About Flyte

Our Story

We are a women's health company on a mission to eliminate bladder leaks and improve pelvic floor health. We were founded by an international team of physicians and medical device professionals. 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.

17 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, proprietary technology capable of delivering mechanotherapywhich is a proven method for healing and strengthening muscle systems.¹ 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 for OTC and prescription sales. 

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.

Engber DE. Cellular mechanotransduction: putting all pieces together again. FASEB J 2006; 20: 811-827.

Iskratsch T, Wolfenson H, Sheetz MP. Appreciating force and shape – the rise of mechanotransduction in cell biology. Molecular Cell Biology 2014; 15: 825-833.

Paulch EP, Nelson CM, Biais N, Fabry B, Moeller J, Pruitt BL et al. Mechanotransduction: use the force(s). BMC Biology 2015: 13-47.

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.

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

Flyte Milestones

2000s: Product Concept Development & Validation

Flyte's® technology was developed in Norway in the 2000s through a partnership between the Arctic University of Norway in Tromso and Ergotest, a company providing training equipment and protocols to professional athletes.
snow capped mountains and scenic view

2015: Norway Clinical Trial Completed

A 60-person, single-center study was completed at the Arctic University of Norway. Results showed that Flyte® significantly reduced urinary leaks in women. Findings were published in the peer-reviewed journal Acta Obstetrica et Gyncologica Scandinavia.
Woman writing. Flyte pelvic floor therapy

2016: Company Founding

We were established as a privately held company in Minneapolis, Minnesota, in the heart of Medical Alley. We acquired the rights to the technology and our Norwegian founders serve on our board and provide day-to-day support.
Bridge and scenic view - Flyte

2019: US Clinical Trial Completed

At 119 patients, our P-SUIT trial was one of the largest multi-center, randomized, double-blind studies of its kind in a home-use SUI device. Between P-SUIT and our Norway study, more than 170 patients were treated using Flyte®; most patients were dry or near dry after 2 - 12 weeks of treatment.
Pelvic floor weakness help with Flyte

2020 & 2021: FDA 510(k) Clearance & Limited Market Release

Flyte® was cleared for release in 2020 and was launched commercially in 2021.
Group of women - flyte pelvic floor therapy device

Who We Are

Team

Lydia Zeller

President & Chief Executive Officer

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Lisa Ries

Chief Growth Officer

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Amanda Franey

Director of Operations

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Stacey Zeutschel

Senior Director of Sales

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Leah Fulker, PT, DPT, PCES

Customer Success & Education Manager

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Shravya Kovela, PT, DPT, OCS

Clinician Success & Education Manager

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Joy Schmitz

Business Development Manager

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Leota Pearson

Contract CFO

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Marcus Mianulli

Research Director

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Board of Directors

Lydia Zeller

CEO, Director

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Josh Nickols, PhD

Director 

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Juleen Christopher, PhD, BCC

Director

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Preetha Ram, PhD

Director

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Wanda Filer, MD, MBA, FAAFP

Director

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Edward Bergmark, PhD

Board Observer

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Dale Wahlstrom

Co-Founder, Director Emeritus

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Advisory Board

Gunnar Leivseth, MD, PhD

Co-Founder, Emeritus CMO

Ole Olsen

Co-Founder, Emeritus CTO

Nissrine Nakib, MD

Director of Female Urology and Urodynamics, University of Minnesota

Alpert for Flyte Therapy Device

Dr. Susan Alpert

Former Chief Regulatory Officer
Medtronic; former FDA Director of
Device Evaluation

Paul Iaizzo, PhD

Professor of Surgery, Integrative
Biology and Physiology
University of Minnesota

Kathy Sherwood

Senior VP Global Market Access InspireMedical

Craig for Flyte Therapy Device

Craig Hankins

Chief Strategy Officer at Visana Health;
former VP Digital Products & Strategy
United Healthcare

Additional Clinical Advisors

Kevin Hallman, MD, FACOG, FPM-RS

Private Practice, Metro OBGYN, St. Paul, MN

Suzette Sutherland, MD

Director of Female Urology, University of Washington

Annelise S. Swigert, MD

Private Practice, Southdale Obstetric and Gynecologic Consultants, Minneapolis, MN; Medical Director, Premier ObGyn of Minnesota

