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The Journey To Create A New, Patient-friendly Bladder Control Treatment | By Jill Schiaparelli, Co-Founder And CEO Of Avation Medical – Medical Device News Magazine

  • Jill realized that there was an opportunity to create an entirely new way to treat OAB and focus on the patient experience – ensuring that the treatment was not only effective but also eliminated the need for drugs and invasive procedures that left scars and required permanent implants.
  • With initial funding from an incubator in Ohio, Avation Medical was spun out in January 2019 with a goal to create a wearable neuromodulation system to treat OAB.
  • Today, Avation Medical is an innovative neuromodulation and digital health company with a mission to make wearable neuromodulation accessible and affordable to patients across a variety of clinical conditions.

Jill Schiaparelli, Co-Founder and CEO of Avation Medical, is on a mission. She wants to help millions of patients who suffer from overactive bladder (OAB) pee better. In 2018, as she studied treatment options for the chronic and life-altering condition of OAB, she noticed something: Patients were saying “no” to the many different FDA-cleared OAB therapies that were available on the market. They all had studies demonstrating efficacy but more than 90 percent of patients opted out of therapy within a few years.

Jill realized that there was an opportunity to create an entirely new way to treat OAB and focus on the patient experience – ensuring that the treatment was not only effective but also eliminated the need for drugs and invasive procedures that left scars and required permanent implants.

With initial funding from an incubator in Ohio, Avation Medical was spun out in January 2019 with a goal to create a wearable neuromodulation system to treat OAB. Jill began hiring a team for the journey, including a VP of R&D to help with the technical design.  Very quickly, the team began feasibility testing and working with physicians, payers, and patients to ensure that the design and the business model would deliver value to all of them.

The company closed on a financing round in February 2020 with Arboretum Ventures as the lead and additional investment from others, including medtech company Medtronic. These funds helped Avation conduct two clinical efficacy studies and obtain FDA clearance of its first product, the Vivally™ System.  In January 2024, Avation closed on a $22 million round of financing led by ShangBay Capital and Asahi Kasei; the funding is being used to support sales and marketing efforts to validate, commercialize, and scale Vivally in the U.S. market.

Previous to being lured into the excitement of the startup world, Jill had a long career at several large medical companies, including Johnson & Johnson, where she worked with innovative technologies. Once in the startup world, she worked as an executive at several innovative new companies, where she launched category changing products, including a synthetic bone graft and the first decellularized peripheral nerve graft. Avation Medical was her chance to build a solution from the ground up — with a starting point of focus on the patient. Today, Avation Medical is an innovative neuromodulation and digital health company with a mission to make wearable neuromodulation accessible and affordable to patients across a variety of clinical conditions. Jill established the company’s building principles of inclusivity and empowerment for developing technologies that revolutionize patient care with personalized, non-invasive solutions that optimize therapeutic outcomes while enhancing quality of life. Her vision is for Avation Medical to embody the commitments of excellence, integrity, and patient-centricity – delivering on high-quality patient-friendly technologies while being an excellent place to work.

The company’s Vivally System is the only FDA-cleared, closed-loop, at-home wearable neuromodulation device system. Combined with a companion mobile application, Vivally is a comprehensive therapy and support system for patients suffering from urge urinary incontinence (UUI) and urinary urgency caused by OAB. Vivally is prescribed by a clinician following a brief clinical evaluation that includes a personalized calibration session with the patient. The system uses EMG sensing to confirm activation of the target nerve and determine a personalized output of neuromodulation energy for each unique patient. Vivally delivers clinically effective therapy for UUI and OAB in 30 minutes, as little as once per week, and is self-administered by the patient in their home.

OAB is a chronic, progressive condition with a constellation of symptoms that include urinary urge, urinary frequency, urinary incontinence, and disrupted sleep due to nighttime voiding. People with symptoms think about their condition 24 hours a day because it impacts every aspect of their lives. They adopt behaviors to compensate for their condition — constantly scanning for bathrooms while out in public, choosing to wear dark pants, carrying a change of clothing, and frequently excusing themselves from work settings. As their symptoms progress, they may avoid social and work situations altogether. This results in people with OAB having increased rates of anxiety and depression.

OAB is incredibly common, impacting 1 in 6 adults and affecting both men and women, and adults as young as 18.  Despite the availability of many different treatment options for OAB, the majority of patients drop out of the care pathway or choose not to be treated for their symptoms because current options all have drawbacks that aren’t desirable.

Medications, for example, have many side effects, ranging from dry mouth and constipation to increased risk of dementia, and patients worry about their interactions with other pharmaceuticals. Invasive options like Botox require multiple injections into the bladder wall through a cystoscope in a procedure that needs to be repeated every six months and is associated with urinary retention (which can require self-catheterization for weeks or months). Percutaneous tibial nerve stimulation requires a puncture from a needle-electrode into the ankle and weekly travel to a physician’s office to receive therapy. Sacral nerve and tibial nerve implants require major surgery, resulting in a permanent foreign object inside the body, with the potential for reoperation and scarring.

Of the 45 million people currently living with OAB and UI in the U.S., less than 20 percent have been treated with drug therapy. Less than 3 percent (i.e., fewer than 1 million people) have been treated with invasive therapy.

