Our preliminary results in a snap shot
Cancer
We selectively killed aggressive cancer without harming healthy tissue in mice. link
Mental Disease
In a 20 person clinical trial with the same device we have treated severe depression in humans. Over a third of patients went into remission. link
Stroke
Time to Diagnosis is the key to changing outcomes for the #2 killer in the world: Large Vessel Occlusion Stroke. We have impressive specificity and sensitivity data on detection of LVO stroke in a mobile device. link
These early results show the promise of scaling to many diseases with huge cost & time advantages as a platform
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Stroke (LVO — Large Vessel Occlusion)
Openwater 79% Sensitivity 83% Specificity Record mobile device large vessel occlusion (LVO) stroke detection. 151 Stroke patients measured at comprehensive stroke centers: 68 LVO, 36 Ischemic non-LVO, 15 Hemorrhagic, 39 mimics.
Equipment: Openwater Open-Motion Gen 2
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Severe Depression
BDI scores went from severe depression to remission in a week with 10 minutes per day therapy via our headset. Week 2 and 3 treatment see further improvements. Over 1/3 of patients reached remission - publication eminent.
Equipment: Open-LIFU gen 1 unit
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Glioblastoma
Stunning tumor shrinkage on study of 38 mice with glioblastoma shown above. One 2-minute treatment on day 0. All are Openwater treatments which can be delivered by our wearable non-invasive headset or body unit which was modified for physically smaller mice.
Equipment Open-LIFU gen 0.1
Most Recent Presentations
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Overview of Openwater here with deck from our latest general audience presentation
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Recent video presentation - an Openwater Overview Spring 2024 explaining how we can speed up the regulatory approval process by a decade (or more) for many diseases in parallel. It's truly in reach and where we are focused today.
Publications
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Stroke
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“Validation of the Openwater wearable optical system: cerebral hemodynamic monitoring during a breath hold maneuver” Published in Neurophotonics.
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“Portable Cerebral Blood Flow Monitor to Detect Large Vessel Occlusion in Suspected Stroke Patients” Published in Journal of NeuroInterventional Surgery.
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“Portable Optical Blood Flow Monitor for the Detection of Large Vessel Occlusion” Presented 2/7/2024 ASA International Stroke Conference.
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Glioblastoma
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“Preclinical Oncolysis Results using Low Intensity Ultrasound” Posted on Openwater Github repository.
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Severe Clinical Depression
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“A wearable, steerable, transcranial low-intensity focused ultrasound system” Journal of Ultrasound in Medicine - Oct 24 2024
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“Transcranial Focused Ultrasound Targeting the Default Mode Network for the Treatment of Depression” Submitted, in review.
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An additional paper describing the effects of the treatment on functional connectivity MRI scans is expected to be submitted within two months.
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A link to publication on our wiki using Openwater technologies.​​
Regulatory Filings
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Stroke
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Severe Clinical Depression
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A summary link here of our regulatory filings and responses to date across Stroke, Cancer, Mental disease and more using Open-Motion and Open-LIFU platforms.​
Pre-Clinical and Clinical Data
An overview link here
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Clinical Bloodflow Results using our Open-Motion Platforms
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Neuromodulation Overview using our Open-LIFU platform here. ​​​
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COVID/Long COVID Research Projects
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We're in the process of refining a few long-COVID research projects regarding microclots and would love some feedback. See our wiki page on the matter for the full proposals​
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Key questions at the moment are:
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1. Are traditional microclots a reasonable enough model for first studies of long-COVID microclots? The ideal model would be to use real patient blood, but the hurtles of running a small clinical trial to collect the blood and then dealing with biohazard aspects of human blood would be extremely time-consuming for the preliminary first phase of the study.
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2. What's the best way to get stable microclots in a blood solution? Are re-introduced dried and sized blood clots reasonable, or will they just re-dissolve because of the thrombolytics already present in the blood? Or will they possibly catalyze additional thrombosis?
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3. Other comments or counter proposals are welcome.
Discussion on our Covid Openwater discord channel link here:
Therapeutic Ultrasound Reach
The field of therapeutic ultrasound is growing: collectively more than 500,000 people have been treated with it in the last 20 years with a variety of systems.. The chart below shows the range of diseases that have potential for impact. Credit: Focused Ultrasound Foundation (link here)
Openwater is unique in this field therapeutic ultrasound in creating low-cost open-source portable low-intensity treatment solutions that may dramatically expand the reach of treatments and lives saved.
Unlocking Talent
Over 1 million scientific papers in these areas over the last 20 years and yet very little is available in your local hospital. Our highly reconfigurable open-source devices are poised to change this.
Important Safety Information
Research-Only Purpose
The platform discussed on this site is exclusively intended for research purposes and are not cleared or approved by the FDA for clinical use. It is solely available to researchers and research institutions.
Lack of FDA Review
The safety and effectiveness of our platform have not been established through the FDA's formal review process. Researchers should be aware that the platform has not undergone the regulatory scrutiny required for general medical use and may not be used outside the research environment
Risk Awareness
The potential risks associated with our platform are not fully known. Researchers and research institutions are advised to exercise caution and fully inform allinvolved parties about the investigational nature of the component and the uncertaintiessurrounding its safety and efficacy.
Informed Consent
Researchers using this platform are responsible for obtaining informed consent from participants, clearly communicating the experimental nature of the device and any potential risks associated with its use.
Monitoring and Reporting
Researchers must comply with all applicable legal requirements related to investigational use of the platform, including, but not limited to, reporting adverse events or unexpected side effects to Openwater at safety@openwater.cc This information is crucial for ongoing evaluation and refinement of these components.
Restricted Use
This platform should be confined to research settings and not used in clinical practice or commercial applications. Their use should be limited to researchers and research
institutions with the expertise to manage and monitor the investigational nature of the component. For inquiries or additional information, please contact safety@openwater.cc
How to Participate in Safety Sharing
Safety Disclosure
This notification serves as a safety disclosure for the our Open-LIFU and Open-Motion systems intended exclusively for research purposes. Openwater acknowledges that, as of January, 2024 the device has not undergone review and clearance or approval by the U.S. Food and Drug Administration (FDA) for commercial distribution and use.
Openwater Safety Monitoring Template
Please use this template to share your safety data here. Also register safety@openwater.cc for more tools to ease submissions burden.
This notification serves as a safety disclosure for our Open-LIFU and Open-Motion systems intended exclusively for research purposes. Openwater acknowledges that, as of January, 2024 the device has not undergone review and clearance or approval by the U.S. Food and Drug Administration (FDA) for commercial distribution and use.