PREVENTING STROKE AT HOME
June 1, 2018
Exclusive interview for SPINOFF.COM with Dr. Luka Fajs, Eclipse Diagnostics Inc., CEO, about blood-testing medical platform
Eclipse Diagnostics
Preventing Stroke At Home
Regulation Crowdfunding
Los Angeles, CA
Biotechnology
Accepting International Investment
Just launched! Our next Reg CF Offering is now live.
Click here to learn more!
Preventing Stroke at Home
Invest in Eclipse Diagnostics
We are developing an easy-to-use home test to monitor the risk of stroke. The device is based on our patented technology, based on biomarker detection that is accurate, low cost and simple to use.
Each year nearly 800,000 people in the U.S. experience a new or recurrent stroke, and stroke is the fifth leading cause of death in the U.S. Up to 80 percent of strokes can be prevented, and our mission is to give surviving stroke patients, diabetics, and others a home testing device that can give an early warning sign and help prevent stroke at home.
Stroke Screening Home Test
Take control of your health from the comfort of your home
One-time-use, disposable test
Simple-to-use test cartridge that is used like a glucose test strip or pregnancy test. All that's needed is a drop of blood.
Bluetooth-enabled reader
The reader enables an accurate readout of the test in 15 minutes and transfers the data to the mobile application.
Mobile application
Portal for users to monitor their stroke risk status, which enables communication with one's doctor or relatives.
"All it takes is a drop of blood and 15 minutes."
"Stroke runs in my family and that drives me to bring a solution to market that can prevent it!
- Luka Fajs, Founder and CEO
Business Model
We will offer our solution direct to consumers using a subscription model that's based on a user's needs and health status.
Casual
$60
per month
free reader
free mobile app
4 tests/month
Basic
$99
per month
free reader
free mobile app
8 tests/month
Monitor+
$160
per month
free reader
free mobile app
15 tests/month
Global stroke management market
Expected to reach $36b by 2023
Growing at a CAGR of 7.1% (2017-2023)
Disrupting Traditional Industry
How big is the opportunity?
It's huge. Our target consumers are stroke survivors and diabetics. In the U.S. alone there are 6.5 million stroke survivors (data from National Stroke Association) and over 10 million diabetics over 40-years old (data from CDC). Considering only the basic subscription model, this amounts to a market opportunity of $9.9 billion per year.
In-vitro diagnostics
$46B
(BCC Research; November 2015; IVD: Technologies and Global Markets)
Point-of-care diagnostics
$19B
(BCC Research; November 2016; “Point of Care Diagnostics)
Technological Breakthrough that Enables Affordable Home Testing
The core of our stroke home test is our patented testing platform - ELLI - that enables measurement of the levels of disease biomarkers within 15 minutes using only a drop of blood and a single-step procedure. How did we achieve that? We combined the underlying technologies of the two most successful tests in the market: pregnancy-test technology and the glucose-test technology. We merged them together with our patented chemical formulation that enables low-cost production and laboratory-grade accuracy.
The technology originates from Prof. Robert S. Marks's laboratory in the Ben-Gurion University of the Negev in Israel. We later proved the concept of the technology in Singapore in the laboratory of Prof. Marks and received several research grants to bring it to a stage, where we were able to prove its utility as a rapid and easy-to-use test for detection of stroke biomarkers, infectious disease, and other medical conditions.
History
The technology was first developed in Prof. Robert S. Marks's laboratory in the Ben-Gurion University of the Negev in Israel and further developed in Singapore with funding from the Singapore-MIT Alliance for Research and Technology (SMART), the National Research Foundation and SPRING Singapore.
The company that was spun-out (Biosensorix - founded by Robert and Luka) and continued to develop and improve the performance of the technology and to develop several applications ranging from detection of infectious disease, male fertility, heart disease and stroke diagnostics.
