Avation Medical is utilizing new ways to use wearable neuromodulation therapies to improve patients’ health and quality of life. The company’s first product targets adults with overactive bladder (OAB) syndrome and urge urinary incontinence (UUI) and offers a non-invasive, at-home treatment.
CEO: Jill Schiaparelli
Headquarters: Columbus, OH
Year Founded: 2016
Year Avestria First Invested: 2020 (Fund I)
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Recent Press:
The journey to create a new, patient-friendly, bladder control treatment
Five wearable neuromodulation device design tips from Avation Medical
Jill Schiaparelli is a finalist for EY’s Entrepreneur Of The Year® 2024 East Central Award
Avation hires VP of market access and payer relations
This device treats overactive bladder without drugs or surgery
Dr. Goudelocke discusses Vivally in the Urology Times
Avation Medical achieves Certification of Accreditation from The Compliance Team™
Medical Design Briefs: A breakthrough in wearable neuromodulation
Avation unveils Vivally at the 2024 SUFU Conference
Overactive Bladder Treatment Report highlights Avation
Avation’s results published in Urology
Using digital to develop devices with the patient in mind
Avation wins most innovative wearable award
Avation announces FDA 510(k) clearance for its Vivally® System
Avation Medical is at the intersection between neuromodulation and personalized medicine
The top 25 healthcare technology leaders of Houston in 2022
“The Cutting Edge of Digital Health” panel
Avation presents at the American Urogynecologic Society (AUGS) annual meeting
Avation appoints Chief Marketing Officer
Jill Schiaparelli named one of the top 25 women leaders in medical devices of 2022
Avation announces Board of Director appointments
Webinar: Female Leaders in Uncertain Times (featuring Jill Schiaparelli)
Urinary incontinence is common and treatable - but often hard to discuss
Global urinary incontinence device market expected to reach $4.8b by 2026
May 14, 2024: Various, effective FDA-approved treatments for overactive bladder are and have bene on the market - but Jill Schiaparelli found that more than 90% of patients chose to opt-out of those therapies within a few years. In fact, the Avation team heard that many patients would rather wear a diaper and deal with their overactive bladder syndrome that way than pursue one of the currently available methods. Those learnings helped propel the Vivally System, which is not only safe and effective but also designed for the patient and what they want and need. This article, from Medical Device News Magazine, goes into more detail about the inspiration behind Vivally, Avation’s journey so far, and what might be next for the company.
May 6, 2024: In this article from Medical Design and Outsourcing, Avation’s CEO Jill Schiaparelli and CTO Manish Vaishya share their tips for designing a wearable neuromodulation device, such as Avation’s Vivally System. Their tips include finding an unmet need, designing for comfort and ease of use, and using data both to inform future decisions and to improve patient outcomes.
April 26, 2024: For the last 38 years, Ernst & Young LLP (EY) awards the Entrepreneur Of The Year, which recognizes audacious, disruptive leaders across business sectors and regions. Jill Schiaparelli is one of the 29 finalists in the East Central category, which includes Western Pennsylvania, West Virginia, Northeast and South-Central Ohio and Kentucky. She and the other finalists were selected by an independent panel of judges who demonstrated “building long-term value through entrepreneurial spirit, purpose, growth, and impact, among other core contributions and attributes”.
April 19, 2024: On the heels of Avation’s commercial launch of its Vivally System, the company has appointed a new VP of market access and payer relations: Michael Hoffman. Michael Hoffman has prior first-hand experience in bringing medical technologies to market; with Vivally specifically, he’ll focus on establishing, executing, and optimizing market access strategies, reimbursement, and coverage with commercial payers, government payors, and employer groups.
April 17, 2024: Avation’s co-founders Jill Schiaparelli (CEO) and Manish Vaishya (CTO) explained the workings and advantages of Avation’s Vivally System in this interview with Medical Design and Outsourcing. They explained how they made the Vivally System - complete with a constant electrical current and a proprietary material to form the outer garment - for an effective device that is also relatively comfortable. Jill Schiaparelli also mentioned the company’s journey in educating patients around the benefits of neuromodulation in general since it currently is the best treatment for overactive bladder but is not being used widely.
