Openwater is revolutionizing how we deliver care to patients, using software and phase wave breakthroughs aided by AI to develop a new generation of portable, wearable medical imaging technology for stroke and neuro diseases.
The U.S. imaging services market was valued at $117.6B in 2021, and is expected to expand at a compound annual growth rate (CAGR) of 4.2% from 2022 to 2030. The major factors attributed to the growth include increasing usage and growing awareness of medical imaging technology. Based on the Fortune Business Insights’ report, the medical imaging market size is anticipated to reach $56.5B by 2028, at a CAGR of 5.8%. New innovations and technological advancements in the field will be key drivers in the growth of the market. Breakthroughs such as artificial intelligence (AI), augmented intelligence and virtual reality (VR) combined with 3D imaging allow for better patient care, facilitating the progression of the market share. These techniques are used extensively by healthcare specialties to diagnose disease conditions and to help in treatment, in departments like cardiology, neurology, oncology, orthopedics, and others.
Stroke, the #2 leading cause of death globally, and #1 cost of long-term disability in the US, is a great high impact market for which a solution is urgently needed. There are 1 million strokes each year in the US alone. With a small time window to use clot busting drugs or to conduct a thrombectomy, fast, in-ambulance stroke diagnosis saves precious time to get patients to the correct hospital for proper treatment. There are 6 million people with Alzheimer’s, 25 million living with severe mental diseases and 15 thousand living with glioblastoma. Globally, these numbers are far worse. The US TAM of stroke detection & routing is $10B per year, neurostimulation therapy for mental diseases is over $100B per year, glioblastoma brain cancer therapy is $1.6B per year.
* Multi Market Opportunity: Openwater is tapping into three different large addressable market opportunities. Openwater’s applications are based on phase wave technology across stroke detection ($10B per year), neuromodulation therapies (over $100B per year) and glioblastoma ($1.6B per year).
* Attractive Progress: Since our last investment in Openwater’s SAFE in 2021, the company has progressed in multiple clinical trials. Stroke detection’s in-human trial has completed scanning of 92% Large Vessel Occlusion (LVO) patients needed for FDA Breakthrough Submission; neuromodulation therapy for depression has completed phase 1 human trial; Glioblastoma cancer therapy successfully demonstrated in vitro and in vivo validation.
* Protected Breakthrough Technology: Openwater targets multiple shots on the goal as a platform company. With 19 issued and 62 in-process patents, Openwater's proprietary system of portable hardware and AI-managed software is transforming neuro diagnostics & brain therapeutics through utilizing breakthroughs in phase wave technology with compelling benefits and applications across stroke detection, neurostimulation therapies and glioblastoma therapy.
* Key Partnerships In Place: Openwater has key partnerships for its human clinical trials with UPenn Medicine, Brown Medicine and University of Arizona. For glioblastoma cancer therapy studies, Openwater is working with the Terasaki Institute for Biomedical Innovation.
* All-Star Team: Dr. Mary Lou Jepsen, the CEO and Founder of Openwater, was a professor at MIT with a PhD in Physics. She was a former executive at Facebook, Oculus, Google X, and Intel. As a leader in optical imaging, she has built a team of experts in advanced physics, optics, lasers, ultrasonics, electronics, medical devices, software and manufacturing.
* Investment Opportunity: The Company is raising a Pre-Series B SAFE round of $15M at a $110M valuation cap, with participation from new and prior investors. The use of proceeds will be deployed to complete clinical trials towards FDA clearance for the stroke detection device. It will also support scaling towards an attractive Series B funding in early 2024.
Investment Opportunity
Openwater is raising a $15M SAFE to support their regulatory path and growth. The SAFE, with a $110M valuation cap, will convert into a Series B equity round anticipated in early 2024. The Plum Alley team has secured an allocation for our syndicate member investors and the Plum Alley Venture Fund I.
This SAFE round will be attributed for completing clinical trials towards FDA clearance of the stroke detection device, and creating strategic partnerships that enable rapid scaling. Existing investors include Khosla Ventures, Excel Venture Management and BOLD Capital Partners, as well as key technologists Brook Byers, Howard Morgan, Juan Enriquez and Nicholas Negroponte.
Investment Timeline
As a special event for member investors, Plum Alley has organized a visit to Openwater’s HQ, to experience their proprietary technologies. The site visit will occur in San Francisco, CA on Wednesday, Feb 22nd, 2023 at 11am-1pm PT. RSVP here.
Founder Discussion (In Person and Virtual)
Friday, March 3rd, 2023,
12pm ET // 9am PT,
Rise New York, 43 W 23rd St, New York, NY 10010
Dial-in details were shared via a Google Calendar invite, and are available here. If you would like to join us in person, please RSVP here.
