)
Australis Scientific has secured US$6 million ($9.3 million) from Japanese healthcare giant Rohto Pharmaceutical to back development of its neuromodulation technology that alleviates symptoms of overactive bladder (OAB) - a condition that affects more than 400 million people worldwide.
The Sydney-headquartered company launched its first-in-human clinical trial in Australia in October for its trademarked Confidanz smart patch, a discreet, band aid-sized patch worn near the ankle that uses gentle tibial nerve stimulation to calm the bladder and reduce symptoms of OAB and urinary incontinence.
Known as the SPARC Study, which stands for 'Stimulating Percutaneous Array for Urinary Reflex Control', the 90-day trial is taking place across Sydney and Brisbane.
The latest funding from Rohto Pharmaceutical, which takes the total capital raised to $11.425 million, will accelerate the trial and support regulatory submissions in Australia, the US and Japan, along with expanded market entry into Asia through Rohto’s extensive presence in Japan and China.
In Japan alone there are an estimated 12.5 million adults with OAB, yet treatments are often invasive, costly or difficult to access.
The company notes that adult diapers outsell infant ones, and the scale of the waste problem is staggering - by 2023, 1.8 million tonnes of adult diapers are expected to enter the waste stream each year, at a time when people over 65 will make up almost a third of the population.
"This partnership with Rohto is transformational," says Nicky Agahari, the inventor of the original intellectual property who co-founded Australis Scientific in 2021 alongside Martin Jensen, Mihir Shanker, Helena Franco and Danielle Delaney.
"Not only does it provide the capital we need to scale our clinical program, but it also opens the door to Japan and broader Asia - markets where ageing populations mean demand for bladder health solutions is urgent and growing," explains Agahari, who is also a Harvard Medical School HealthTech Fellow.
Australis believes its approach has the potential to reduce reliance on surgery and medication while providing a scalable solution for regional and remote communities.
Rohto Pharma, headquartered in Osaka, Japan, is a diversified healthcare company with a global presence across eye care, skincare, and consumer health products. By backing Australis Scientific, Rohto expands into digital therapeutics and medical devices, aligning with its long-term focus on meeting the needs of ageing populations in Japan and China.
Rohto Pharmaceutical president and representative director, Hidetoshi Segi, says the listed group invested in Australis Scientific because its smart patch offers a "scalable, patient-centric way to treat overactive bladder at home", which aligns with Rohto's focus on healthy longevity.
"We believe this combination of neuromodulation and digital therapeutics can create a new category in urinary incontinence care," he says.
"Our partnership with Australis Scientific is more than an investment," adds Rohto's vice president of international business development, Takako Hirata. "It is Rohto’s pathway to bring well-being to an aging world, bridging our trusted distribution with groundbreaking health technology."
The company is also advancing a licensing pathway into China, where regulatory fast-tracking could see Confidanz reach patients earlier than in Western markets.
)
