Avation’s Vivally System revolutionizes the treatment of overactive bladder symptoms without drugs, surgery, or needles.

, an innovative neuromodulation and digital health company on a mission to make non-invasive, physiologic, closed-loop neuromodulation accessible to patients across a variety of clinical conditions, is presenting “

A Novel Wearable Neuromodulation System Using Physiologic Closed Loop Control Shows Significant Improvements in Quality of Life for OAB Patients in a Randomized Multi-Center Study” 

on September 27, 9:15-10:15 a.m. EDT to urology professionals at the 2024 SUNA uroLogic Conference, in Orlando, Florida. The talk will feature a demo of the new Vivally System and will be given by one of the study investigators: Kavi Rajendran, PA, of Women's Health Institute of Illinois.

In addition, on Thursday, September 26, from 5:15-6:30 p.m. EDT, Michelle J. Lajiness, DNP, FNP-BC, FAUNA, will demonstrate the Vivally System together with a Vivally patient who is experiencing its clinical and ease of use benefits. This educational event is an open forum for any urology professional interested in the therapeutic possibilities available through at-home, wearable technology paired with comprehensive digital support.

Throughout the conference, the Vivally System will be demonstrated at the Avation Medical exhibit, #107.

The Vivally System is an at-home neuromodulation wearable and mobile application to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency — without the need for surgery, needle electrodes, or drugs. To date, there are more than 46 million people who suffer from OAB in the U.S.

The Vivally System can be used by any OAB patient in the care pathway, including drug-naïve, drug-stable and drug-refractory. The device and mobile app are easy and efficient to prescribe and allow prescribers to monitor patient progress remotely. The Vivally System is the only device of its kind to harness the power of physiologic, closed-loop control with transcutaneous tibial nerve stimulation (PCLC-TTNS) and continuous EMG sensing, which autonomously adjusts stimulation parameters during therapy to ensure optimal therapeutic output is delivered in real-time based on a patient’s EMG signal.

About Avation Medical and the Vivally System

Avation Medical is an innovative neuromodulation and digital health company with a mission to make non-invasive, physiologic closed-loop neuromodulation accessible to patients across a variety of clinical conditions. The company’s Vivally System is the only FDA-cleared, physiologic closed-loop, at-home wearable neuromodulation device system to treat symptoms of OAB. Combined with a companion mobile application, Vivally offers a comprehensive therapy and support system for patients suffering from urge urinary incontinence and urinary urgency caused by overactive bladder syndrome (OAB). Vivally is prescribed by a clinician following a brief clinical calibration which establishes an EMG target and range of neuromodulation energy needed for consistent nerve activation. Vivally delivers clinically effective therapy in just 30-minute sessions, as little as once per week. Vivally is available by prescription in select geographies in the United States. Physicians wanting to offer the Vivally System to their patients can visit 

Avation Medical to Present Positive Quality of Life Data for the Vivally Physiologic Closed-Loop Wearable Neuromodulation System for Patients With OAB at SUNA uroLogic Conference 

Columbus Business First honors the company’s Vivally® System as advanced BizTech innovation.

– Avation Medical, an innovative neuromodulation and digital health company on a mission to make non-invasive, physiologic, closed-loop neuromodulation accessible to patients across a variety of clinical conditions, has been recognized by 

weekly news organization as a 2024 BizTech award honoree. The BizTech awards recognize the most promising startups, entrepreneurs, and innovators reshaping the ecosystem in the Columbus region.

“Columbus has been an ideal ecosystem of innovation and entrepreneurship for our business,” said Jill Schiaparelli, Avation Medical Co-founder and CEO. “Recognitions like this continue to fuel our mission of improving the lives of the more than 500 million people globally who suffer from the life-altering chronic conditions of overactive bladder (OAB) and urinary incontinence. OAB significantly interrupts everyday activities like traveling, working, socializing, and being active, and can lead to isolation and depression. Our purpose is to change this.”

Avation Medical created the only patient-centered solution to chronic bladder conditions, the Vivally® System, the first physiologic closed-loop, non-invasive neuromodulation therapy with a digital support application. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting only 30 minutes as little as once per week. Because Vivally requires no surgery, drugs, or needles, it sets a new standard for the treatment of OAB. Vivally is available in select geographies in the United States.

Avation Medical is an innovative neuromodulation and digital health company with a mission to make non-invasive, physiologic closed-loop neuromodulation accessible to patients across a variety of clinical conditions. The company’s Vivally System is the only FDA-cleared, physiologic closed-loop, at-home wearable neuromodulation device system to treat symptoms of OAB. Combined with a companion mobile application, Vivally offers a comprehensive therapy and support system for patients suffering from urge urinary incontinence and urinary urgency caused by overactive bladder syndrome (OAB). Vivally is prescribed by a clinician following a brief clinical calibration which establishes an EMG target and range of neuromodulation energy needed for consistent nerve activation. Vivally delivers clinically effective therapy in as little as one 30-minute session once per week. Vivally is available by prescription in select geographies in the United States. Learn more at Avation.com.

Avation Medical Receives Tech Recognition

– Avation Medical, an innovative neuromodulation and digital health company on a mission to make non-invasive, physiologic, closed-loop neuromodulation accessible to patients across a variety of clinical conditions, announced it has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System after an extensive audit of its facilities. ISO 13485 recognizes companies that demonstrate high-quality standards in the design, production, representation, and servicing of regulated medical devices through robust policies and procedures. The audit was conducted by TÜV SÜD America, Inc., an independent third-party certification firm.