Holly Tanner, DPT, PT, MA, OCS, LMP, PRPC, BCB-PMD, CCI

Owner, Physical Therapy Services, Seattle, Washington

David Boulware, MD, MPH

Clinical Trial Specialist, University of Minnesota

Kristin Chrouser, MD

Associate Professor of Urology, University of Michigan

Additional Business and Scientific Advisors

Ryan Willemsen

Former Senior Director, Medtronic Pelvic Health and Gastric Therapies

Gerald Timm, PhD

Entrepreneur, Professor of Urology, University of Minnesota

Mark Cook, PhD

Assistant Professor, Dept. of Integrative Biology and Physiology, University of Minnesota

Will Dufree, PhD

Morse Alumni Distinguished Teaching Professor in Dept. of Mechanical Engineering University of Minnesota

Dan Tenenbaum

Business Attorney, Lathrop GPM

Greg Koeller

Intellectual Property Attorney

News & News Releases

Pelvital Appoints Dr. Wanda Filer To Its Board of Directors

Eagan, Minnesota – May 9, 2024 – Pelvital, the women's health MedTech company on a mission to transform the standard of care for urinary incontinence, is pleased to announce the election of Wanda Filer, MD, MBA, FAAFP, to its Board of Directors as an independent director, effective April 29, 2024. Dr. Filer brings a wealth of leadership experience in clinical family medicine practice, health and public policy, and national advocacy for transformative care and underserved populations.

Dr. Filer's commitment to improving healthcare access and outcomes aligns with Pelvital's mission to provide accessible, clinically proven solutions for pelvic health disorders, as evidenced by Flyte, the company's novel FDA-cleared conservative treatment for stress urinary incontinence and weakened pelvic floor muscles. With her extensive background in business, healthcare, and healthcare policy, Dr. Filer will be instrumental as Pelvital advocates to improve women's health by instituting proactive incontinence screenings and proactive conservative treatment as standard in OB/GYN, family medicine, and primary care practices.

Dr. Filer shared her excitement about joining Pelvital's Board of Directors. "I am honored to join Pelvital's board and deeply energized by this transformative opportunity to improve the lives of the 62% of women suffering from urinary incontinence, and in so doing, also reduce the significant comorbidities and downstream effects of UI," she said. "The only way to impact the immediate and downstream effects of UI at scale is to address it proactively and upstream. Family medicine, primary care, and OB/GYN practitioners have both a responsibility and an opportunity here to positively impact individual women, public health, and the cost of care."

"We are thrilled to welcome Dr. Filer to Pelvital's Board of Directors," says Lydia Zeller, CEO and President of Pelvital. "With her vast experience and deep understanding of the healthcare ecosystem, she will provide invaluable guidance as we work on multiple fronts to increase access to high value, effective care and change the paradigm for incontinence."

Dr. Filer recently retired as Chief Medical Officer at VaxCare, where she oversaw medical affairs, public health initiatives, science, and policy. Before this role, she held various leadership positions including President and Board Chair of the American Academy of Family Physicians, Pennsylvania Physician General, President of the Strategic Health Institute, and Board Director at Capitol Blue Cross. Additionally, she holds current board positions at Traditions Bank and Telligen.

Dr. Filer's appointment reflects Pelvital's devotion to assembling a diverse and accomplished Board of Directors to usher the company on an exciting phase of innovation, increased visibility, and market access expansion.

About Pelvital

Pelvital USA, Inc. is a women's health medical device company empowering women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte®, is an FDA-cleared novel in-home treatment for stress urinary incontinence and weakened pelvic floor muscles. Flyte is the first and only in-home product to deliver the therapeutic treatment modality of mechanotherapy to the pelvic floor. Mechanotherapy is a well-established treatment modality that stimulates tissue regeneration and the creation of neuromuscular memory. Learn more at flytetherapy.com.

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Pelvital Raises A Total of $5 Million In Seed Funding Spearheaded By Boomerang Ventures To Address Underserved Pelvic Health Issues

Eagan, Minnesota – April 22, 2024 – Pelvital USA, Inc., a leading innovator in women's health, is pleased to announce the successful closing of an additional $2.32 Million in its seed-plus funding round, closing the round out $500,000 oversubscribed at $5 Million. The seed plus funding will be instrumental in expediting the commercialization of Flyte, Pelvital's novel FDA-cleared revolutionary, accessible, and clinically proven treatment for stress urinary incontinence (SUI) and weakened pelvic floor muscles.