April 6, 2024: Urologist Dr. Colin Goudelocke, MD, was involved with one of Avation’s clinical trials for the Vivally System and is currently working on a paper on some of his other learnings from the trial. In this article, though, he shared what Vivally does and how it works, how it is unique, and why it appeals to those with overactive bladder syndrome who would otherwise have to take daily medications or resort to surgery to address their condition.
March 4, 2024: Avation has achieved a Certificate of Accreditation from The Compliance Team™, a nationally recognized healthcare accreditation organization. Avation also met the requirements of The Compliance Team™’s Exemplary Provider Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Quality Standards. The result is that Avation earned the Exemplary Provider accreditation, which is granted to healthcare companies that “demonstrate outstanding patient care practices and compliance to The Compliance Team’s comprehensive Safety Honesty-Caring® quality standards”
February 28, 2024: Jill Schiaparelli joined the Medical Design Briefs’ podcast to talk about Vivally: the first FDA-cleared, non-invasive, closed-loop wearable neuromodulation technology for at-home bladder treatment. Although Vivally is focused on overactive bladder, the wearable neuromodulation technology behind it can be utilized for a variety of clinical conditions where patients are looking for a treatment option that doesn’t require surgery and/or drugs.
February 20, 2024: At the 2024 SUFU (Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction) Conference, Avation Medical will officially unveil its Vivally® System to the urology community. The conference will also feature a poster highlighting the outcomes from Vivally®’s REDUCEOAB study, which demonstrated a statistical difference over the shame. SUFU is the kick-off event for Vivally®, which will be available starting next month in select U.S markets before it is nationally available.
February 1, 2024: In its latest fundraising round, a Series C, Avation raised $22M. The capital will be used for the launch of Vivally®, which Avation plans to launch via prescription this spring. Avation’s new investors ShangBay Capital and Asahi Kasei led the round while several other new and existing investors, including Avestria, also participated.
January 21, 2024: According to the latest comprehensive research report on overactive bladder, this market is set to reach a valuation of $3.13 billion in 2024. Along with the growth factors - such as an aging population - that contribute to that valuation, this report also includes the current state of and recent innovations in the field. In the later category, it gives a shoutout to Avation’s Vivally® System specifically.
November 15, 2023: The results of Avation’s FREEOAB study - which measured the safety and efficacy of Avation’s Vivally® System - have been published in Urology: a leading peer-reviewed journal for urologists. Patients using Vivally® saw a “significant reduction in symptom burden” around 12 weeks - results that persisted for 12 months - and an improved quality of life. These patients also didn’t need surgery or drug therapies: two common ways of treating overactive bladder and urinary urge incontinence. The full journal article can be found here.
August 30, 2023: Avation’s Vivally® System was designed with the patient in mind - and Jill Schiaparelli goes into more detail in this article that she wrote for Med-Tech Innovation News. She remembers how patients told Vivally®’s team that they would rather wear a diaper or simply just deal with urinary incontinence than get treated because of the significant drawbacks of the existing treatment options. That feedback led Avation to develop Vivally with the patient in mind. The result is a system that can treat urinary incontinence that is non-invasive, drug-free, surgery-free, and implant-free as well as being easy, convenient, comfortable, and personalized.
May 4, 2023: Avation’s Vivally® System won the “Healthcare Wearables Innovation” Award as part of the annual MedTech Breakthrough Awards program. MedTech Breakthrough is a third-party market intelligence organization focused on the global health and medical technologies market. The 2023 Awards, which mark the seventh consecutive year these awards have been given, recognized companies across clinical and health administration, care management and delivery, genomics, and more. Another Avestria portfolio company, Genome Medical, won the MedTech Breakthrough Award for for genomics innovation.
