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Dr. Colin Goudelocke, investigator in the "FreeOAB Study", will present the results of Avation Medical’s recent clinical trial evaluating the safety and efficacy of a novel at-home wearable neuromodulation and digital behavioral support system to treat the symptoms of OAB and UUI at the American Urogynecologic Society (AUGS) and International Urogynecological Association (IUGA) 2022 Scientific Meeting in Austin, Texas June 14-17, 2022

Avation Medical, an innovative neuromodulation and digital health company pioneering a wearable platform to treat the symptoms of overactive bladder (OAB) and urge urinary incontinence (UUI), today announced that Dr. Colin Goudelocke, investigator in the FreeOAB clinical study and urologist at Ochsner Health in New Orleans, will present evidence in support of the safety and efficacy of a new therapy and digital behavioral support system to treat the symptoms of overactive bladder (OAB) and urge urinary incontinence (UUI).
The Vivally™ System is a wearable bladder control therapy and digital health system utilizing neuromodulation to treat patients with the chronic conditions of overactive bladder (OAB) and urge urinary incontinence (UUI) and their associated symptoms including urinary urgency, urinary frequency, and urge urinary incontinence, without the need for surgery, permanent implants, or drugs. The non-invasive therapy and digital health system is intended to provide personalized treatment with the ability to conduct therapy at home, in as little as 30 minutes per week. The Vivally System features patented closed-loop control technology that uses the patient’s own physiologic response to objectively confirm activation of the tibial nerve and continuously monitor nerve recruitment, automatically adjusting the stimulation within a personalized therapeutic range set by the physician, for each patient, to ensure both comfort, and optimal therapeutic output.

The Vivally System is prescribed by a physician following a brief clinical screening and personalization to ensure that the therapy is tailored to each patient and provides a comfortable experience. The Vivally System Patient Kit includes a Stimulator with rechargeable battery, wearable garment, gel cushions, and accessories. Its digital components include a mobile app that allows patients to control and monitor therapy, symptoms, and other activities, and a HIPAA compliant cloud-based web portal for physicians and patients that collects therapy history, bladder events and patient behavior, allowing users to easily track the treatment progress and enabling additional therapy adjustments when appropriate.

Jill Schiaparelli, Avation’s CEO commented “Avation Medical is a strong team of professionals that is committed to making neuromodulation more accessible to patients suffering from chronic conditions like OAB through its wearable therapy and digitally enabled behavioral support platform. We are honored that Dr. Goudelocke will present this groundbreaking evidence on behalf of the investigators.”
Vivally is currently available for investigational use only and is not yet FDA cleared.
Details of the clinical evidence presented at AUGS can be found here.
Corporate Contact

Jackie Gerberry
Senior Director
Jgerberry@Avation.com
www.Avation.com

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