The technology received several awards including:
- Most Investible Team at InnovFest Unbound 2017
- Most Disruptive Technology Innovfest Unbound 2017
- Rockstar Pitch Innovfest Unbound 2017
- Winner at the Singapore Airshow Exhibition Startup Competition 2018
- 3rd prize at TechCrunch 2017 in Shanghai.
First prototype
Stage of the Technology Today
Working prototypes and technology that are on par with laboratory-based testing
We have developed several versions of our laboratory prototypes and have tested them with several target medical applications ranging from infectious disease, male fertility, heart markers and, of course, our target stroke biomarker. We have shown that the technology is highly sensitive and specific. The sensitivity and specificity of our tests are linked mainly to the source of antibodies we use for the detection - we use off-the-shelf, commercial antibodies that have been validated by others. Our innovation is to bind them in our patented testing platform, that enables rapid and accurate measurement of the biomarker levels. For now, we do not focus on antibody production or biomarker discovery. We use validated and known markers and apply them in our technology.
How do we intend to prevent stroke?
We measure a heart failure blood marker that, when elevated, indicates a high risk of stroke. A weakened heart cannot pump blood efficiently, and that can lead to the formation of blood clots that can cause a stroke. With continuous monitoring - at least once a week - we will be able to provide an early warning sign and recommend a visit to a physician who will provide the final diagnostics and treatment. Our stroke screening test is NOT intended to be a substitute for professional medical advice, diagnosis, or treatment. Always talk to your doctor or other healthcare provider about any questions you have about medical conditions. (source: Biosensors)
Stroke is the second leading cause of death worldwide
and it can happen to anyone anywhere
6+ million
deaths
16+ million
new strokes per year
5+ million
permanently disabled
Stroke can be prevented
Up to 80 percent of strokes can be prevented. Risk of stroke can be reduced by lowering blood pressure, losing weight, exercising, treating diabetes, treating atrial fibrillation, quitting drinking, and quitting smoking. These are all effective ways to reduce the risk of stroke, but today there is no way to assess and monitor the risk of stroke at home. (American Stroke Association)
We aim to do just that. Our solution is to monitor the risk of stroke using a simple-to-use blood test, similar to the glucose test used by diabetic patients. This was not available up to now because there was no affordable way to measure disease markers at home. Our technology enables that.
With a rapidly aging population and increased incidence of cardiovascular disease, stroke is becoming one of the leading causes of morbidity and mortality in the U.S. and across the world.
A stroke is a "brain attack". It can happen to anyone at any time. It occurs when blood flow to an area of the brain is cut off. When this happens, brain cells are deprived of oxygen and begin to die. When brain cells die during a stroke, abilities controlled by that area of the brain such as memory and muscle control are lost.
How a person is affected by their stroke depends on where the stroke occurs in the brain and how much the brain is damaged. For example, someone who had a small stroke may only have minor problems such as temporary weakness of an arm or leg. People who have larger strokes may be permanently paralyzed on one side of their body or lose their ability to speak. Some people recover completely from strokes, but more than two-thirds of survivors will have some type of disability.
After experiencing a stroke, survivors and their families usually concentrate their efforts on rehabilitation and recovery. However, preventing a second stroke from happening is also critical. In the U.S. stroke kills more than 130,000 people each year. About 40 percent of deaths occur in males and 60 percent in females. About 25% of the nearly 800,000 strokes that occur each year are recurrent events.
Who benefits the most?
Stroke survivors and diabetic patients are at the highest risk of stroke and are therefore the main groups that we want to reach. Our stroke screening test still requires a blood prick, and that is often a barrier for a number of healthy people. However, this is not the case with people who have experienced the terrifying consequences of stroke and also with diabetic patients who have to do a daily blood pricks to monitor their glucose levels.