"Completing this round is an important step in continuing Pelvital's unwavering dedication to provide women with innovative solutions for pelvic health, including the treatment of SUI," says Lydia Zeller, President and CEO of Pelvital. "This funding will play a crucial role in accelerating our commercialization of Flyte with a strong emphasis on expanding payor coverage and enhancing clinical education and clinician awareness."

The investment round was led by Boomerang Ventures, a venture capital firm focused on transformative connected health. With this final close, Pelvital welcomes new investors including Pier 70 Ventures, Life Science Angels, Tech Coast Angels Orange County, and Blue Pacific Fund.

Concurrent with the close, Preetha Ram, PhD, Managing Partner at Pier 70 Ventures, joins the Pelvital Board of Directors. "Joining Pelvital's Board alongside this investment round is truly an honor," she shares. "Pier 70 and I are thrilled to be part of this transformational opportunity, as Pelvital's mission aligns beautifully with our dedication to support disruptive technologies that shake up the status quo in healthcare. Pelvital's pioneering work is shaping a future where women's health receives the attention and innovation it deserves with novel medical devices like Flyte."

"We are thrilled for the successful completion of this round as we aim to tackle the most pressing healthcare challenges," explains Oscar Moralez, Founder and Managing Partner of Boomerang Ventures. "Our participation aims to address the chronic underfunding in women's healthcare. Investing in Flyte, a truly groundbreaking treatment, addresses underserved pelvic health issues like SUI and contributes to raising vital awareness."

Two published clinical trials have validated Flyte's safety, efficacy, and durability of treatment effect for women with SUI. Most recently Pelvital published a paper in Therapeutic Advances in Urology, showing that 71 percent of study participants achieved dry or near dry conditions as evidenced by a reduction in 24-hour pad weight after using Flyte for between 2 and 12 weeks.

Flyte is effective for mild, moderate, and severe SUI. Typical treatment is only five minutes per day for six weeks. While Flyte is FDA-cleared for over-the-counter use, the majority of units are prescribed by clinicians. Please visit FlyteTherapy.com for more information.

About Pelvital

Pelvital USA, Inc. is a women's health medical device company empowering women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte®, is an FDA-cleared novel in-home treatment for stress urinary incontinence and weakened pelvic floor muscles. Flyte is the first and only in-home product to deliver the therapeutic treatment modality of mechanotherapy to the pelvic floor. Mechanotherapy is a well-established treatment modality that stimulates tissue regeneration and the creation of neuromuscular memory. Learn more at flytetherapy.com.

About Boomerang Ventures

Founded in 2020, Boomerang Ventures is a venture capital firm focused on early growth-stage connected health technology companies. Leveraging a combination studio and venture fund, Boomerang provides the collaborative direction, deep industry expertise, and continuum of support founders need to take their innovations from ideation to market. Boomerang believes that better patient care begins with identifying and solving the biggest challenges in healthcare. Boomerang Ventures is proudly and strategically based in Indianapolis, where the healthcare and entrepreneurial business climate is a thriving community ripe with opportunities. With a secure niche at the intersection of health technology, studio-fund synchronization, and the Midwest, Boomerang differentiates itself from the competition. Boomerang Ventures is Healthcare Innovation, Reimagined. Learn more at boomerang.vc.

About Pier 70 Ventures

Pier 70 Ventures is a US-based venture capital firm investing in innovation with the potential to create the future of healthcare. We invest in talented entrepreneurs pushing humanity forward with innovation that encompasses digital health and AI, precision medicine, medical devices/medical technology and health services. We VENTURE BOLDLY by empowering bright, enthusiastic leaders with capital, mentorship, and access to our global networks.

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Pelvital Announces Landmark Study Demonstrating Efficacy of Flyte® Device in Treating Stress Urinary Incontinence

Eagan, Minnesota – February 21, 2024 - Pelvital published a milestone paper in the peer-reviewed journal Therapeutic Advances in Urology showing the efficacy of its FDA-cleared novel device Flye to treat stress urinary incontinence and weakened pelvic floor muscles.

  • The Flyte® device resulted in continence or clinically significant improvement in 2-12 weeks, as evidenced by reduction in 24-hour pad weight.
  • Transvaginal mechanotherapy presents a new and beneficial approach to the treatment of SUI in women.
  • Subjective improvement in SUI-related symptoms and quality of life maintained over long-term follow up.

Pelvital, the women's health MedTech company on a mission to transform the standard of care for urinary incontinence, announced today the publication of its landmark paper "Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women" in the peer-reviewed journal Therapeutic Advances in Urology. The paper presents evidence of the efficacy of Pelvital's novel, FDA-cleared device, Flyte, for the treatment of stress urinary incontinence (SUI) and weakened pelvic floor muscles, with results comparable to surgical intervention.

