February 13, 2024
Curavit Clinical Research announced that its virtual trial for the Sana Device, a novel digital therapeutic aimed at easing PTSD symptoms through audiovisual stimulation, has shown promising outcomes. Involving more than 45 participants from a Veteran’s hospital, the study not only achieved a commendable 76% retention rate but also marked a pivotal advancement in mental health treatment methods, with the data now under FDA review for Breakthrough Device Designation.
Leveraging its expertise in decentralized clinical trials (DCTs) for digital therapeutics (DTx), Curavit Clinical Research has made strides in mental health treatment with the Sana Device. This wearable, virtual-reality-style mask employs audiovisual stimulation for on-demand anxiety relief, specifically targeting symptoms of post-traumatic stress disorder (PTSD).
The success of this innovative therapy has led to the submission of trial data to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation consideration, showcasing the potential of digital interventions in modern healthcare.
Richard Hanbury, CEO of Sana Health, highlighted the potential of the Sana Device to assist patients with pain and mental health issues, stating, “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.”
More than 45 patients from a Veteran’s hospital participated in the 28-day study. Curavit exceeded Sana’s expectations for participant retention with a 76% retention rate. The trial was managed remotely, with all aspects of participation overseen by remote-based clinical research coordinators (CRCs), a remote-based principal investigator, and a comprehensive technology platform that included ePROs, eCOA, telehealth, device training, and randomization.
Curavit CRCs documented participants’ experiences with the Sana Device using the industry-standard PHQ-9 survey and the Columbia Suicide Severity Risk Scale (C-SSRS) to assess levels of depression—all conducted remotely through electronic patient-reported outcomes assessments.
The Sana Device is designed to provide anxiety relief on demand. The trial aimed to collect evidence of the device’s capability to offer additional relief to patients suffering from PTSD while they are on waiting lists for further specialty care. In 2021, the Sana Device received FDA Breakthrough Device Designation for the treatment of Fibromyalgia.
“Real-world evidence is crucial for DTx companies to secure insurance coverage and reimbursement by demonstrating to payers and providers the full impact of these innovations. Curavit’s HEOR services generate the real-world data required to unlock wider coverage and greater availability for transformative digital treatments,” added Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA).
The successful trial represents a significant milestone in the treatment of mental health disorders, offering a glimpse into the future of non-invasive, accessible therapeutic options. Curavit has recently introduced its Health Economics and Outcomes Research services to gather evidence on the economic value of novel pharmaceutical products, with a particular focus on digital therapeutics.