Avation Medical is currently launching its new Vivally® System, the first FDA-cleared non-invasive, physiological closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs. Using proprietary algorithms and electromyographical (EMG) sensors, Vivally continuously reads the patients EMG signal and automatically adjusts the level of stimulation energy being delivered to a patient’s tibial nerve to ensure optimal, customized therapy in a real-time, closed-loop system. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting only 30 minutes as little as once per week. Because Vivally requires no surgery, drugs, or needles, it represents a groundbreaking advancement in the treatment of OAB.

In two multi-center randomized clinical trials, the Vivally System was shown to significantly reduce daily void, incontinence, and urgency episodes and improve patient quality of life while facilitating an 89-percent therapy compliance rate. Symptom reduction was demonstrated out to one year, even with decreasing therapy frequency over time.

The Vivally System is a convenient, next-generation, at-home wearable neuromodulation therapy that is discreet, comfortable, and easy to use. Urology teams collaborate with their patients through online diaries and individualized data to validate, treat, and monitor symptoms for optimal patient success. Clinicians can increase the number of patients they are able to effectively treat while reducing the cost of care, thus positively impacting patients, their practices, and the healthcare system overall.

“The ISO certification represents a milestone confirming that the revolutionary Vivally System, with its physiologic closed-loop system, is managed and delivered under the highest quality conditions,” said Manish Vaishya, PhD, chief technology officer and co-founder at Avation Medical. “Vivally is currently being prescribed to patients in the U.S. with symptoms of OAB and this new certification opens the door for our international expansion.”

Vaishya adds that the latest ISO 13485 standard emphasizes risk-based decision-making, robust design process, patient focus, management responsibility, production and supplier controls, and increased regulatory requirements. “Meeting these particular requirements further highlights the scalability of our business and the millions of lives that our unique solutions can improve.”

Avation Medical is an innovative neuromodulation and digital health company with a mission to make non-invasive, physiologic closed-loop neuromodulation accessible to patients across a variety of clinical conditions. The company’s Vivally System is the only FDA-cleared, physiologic closed-loop, at-home wearable neuromodulation device system to treat symptoms of OAB. Combined with a companion mobile application, Vivally offers a comprehensive therapy and support system for patients suffering from urge urinary incontinence and urinary urgency caused by overactive bladder syndrome (OAB). Vivally is prescribed by a clinician following a brief clinical calibration which establishes an EMG target and range of neuromodulation energy needed for consistent nerve activation. Vivally delivers clinically effective therapy in just 30-minute sessions, as little as once per week. Vivally is available by prescription in select geographies in the United States. Learn more at Avation.com.

Avation Medical Achieves ISO 13485 Quality Standards Certification

The Avation Medical team extends a warm welcome to @Jennifer Estep, who joins @Avation Medical as Vice President of Product Marketing & Customer Care. Jennifer brings more than a decade of medtech and pharmaceutical experience successfully bringing best-in-class solutions to market to benefit patients.

Driven by her passion to advance world-class medtech innovation to benefit patients in need, Jennifer brings experience successfully commercializing a first-in-class combination product, building high-impact teams, communicating strategic life-improving innovations, and delivering solutions through internal and external collaborative partnerships. We are excited for Jennifer’s expertise in bringing the Vivally System to patients. Welcome to the Avation Medical team, Jennifer!

Welcoming Jennifer Estep

Avation Medical’s Bladder Control Therapy Receives Award for Most Innovative Wearable

Avation Medical adds Vice President of Market Access  as it launches first non-invasive, closed-loop wearable neuromodulation for  bladder control

Avation Medical achieves Certification of Accreditation from The Compliance Team™, becomes member of the League of Exemplary Providers®

Avation Medical unveils first non-invasive, closed-loop wearable neuromodulation for bladder treatment to urology community at 2024 SUFU Conference®

Avation Medical raises $22M+ from impressive line-up of new global investors to jump-start sales of the first closed-loop wearable neuromodulation technology for bladder treatment

Multi-center study published in Urology confirms efficacy and safety of Avation Medical’s noninvasive Vivally® System for OAB

Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System, a wearable bladder control therapy and mobile app to treat patients with urinary urgency and urge urinary incontinence.

The Intersection of Neuromodulation and Personalized Medicine

Kimberly Wilkinson of Avation Medical awarded Top 25 Healthcare Tech Leaders  of Houston 2022

Medical Devices and Diagnostic Industries

 announced a keynote panel discussion at BIOMedevice Boston to occur on Thu, Sep 29, 2022. Six female medical device industry executives will team up to talk about innovations in digital health solutions, Artificial Intelligence, and the regulatory challenges these innovations may face. The event will be moderated by Maria Shepherd, president of Medi-Vantage and co-founder of MedExecWomen. The panel, with Shepherd moderating, includes Jill Dooling, vice president of Strategic Accounts at Vapotherm, Sara Kehoe, Senior Director, Clinical Insights at Danaher Diagnostics, Teresa Prego, Chief Commercial Officer at Nile, Mira Sahney, President, Pelvic Health at Medtronic, and Jill Schiaparelli, CEO at Avation Medical. The session, sponsored by MedExec Women, will be held Thursday, Sept. 29, from 9:15 to 10:15 a.m. on the Center Stage.

Avation CEO, Jill Schiaparelli, to join all-female panel  with executives from Medtronic, Danaher, and other distinguished life science companies to discuss digital health innovations at BioMedDevice Boston

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