The companies that participate in the Fogarty Company Accelerator Program (CAP) program are among the most innovative early-stage companies globally, aiming to bring cutting-edge technologies to market to better serve patients. The newest CAP company, Amara Therapeutics, has created a first-of-its-kind app-based platform to help treat the pervasive issue of overactive bladder (OAB).

Solving an Unmet Clinical Need

CEO and co-founder Brendan Staunton became aware of Fogarty and the CAP program during his time with the BioInnovate Programme at the University of Galway, an affiliate of the Stanford Mussallem Center for Biodesign. With the goal of identifying unmet clinical needs in healthcare, his team researched obstetrics, gynecology and neonatology, ultimately cataloguing more than 500 potential problems to solve. The need that stood out most involved the treatment of urinary incontinence, specifically OAB.

“The current pathway is inefficient and failing both patients and clinicians. We decided to tackle improving the quality of incontinence care more broadly by evaluating ways to improve the entire patient journey,” he said.

The first issue the team recognized was how long it can take patients to even seek help, given the stigma often associated with these conditions. And then once patients did reach out, the treatment pathway frequently ended up being long and frustrating for both patients and clinicians.

They decided to focus on overactive bladder, which affects over 100 million women globally and is caused by the brain and bladder being out of sync. This leads to either frequent urination because the bladder is over-signaling to the brain, or an unexpected urgency because the bladder isn’t sending signals when it’s actually full.

The first recommended treatment for the condition is behavioral therapy, which consists of exercises to rewire the brain/bladder connection. Although this approach is incredibly effective and safe, there aren’t enough specialists to deliver it. As a result, patients are often put immediately on the second-line treatment—medications— which can have an array of negative side effects, including  dry eyes, dry mouth, constipation and a potential link to an increased risk of dementia. The third-line treatment is neuromodulation implants and Botox injections in the bladder, which only about 3.5% of patients ultimately receive because by then most have become too frustrated to continue pursuing treatment.

“We felt the whole pathway was ripe for disruption, so we set out to build a technology solution that could open the treatment pathway,  making behavioral therapy more accessible and ensuring every patient has access to the treatment that best suits their particular condition and symptoms,” explained Staunton.  

Revolutionizing the Status Quo

The result is RiSolve®, a medical device software platform that delivers an eight-week treatment through a prescription app that includes evidence-based methods such as behavioral therapy and Cognitive Behavioral Therapy (CBT), alongside bladder retraining and pelvic health Pilates. The guided, step-by-step program empowers women to take control at their own weekly pace with interactive video and audio that educate the patients on their condition and present a series of tasks and challenges to complete. Users receive care from the comfort of their own homes without the need for multiple in-person sessions.

The platform allows clinicians to see the patient’s goals for the program, their key symptoms, their adherence and their improvement via a dashboard. RiSolve® has in-built proprietary algorithms that interpret this data, which helps clinicians better understand each individual patient’s condition.

The device has already received CE Mark approval in the EU. Next on the docket is a 600-patient study at 10 sites in the U.S, one of the largest studies ever completed in the overactive bladder population, with the goal of gaining FDA clearance as a Class 2 medical device.  The study initially will target women, as they are more likely to seek help, with the intent to expand eventually to men as well.

Amara’s go-to-market strategy includes building out a virtual clinic state by state to enable easier access to the pathway using telemedicine. “We are partnering with providers and using our technology and virtual clinic capabilities to optimize their care pathways. This strategy provides more accessible, convenient care for patients while also creating an additional revenue stream for clinicians,” Staunton said. The plan is to launch clinics in Arizona and Colorado this year to test the model before expanding nationwide.

In addition to Staunton, Amara has two other cofounders. COO Emma Carr, MD will use her experience developing digital interventions as a health psychologist to run the digital health trials; and, as former president of the American Urogynecologic Society (AUGS), CMO Geoffrey Cundiff, MD, professor of OB-GYN at University of British Columbia in Vancouver, Canada, is a key opinion leader in the space.  The leadership team is backed by an accomplished cadre of quality, regulatory, commercial and technology specialists.

Benefitting from the Deep Expertise at Fogarty

The CAP program focuses on supporting early-stage companies in developing a comprehensive, cross-functional approach to address their desired opportunity by “starting with the end in mind.” The six-month program is designed to help companies clearly focus on their opportunity and identify barriers to success.

The Amara team is excited about the opportunity with CAP as they target the U.S. market and aim to close a seed round of $6 million, said Staunton. “We are eager to learn from other companies’ journeys and the Fogarty team as we refine our clinical pathways and commercial strategy,” he says. “The next six months will be pivotal in those areas so we are really digging in and taking as much advice as we can about how to successfully execute, while expanding our network.”