Flyte delivers mechanotherapy treatment superimposed on the pelvic floor muscles during voluntary pelvic floor muscle contractions and relaxations (Kegels). Mechanotherapy, the clinical application of mechanotransduction, has been shown in clinical research to stimulate cellular tissue regeneration and create both voluntary and involuntary neuromuscular memory.

Pelvital's clinical trial assessing Flyte is one of the largest trials done examining the clinical benefits of an in-home SUI treatment, with 119 participants in a randomized, controlled, double-blind setting. The trial included women with the highest severity SUI, up to >500 grams of leakage over 24 hours. The results demonstrate Flyte's ability to effectively treat stress urinary incontinence in all levels of severity, as evidenced by reduction in 24-hour pad weight, which objectively measures leakage over 24-hours. Seventy-one percent of participants became dry or near dry over 2 to 12 weeks, and achieved significant subjective improvements as measured by clinically validated questionnaires assessing SUI symptoms and overall quality of life. The trial examined durability of treatment effect with a long-term follow-up and found that quality of life improvements were maintained or improved in all severity groups two-years post-treatment.

"This study is a true gamechanger for clinicians treating the 62% of women who are struggling with urinary incontinence, of which stress urinary incontinence is the largest segment," says Dr. Nissrine Nakib, lead author of the study, "Our research proves that Flyte is a first-line, conservative treatment and a viable alternative to surgery by uniquely delivering transvaginal mechanotherapy to the pelvic floor."

The study builds upon a prior clinical study done at the Arctic University of Norway that validated the effectiveness of Flyte as a non-invasive treatment option for SUI. In that study, participants' average duration of SUI symptoms prior to study was 9.3 years. Using Flyte, 82% of subjects achieved continence in six weeks, and at a two-year follow-up, a remarkable 77% of respondents were still continent. Notably, all participants in the study had been referred for surgery prior to the study, and after using Flyte, none opted for surgical intervention.

"We are thrilled to share this clinical trial affirming that the Flyte device sets a new standard of care for conservative treatment of stress urinary incontinence," says Lydia Zeller, CEO of Pelvital. "Pelvital remains committed to prioritizing women's health by revolutionizing the treatment landscape, providing evidence-based options for clinicians, and empowering women to regain control over their lives".

About the Authors:

  • Dr. Nissrine Nakib, MD, Associate Professor, Department of Urology, University of Minnesota
  • Dr. Suzette Sutherland, MD, Associate Professor, Department of Urology, University of Washington
  • Dr. Kevin Hallman, MD, Metro OBGYN
  • Marcus Mianulli, MA, BA, BS, Gnarus Medical Consulting Inc.
  • Dr. David Boulware, MD, MPH, Professor, Division of Infectious Diseases and International Medicine, University of Minnesota

About Pelvital

Pelvital USA, Inc. is a women's health medical device company empowering women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte®, is an FDA-cleared novel in-home treatment for stress urinary incontinence and weakened pelvic floor muscles. Flyte's mechanism of action is mechanotherapy, a foundational treatment modality that when paired with an active pelvic floor contraction stimulates tissue regeneration and the creation of neuromuscular memory. Learn more at flytetherapy.com.

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Pelvital Announces $2.68 Million Seed Funding Round Led By Boomerang Ventures - Secures Funding for Flyte®, Novel FDA-Cleared Treatment for Stress Urinary Incontinence and Weakened Pelvic Floor

Eagan, Minnesota – August 1, 2023 – Pelvital, a leading innovator in women's health, is pleased to announce the successful closing of a $2.68 million seed funding round for Flyte, a revolutionary, accessible, and clinically proven treatment for stress urinary incontinence (SUI) and weakened pelvic floor muscles. This funding milestone emphasizes Flyte’s significant impact in addressing an underserved health concern among women. Flyte is the only at-home intravaginal device that delivers the proven treatment modality of mechanotherapy to treat SUI and strengthen pelvic floor muscles quickly and effectively.

Flyte is a first-of-its-kind, non-invasive, intravaginal at-home device designed for the strengthening of pelvic floor muscles, which has been found to help stress urinary incontinence. Flyte was originally developed by physicians from the Arctic University of Norway in collaboration with experts in gynecology, muscle rehabilitation and urinary incontinence treatments. Flyte’s mechanism of action is mechanotherapy, a foundational treatment modality that when paired with an active pelvic floor contraction stimulates tissue repair and the creation of neuromuscular memory.

