Avation’s ankle wearable can be used for weekly 30-minute at-home sessions for the treatment of urge urinary incontinence and urinary urgency caused by overactive bladder (OAB) syndrome. Image Credit: Kmpzzz / Shutterstock.

Avation Medical has raised more than $22m in Series C financing to fund the US launch of its Vivally system for patients suffering from urge urinary incontinence and urinary urgency caused by overactive bladder syndrome (OAB).

The wearable device is a non-invasive neuromodulation system that targets the tibial nerve and delivers closed-loop, autonomously adjusted electrical stimulation. The device received 510(k) clearance from the US Food and Drug Administration (FDA) in April 2023. The ankle wearable can be used for weekly 30-minute at-home sessions.

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The Series C financiers included Medtronic, ShangBay Capital, Asahi Kasei, Angelini Ventures, Arboretum Ventures, Tonkawa, and Avestria Ventures. Furthermore, representatives from Asahi Kasei and Angelini Ventures will join Avation’s board of directors.

The Vivally device was tested in a 12-week open-label single-arm study. Reduction in daily voids, incontinence, and urgency episodes were observed in 96 patients at 12 weeks.

The wearable technology market has seen high growth in recent years. As per a GlobalData report, the market size of wearable technology in the medical sector is expected to grow at a compound annual growth rate of 15% up to 2030. The neuromodulation market is also forecast to grow from being worth approximately $7bn in 2023 to $10.7bn in 2030, as per GlobalData market analysis.

Another company that has capitalised on this growing market and developed a wearable neuromodulation device is BlueWind, whose FDA-cleared urinary incontinence system Revi comprises an implant and a wearable ankle strap. The implant is a battery-free device that is placed near the ankle in a minimally invasive procedure under local anaesthesia.

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The wireless ankle wearable provides accessible activation for the implant, upon which the small, inserted device stimulates the posterior tibial nerve. The device therapy should be administered once or twice daily to treat urinary incontinence.