Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), has successfully completed a decentralized trial for the Sana Device. Sana has submitted the trial data for Breakthrough Device Designation consideration from the U.S. Food and Drug Administration (FDA) for its wearable, virtual-reality-style mask that uses audiovisual stimulation to reduce symptoms of post-traumatic stress disorder (PTSD).
More than 45 patients were recruited from a Veteran’s hospital participated in the 28-day study. Curavit exceeded Sana’s expectations for participant retention with a 76% retention rate and managed all aspects of participation with remote-based clinical research coordinators (CRCs), a remote-based principal investigator, and fit-for-purpose technology platform including ePROs, eCOA, telehealth, device training, and randomization. Curavit CRCs captured participant experience with the Sana Device using industry-standard PHQ-9 survey and the Columbia Suicide Severity Risk Scale (C-SSRS) to capture levels of depression – all done remotely using electronic patient-reported outcomes assessments.
The Sana Device is a wearable device that aims to offer anxiety relief on-demand. The trial was carried out with a grant from CDMRP funds, disbursed through the Military Operational Medicine Research Program (part of the DoD). It was designed to gather evidence on the Device’s ability to allow patients suffering from PTSD to gain additional relief whilst on waiting lists for further specialty care.
The Sana Device received FDA Breakthrough Device Designation for treatment of Fibromyalgia in 2021.
“The Sana Device has tremendous potential to help patients with pain and mental health issues, but we needed a more efficient, modern way to study and demonstrate efficacy and safety,” explained Richard Hanbury, CEO of Sana Health. “In addition to gaining FDA approval, it is important for us to demonstrate the impact our device can have on healthcare economics so we can increase market access and get our innovation into the hands of more patients, faster. Curavit provided us with a streamlined path to capture real-world data with the utmost professionalism, allowing us to conduct a high-quality and successful trial. Thanks to Curavit, we are moving onto a larger pivotal study, funded by MOMRP (DoD).”
Curavit recently announced its Health Economics and Outcomes Research services to seamlessly capture evidence of the health economics value of novel pharmaceutical products, especially digital therapeutics. Curavit assesses the value and effect of medical interventions on both individual patients and population health levels of care, which can have an impact on market access post FDA approval.
“Real-world evidence is critical for DTx companies to achieve insurance coverage and reimbursement by demonstrating to payors and providers the full impact of these innovations. Curavit’s HEOR services produce the real-world data needed to unlock wider coverage and greater availability for transformative digital treatments,” added Andy Molnar, CEO of Digital Therapeutics Alliance (DTA).
“Sana Health’s origin story is emblematic of the company’s determination to bring innovative treatments to patients suffering from a range of disorders, and we are honored to help them along this journey,” concluded Joel Morse, CEO and co-founder of Curavit. “Our virtual site model with integrated HEOR data capture is key to helping companies like Sana reach both their scientific and commercial goals faster and give more patients alternative or complementary non-invasive treatment options.”