The investment round was led by Boomerang Ventures, a venture capital firm focused on transformative connected health. Other participants in the round include VisionTech Partners, Wisconsin Investment Partners, and Edward Bergmark, PhD, Founder and former CEO of Optum.

”Pelvital is committed to empowering both women and clinicians with transformative products backed by strong clinical evidence. We are excited to partner with Boomerang as we execute on our vision to be the gold standard of care for treatment of urinary incontinence, an issue that impacts one in two women,” says Lydia Zeller, President and CEO of Pelvital. “Boomerang’s focus on transformative healthcare technology is a perfect match as we introduce our next generation product to the clinical community. In the context of significant gaps in health equity – and in particular for issues that disproportionately impact peri-menopausal and menopausal women – increasing access to clinically proven, patient-centric treatments is vitally important.”

Commenting on the successful investment round, Oscar Moralez, Founder and Managing Partner of Boomerang Ventures, said, “Boomerang Ventures is driven to solve the biggest challenges in healthcare which is why we're so excited about this investment in Flyte by Pelvital. Their commitment to innovation, science-backed results, research and development, and user experience is making a significant impact on lives and on the cost of care. We have understood for a long time both the opportunity and the historic underfunding in women's health care, and we're beginning to understand how largely neglected the menopause segment is. We are incredibly proud to be part of the contingent addressing this gap.”

The seed funding will be used to complete development of the company’s next generation product and to accelerate commercialization, expanding its reach to a broader audience of clinicians and women seeking an effective, convenient, conservative in-home treatment for stress urinary incontinence.

Two clinical trials studied the safety, efficacy, and durability of Flyte in women with SUI. These studies demonstrated that Flyte delivers continence rates and durability comparable to surgery, yet with a conservative, fast, and convenient treatment.

Flyte is effective for mild, moderate, and severe SUI. Typical treatment is only five minutes per day for a total of six weeks. Flyte is FDA-cleared for both over-the-counter and prescription use.

 

About Pelvital

Pelvital USA, Inc. is a women’s health medical device company empowering women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte®, is an FDA-cleared novel in-home treatment for stress urinary incontinence and weakened pelvic floor muscles. Unlike electrical stimulation devices or Kegel trainers, Flyte delivers mechanotherapy, a foundational treatment modality that when paired with an active pelvic floor contraction stimulates tissue regeneration and the creation of neuromuscular memory. Flyte also supports women with a complimentary Ask A (Pelvic) Physical Therapist Service staffed by Doctors of Physical Therapy specializing in pelvic floor health. Learn more at flytetherapy.com.

About Boomerang Ventures

Founded in 2019, Boomerang Ventures is a venture capital firm focused on early growth-stage connected health technology companies. Leveraging a combination studio and venture fund, Boomerang provides the collaborative direction, deep industry expertise, and continuum of support founders need to take their innovations from ideation to market. Boomerang believes that better patient care begins with identifying and solving the biggest challenges in healthcare. Boomerang Ventures is proudly and strategically based in Indianapolis, where the healthcare and entrepreneurial business climate is a thriving community ripe with opportunities. With a secure niche at the intersection of health technology, studio-fund synchronization, and the Midwest, Boomerang differentiates itself from the competition. Boomerang Ventures is Healthcare Innovation, Reimagined. Learn more at boomerang.vc.

About VisionTech

Founded in 2009, VisionTech is a privately held company that links investors to high-potential, early-growth companies. Based in Indianapolis, VisionTech’s angel investing network includes more than 130 active members across Indiana and Ohio. As of November 2022, 215 VisionTech member investors have deployed more than $27.5 million in capital, investing in 65 portfolio companies from across the United States. Membership is open to accredited investors. Those interested in joining are encouraged to contact VisionTech. Learn more at http://www.VisionTech-Partners.com

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Pelvital appoints Lydia Zeller as new Chief Executive Officer

MINNEAPOLIS, Minnesota – March 29, 2022 – Pelvital, a privately held medical technology company focused on women’s health, announced the appointment of Lydia Zeller as Chief Executive Officer effective April 1, 2022. Zeller will succeed Dale Wahlstrom, co-founder and founding CEO, who is retiring but will continue to stay involved in Pelvital serving as executive chair on the Pelvital board of directors.

