Frequently Asked Questions

I have made the decision to step aside as CEO of our remarkable company. This decision comes at a time when I must prioritize a pressing family health issue that demands my full attention and care. I will remain at Openwater both as Chairman of the board and an active team member. In stepping aside, I also recognize a fundamental truth about leadership and growth. As we stand on the cusp of scaling our company to new heights, it is evident that my strengths lie in the vision and innovation that brought us to where we stand today, rather than in the operational and strategic expansion that will propel us into tomorrow. It is with this understanding that I announce we have initiated a search with Russell Reynolds for a new CEO, someone with the unique blend of skills, experience, and vision necessary to guide our company through its next phase of growth. This is no ordinary leadership opportunity. Our technology is nothing short of extraordinary, promising to redefine treatment paradigms across aggressive cancers, mental diseases, and cardiovascular disorders. Through innovative use of infrared light, ultrasound, and electromagnetics, coupled with advanced silicon chip architectures, we are pioneering treatments that offer new hope where traditional methods have fallen short. Our approach has not only shown clinical promise but has also reimagined the path to regulatory approval. We have streamlined the approval process, reducing costs and timeframes by orders of magnitude. Our open-source philosophy further accelerates this progress, fostering trust and collaboration that speeds innovation. Many wonder how a company committed to open-source can be profitable. Let's address this directly. Our business model transforms our research and development into an asset that's "free as in speech," not "free as in beer." This means while our innovative blueprints are openly shared, the true challenge lies not in crafting a few prototypes but in achieving mass production at the quality standards required for FDA approval, specifically under ISO 13485. Our solution? Openwater produces versatile chips capable of novel modulation of infrared light, ultrasound, and electromagnetics on a large scale, leveraging the manufacturing prowess of the same facilities that produce consumer electronics and puts these chips into a highly software reconfigurable device. This strategy allows us to manufacture high-quality, low-cost chips and devices swiftly, facilitating simultaneous clinical trials. These chips are configured with flexible software and AI, leading to pan-disease cost-effective and faster trials. Through shared data on safety and adverse events across various diseases, we reduce clinical trial costs and durations by threefold in near term and and in time more than tenfold is in reach. ISO 13485 certification enables customer retention when they receive regulatory approvals . Why? because otherwise they have put in more millions and years to develop a new device and test it. With our open-source device it’s in reach for our customers to secure novel therapeutic medical device approvals in under three years with and under $10M total investment — dramatically less than the $658 million average capitalized cost and 13-year timeline typical of the industry — we both revolutionize the development process and ensure a sustainable, profitable business model. ​ Mary Lou Jepsen Founder, CEO and Chairman of Openwater March 17th 2024 _________________________________________________________ Job Description - Chief Executive Officer (CEO) Search The new Chief Executive Officer of Openwater will report to the Board of Directors and work collaboratively with Dr. Jepsen, the leadership team, and the Board to develop actionable business strategies, objectives, and plans aligned with short and long-term goals. The CEO will oversee all company operations while building a highly inclusive culture to ensure team members thrive. This individual must be a creative, open-minded thinker who embraces Openwater’s novel business model as a for-profit, open source, hard-tech, hardware/software/healthtech organization, and at the same time brings a crisp focus and drive towards execution. At a high level, this person will establish the company’s short- and long-term plans, and then will develop actionable strategies to guide the team to successfully execute those objectives. The Chief Executive Officer will transcend disciplinary boundaries across hardware, software, and healthcare to formulate and implement organizational policies and procedures that prime the company for outsized growth and efficiency. This person will be expected to operate out of the company’s headquarters in San Francisco. What we are looking for: In terms of professional background, we seek an entrepreneurial leader who is committed to open-source medical devices and driving transformative healthcare initiatives at scale. However, professional experience in healthcare or life sciences is not required – what is most important is that this individual has had experience delivering highly sophisticated and novel product solutions to the marketplace at scale This individual must bring deep experience in translating complex technologies and programs for example in hard tech hardware and software, artificial intelligence, open source, and or/healthcare components and devices into fully formed, commercially scaled products. Further, this individual must have energy and acumen in building enthusiastic, multi-disciplinary teams. It is critical that the Chief Executive Officer have a demonstrable track record in guiding an organization through rapid scale-up and the successful attainment of technical, corporate, and commercial milestones. This individual should have a history of leading successful fundraising efforts for later-stage technology and/or medical ventures, coupled with the ability to motivate, organize, and engage employees of diverse expertise. We are seeking an individual who is familiar and comfortable operating in high-growth, fast-paced environments. The Chief Executive Officer should have broad functional expertise across engineering (hardware and software), operations, product development, and ideally will be well-versed in managing corporate functions: finance, HR, legal, etc.. The Chief Executive Officer should also have a proven track record in forging creative partnerships, leveraging extensive networks, and executing deals while employing analytical acumen to navigate business directions. So, the Chief Executive Officer must demonstrate the ability to simultaneously provide long-term strategic direction for the organization, execute at a tactical level, and effectively function as the lead corporate spokesperson and evangelist for the company. This individual will also have an established reputation and visibility in technology or medical communities. At a personal level, the position requires heightened intelligence, mature business judgment, decisiveness, an elevated work ethic, personal warmth, and rich imagination. This individual must possess well-developed leadership skills in order to motivate and retain high-quality individuals while inspiring hyper-achievement across the organization. Paramount to success in the role is executive seasoning, forcefulness of personality, and other strong charismatic qualities that will enable him/her to lead effectively. From an educational perspective, it is likely that this individual will have achieved an advanced degree in a business or technical discipline. Education, while important as an indicator of character, intellectual ability, and achievement, will be subordinate to personal qualities and professional accomplishments as variables in the selection process. This position is based in San Francisco, California. Apply with a cover letter and resume sent to CEO-candidate@openwater.cc

