Company Profile: Openwater

Key Points

• Openwater is an innovative medtech start-up that was founded to integrate various technology fields toward a goal of curing disease.
• We spoke with CEO and Foundation Council member Mary Lou Jepsen about how the company is revolutionizing open-access health innovation.

Openwater is an innovative medtech start-up that was founded in 2016 to explore the question, “What if advancements in fields as diverse as consumer electronics, semiconductor device physics, and artificial intelligence could come together for a future where the profound act of curing disease becomes a reality for all, transcending borders and transforming the course of human health?”

We spoke with Openwater’s CEO and Foundation Council member Mary Lou Jepsen about how the San Francisco-based company is revolutionizing open-access health innovation.

Tell us about your company structure: ownership, lead executives, and their roles.

We heard you have recently made a big announcement. Can you tell us about it?

We recently announced three important milestones.

1. Our past, present & future is now 100% open source. We have pledged our commitment to becoming the world’s first open-source, open-patent, open-clinical-data, and open-safety-sharing company, centered on the new idea of the Silicon Hospital. The Silicon Hospital is a new paradigm in which many diseases and conditions can be detected, diagnosed, and treated, noninvasively using the best tools of our time.
2. We have raised $54 million of new funding, in addition to the approximately $50 million that we have raised since inception in 2016. 

3. We are now taking order reservations for our Early Access Systems, which include ​Open-LIFU 2.0, our therapeutic ultrasound unit model, and Open-Motion 3.0, our blood flow unit model.

Tell us more about the Open-Motion 3.0 System.
It is a multi-user, multi-application, diagnostic platform using low-intensity, near-infrared light. It employs short pulses of highly coherent laser light and a holographic detection system to measure blood flow, blood volume, micro-motions, and oxygenation deep under the tissue surface with unprecedented precision. The modular design can be configured into prototypes to support clinical research across a gamut of users and applications. By allowing individual users to configure their own systems, they can select and configure components optimized for their specific applications and develop medical devices that are efficient, low-cost, and portable.

Key features of the Open-Motion 3.0 system include:

• Modular design creates flexibility for many applications in a wearable form factor.
• Custom lasers deliver 100 microsecond pulses of up to 400 uJ with <60 MHz linewidths, maximizing sensitivity to small changes in blood flow while minimizing light delivered to patients
• Diffuse laser output meets IEC-60825-1 Class 1 laser standards
• Megapixel sensors provide high SNR and sensitivity to deep tissue.
• One module computation enables high data throughput with a large number of modules.
• Battery power for portable use in ambulances or helicopters, for example
• Advanced machine learning tools for classification of measured waveforms.
• Accurate registration of modules to the body and medical images.
• Components pass all IEC 60601-1 electronic safety standards. ISO 13485 in process 2024
• Design controls include assessment of risks common to all configurations of the platform, characterization of performance of critical components, verification test protocols, and unit tests for software.
• Complete platforms in standard configurations as well as OEM hardware and software components available.

Tell us more about the Open-LIFU 2.0 System
Open-LIFU 2.0 is Openwater’s platform for multi-user, multi-application, low-intensity focused ultrasound (LIFU) therapy. The modular design can be configured into proof-of-concept prototypes to support clinical research across a gamut of users and applications. By allowing individual users to configure their own systems, they can select and configure components optimized for their specific applications and develop medical devices that are efficient, low-cost, and portable.

Key features of the Open-LIFU 2.0 system include:

• Allows for the selection of complex-shaped, patient-specific targets.
• Selection of anatomical, functional, and geometric target locations.
• Accurate registration of transducer assembly to the body and medical images.
• Electronic steering using one or more 2D 64-element arrays (4x4cm including housing).
• Modular ultrasound arrays enable a wide range of transmit frequencies from 100kHz to 500kHz
• Large range of pulse parameters intensities, from short pulses at 0.1% duty cycle to longer potentially continuous wave applications (100% DC).
• Pressure output of up to 1MPa at a focal depth of 8cm in water (@ 500kHz)
• Arbitrary waveform generation such that complex different driving/apodization schemes can be realized at the output
• Components pass all IEC 60601-1 electronic safety standards.
• Design controls include assessment of risks common to all configurations of the platform, characterization of performance of critical components, verification test protocols, and unit tests for software.
• Complete platforms in standard configurations as well as OEM hardware and software components available.
• Software and AI analysis tools, documentation
• Industrial Design integration service (examples available)

Tell us about your dream for the future of Openwater.
Our ultimate goal is to create a single device to treat, monitor, and diagnose hundreds of diseases. That device could be made in the factories that make our phones and laptops. Our focus is not on making a million dollars per treatment, as is increasingly becoming the norm for healthcare. Instead, we want to treat millions of people quickly. The idea is to charge a smaller amount of profit per unit and use the same unit with differentiated software to treat many diseases, thereby saving millions of lives faster.