Stroke survivors
Diabetic patients
Work to Be Done
Product Development & Regulatory Approval
We have successfully built and tested our first prototypes in a controlled laboratory environment. We are still assembling and manufacturing the devices in our laboratory and now need to move towards a controlled and optimized manufacturing with proper quality control. Translation of our initial product design to manufacturing will require a degree of additional research and development in order to maximize the design and manufacturing efficiency. We are also developing the second generation hand-held reader that will be Bluetooth enabled and will be able to communicate with the mobile application that we are yet to build. Our goal is to achieve these development goals within 18 months, which is when we will submit documentation to the FDA for regulatory approval. Based on initial discussions with FDA consultants we estimate that a 510k submission will be sufficient and that the process should take one year.
Do we have FDA approval yet?
We do not yet have FDA approval, but we are in early discussions with FDA consultants.
Do we need FDA approval?
Based on initial assessment with regulatory advisors we need to file a 510k premarket notification for a Class II screening device.
How long will it take?
Conditional we achieve all our R&D targets in time and 510k submission is sufficient, we estimate we can get the approval within 3 years.
Made in America for Americans
Our goal is to develop, manufacture and sell our Stroke Screen home test in the U.S.A. We want to support local industry and workers and bring a product of highest quality to market. Our intention is also to market the product first in the U.S. as per commitment form FDA to make the U.S. market a top priority for most developers of novel devices by the end of 2020. Today, many medical device companies target Europe first before setting their sights on FDA approval, thereby depriving U.S. patients of leading-edge products.
Our Competitive Advantage
Today, the main gap in the market of point-of-care (POC) devices lies in the detection of disease markers other than simple blood chemistry and electrolytes and glucose. Immunoassays are more complicated. Those molecules are currently identified using laboratory-based ELISA (enzyme-linked immunosorbent assay). Another benefit of current ELISA tests is that they offer both qualitative and quantitative results.
Many attempts have been made to “transfer” ELISA to POC, mostly utilizing expensive optics or microfluidics-based technologies. Immunoassays are also more challenging because they require proteins to interact and bind to each other and they require a wash cycle. The washing step is the main reason why most of today’s approaches use some kind of microfluidic mechanism - that in turn increases the cost and reduces the robustness of the tests.
To the best of our knowledge, our technology is the only one that enables truly affordable measurement of biomarker levels at home. Namely, most other competing approaches rely on detection and quantification of biomarkers using optics, spectroscopy, fluorescence, chemiluminescence or visualization of test band using a camera. While the underlying technologies are often very sensitive and reliable, their main barrier is the high cost of the readers that are typically over $1000. Moreover, they are often bulky and not suitable for home use.
We have created our technology with the end user in mind. We wanted to develop something that is both easy to use, affordable and at the same time of laboratory-grade quality and precision.
Point-of-care diagnostics and diagnostics markets are widely recognized as markets with a high barrier of entry due to the concentration of the markets and dominance by big multinational diagnostic companies such as Roche, Abbott, Alere, BD Diagnostics, BioMérieux and others. Development of novel diagnostics is associated with high research and development costs that compound the barriers of entry.
However, the existing diagnostic market is shifting towards the idea of recentering diagnostics on people, rather than using the widespread centralized diagnostic laboratory model. As reported in Nature Biotechnology: “Investors are pumping money into start-ups chasing the holy grail of finger-prick diagnostics, and big players keep on acquiring innovators in the space." (Nature Biotech)
Here lies the key to lowering the perceived high-barrier of entry by employing the business strategy of bringing a product to a stage where the ‘big players’ are incentivized to take-over, acquire or license the technology.
Our technology serves this niche market because we can provide laboratory-grade performance at a price that is accessible to a general consumer.
Data, Data, Data, Data
The greatest value beyond preventing stroke is the continuous health data.
We will collect the anonymized data to drive new research, machine learning and to provide novel health insights to our users. This will drive our business growth. We are developing an Internet-of-Things-enabled medical device that you will be able to embed in your smart home.
