Curavit Completes Virtual Recruitment for The APPROVE Decentralized Clinical Trial

BOSTON and COLUMBIA, Md. and GALWAY, Ireland, Oct. 30, 2025 /PRNewswire/ -- Curavit Clinical Research, "The Innovation CRO," has reached the milestone of recruiting half of the participants for The APPROVE Trial a full two months ahead of schedule. The APPROVE Trial, a randomized trial evaluating the efficacy and safety of a prescription digital therapeutic for treatment of overactive bladder in women, is multi-centered and compares a prescription digital therapeutic (PDTx) application called RiSolve to standard behavioral education. Amara Therapeutics partnered with MedStar Health, a leading academic health system located in Maryland, Virginia, and Washington, D.C., to initiate and conduct a multi-site clinical trial to produce key data to support FDA marketing clearance.

Curavit was engaged for its Virtual Clinical Site and to recruit 298 of the 596 total study participants within six months. The screening and enrollment process was rigorous, spanning multiple days and requiring participants to both consent to medical record collection and complete a multi-day diary. Despite the complexity of the process, the scalability of Curavit's Virtual Clinical Site, supported by the Virtual Clinical Site platform STRATUS, enabled recruitment to be completed in just four months. 

"Curavit's role as the virtual site in The APPROVE Trial has been outstanding," said Brendan Staunton, CEO of Amara Therapeutics. "Within just four months, they successfully recruited 298 participants—clearly demonstrating the power and efficiency of their virtual site. This accelerated timeline reduces study duration and enables us to deliver evidence-based digital therapies to women faster. Curavit provides both exceptional performance and significant strategic value." 

"We are proud to partner with Amara Therapeutics and MedStar Health in advancing RiSolve DTx to market," said Joel Morse, CEO and co-founder of Curavit Clinical Research. "Amara's mission—to raise the standard of care for women living with incontinence by delivering accessible, evidence-based solutions—aligns perfectly with our commitment to supporting innovative digital therapeutics. This is another strong validation of the decentralized trial model, and a demonstration of how digital therapeutics and digital clinical trials can work hand-in-hand to drive innovation in women's health."

About Curavit Clinical Research
Curavit Clinical Research, The Innovation-CRO, designs and executes modern clinical trials for medical devices, digital therapeutics, and novel pharmaceuticals. Headquartered in Boston, Massachusetts, Curavit combines full-service CRO capabilities with a fully integrated Virtual Clinical Site to expand access, accelerate timelines, and improve the patient experience. Learn more at Curavit.io.

About Amara Therapeutics
Amara Therapeutics are developing digital therapies that help women living with incontinence take control of their lives. Headquartered in Newcastle, Ireland, Amara Therapeutics' solutions empower women to access evidence-based care anytime, anywhere. Learn more at AmaraTherapeutics.com.

AboutMedStar Health
At MedStar Health, we use the best of our minds and the best of our hearts to serve our patients, those who care for them, and our communities. Our 30,000 associates and 4,000 affiliated physicians are committed to living this promise through our core SPIRIT values—Service, Patient first, Integrity, Respect, Innovation, and Teamwork—across our more than 300 locations including 10 hospitals, ambulatory, and urgent care centers. As the medical education and clinical partner of Georgetown University, MedStar Health is training future physician leaders to care for the whole person, and is advancing care through the MedStar Health Research Institute. From our telemedicine and urgent care services to the region's largest home health agency, we're committed to providing high-quality health care that's also easy and convenient for our patients. At MedStar Health—It's how we treat people. Learn more at MedStarHealth.org.

SOURCE Curavit Clinical Research