Avation Medical Achieves ISO 13485 Quality Standards Certification

Columbus, Ohio (June 17, 2024) – 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.”

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. Learn more at Avation.com.