During her research, Jill and her team heard that patients would rather wear a diaper, or simply try to endure life with their symptoms, rather than be treated with the currently available methods. Jill knew that reimagining a treatment option from the patient’s perspective would be key to addressing this problem.

The Vivally System was studied in two efficacy and safety trials. The results of the company’s FREEOAB Study were published in a cover story in the January 2024 issue of Urology – The Gold Journal, a leading, peer-reviewed journal for urologists. The study demonstrated significant reductions in voids, incontinence, and urgency episodes. Quality of Life measures, which are used to assess treatment success for OAB, exceeded the minimal clinically important difference in all questionnaires. Long-term efficacy results remained robust at 12 months, even with a therapy reduction to just twice per month. Even more significantly, Vivally had no device-related significant adverse events and other side effects were mild.  Therapy compliance was 88.5 percent and patients reported high satisfaction.

In March 2024, Avation Medical became an official member of the League of Exemplary Providers®. Its membership accreditation verified that the company had established processes that met the requirements of The Compliance Team™ Exemplary Provider Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Quality Standards.

In early 2024, Jill and the Avation team initiated the launch of Vivally to physicians and patients in select U.S. markets. The team is currently working with payers to expand coverage and its commercial footprint.

In the ever-evolving landscape of the medical device industry, Jill focuses on innovation as a catalyst for progress as she and her team seek to define a new category of OAB/UUI treatment with Vivally. Central to Avation Medical’s mission is the development of cutting-edge solutions that transcend traditional boundaries, empowering individuals to reclaim control over their health and well-being. Vivally represents a transformative leap forward in the management of bladder control, with its comprehensive therapy and support for the patient.

The heart of the Vivally System’s efficacy is its unique closed-loop design. Unlike traditional medical devices that operate in an open-loop manner, Vivally dynamically adjusts therapy delivery in response to real-time physiological feedback from the patient’s body, which enables it to optimize therapeutic outcomes while minimizing side effects. This adaptive approach not only enhances treatment efficacy but also fosters a sense of reassurance and confidence among patients, empowering them to actively participate in their treatment journey and shift therapy into the home.

Closed-loop technology provides a number of benefits. Vivally calibrates therapy to the patient’s own EMG signal (an indicator of nerve activation), allowing the physician to establish a personalized therapeutic output range for each patient based on the person’s unique physiological profile, and sensors built into the garment continuously provide objective confirmation that the target nerve is being activated during therapy. Proprietary algorithms automatically adjust output in response to patient movement, allowing wearers to move about freely during therapy and be confident that the nerve remains sufficiently stimulated. Ensuring consistent nerve activation means that only minimal stimulation is needed to achieve a positive therapeutic effect.

Jill and her team foresee several other applications for their closed-loop technology in the future.

The simplicity and convenience of Vivally enhances its appeal and accessibility. Vivally offers a non-invasive, time-efficient solution that can be incorporated seamlessly into patients’ daily routines in their own homes. Vivally accommodates the diverse lifestyles and preferences of patients, ensuring that treatment compliance remains high and any barriers to a patient’s care are minimized.

Beyond its clinical efficacy, Vivally extends its impact through its companion mobile application, which serves as a comprehensive therapy and support platform for patients. From personalized therapy reminders and progress tracking to educational resources and remote clinician connectivity, the mobile application empowers patients with the tools and resources necessary to navigate their personalized treatment journey with confidence and resilience. The application also features an electronic diary that promotes awareness of bladder and fluid intake behaviors to help patients optimize their therapy and control their symptoms.

The potential of Vivally extends beyond individual patient care, offering new implications for healthcare providers and payers. It is a cost-effective, non-invasive alternative to traditional treatment modalities, and reduces healthcare expenditures associated with OAB management while simultaneously improving patient outcomes and quality of life. Its remote monitoring capabilities enable clinicians to remotely assess patient progress, adjust therapy parameters, and intervene proactively as needed, thereby streamlining care delivery.

With the Vivally System, Avation Medical is establishing a new category of treatment that will not only change the lives of those living with OAB, but also pave the way for new, innovative ways of applying closed-loop technology in the home care, self-administration environment of tomorrow’s patients.

Editor’s Note: Jill Schiaparelli is passionate about bringing cutting-edge medical technologies to markets to help improve the lives of patients. With more than 20 years of experience in the healthcare industry, she has honed her expertise in leading innovative healthcare organizations, driving them to success with business strategy for healthcare technologies and care providers, specializing in global medical device commercialization, emerging technologies, strategic marketing, healthcare consumerism, and patient care pathway modeling. She has held leadership roles with major healthcare companies such as Johnson & Johnson and Baxter as well as serving as an executive at high-growth, innovative companies such as ApaTech (UK), a company she helped sell to Baxter, AxoGen where she assisted their up-list to NASDAQ, InteloMed where she launched the CVInsight™ Monitoring and Informatics System, and Neurotechnology Innovations Translator, an incubator and investment vehicle to launch and grow companies in the neuromodulation space. She has a MBA in Finance and Business Management from the Stern School of Business at New York University and a BS in Finance and International Management from the Questrom School of Business at Boston University.