Final Commitments Due
Friday, March 10th, 2023
Please submit commitments via the Investment Form. Note these will be considered as your final investment amount.
Final Funds Due
Friday, March 17th, 2023
Upon submitting your commitment, you will receive details regarding closing documentation and wiring instructions via Carta.
The Company's confidential financing documents and diligence materials are available for review in DropBox. Please request access to Dropbox materials on the left side panel. All documents are confidential and not for further distribution. If you have specific questions or are interested in investing in Openwater, please contact us and submit your investment total here.
Business Updates
Clinical Updates
Openwater continues executing their in-human clinical trials for the Stroke Detection & Routing applications at UPenn Medicine for FDA Breakthrough Designation. The clinical trial design includes 100 patients across various categories. 25 of the patients have to present with LVO severe stroke. Since August 2022, Openwater has completed 23 of 25 to support their Breakthrough Submission.
In addition to the optical diagnostics, the Company is also developing acoustic therapeutics for the Neuromodulation Therapies and Glioblastoma. For neuromodulation, Openwater has completed the first phase of human trial enrollment at University of Arizona for human proof of concept and feasibility. This milestone will help Openwater launch a pivotal design strategy by 2025 and target submission for first therapeutic FDA approvals by 2027.
For the Glioblastoma Brain Cancer Therapy application, Openwater has successfully demonstrated selective cancer killing and isolated the proprietary sonication beam parameters for harmonic excitation at Terasaki Institute. Additional in vitro and in vivo validation are on-going to strengthen the data. Openwater has achieved in vitro proof of concept and is expected to have animal study efficacy readouts by Q2 2023 to show the treatment is stopping the tumor, which will trigger pivotal trials. The Company is targeting the launch of first-in-human studies by 2025, and submission for FDA approval as early as 2027.
Partnership Updates
Openwater is in conversations with potential strategic partners with over 3,000 hospitals in their network on installing the stroke detection application to bring in early pre-market revenue. Openwater is currently in diligence conversations with the potential to quickly move forward with the partners to execute on this application and focus on pre-hospital assessment as an extension of ER.
The neuromodulation therapeutic platform’s potential disease indications could provide Openwater opportunities for certain non-dilutive grants, as well as partnerships with biopharma for early revenue. Research has shown drug + device combinations in neuromodulation therapeutics could be far more effective in treating patients with depression. Openwater has also started conversations with partners to fund the pivotal studies of the glioblastoma cancer therapy application with a drug + device combination.
Overview: Why We Built Openwater
Openwater was founded in 2016 by Dr. Mary Lou Jepsen. At that time, Mary Lou was the Executive Director of Engineering at Facebook Oculus where she oversaw manufacturing capabilities at factories around the world. As an optical physicist, Mary Lou noted that with phone camera development, the size of pixels in camera sensors had gotten so small that they could be used to measure individual waves of light. In 2017, Mary Lou started testing to see if this could allow for laser-based medical imaging and her initial prototype was successful in capturing images of phantom tumors (>1cm). Mary Lou's academic and professional background alongside her personal story of experiencing a craniotomy to remove a pituitary gland tumor that was undetected for many years drives her passion towards creating a new gold standard in medical imaging that is portable, affordable and democratizes technology access. Since starting Openwater, she has been focused on improving the technology, by developing new lasers, camera chips, and ultrasonics towards disrupting the expensive MRI and CT technology established in the 1980s. While innovation in the medical imaging industry has been incremental, Openwater has developed technology capable of both blood flow measurement and structural imaging with high accuracy, alongside a cost reduction of 1000x compared to current options.
Openwater's initial focus towards stroke detection utilizing blood flow measurement technology aims to revolutionize the medical imaging industry with a product that is accessible, portable, cheaper and better, with further applications in neurostimulation therapy and glioblastoma brain cancer therapy under clinical trial or preclinical studies.
Business Model - Stroke Detection
Openwater uses the consumer electronics supply chain that makes smartphones and their subcomponents for manufacturing. At scale, the Company can bring down the unit cost, and the unit price approaches the price of a smartphone, which enables a Per-Click business model, akin to Software-as-a-Service (SaaS). The product is the diagnosis or therapy, not the hardware. There is no capex investment required for Openwater’s clinical customer, and a revenue partnership will be adopted.
Business Model - Neuromodulation Therapies/Glioblastoma Therapy
Openwater is engaging in conversations with strategic biopharma to create partnerships and joint ventures to develop the combinatorial therapy. These joint venture structures will expedite funding and commercialization across these therapeutic areas.