Zeller joins Pelvital from Kiio, a B2B2C provider of digital musculoskeletal healthcare. As Kiio’s President and CEO, she raised funds, drove revenue, and led the company through a period of rapid growth culminating in acquisition by a leading digital health company. Zeller brings more than 30 years of entrepreneurial experience and deep expertise in virtual health, consumer-centric care, and the payer and consumer markets.

Speaking on behalf of the Board, Kathy Sherwood said “we are delighted with the appointment of Lydia as CEO. Lydia’s executive leadership experience and deep expertise in consumer engagement, novel care delivery models, and the payer/provider/consumer ecosystem will be instrumental in driving the growth of Pelvital. In addition, the board would like to thank Dale Wahlstrom for the leadership he has provided. Pelvital was founded under Dale’s management in 2016. Since then, Pelvital has completed one of the largest clinical trials of its kind and has commercialized Flyte, a clinically proven, convenient solution for women coping with female stress urinary incontinence (SUI) and pelvic floor muscle weakness.”

“This leadership transition occurs during a period of positive momentum for Pelvital as we mark one year into our commercialization,” said Dale Wahlstrom. “Lydia is uniquely qualified for this role as an entrepreneurial leader who brings strong digital health experience and impressive achievements in transforming and scaling an organization. Under her leadership and vision, Pelvital can expand its reach, to help more people through solutions that are based on our novel mechanotherapy technology platform.”

Prior to serving as Kiio’s CEO, Lydia held a variety of leadership roles at Kiio. As VP of Product Strategy, she handled product, sales and marketing, landing contracts with national payers, increasing consumer adoption, and growing Kiio to national recognition as a proven player in digital musculoskeletal care. As Director of Patient Engagement Solutions, she conceptualized and operationalized the company’s pivot from clinical hardware/software sold to provider systems to a digital therapeutic sold to health insurance companies and large employers and provided as a covered benefit to their members. Prior to Kiio, Lydia was co-founding associate at a niche wealth management firm where she led operations and later consulted in financial regulatory compliance. Lydia earned a BA and Executive MBA from University of Wisconsin-Madison.

“I am thrilled to lead the Pelvital team and continue to advocate for improved access to healthcare,” said Lydia Zeller. “I have a passion for women’s health, rooted in a conviction that women deserve safe, effective, convenient solutions that respect their busy lives. As a healthcare community, it is imperative that we come together to advance health equity and address unmet needs. Pelvital has a tremendous opportunity to improve the quality of life for millions of women through the simple and efficient at-home treatment of Flyte.”

 

About Pelvital

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, evidence-based, easy-to-use products offered directly to consumers via Flytetherapy.com and in partnership with clinicians. Founded in Minnesota in 2016 with roots in Norway, the company is focused on expanding conservative treatment options.

Pelvital’s first product, Flyte®, is a clinically proven, in-home treatment for pelvic floor muscle strengthening and bladder control. Paired with expert education and encouragement from our on-staff pelvic floor physical therapists or our partners, Flyte is the proven effective, simple solution for women who want to treat at home and improve quality of life

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Pelvital appoints Chief Operations Officer

July 13, 2021 – Pelvital, a privately held medical device company that has developed Flyte™, a clinically proven, FDA-cleared, non-surgical treatment for female stress urinary incontinence (SUI), announced today that Ryan Willemsen has been appointed Chief Operations Officer.

In this role, Willemsen will be responsible for leading the operations of Pelvital with a focus on market adoption of Flyte, building a global sales and distribution capability, expanding operational infrastructure of Pelvital, and bringing next generation products to the market. Ryan joined Pelvital in December of 2020 as the Chief Commercial Officer where he has focused on developing an understanding of the commercial needs for an at-home therapy such as Flyte and implementing strategies to assure the adoption of Flyte. With more than 14 years of medical technology leadership experience, including 8 years in pelvic health, Willemsen has experience at developing new markets, bringing new products to market, and leading successful commercial organizations.

“We are excited to have Ryan expanding his influence in developing and growing Pelvital. His proven track record of executive leadership will not only help us develop the market for Flyte but will help us prepare the company for expansion into other applications of our unique mechanotherapy technology.” said Dale Wahlstrom Co-Founder and CEO of Pelvital. “His success in his past roles has helped him to rapidly grasp the challenges of people suffering from Stress Urinary Incontinence and will be invaluable in achieving Pelvital’s mission to help people suffering from skeletal muscle conditions.”

