In a significant milestone for medical innovation, Curavit Clinical Research has concluded a groundbreaking decentralized trial for the Sana Device, marking a significant step forward in the treatment of post-traumatic stress disorder (PTSD).
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,” said 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.
Decentralized Trial for Sana Device
The Sana Device, developed by Sana Health, is a wearable, virtual-reality-style mask designed to alleviate symptoms of PTSD through audiovisual stimulation.
Following a rigorous 28-day study involving more than 45 patients recruited from a Veteran’s hospital, Curavit exceeded expectations by achieving an impressive 76% participant retention rate.
Innovative Approach by Curavit
Utilizing a virtual site model with remote-based clinical research coordinators (CRCs) and a principal investigator, Curavit managed all aspects of participation seamlessly, including electronic patient-reported outcomes assessments, telehealth services, device training, and randomization.
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).
Funding for Military Operational Medicine Research Program (DoD)
The trial, which received funding from the Military Operational Medicine Research Program (DoD), aimed to assess the effectiveness of the Sana Device in providing relief to PTSD patients while on waiting lists for further specialty care. This initiative aligns with Sana Health’s mission to offer anxiety relief on-demand and expand treatment options for individuals suffering from mental health disorders.
FDA Breakthrough Device Designation Consideration
The trial data has been submitted to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation consideration, a step toward validating the Sana Device and facilitating its accessibility to patients in need.
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).
More in the Press Release published here