Decentralising Healthcare
Preventing stroke is just the begining
Stress management
Military applications
Athlete recovery
Fertility
Team of Top Talent
Dr. Luka Fajs (Feiss)
Founder and CEO
Luka comes from Slovenia and holds a PhD in Medical Microbiology. Before starting the company he was doing research and clinical laboratory diagnostics of hemorrhagic fevers, biothreats and other infectious diseases. He spent a lot of time in the field, helping doctors and nurses in low-income countries to set up and improve their diagnostic preparedness. During his work, he saw firsthand the drawbacks of the existing medical diagnostics system that is mostly centralized, capital-intensive, with many people not enjoying adequate access to it. That was the motivation to join Prof. Robert's laboratory in Singapore where he took over the fundraising and startup activities of the technology. He continued as CEO of Biosensorix and helped secure early funding and directed the research and development activities. He is a passionate entrepreneur with deep knowledge of diagnostics, user expectations, and basic science.
Prof. Robert S. Marks
Founder and Chief Scientist
Prof. Dr. Robert S. Marks is the co-inventor of the technological platform and is a renowned expert and key opinion leader in the field of biosensors. He is a Full Professor at the Ben-Gurion University of the Negev, Israel, at the Department of Biotechnology Engineering, The National Institute for Biotechnology in the Negev and the Ilse Kats Centre for Nanotechnology. He is presently a Visiting Scientist in the NTU-MSE, and was a program coordinator for the NRF CREATE program “Nanomaterials for Water and Energy Management”. Robert has previously co-founded Biosensing Technologies Ltd, Biopixel Ltd and Polyrizon Ltd. He will be assisting with advising the development of the next generation prototype and establishing the business collaboration with potential partners. Prof. Marks has extensive experience in development of biosensors. He is the Editor-in-Chief of a 2007 2-volume Wiley Handbook in Biosensors and Biochips and a 2014 Viral Diagnostics book for virus detection. He is the author of 150+ papers (H-index 27), and numerous chapters. He has 4 issued patents as well as a dozen filed.
Tina Semolic
Marketing
Head of Marketing
Previously at Adglow.com (clients: Prada, Miu Miu, Moschino, Pinko, Max Mara, Armani ect.), Httpool.com (over 50 clients: Generali insurance, Mercedes, Audi, STO - Slovenian touristic org. ect.), Adroll.com (Head of Business Development SMB) Facebook.com (over 500 clients: Adidas, Nike, Ferrari, illy, Morellato, Fossil, Head, Hugs ect.)
Đina Mandic
Marketing
Social Media Marketing Manager
Currently at Đina's Real Estate Agency. Đina is an experienced salesperson and marketer with a passion for social media and PR.
Advisors
Dr. Joseph Mocanu
Joseph is a founding partner at Verge Capital Singapore, and was a Principal in Oliver Wyman’s Singapore office, leading life sciences and digital health across Asia, sits on the Advisory Board of Galen Growth Asia and is a startup mentor at the Singapore Institute of Management.
Branka Palic
BSc in Medical Technology/MSc in Molecular Biology with 20 + years of experience in directing and managing Clinical Trials and Clinical Operations previously at Roche, currently at Bayer. Directed and managed clinical trials Phase II –IV in HIV/HVC Co-infected patients, HIV, HCV, Cardiology, Urology and Women’s Health and currently Phase I trials in Chagas disease.
John Molyneux
VP Manufacturing Operations at TriReme Medical, LL. Previously at Abbott (i-STAT).
//Geek section
The proof-of-principle has been previously demonstrated with a model protein. The immunoassay research comprised of an immunocomplex between antigen NS1 protein and NS1 antibody conjugated onto the immuno-nanobeads. Applying a running buffer, the immunocomplexes flowed to the immuno-conjugated SPGE surface and formed a specific sandwich detection due to biomolecular recognition. The immunocomplex formation was successfully analysed by electrochemical detection. An electrochemical signal due to the specific detection of NS1 was contributed by a redox label functionalised on the bead containing the NS1 antibody. A proportional increase of faradic current with the increase of the analyte NS1 protein concentration was observed. The ELLI prototype was assembled in a cassette and it successfully demonstrates a linear response over a concentration range of 1–50 ng/mL with an R2 of 0.928. The specificity of the NS1 protein detection system was investigated. Non-specific capture antibody (mouse IgG) was immobilized onto the surface of the SPGE instead of NS1 antibody. Control experiments were treated identically to the specific experiments from 0.5 ng/mL to 400 ng/mL and no significant changes were observed in the impedimetric responses. This demonstrated the specificity of the developed detection system.