Willemsen’s 14 years of experience at Medtronic include executive leadership positions in marketing, strategy, business development and finance. While at Medtronic, Ryan developed and led strong teams to drive growth in new and developing global medical device markets.

“I am very excited to be part of the Pelvital team and thrilled to be part of bringing a proven new technology platform to the market,” said Willemsen. “The clinical data, and the response of patients who have used the product since our market release in January, have confirmed that mechanotherapy really works to treat SUI. We will continue our focus on market adoption to treat SUI but will begin the process of expanding the application of the technology to other unmet needs. Our journey is just beginning.”

About Pelvital
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. Founded in Minnesota in 2016 with roots in Norway, the company is focused on expanding conservative treatment options to inspire consumers to treat conditions rather than cope with symptoms.

Pelvital’s first product, Flyte, is a clinically proven, in-home treatment for stress urinary incontinence, designed to treat weakened pelvic floor muscles to reduce bladder leaks, restore continence and improve quality of life.

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Gerald R. (Jerry) Mattys Joins Pelvital USA, Inc. Board of Directors

May 24, 2021 – Pelvital USA, Inc. announces that Jerry Mattys has joined its Board of Directors.

Mr. Mattys is an accomplished executive who most recently served as Chief Executive Officer at Tactile Medical from January 2005 until his retirement in June 2020. During his tenure, Tactile grew from start up to over $190 million in revenue and transitioned from a private to public company (Nasdaq: TCMD). Tactile Medical earned honors as a “Top Workplace” in Minnesota for 11 straight years. From 2002 to 2004, Mr. Mattys was Chief Executive Officer of Medisyn Technologies, Inc., a development stage biotechnology company. From 2000 to 2002, Mr. Mattys served as President and Chief Executive Officer of Timm Medical Technologies, Inc. where under his leadership, Timm Medical completed three strategic alliances and was successfully sold to Endocare, Inc. Mr. Mattys also held a variety of division management positions with Mallinckrodt, Inc. and Nellcor Puritan Bennett, Inc.

“Jerry’s extensive experience in corporate management and business development combined with his operational experience in marketing and sales, where integration of clinical and direct to consumer markets was the key to success, is exactly the knowledge we need at Pelvital,” said Dale Wahlstrom, CEO of Pelvital. “As we continue our transition from a development company to a commercial company, Jerry’s experience fits perfectly, and we feel very fortunate to have him join our board.”

Driven mostly by childbirth, obesity, and aging, one in three women either have or will develop incontinence in their lifetime. “In my past roles I became aware of the intense need for a conservative solution for the treatment of incontinence. Women are dealing with this problem with few successful options other than surgery,” Mattys said. “I have been following Pelvital since its formation in the U.S. in 2016 and am very impressed with the clinical outcomes this new platform technology has achieved. I look forward to being able to help bring Flyte to people who need it.”

Jerry holds a Bachelor of Science degree in Economics from The Pennsylvania State University, as well as completing Master level studies in Business from the Katz School of Business in Pittsburgh. He is also a graduate of the Managing High-Tech Company program from Stanford University.

About Pelvital
Pelvital is a privately held company founded in 2016 and headquartered in Minneapolis, Minnesota. Its vision is to improve the lives of people who suffer from pelvic floor disorders. The company is currently beginning commercialization of the Flyte in-home pelvic floor treatment device, a product designed as a conservative solution for stress urinary incontinence.

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Kathy Sherwood Joins Pelvital USA, Inc. Board of Directors

May 13, 2021 – Pelvital USA, Inc. announces that Kathy Sherwood, Senior Vice President, Global Market Access of Inspire Medical Systems, has joined its Board of Directors.

Kathy is a seasoned medical device professional with 30+ years of industry experience including urology & pelvic health, cardiac rhythm management, neurology, obstructive sleep apnea, wound care and diagnostics with experience in R&D, operations, sales, marketing and market access & reimbursement. Her work experience, which includes a diverse group of medical product companies such as Boston Scientific, American Medical Systems, St. Jude Medical, Kinetic Concepts, Transoma Medical and Medtronic, gives her an understanding of the problems faced by both large and small companies. She has both U.S. and international experience having lived in the Netherlands for several years, leading a European market access and reimbursement function. In Kathy’s current position at Inspire Medical, Kathy has successfully led efforts to penetrate the market with a new technology to address an unmet and underserved need in obstructive sleep apnea.