April 11, 2023: Avation Medical announced that it has received FDA 510(k) clearance for its Vivally® System, Vivally® is non-invasive bladder control therapy device to treat urinary urgency as well as urge urinary incontinence (UUI) without surgery or drugs. Both conditions are caused by overactive bladder syndrome (OAB). During the company’s clinical study, 98% of subjects found the Vivally® System easy to use while 69% of subjects were responders for urinary urgency and 63% were for urge incontinence. A responder is a subject who shows at least a 50% symptom improvement or a return to normal.
December 1, 2022: Neuromodulation, or the changing of the brain through an external stimuli, dates back to the 1930s. This article describes how, now, Avation Medical is utilizing that same treatment option. The company’s first device, the Vivally System, is currently under FDA review to treat urinary incontinence and overactive bladder. The Avation team first purused those areas because of the lack of appealing alternate treatment options but is looking forward to using future neuromodulation-based products to treat patients and improve their lives.
October 5, 2022: Kimberly Wilkinson MSHS, Senior Director of Clinical Operations, was recognized as one of the top 25 healthcare technology leaders of Houston for 2022. The list, compiled by the Healthcare Technology Report, recognizes leaders for their level of knowledge, their dedication, and their pursuit to developing the best products and services, all meant to improve patients’ lives.
September 29, 2022: Jill Schiaparelli is a panelist on a keynote panel discussion at the BIOMedevice Boston conference, called “The Cutting Edge of Digital Health”. Hosted by MedExecWomen, this panel features six female executives who have expertise in both medical devices and digital health. Along with Jill Schiaparelli, the panel features Jill Dooling of Vapotherm, Sara Kehoe of Danaher Diagnostics, Teresa Prego of Nile, and Mira Sahney of Medtronic.
June 14, 2022: Avation presented the results of its latest clinical trial at the American Urogynecologic Society annual meeting, which was held from June 14 to June 18. AUGS’ goal is to connect urogynecologists with industry experts, entrepreneurs, physicians, advance practice providers and physical therapists for continued education on female pelvic floor disorders, such as overactive bladder and urinary urge incontinence: the twin focuses of Avation’s first product.
April 13, 2022: Avation has appointed Darren Wennan as the company’s Chief Medical Officer. Darren Wennan has prior experience as VP of Marketing and Clinical Affairs and SVP of Commercial Operations for Tactile Medical as well as roles at Stryker Orthopedics, Gyrus/ACMI (now Olympus), St. Jude Medical (now Abbott) and Sterilmed (a J&J Company). He will be responsible for all marketing, sales operations and customer care once Avation’s first product is commercially available.
January 11, 2022: Jill Schiaparelli of Avation Medical was named one of The Healthcare Technology Report’s top 25 women leaders in medical devices of 2022. This report recognizes. among other factors, the leadership skills, creative thinking, professional insight, and contributions to their company’s technology of these women.
December 8, 2021: Avation announced that two industry veterans are joining its Board of Directors: Renee Selman, former Worldwide President, Women's Health and Urology for Ethicon (a Johnson & Johnson company) and Raymond Huggenberger, former President and CEO of Inogen, Inc. Their experience with medical devices, healthcare, and commercialization will help Avation bring its first product to market.
August 5, 2020: Jill Schiaparelli joined Ryan K. Baird of MedtoMarket, Patti Rossman of Globiox, and Eva Diaz of Phoenix Human Capital Solutions in this Women in the Life Science webinar. The four female executives talked about being a female leader in these uncertain times. (Note: Membership or payment is required for viewing.)
November 17, 2019: This Wall Street Journal article covers the urinary incontinence: from its prevalence - one-third of Americans over 40 suffer from it - to the ongoing reluctance to discuss it with a medical professional.
July 15, 2019: The urinary incontinence device market is expected to grow from $1.6b to $4.8b from 2017 to 2026. This market growth could be triggered by a several factors, including an increasing demand for non-/minimally invasive or non-surgical products and innovative devices.
December 12, 2018: This study, reported in the International Urogynecology Journal shows the effect of Percutaneous Tibial Nerve Stimulation (PTNS) on treating nocturia urinary incontinence. Avation’s Vivally OAB Treatment and Digital Health System brings that same option to patients in their house, eliminating the need for reoccurring visits to a doctor.