University of Arizona Study Finds Openwater’s Open-LIFU 2.0 Device Achieves Significant Depression Symptom Reduction After Less Than Two Hours Total Treatment Time

Clinical Trial Utilizing Low-Intensity Transcranial Focused Ultrasound Pulses to Key Brain Region Shows Notable Reduction in Negative Thoughts, Improved Well-being, and Enhanced Quality of Life for Participants with Treatment-Resistant Depression

Openwater, an open-source medical technology company delivering portable, hospital-grade diagnostic and therapeutic devices, today announced compelling results from a University of Arizona study published in Frontiers in Psychiatry. The study, “Transcranial Focused Ultrasound Targeting the Default Mode Network for the Treatment of Depression” utilized Openwater’s Open-LIFU 2.0 device to deliver targeted, low-intensity transcranial focused ultrasound pulses to the anterior medial prefrontal cortex, a critical region within the brain’s default mode network implicated in persistent negative thought patterns common in depression. Following 11 brief, ten-minute sessions administered over three weeks (less than two hours of total treatment time), significant reductions in depression severity were seen in 45-60% of the 20 participants (using two widely-used assessments of depression severity). Impressively, 35% achieved clinical remission in this brief treatment modality.

Unlike other ultrasound systems that rely solely on placement on the head, Open-LIFU 2.0 employs an advanced ultrasound array to precisely steer the ultrasound focus to the targeted location. Its wearable and compact design facilitates targeted transmission through the forehead directly to specific brain regions, even while the participant is moving.

Traditional treatments, including medication and psychotherapy, both of which involve longer courses of treatment, leave up to 50% of patients who complete treatment without meaningful improvement, and up to one-third fail to complete treatment. In contrast, participants in this trial reported substantial decreases in repetitive negative thoughts, enhanced psychological and physical well-being, and increased environmental satisfaction following treatment with Openwater’s Open-LIFU 2.0 technology, and the dropout rate was only 10%. Importantly, these outcomes were achieved without significant adverse effects, highlighting both the safety and acceptability of the therapy.

"These results provide a meaningful step forward in neuromodulation techniques for treating depression," said Dr. John J.B. Allen, Professor of Psychology, Cognitive Science, and Neuroscience at the University of Arizona. "We saw substantial improvements in depressive symptoms and quality of life in a shorter treatment protocol than standard treatments, suggesting the potential for transcranial ultrasound technology to offer rapid, lasting relief for individuals whose depression has resisted traditional therapies. An important unanswered question is whether a longer LIFU treatment protocol could assist those who did not completely respond during this rapid 3-week protocol."

Aaron Timm, CEO of Openwater, added: "With over 280 million people affected by depression globally, there is an urgent need for treatments that are effective, portable, and affordable. Openwater’s technology offers the potential for precise, targeted ultrasound treatment designed specifically for accessibility. We are encouraged by the results of the University of Arizona study using Openwater’s technology.”

Future research will include larger, randomized controlled studies to further explore the efficacy of transcranial focused ultrasound and its role in treating depression.

About Openwater

Openwater is a medical technology company founded by Dr. Mary Lou Jepsen to make hospital-grade care universally accessible. Backed by notable supporters including Khosla Ventures, Plum Alley, BOLD Capital Partners, Vitalik Buterin, Esther Dyson, and Peter Gabriel, Openwater employs open-source development and consumer electronics manufacturing to lower the cost and speed the delivery of non-invasive medical devices. The company collaborates with leading institutions worldwide to research, validate, and distribute these technologies, aiming to reach patients across borders and income levels. For more information, visit www.openwater.health.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250404525897/en/