Our latest laboratory results show that we can obtain results that match the performance of ELISA in under 15 minutes. We have tested our platform with different target molecules (eg. E. coli, cancer markers and dengue NS1), and have shown that our platform is equally efficient/independent of the target antibody/antigen target we use.
All in all, the main advantage of the ELLI is that it shows qualitative and quantitative detection of NS1 protein down to a detection limit of 0.5 ng/mL involving an electrochemical signal based on a redox label ferrocene which is stable to both thermal and photobleaching. Moreover, a small volume of sample was also used and no enzymes were needed in the construction of the ELLI. The development and assembly of the ELLI is relatively simple, biocompatible, disposable, and inexpensive involving affordable technologies applying cellulose paper and screen printed electrodes thus providing POCT capabilities.
Proof-of-principle of detecting clinically-relevant (picogram) concentrations of NT-proBNP using ELLI was done with at least twelve independent biofunctionalized SPGEs were used for each concentration of NT-proBNP, ranging from 100 pg/mL up to 5000 pg/mL, in duplicates. A drop of 50 µL NT-proBNP was applied during a 10-min incubation before the SPGE was washed with running dI water thoroughly (~10s). The SPGE was then slightly dried around its periphery and it is important to avoid contact with the electrodes surface. Afterwards, CV and EIS were performed sequentially. With an increase of NT-proBNP concentration, the current of redox reporter decreased while the resistance of the SPGE surface increased due to an increasing amount of NT-proBNP captured on the specific biofunctionalized SPGE.
For more detailed information check out our published peer-reviewed manuscripts:
The Offering
Investment
$10/share of Common Stock
$10.1 million post-money valuation
In the Press
Offering Summary
Company | : | Eclipse Diagnostics Inc. |
Corporate Address | : | 750 N. San Vicente Blvd, Los Angeles, CA 90069 |
Offering Minimum | : | $10,000.00 |
Offering Maximum | : | $1,070,000.00 |
Minimum Investment Amount(per investor) | : | $500.00 |
Terms
Offering Type | : | Equity |
Security Name | : | Common Stock |
Minimum Number of Shares Offered | : | 1,000 |
Maximum Number of Shares Offered | : | 107,000 |
Price per Share | : | $10.00 |
Pre-Money Valuation | : | $10,000,000.00 |
Perks*
All investors
Regular updates on our technology progress
$2,000+
Exclusive content and regular company updates -
Canabinox test prototype
$5,000+
Your place on the Technology Ambassadors Page of the website - Exclusive content and frequent company
updates –
Canabinox test prototype
1-year 'Casual' subscription to the Canabinox testing - FREE
$10,000+
Your place on the Technology Ambassadors Page of the website - Exclusive content and regular company
updates –
Canabinox test prototype
Invitation to our annual company VIP events.
1-year 'Basic' subscription to the Canabinox testing - FREE
Irregular Use of Proceeds
The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments and salaries; Any expense labeled “Administration Expenses” that is not strictly for administrative purposes; Any expense labeled “Travel and Entertainment”; Any expense that is for the purposes of inter-company debt or back payments.
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Risks
A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.
Updates
Notice to Investors
29 days agoWe will be unable to meet our April 29, 2020, annual report filing requirements for securities sold pursuant to Regulation CF as a result of administrative delays caused by shutdowns due to the COVID pandemic. As such, we intend to rely on the temporary relief being provided by the Securities and Exchange Commission. We will continue to use our best efforts to comply with our ongoing reporting obligations.