Technology & Product
Technology
Openwater is revolutionizing applications in stroke detection, neurostimulation therapies and glioblastoma therapy.
In Stroke Diagnostics, the Company is using a light phase wave which reads features of the brain that haven’t been possible to ready before, like blood flow throughout the brain. Openwater has developed a device to measure blood flow by analyzing phase changes of light caused by moving blood cells, using wavelength sized pixels and camera chips, which determines if the patient has a stroke based on the blood flow.
In addition to its first application in early stroke detention, Opewnwater also has therapeutics applications in neuromodulation and Glioblastoma.
* In traditional brain cancer treatments, glioblastoma cancer cells hide amid the neurons, preventing doctors from treating and killing just the cancer cells. Openwater uses harmonic excitation to burst only the uniquely brittle cancer cells while avoiding harm to the healthy tissues in the brain. This is akin to when an opera singer sings, a wineglass could shatter but all other things remain unbroken.
* For neurodegenerative & mental health diseases, Openwater’s harmonic excitation can create an electric chemical effect on the neurons to release key neurotransmitters, which can stimulate or inhibit the target section of the brain. This unlocks the ability to directly treat mental and other neurodegenerative diseases.
Openwater has filed IPs to protect their proprietary technology. By Jan 2023, the Company had 19 issued patents, 7 published, and 62 patents in process.
Product
Openwater is developing the next generation of phase wave technologies that enable a platform of wearable diagnostics and device therapeutics for the treatment of brain diseases at the point of care without routing patients to specialized facilities. After five year’s of research and development, Openwater has built an AI-based headset for the first application in stroke detection that can diagnose the patients in the hospital, in an ambulance, at home or wherever they may be.
The device emits laser light that scatters through the brain; light passing through a specific region gets received by the camera chip, and its patterns are analyzed by the chip to determine if the bloodflow has stopped, like in a stroke. The results are indicated as a mobile phone alert that will immediately direct the ambulance to the hospital, room, and doctor who is now getting ready to perform the thrombectomy, saving the precious time for the patient.
Enabled by new chip manufacturing processes, at scale Openwater can achieve consumer electronics device costs. The headset for stroke application is currently under clinical trial for FDA Breakthrough Designation and is estimated to get De Novo approval by 2024.
Team
Dr. Mary Lou Jepsen (CEO & Founder) - Named 1 of the 100 most influential people in the world by Time Magazine. Former tech exec. at Facebook, Oculus, Google, and Intel. Founded 4 hardware companies including Co-founder & CTO of One Laptop per Child (OLPC)
Maruizio Vecchione (President) - Ex EVP of Global Good reporting directly to Bill Gates for 7 years via Intellectual Ventures. Launched 70 products in health tech and therapeutics. Ex CEO of Arrgene, Compu-med, Trestle Holding and Microwave Photonics.
Achal Singh Achrol MD (Chief Medical Officer) - Achal is a neurosurgeon who has led brain tumor, stroke and neuroscience translational research programs in academic university hospitals, health systems and industry. Achal Has served as CMO of InsightTec, and as a PI in many international clinical trials involving the brain.
Dr. Soren Konecky (Chief Technology Officer) - Soren has decades of experience in optical imaging and algorithm development for both life science and semiconductor applications. Formerly he held top architect positions at Perkin Elmer and KLA.
In addition to the leadership team, Openwater currently has 10 more full time employees.
Impact & Recognitions
Globally, one in four adults over the age of 25 will have a stroke in their lifetime. 12.2 million people worldwide will have their first stroke this year and 6.5 million will die as a result. Stroke, a leading cause of death and long-term disability, is a huge global market that requires an urgent solution. The early in-ambulance stroke detection is especially important for stroke patients who have a short treatment window. Using the phase wave technology, Openwater is developing a new generation of portable, wearable diagnostic and therapeutic devices, saving lives of the patients. The Company’s technology also has the potential for huge impact to the millions suffering from devastating brain diseases and mental health illnesses, and provides a possible cure for otherwise fatal brain cancers, bringing relief to patients around the world.
Select Recognitions(take icons)
Mary Lou Jepsen has been selected on the Forbes 50 Over 50 – Entrepreneurs list 2022
Openwater was listed on Fierce Medtech's Fierce 15 as one of the top 15 company innovators in healthtech 2021
World Economic Forum Technology Pioneer Award for Openwater - 2019-2022
Openwater was named one of the 23 biotech startups that are set to take off in the next 12 months by Insider in 2022
Mary Lou Jepsen was named Forbes Top 50 Women in Tech in 2018
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