Many wonder how a company committed to open-source can be profitable. Let's address this directly. Our business model transforms our research and development into an asset that's "free as in speech," not "free as in beer." This means while our innovative blueprints are openly shared, the true challenge lies not in crafting a few prototypes but in achieving mass production at the quality standards required for FDA approval, specifically under ISO 13485. Our solution? Openwater produces versatile chips capable of novel modulation of infrared light, ultrasound, and electromagnetics on a large scale, leveraging the manufacturing prowess of the same facilities that produce consumer electronics and puts these chips into a highly software reconfigurable device. This strategy allows us to manufacture high-quality, low-cost chips and devices swiftly, facilitating simultaneous clinical trials. These chips are configured with flexible software and AI, leading to pan-disease cost-effective and faster trials. Through shared data on safety and adverse events across various diseases, we reduce clinical trial costs and durations by threefold in near term and and in time more than tenfold is in reach. ISO 13485 certification enables customer retention when they receive regulatory approvals. It’s in reach for our customers to secure novel therapeutic medical device approvals in under three years with and under $10M total investment — dramatically less than the $522 million average capitalized cost and 13-year timeline typical of the industry — we both revolutionize the development process and ensure a sustainable, profitable business model. ​

Sure - this is a presentation deck with a talk track to it from a presentation our CEO gave in March 2024.

60 Minutes featured the astonishing work being done with MRI and focused ultrasound to treat both neuro-degenerative disease and severe addiction. Watch the video linked here: https://cbsnews.com/video/neurosurgeon-alzheimers-addiction-research-60-minutes-video-2024-01-14/ It's this work, +1M other papers in the field that drove the founding of Openwater and now our move to fully open-source our work at Openwater this month. We have low-cost focused ultrasound and blood/oxygen flow detection units coming on line now and could enable access for these procedures to all including the possibility of at-home treatments in the near-future.

