What You Should Know:

Curavit Clinical Research, a leader in decentralized clinical trials (DCTs) for digital therapeutics (DTx), successfully completed a study for the Sana Device, a virtual reality (VR) mask aiming to reduce post-traumatic stress disorder (PTSD) symptoms.

– Overall, this study represents a significant step forward in the development of VR-based treatments for PTSD. If approved, the Sana Device could offer a valuable tool for patients struggling with this condition.

Study Details

More than 45 patients were recruited from a Veteran’s hospital to participate in the 28-day study. Curavit exceeded Sana’s expectations for participant retention with a 76% retention rate. 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.

Potential Impact

– Improved access to care: The Sana Device could offer on-demand anxiety relief for PTSD sufferers, especially those waiting for specialized treatment.

– Market access and affordability: Demonstrating healthcare economic value can lead to wider insurance coverage and reimbursement.

– Paving the way for DTx: Curavit’s HEOR services help DTx companies gather real-world data to secure market access and impact patient lives.

“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.”