Avation Medical Secures $22M Series C Funding to Launch FDA-Cleared Vivally® Wearable Neuromodulation System for Overactive Bladder

Text | Li Nana

Avation Medical is an innovative neuromodulation and digital health company headquartered in Ohio, USA. The company has pioneered a closed-loop, patient-adaptive wearable neuromodulation therapy that provides personalized treatment based on the patient’s own physiological responses.

On February 1, Avation Medical announced that it had secured over $22 million in equity financing in its oversubscribed Series C round. The round was led by new investors ShangBay Capital and Asahi Kasei, with participation from several existing investors, including Angelini Ventures, JOGC, Arboretum Ventures, Tonkawa, Medtronic, and Avestria Ventures. Avation Medical will use the proceeds from this round to launch the Vivally system in major U.S. markets in early spring 2024. The system will require a prescription.

Avation Medical's Vivally System is the only FDA-cleared closed-loop home wearable neuromodulation device system. Combined with a companion mobile application, Vivally offers a comprehensive treatment and support system for patients suffering from urgency urinary incontinence and urgency caused by overactive bladder (OAB). This smart wearable therapy objectively confirms the activation of targeted nerves and shifts treatment to the home environment by eliminating the need for surgery, needles, and permanent implants, allowing millions of patients to access neuromodulation technology across various clinical applications.

Vivally is prescribed by clinicians after a brief clinical assessment. Personalized calibration identifies EMG targets and neuromodulation energy ranges correlated with detected EMG signals to indicate neural activation. The system uses proprietary algorithms and electromyography (EMG) sensors to detect and calibrate the energy levels delivered to the tibial nerve during stimulation, ensuring optimal customized treatment output in true real-time closed-loop operation. Vivally can be worn around the ankle and used at home. Unlike other implantable neuromodulation methods for bladder treatment, Vivally requires no surgery or medication and provides clinically effective treatment in just 30 minutes, with only once-a-week sessions required. Currently, Vivally is available by prescription in select regions of the United States.

A Home-Use Wearable Neuromodulation System Without Surgery or Medication Represents a Major Advance in OAB Treatment. Although neuromodulation has historically been effective in treating OAB symptoms, until now it required clinic visits or invasive surgery, limiting treatment to less than 10% of patients seeking care. Vivally can be used early in the treatment pathway to address approximately 9 million patients annually who seek treatment for their symptoms. In two multicenter clinical trials, the Vivally system was shown to significantly reduce daily urination, incontinence, and urgency episodes while improving patients' quality of life. Additionally, the system demonstrated an 88% treatment adherence rate. Symptom relief lasted up to one year, even with reduced treatment frequency.

Editor | Hai Ruojing