage in women suffering from stress urinary incontinence: A prospective cohort study with a 2-year follow up. Acta Obstet Gynecol Scand. 2018;00:1-7. https://doi.org/10.1111/aogs.13412

People

 

Team 

Luke Dery
Vice President of Operations, Co-Founder

Bukky Durosanya
Associate Director of Operations

Greg Koeller
Intellectual Property Attorney

Gunnar Leivseth, MD, PhD
Chief Medical Officer, Co-Founder

Kristen Malek
Director of Quality Systems and Regulatory Affairs

Ole Olson
Chief Technology Officer, Co-Founder

Leota Pearson
Chief Financial Officer

Carrie Vollmer 
Senior Director of Marketing

Dale Wahlstrom
Chief Executive Officer, Co-Founder

 

 

Board of Directors

Cathy Barr, RN, BSN, MBA
Director

John Feriencek
Co-Founder, Director

Gunnar Leivseth, MD, PhD
Co-Founder, Director

Ole Olson
Co-Founder, Director

Dale Wahlstrom
Co-Founder, Director

 

 

Consultants and Advisors 

David Boulware, MD, MPH
Clinical Trial Specialist, University of Minnesota

Carrie Hetrick
Hetrick Medical Device Consulting

Marcus Mianulli
Gnarus Medical Consulting

Dan Tenenbaum
Gray, Plant, Mooty Law

Gerald Timm, PhD
Professor of Urology, University of Minnesota

 

 

News

Cathy Barr Joins Pelvital USA, Inc Board of Directors

MINNEAPOLIS, February 8, 2019, 2019 – Pelvital USA, Inc. announced that Cathy Barr joined its Board of Directors on January 1, 2019.

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 USA 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 FlyteTM incontinence product to market”, said Dale Wahlstrom, CEO of Pelvital USA.

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 a was 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.

 

Pelvital Clinical Study Now Enrolling Patients

Doctors at select US centers are accepting participants for a new clinical study to evaluate the Pelvital System for the treatment of stress urinary incontinence (SUI). Participants who qualify and choose to participate in the study will receive the Pelvital System and all study-related costs will be covered at no charge to them. Click here for more information.

Initial study eligibility criteria include the following:

  • Stress urinary incontinence diagnosis
  • Female
  • 18-75 years old
  • Not currently pregnant
  • Not currently taking prescription medications for SUI
  • Able to attend up to 8 clinic visits over 3-months

Contact Us

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