Our mission is to do this all open-sourced. While our research and development (R&D) is free and open to all, we make money selling our hardware and services. The old adage for open-source went, “Free as in speech, not free as in beer.” Using this analogy, we make the recipe for the beer freely available but still sell the beer for those who prefer not to make it themselves. Additionally, we guarantee the quality of the beer through our manufacturing process. By making it at scale at the research and development stage – that is prior to FDA approval – we can offer the beer to enable concurrent, cost-effective trials without the burden of expensive product development costs for our customers. 

​Trial costs can also be substantially reduced by sharing safety data across all trials. Our customers will fund the trials and take ownership of the regulatory approvals, not us. Also, because of the shared safety data, fewer patients could be required per trial. We provide them with components, hardware, software, and quality management support, among other services.

One option we are interested in testing is the idea of patient groups funding trials. Theoretically, they could persuade their preferred doctors to enroll say 20 patients, purchase our hardware, and raise funds to hire someone to shepherd it through IRB processes and oversee the trial with the doctor. This approach can be remarkably cost-effective, and for certain diseases, just 20 patients may be sufficient for approval. The sharing of safety and adverse event data across trials – even for different diseases – reduces the number of required patients for each trial, significantly lowering trial costs initially and promising even greater reductions (10-100x) as safety data accumulates and becomes accessible to all.

Our vision is that this device could treat diseases such as mental disorders, neurodegenerative diseases, cancer, COVID and the effects of Long COVID, and stroke. It could also stimulate stem cells, enable noninvasive Brain Computer Interface (BCI), rejuvenate senescent cells.

For example, 60 Minutes featured the astonishing work being done with MRI and focused ultrasound to treat both neuro-degenerative disease and severe addiction. It’s this work, plus one million other papers in the field that drove me to both found and now to fully open-source our work at Openwater. We have low-cost focused ultrasound and blood/oxygen flow detection units coming online now.

Tell us about your open access research model. Why did you decide to pivot to this new untested model for a start up?
It’s actually a business model that accelerates not just research, but more importantly, saving lives and lots of them faster. It also will accelerate the growth of ultrasound-based therapies with our partners.  

Open-source companies such as Red Hat have generated billions of dollars while providing the trusted infrastructure for the internet, smart phones, web services, and more. We believe we can replicate this success in healthcare. By allowing everyone to scrutinize (and improve) the software, hardware designs, and data line-by-line, we can expedite progress and scale solutions across hundreds of diseases. As the volume of production increases, costs decrease exponentially—every 10x increase in production roughly corresponds to a 10x decrease in costs. Thus, a semiconductor-based platform with adaptable software for each disease and treatment could yield million-fold cost savings per treatment, spread across numerous diseases using the same hardware/software platform. Additionally, this platform introduces the potential for significant advancements in the treatment of common and rare diseases alike as shown already in our clinical feasibility results for treatment of diseases like glioblastoma, severe depression and large vessel occlusion stroke.

What is the biggest risk in this new open access model?
Our approach is less risky than traditional business models for medical device development. It allows for numerous opportunities, using the same hardware/software platform for treating multiple diseases and eliminating single points of failure that often thwart diagnostic or therapeutic development—either in the laboratory or during clinical trials. Many companies have faltered due to failed stage 3 trials, and countless others have perished prematurely because they couldn’t amass the vast sums required for large-scale trials. Why not separate clinical trials from hardware/software platform development to reduce costs for a company and further reduce trial costs by extensively sharing adverse event and safety data across trials?

A silicon/software platform has the potential to disrupt healthcare, just as it has disrupted nearly every other industry over the past 30 years. An open-source platform can achieve this disruption both faster and cheaper. It’s within reach to establish a multi-billion-dollar business by selling the hardware systems and services, much like Red Hat has with its open-source business model. The concept of a healthcare R&D company focused on saving more lives more rapidly for less money should not be a novelty, yet regrettably, it is.

What are the benefits of this model over traditional research?
The journey from research to approval for medical devices often spans decades and frequently fails to achieve platform status, resulting in continued high costs upon regulatory approval for a narrow range of diseases.

Instead, we are creating an open-source platform with the potential to treat many aggressive cancers and mental disorders. The users would then be able to change the software for applications like stem cell stimulation, senescent cell rejuvenation, high fidelity blood flow detection including oxy/deoxy, pathogen deactivation, immune priming, and more – all achieved noninvasively at a per unit cost similar to that of a smartphone at scale where each unit can treat thousands of people.

What do you find most promising about the focused ultrasound field?
The astonishing work that has been done so far in treating over half a million people over the last 20 years. It’s ready to go mainstream. Let’s work together to make that happen faster. Our efforts at Openwater, especially with our Open-LIFU platform are part of that. You can pre-order Open-LIFU 2.0 now or use the data on our website, wiki and github to make your own.

What has been your most notable lesson learned over the years?
When they say it’s impossible and laugh at you, let them. Chuckle with them. Really. Then tell them what actually would be useful is for them to tell why they think it’s impossible. Take notes. They might help identify issues you need to solve, or you may gain support by showing you have already solved those problems which you should mention in a collaborative way.

How do you partner with other companies or organizations?
Our hope is to create partnerships with sites and companies now through our Early Access Systems for their clinical studies and trials.

What is next for Openwater?
We are planning to scale up after this big announcement.