Free as in Speech, Not Free as in Beer ​ At the JP Morgan Healthcare conference this week in San Francisco I got lots of questions from the investment community regarding our business model at Openwater and announced here on January 4. I took the initiative to compile these questions and share my responses below with everyone. ​ Our goal : A single device to treat, monitor and diagnose hundreds of diseases that can be made in the factories that make our phones and laptops. Open sourced. Trusted. Innovating at the speed of Moore’s Law not multi-decade speed and multi-billion dollar investment typical for medical innovation. While our R&D is free and open to all - we make money selling our hardware and services. Our focus is not on making a million dollars per treatment (as is increasingly becoming the norm for healthcare) but on treating millions of people quickly. We make it up on volume. Charge a smaller amount of profit per unit, use the same unit with differentiated software to treat many diseases and save millions of lives faster. ​ The old adage for open source went “Free as in speech, not free as in beer”. In our 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 (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 are also substantially reduced by sharing safety data across all trials. Our customers fund the trials and take ownership of the regulatory approvals, not us, and need fewer patients per trial (less cost) because of the shared safety data. We provide them with components, hardware, software, and quality management support, among other services. Even patient groups could fund trials. How? They can persuade their preferred doctors to enroll say 20 patients (including themselves at no cost), 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 rare diseases, even with just 20 patients FDA approval has been achieved: link. 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. ​ Open source companies have generated billions of dollars while providing the trusted infrastructure for the internet, smart phones, web services, etc. 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. Our approach is less risky than traditional business models for medical device development. It allows for numerous opportunities, utilizing 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 in 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. 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 all aggressive cancers. With a simple software change, we could treat any mental disease. Change the software once more 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 non-invasively at a unit cost similar to that of a smartphone at scale where each unit can treat thousands of people. Currently, we are collaborating with other companies by providing them with our Early Access Systems for their clinical studies and trials. These systems called Open-Lifu 2.0 and Open-Motion 3.0 can be ordered here for R&D efforts. (links here and here) ​ Please join us!

See founder’s letter: here

We’re going into this whole-hearted: we are opening our patent library, our designs, our code, and our clinical data.

No. We believe our corporate structure makes that impossible. Our past, present, and future software is now AGPL licensed. Our hardware and other data are open via Creative Commons 4.0 Share-alike. All our patents are available via our Patent Pledge. These are enduring rights.

AI giants are creating confusion about open source. For some of them, having their models partially open is a gambit to help secure widespread support of their very expensive projects. That’s not at all what we’re trying to do. In contrast we are working in healthcare where therapeutic development often takes 20 years and $2.6B to develop a new drug and the cost per person can be a few million dollars for treatment. Access to good healthcare remains only for the very rich. We can change that by creating a pan-disease therapeutic technology suite open to and available for all.

We are releasing all the data that we can that isn’t protected by privacy constraints like HIPAA or existing agreements with the hospitals and clinics with whom we have been working. We will do everything we can to release more data as soon as we can. We have already released quite a bit here: www.openwater.health/clinical and wiki.openwater.health and github.com/OpenwaterHealth

Because we can. It’s a shame that it is almost unheard of to do so. We are trying to do the right thing. Seeing FDA responses helps everyone get better at addressing concerns they raise and responses from the companies that raise concerns about the FDA. This will also be true for other regulatory bodies.

Although we use infrared light and ultrasound at known safe levels as shown on billions of people (link), We are not FDA- or regulatory-approved yet in any country. Our early access systems can be used by a research organization for clinical trials or other research.

This year - 2024. Exact dates to be determined based on the order quantities

The best way to do this now is to find a doctor/clinic interested in doing a clinical trial or feasibility study. They need to have an IRB which can review the plan for testing, and the safety of our devices, and the plan to assure patient privacy and security of data. We have worked with many IRBs to do this. Then patients need to be recruited, usually beyond just your loved one.

The laws and regulations on biohacking vary from place to place. Check yours and share it with us when you put in an order.

A single device to treat, monitor and diagnose hundreds of diseases that can be made in the factories that make our phones and laptops. With shared safety data across clinical trials the number of patients required (and thus the cost of the trial) could also go down by 10x. This in contrast to drug development where it’s become typical for new drugs for a rare disease to cost over a million dollars a dose.

See this link: www.openwater.health/safety

Even an aspirin can cause a safety issue from time to time. We want to know anything that can go wrong for humans with any disease using our devices. But yes, we are using low levels of infrared light and low strength ultrasound shown to be safe on billions of humans (link here). Still we need to assure safety, and the regulatory agencies require the data. Since we are collecting it anyway, why not pool it and make outcomes even safer, even faster?

We don’t think so but in an abundance of caution we are out to overachieve on safety data.

Because you can make money by doing good. We can sell our Early Access Systems and when our customers get regulatory approval hopefully they choose to buy from us: the brand of safety, trust and community.

Yes just email us at community@openwater.health

Check out our job ads. We are hiring. www.openwater.health/jobs

We will be posting how to see these. We are likely to host an event in January in conjunction with SPIE Photonics West to demo our Developer Early Access Systems at our offices in San Francisco. We will make that event widely known on our community pages and in social media.

We haven’t done many internships but are considering it. We need people with certain skills to help us build the future. The best place to look is www.openwater.health/jobs

Email community@openwater.health