Thank you for your continued support.
Eclipse Diagnostics Team
Canabinox Mobile App Update
10 months agoMobile App Updates
Canabinox Mobile App has new updates available now. From today on with Canabinox Mobile Application you are able to:
- MEASURE your plant or product profile
- CHECK your history data and past measurements
- ORDER A NEW reader and testers
Stay tuned on our social media channels for more info:
Facebook: https://www.facebook.com/canabinox/
Instagram: https://www.instagram.com/canabinox/
Twitter: https://twitter.com/Canabinox1
Linkedin: https://www.linkedin.com/company/canabinox/
-Eclipse Diagnostics Team
Attending the Nanjing Tech Week 2019 in China
11 months agoNanjing Tech Week 2019
A successful week behind us! Thank you Nanjing Tech Week for having us we loved to share our knowledge and tech with all of you. We made great connections and met some amazing people. We shared and learned a lot.
Till next year!
-Eclipse Diagnostics Team
Attending the Nanjing Tech Week 2019 in China
11 months agoNanjing Tech Week 2019
Another great day behind us in Nanjing, China at the Nanjing Tech Week 2019. 💚
Our team had several interviews for the Chinese media and they loved our Technology.
Our co-founder Robert was also pitching at the StartUpGrind. 💚
Stay tuned on our social media channels for more info:
Facebook: https://www.facebook.com/canabinox/
Instagram: https://www.instagram.com/canabinox/
Twitter: https://twitter.com/Canabinox1
Linkedin: https://www.linkedin.com/company/canabinox/
-Eclipse Diagnostics Team
Attending the Nanjing Tech Week 2019 in China
11 months agoNanjing Tech Week 2019
Our team had a great first day at the Nanjing Tech Week 2019 in Nanjing, China. If you have a chance you are welcome to stop by our booth. We will also have an official presentation pitch about our tech. Stay tuned on our social media channels:
Facebook: https://www.facebook.com/canabinox/
Instagram: https://www.instagram.com/canabinox/
Twitter: https://twitter.com/Canabinox1
Linkedin: https://www.linkedin.com/company/canabinox/
-Eclipse Diagnostics Team
Our article for L.A. Cannabis News is out!
11 months agoL.A. Cannabis News
Check out our new article for L.A. Cannabis News where we spoke about our technology and more.
Or follow the link: https://lacannabisnews.com/affordable-handheld-cannabis-testing-device/
-Eclipse Diagnostics
At the BIO 2019 International Convention in Philadelphia
12 months agoBIO 2019 International Convention
We had a great time at the BIO 2019 International Convention in Philadelphia where the cannabis tech gets its first representation at BIO International Convention thanks to Auxly Cannabis Group, Farkel and Panarea Partners.
Great presentation by Gabriela Cezar showing the cannabis biotechnology outlook for the future!
-Eclipse Diagnostics
Are you a Cannabis Grower or you know some? Watch this!
almost 1 year agoHow can you invest in Canabinox, How can you get Canabinox and more...
Our CEO Luka Fajs, sharing some additional information about our Cannabis testing device with our community. We welcome your feedback and comments!
Watch the video here:
Or go to https://www.youtube.com/watch?v=O45jZY_xXXk
Thanks for funding the future.
-Eclipse Diagnostics Team
Why is Canabinox crucial for the Cannabis Industry?
about 1 year agoWhy would a Grower, Weed user or Hemp user use Canabinox?
Our CEO Luka Fajs, sharing some crucial information about our Cannabis testing device with our community. We welcome your feedback and comments!
Watch the video here:
Or go to https://www.youtube.com/watch?v=gDFVVwvDFNk
Thanks for funding the future.
-Eclipse Diagnostics Team
We are closing our campaign!
over 1 year agoDear Investors!
We are closing our campaign and we would like to thank you for your support, your comments and your letters. We we will keep you updated on our progress as we move forward.
A Big Thank You From Eclipse Diagnostics!
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