The Department of Defense has granted Sana Health a $3.4 million grant to conduct a pivotal study on PTSD through the first quarter of 2026. This grant is part of a broader investment by the Department of Defense into Sana's technology, which also includes grants for pilot studies on Adjustment Disorder and Pain and Fatigue in military healthcare workers.
Sana Health has achieved significant clinical results, with their PTSD pilot study demonstrating statistical significance in PTSD, Anxiety, and Depression. This study was led by Dr. Ron Acierno at the Ralph H. Johnson VA Medical Center. Additionally, Sana Health’s Neuropathic Pain Pivotal study was run by Dr. David Putrino at Mount Sinai Hospital and is set to be submitted as a De Novo application to the FDA in May of 2024.
With the De Novo timeline, Sana Health expects FDA approval between the end of 2024 and the second quarter of 2025, with expedited coding and coverage anticipated for Neuropathic Pain and PTSD due to their existing Breakthrough Device Designation.
Sana Health has initiated new key initiatives, including a pilot study in Pain and PTSD in collaboration with the Israeli Ministry of Health to be carried out in rehab clinics in Isreal this year, and an application for a $10M ARPA-H Launchpad grant for adolescent and young women's PTSD.
In terms of financing, Sana Health is currently raising $3 million on an existing SAFE note to provide two years of runway, with plans for a Series B funding round post-FDA approval and post-VA commercial pilots.
Sana Health expresses gratitude for the support received and aims to fulfill their mission of addressing high unmet needs in healthcare, starting with Neuropathic Pain and PTSD, for a population of 35 million individuals in the U.S. alone.
Investors, please click here to contact Sana Health’s CEO, Richard Hanbury.
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