“Women I know are suffering in silence from stress urinary incontinence. It is a very large, rapidly growing, and largely underserved market that affects the quality of people’s lives. The world needs better solutions, and I am very impressed with the clinical outcomes of the work done by the original inventors in Norway and the Pelvital team. I am confident we can help women around the world to regain control of their lives,” Sherwood said. “I am very pleased to be joining the Pelvital Board and to help bring this new technology to women.”

“With extensive experience in direct-to-consumer and clinical marketing, reimbursement, pricing, and commercialization across multiple medical device companies, Kathy is uniquely qualified to help Pelvital transition from a development company into a commercialization company,” said Dale Wahlstrom, CEO of Pelvital. “We look forward to Kathy providing guidance to the Pelvital team as we bring the Flyte incontinence product to market.”

Kathy holds a Bachelor of Science degree in Mechanical-Industrial Engineering from the University of Illinois, Urbana-Champaign, and an MBA from the University of Minnesota, Carlson School of Management in Minneapolis. She is active in outdoor sports and an involved supporter of charity organizations including the Children’s Hospital Guild and Habitat for Humanity.

About Pelvital
Pelvital is a privately held company founded in 2016 and headquartered in Minneapolis, Minnesota. Its vision is to improve the lives of people who suffer from pelvic floor disorders. The company is currently beginning commercialization of the Flyte in-home pelvic floor treatment device, a product designed as a conservative solution for stress urinary incontinence. 

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Pelvital appoints Chief Commercial Officer

December 15, 2020 – Pelvital, a privately held medical device company that has developed Flyte™, a clinically proven, FDA-cleared, non-surgical treatment for female stress urinary incontinence, announced today that Ryan Willemsen has been appointed Chief Commercialization Officer.

In this role, Willemsen will be responsible for leading market adoption of Flyte, building a global sales and distribution capability, establishing operational infrastructure to scale the growth of Pelvital, and helping to assure the financial wellbeing of the company.  With more than 14 years of medical technology leadership experience, including 8 years in pelvic health, Willemsen has excelled at developing new markets, bringing new products to market, and leading successful commercial organizations. 

“We are excited to welcome Ryan to the Pelvital team. His deep commercial experience and proven track record of executive leadership will help us develop the market for Flyte therapy and grow Pelvital to successfully help women treat, rather than cope with, stress urinary incontinence.” said Dale Wahlstrom Co-Founder and CEO of Pelvital. “His success in both the traditional clinician and direct-to-consumer channels will be instrumental in driving the adoption of Flyte and creating a new first-line standard of care for effective, non-surgical treatment of female urinary incontinence.”

Willemsen’s 14 years of experience at Medtronic include executive leadership positions in marketing, strategy, business development and finance.  While at Medtronic, Ryan developed and led strong teams to drive growth in new and developing global medical device markets. 

“I am thrilled to join the Pelvital team at this important time and I look forward to helping lead the business to serve the needs of women coping with stress urinary incontinence,” said Willemsen. “I believe that women deserve safe, effective, clinically proven, FDA-approved, non-surgical and cost-effective products to treat common issues like stress urinary incontinence. Pelvital has a tremendous opportunity to improve the quality of life for millions of women through the simple and efficient at-home treatment of Flyte.”

About Pelvital

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. Founded in Minnesota in 2016 with roots in Norway, the company is focused on expanding conservative treatment options to inspire consumers to treat conditions rather than cope with symptoms.


Pelvital’s first product, Flyte, is a clinically proven, in-home treatment for stress urinary incontinence, designed to treat weakened pelvic floor muscles to reduce bladder leaks, restore continence and improve quality of life. 

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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. 

About Pelvital

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. Founded in Minnesota in 2016 with roots in Norway, the company is focused on expanding conservative treatment options to inspire consumers to treat conditions rather than cope with symptoms.

Pelvital’s first product, Flyte, is a clinically proven, in-home treatment for stress urinary  incontinence, designed to treat weakened pelvic floor muscles to reduce bladder leaks, restore continence and improve quality of life. 

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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, Customer Experience and Ecommerce. 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.

About Pelvital

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. Founded in Minnesota in 2016 with roots in Norway, the company is focused on expanding conservative treatment options to inspire consumers to treat conditions rather than cope with symptoms.

Pelvital’s first product, Flyte, is a clinically proven, in-home treatment for stress urinary  incontinence, designed to treat weakened pelvic floor muscles to reduce bladder leaks, restore continence and improve quality of life.

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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.