Clinical trials of a new wearable medical device are showing positive results for people with urinary incontinence issues. The InConfidence Patch works by stimulating the tibial nerve in a patient's ankle to help soothe bladder functions, giving hope to the estimated 40 million Americans who experience the condition.

New York

Clinical trials of a pioneering wearable medical device are bringing hope to individuals dealing with urinary incontinence. Named the InConfidence Patch, this device works by stimulating the tibial nerve in the patient's ankle to help regulate bladder functions. This innovation is particularly significant for the estimated 40 million Americans impacted by this condition, which can entail symptoms such as frequent urination, urgency, and nocturia.

The development of the InConfidence Patch is spearheaded by Marcel Botha, CEO of 10X Beta, and Harvard innovator Nikki Agahari. Botha's company has a history of crafting revolutionary medical devices, including a low-cost ventilator developed quickly to address demands during the COVID pandemic in New York City. The wearable patch marks a new direction, aiming to tackle the stigma and embarrassment often faced by urinary incontinence sufferers.

Support from Japanese investors has facilitated the world's first clinical trials of the InConfidence Patch in Australia. Despite the existence of medications and surgical treatments, the patch offers a discrete and non-invasive alternative solution. Agahari's inspiration partially stems from personal experience, as her grandfather’s battle with incontinence highlighted the often emotional struggle linked to the condition. The device allows for treatment privacy and promises an improvement in quality of life, removing the reliance on adult diapers and empowering users.



Wearable device helping incontinence patients manage symptoms

Along New York's East River, inside Brooklyn's historic Navy Yards precinct, a healthcare revolution is happening. Modernizing, optimizing, and scaling it for a future that is really outside of the hospital. Marcel Botha is CEO of 10X Beta, a company dreaming up and developing some of the world's most innovative medical devices. Drug delivery and therapeutics, diagnostic devices, monitoring devices, and also durable medical equipment. During New York's devastating COVID wave, Marcel and his team of researchers, scientists, and engineers worked around the clock to deliver a new low-cost, life-saving ventilator to the city's overstretched hospitals. March 18, 2020, the New York mayor's office called and said they needed somebody to lead the ventilator response for New York City. And by day 30, we had technology with a similar functionality as a $30,000 ventilator shipping to New York City at a rate of about 500 units a day. Now with their latest project, the 10X Beta team have turned their attention to a condition affecting more than 40 million Americans. For the majority of patients that suffer from the condition, there's so much embarrassment and stigma. Harvard innovator Nikki Agahari is the brains behind the InConfidence smart patch, a first-of-its-kind device designed to give people experiencing urinary incontinence control over their symptoms. Urinary incontinence presents itself with three major symptoms. One is frequency, which is running to the toilet all the time. Second is urgency, that desperate need to urinate. And the last one, nocturia, is waking up multiple times at night to urinate. And this is actually the largest cause of falls. The device works by stimulating the tibial nerve in the ankle, which sends impulses to the brain to soothe abnormal bladder spasms. Everyone's ankle's quite lean, so we're able to access that nerve minimally invasively using our microarray needle. With support from Japanese investors, Nikki and Marcel are now monitoring the world's first clinical trials of the InConfidence patch, currently underway in Australia. The U.S. is still the gold standard as a location to commercialize new medical devices. American innovation, but a global effort, which Nikki Agahari says also has a very personal side. My grandfather who suffered from the condition, that was the only time I've ever seen my grandfather cry, was when he wasn't able to control his symptoms and he didn't want anyone to know about it. While medications and surgical treatments for chronic incontinence do currently exist, the InConfidence patch promises to offer patients an effective and empowering alternative. What makes me excited about the product is that it brings privacy back to the therapy. It negates the need for adult diapers. Seeing more elderly patients out in the community laughing, enjoying their time with the family, while they have a smart patch on, that would be the moment that would go, wow, I haven't done too bad.

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