Now available in select US geographies.

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. 

Leave a Reply

Your email address will not be published. Required fields are marked *

Skip to content