Alright, here's the Deal..I tried to Copy/paste the entire document..Keep it confidential..Why? I really do not Know why..LOL!! I am not sure how much of this Copy/paste will transfer. If it doesn't..do what I have told you to do via Contacting Rob directly..Just like i had to do! Hope this works..If not..Sorry! It did not all go through..SORRY!
CONFIDENTIAL AND SENSITIVE INFORMATION OF CYRCADIA INC. Based upon information which we have reviewed, India and China have over 1.2 million women who would benefit from monthly screening using technology such as ours, and, for example, with less than 20 digital mammography system in India, population based general screening is in high demand. In view of that, Cyrcadia will be working to launch our initial product commercially in Malaysia, Indonesia, Singapore, and India, as key markets for mass population monitoring in Asia as of the second half of 2017. The regulatory process in each one of these countries requires special handling, but most importantly such processes recognize FDA clearance which will help expedite Cyrcadia to market in these highly-populated countries. Japan and South Korea are also excellent market opportunities in which we can utilize our FDA clearance for launch. We are furthermore in communications with some of the world’s largest health insurance companies and pharmaceutical distributors to enter these countries with insurance industry, commercial and government support. We firmly believe that best way to outpace competition is to simply be the best product in the market with the highest accuracy. We are confident that Cyrcadia’s technology and products can do this through large-scale de-identified population health data imported through our proprietary predictive analytic software programs. We also believe that, since it is recognized that predictive analytic algorithms teach themselves, the greater the amount of de-identified population data in the database, the more accurate our technology will become. From the US perspective, we are also capable of launching into the US, with the aforementioned FDA clearance. As we develop the distribution infrastructure in the US, we will leverage the information obtained from our initial launch in the Asia markets to ensure the highest predictive value for our US customer launch. The US launch will require top physician testimonials and referral to ensure rapid adoption. In that regard, we are pleased that leading medical institutions and leading health care providers, beyond those with which we are currently associated, have requested Cyrcadia’s participation in short pilot programs for publication and roll-out in the US now. We are in the planning process for our commercial pilot program in the US in H2 2017 with launch to follow. From a European perspective, CE Marking or European Conformity marketing clearance is required. The CE Marking follows first commercial release and additional months of clearance from regionally based Notified Bodies, which will allow European entry by 2018. For China and Australia, once the FDA process is completed, another set of documentation and testing must follow and thus our estimate for Australia and China entry in 2018.
CONFIDENTIAL AND SENSITIVE INFORMATION OF CYRCADIA INC. From the market launch perspective, we have asked Jabil to prepare prototypes for us to pilot test our new smart phone enabled technology by mid-2017. In what we consider to be a prelaunch, the small pilots will allow our proof of principle in multiple countries where key clinical sites are already requesting our participation. Finally, Jabil has committed to full product launch, providing we receive funding for our commercial product, by Q4 of 2017 beginning in Asia and evolving to rest of the world as previously mentioned. Financing Through the help of all of you, Cyrcadia has raised approximately $5.0 million over the last four years. The average contribution by a stockholder into Cyrcadia was approximately $42,000 at an average price of $.45 per share into Common Stock. We have now evolved to a purchase price of $1.00 per share of Common Stock, with many participants investing at that price with frequent contributions over $100,000 per investment. We also have commenced and are actively pursuing a Series A Preferred Stock financing of the Company of $6.5 million in purchase price proceeds, at a price of $1.00 per share for the Series A Preferred. We will be utilizing the $6.5 million financing proceeds for finalization of the commercial product, expansion of our intellectual property portfolio, finalization and progress with respect to our global regulatory processes, clinical pilots in certain countries, and paving the way for product launch in Asia, US, and Europe. In the $6.5 million raise, we are in active discussions with several interested lead and associated investors who are willing to invest substantial amounts in the financing post due diligence completion. We are working to close that financing as quickly as possible. Patent Portfolio Expansion and Renaming The three current patents for our technology, held by LLBO, are issued in the US only. Therefore, Cyrcadia will need to file for an extensive patent portfolio in the rest of the world in preparation for our market entry. Cyrcadia has engaged one of the largest and most respected patent agencies in Europe and Asia to assist us with filing for patent protection for Cyrcadia globally. We are planning to file multiple patents on a worldwide basis shortly for breast cancer and other cancers with respect to major commercial markets once financing allows for the drop down of patents into Cyrcadia from LLBO. The named First Warning Systems, Inc. evolved to Cyrcadia, Inc. which we also present commercially as Cyrcadia Health. The reason for the naming evolution was initially to ensure
CONFIDENTIAL AND SENSITIVE INFORMATION OF CYRCADIA INC. women’s comfort with our new name as a health monitoring company, and secondly to enable Cyrcadia to create an entire patent portfolio, and future product expansion into other applications beyond breast cancer. Summary The historical principles by which the original technology was derived through technology inventors Dr. Lewis Keith and Dr. William Reeves have proven to carry forward into a scalable wearable technology. We are deeply thankful for Drs. Keith’s and Reeves’ vision, which now enables our ability to reach mass populations in 2017. The pathway to commercialization over the last four years has not, however, been easy. We have had to convince key thought leaders of the potential value of what was referred to as interesting, but unproven technology. We have had to design clinical protocols that were acceptable to some of the top institutions in the United States based upon studies conducted decades ago and upgraded in 2007 to 2009 with the assistance of engineers at Nanyang Technological University in Singapore, leading to three patents issued to Lifeline Biotechnologies, licensed to Cyrcadia. We have had to navigate necessary regulatory processes as we convert from technology which originated 30+ years in the past to world-class current state-of-the-art technology which we are producing today through our relationship with leading wearable companies such as Flextronics and Jabil in preparation for our 2017 launch. From a public recognition stand point, in 2016 Cyrcadia won the prestigious Gold Edison award for the Top Wearable Device in Healthcare; see 2016 Gold Edison Award and among many other major national news media, was featured in The Huffington Post; see Cyrcadia in Huff Post. We were also honored and delighted that Cisco Systems financed, because of its interest in what we are doing, Emmy nominated video production company, Ironbound Films, to create a documentary about Cyrcadia’s experiences in producing the first wearable product in healthcare that transcends fitness to wellness for all women. The trailer for the documentary has been widely available on the internet and has generated considerable publicity for the Company and our technology, and will be released in its full version later in 2017; See: Detected Cyrcadia was also awarded one of the Top 40 Healthcare Transformers awards by MM&M (Medical Marketing & Media) Magazine in late 2016. Furthermore, Forbes published an article featuring Cyrcadia on December 22, 2016 entitled “In Cancer Fight, Artificial Intelligence Is A Smart Move For Everyone.” See: Cyrcadia in Forbes
