By Clinical Research News Staff 

August 19, 2025 | Clinical trials and preclinical studies are demonstrating the therapeutic potential of Openwater's infrared light and low-intensity focused ultrasound technologies across a diverse range of medical conditions, from cancer treatment to stroke diagnosis. 

San Francisco-based Openwater has been conducting clinical research with its Open-Motion and Open-LIFU devices through academic partnerships with leading institutions including University of Arizona, University of Pennsylvania, Brown University, University of Birmingham, and MIT. 

Breakthrough Results in Neurological Applications 

The most advanced clinical application involves stroke diagnosis using Open-Motion's infrared light technology. In published clinical trials, the device has demonstrated superior precision and accuracy in detecting large vessel occlusions (LVO) that cause acute ischemic stroke, significantly outperforming traditional diagnostic methods that rely on observing facial drooping, slurred speech, and loss of body control. 

Recent clinical data published in the Journal of Stroke & Cardiovascular Diseases shows the Open-Motion-based device successfully identifies patients requiring endovascular therapy when optimized for maximum sensitivity, while effectively minimizing false positives at maximum specificity settings. 

Mental Health and Oncology Breakthroughs 

Open-LIFU technology has shown remarkable efficacy in treatment-resistant depression. In a clinical trial published in Frontiers in Psychiatry, a significant proportion of patients entered remission after treatment with the low-intensity focused ultrasound device—a notable achievement given the challenging patient population. 

Preclinical oncology studies in mice have demonstrated Open-LIFU's ability to successfully break up glioblastoma tumors and delay disease progression. The technology has also shown therapeutic potential in targeting and breaking up cancer cells and small tumors through focused ultrasound modulation. 

Researchers are investigating Open-LIFU's potential in treating long COVID symptoms, specifically testing its ability to break up amyloid microclots thought to be linked to the condition. Early research published in Frontiers: Bioengineering & Biotechnology suggests promise in this emerging therapeutic area. 

Additional clinical research has explored the technology's capability to modulate brain activity and break up blood clots, expanding its potential vascular and neurological applications. 

Accelerated Clinical Development Path 

The open-source platform approach is streamlining clinical development by enabling shared safety datasets across multiple research projects. This collaborative model allows investigators to build upon existing clinical data rather than starting safety validation from scratch, potentially accelerating the path to FDA approval. 

CEO Aaron Timm expects FDA approval for the LVO diagnosis application within the next couple of years, with most marketed products likely classified as Class II medical devices—a relatively low-risk regulatory category that includes devices like powered wheelchairs and pregnancy tests. 

The devices' inherently safe profile, using low-intensity rather than high-intensity focused ultrasound, supports their clinical development across multiple indications without significant safety concerns. 

For comprehensive details on Openwater's clinical research program and complete study results, read the full coverage at Diagnostics World News.