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About our project
The problem we solve: Saliva is the new blood, when it comes to diagnostics. Doctors, patients, healthcare workers, and insurance companies would welcome a cheaper, less invasive way to diagnose various health related conditions.
About our solution:
Baseline Global has a simple device (akin to the pregnancy test) that uses salivary biomarkers to detect various different health related conditions. URGENTLY, we have the patent for 6 biomarkers that are identified in symptomatic and asymptomatic COVID-19 patients. Additional conditions we are developing or are in the pipeline are mTBI, Alzheimers, Parkinson's, stroke, PTSD and depression.
Progress to
date:
Our team has developed a prototype device, and are currently working with the FDA for COVID-19 and mTBI. The concept and science has been tested and vetted. We are not in the stages of development of antibodies for each of the two conditions, and are working with the FDA to develop clinical trials protocols.
About Our Team
Creator: Matthew Kwok
Location: California
Bio: Matthew Kwok is a business executive that has run a range of different businesses. From sports broadcast to event staffing to medical diagnostics, he has spent the last 20 years building companies that create value for clients, investors and communities. Kwok's latest successes include an Emmy award for his work in sports broadcasting, the re-launch of Legend FC (a Mixed Martial Arts league in China) and recent progress with the FDA for Baseline Global.
Title: Founder / Board Memeber
About Team Members
Lenny Kristal
Founder/Chairman, Phd Biography: Lenny received his Ph.D. in Psychology at Cambridge University with a Postdoc at Oxford. It was his work as a corporate HR consultant that first inspired Lenny's ideas about delivering interactive games online to measure, match and rank cognitive performance. In 2000, he founded MatchPower (later Cognisess).
Title: Founder/Chairman Advanced Degree(s): Phd LinkedIn:https://www.linkedin.com/in/lenny-kristal-6438142/
Jeff Mcallister
CEO, Bachelors Biography: Currently the President, CEO of Baseline Global, Inc.
Formerly President North America and United Kingdom for Cellum Global, a mobile payment solution for world markets.
* Experienced operational CEO from Fortune 50 companies to entrepreneurial start-ups. Established operations for GTE in Belgium in 1994 and Hungary in 1995, receiving GTE President's Award for Outstanding Achievement. CEO and Chairman of U.S. company publishing business titles in 3 Central European countries (Budapest, Prague, Warsaw). American with experience working within structure of the largest corporations and able to maintain the entrepreneurial attitude, having lived in Europe building businesses for more than 20 years.
Title: CEO Advanced Degree(s): Bachelors LinkedIn:https://www.linkedin.com/in/jeff-mcallister-246433/
About Our Company
Baseline Global Inc
Location: 2082 BUSINESS CTR DR STE 292 Irvine, CA 92612
Current testing for COVID-19 either involves a healthcare provider or sending a test to a lab to determine results. Baseline will leverage our patented device to measure multiple salivary biomarkers to determine ‘Pass/Fail’ in a similar manner to both a pregnancy test and our concussion assessment device. After seeking guidance from our regulatory consultants, we are in discussions with the FDA to determine our fastest pathway for clearance and commercial sale.
Our COVID Solution
An essential characteristic of the COVID-19 test will be the goal to detect positive results in asymptomatic users. Baseline’s vision is to use this testing sensitivity to allow segments of the population to create ‘Safe-Zones’, allowing entry only to point-of-test negative result individuals. This can be applied to airports, sporting venues, theaters, conferences, concerts, office complexes, schools, the military, etc. In addition, the ability to identify a positive test early allows for timely treatment and continual monitoring.
Innovation Details
Intellectual Property Summary
IP Protection Below
Baseline Global Device: Filed and response given. In process. Provisional patents for mTBI, Parkinsons and Alzheimers biomarkers have been applied for in India and are currently fully licensed perpetually to Baseline Global by inventor.
COVID-19 Biomarkers: PCT Filed
mTBI Biomarkers: PCT Filed
Alzheimers Biomarkers: PCT to be filed by end of week
Parkinson's Biomarkers: PCT to be filed by end of July
PTSD Biomarkers: PCT to be filed by end of August
Stroke Biomarkers: PCT to be filed by end of September
All PCTs to be filed by end of 2020.
Clinical Information
Our Chief Scientist has done preliminary studies on all saliva biomarkers and compared to various different tests based on the condition. These studies are part of our patent and FDA applications. Additional studies may be done to verify there are no differentiations between Indian and American subjects. That said, we are in the Pre-Sub process for both mTBI and Covid19. Once we have cleared these conditions, we will continue forward with the others.
Regarding clinical trials, we have developed a protocol for mTBI and have received feedback from them. Our final submission for the mTBI clinical trials protocol will be at the end of July.
Regarding COVID-19, intial bench tests have been done via 2 independent labs, as well as our Chief Scientist's lab. These data has been submitted along with our EUA application to the FDA.
Our team has identified a clinical trial partner for both mTBI and COVID-19. A significant portion of our funding will go toward this cost.
Regulatory Status
As noted above, we have developed a protocol for mTBI and have received feedback from them. Our final submission for the mTBI clinical trials protocol will be at the end of July. The FDA has been extremely helpful in our back and forth with them.
Additionally, we have been assigned a reviewer for our COVID-19 project. We are currently in the EUA submission/review phase.
How we will use the funds raised
Currently funding will go toward antibody and lateral flow test strip development, clinical trials and ongoing operations. We have an outsource and orchestrate model, so our staff overhead is relatively low. The funds raised will help us get to market more quickly.
Thank You
Baseline Global is developing a novel device that will help further the identification of illnesses that may or may not be symptomatic. From COVID-19 to PTSD, our goal is to help with early detection, so individuals can be identified, treated and potentially stop the spread in the event of a communicable disease.
Investor Info
Market Size
Total market opportunity is undeterminable. This device is an OTC device to be used by anybody that can read the results. That said, once our COVID-19 product clears regulatory and can be manufactured, the sky is the limit. Our conservative estimate is that our initial run will be no fewer than 10M units. However, we understand that once we are approved by regulatories throughout the world, that number turns into over 100M per month.
Regarding mTBI, this is a $250B industry. From peewee football to military to law enforcement, the market for a rapid detection mTBI device is in the billions. Each condition for which we will file patents for, is a huge market.
Projected 3 Year Growth
Our gross margins once the R+D is complete run between 60 and 85%. This will produce revenue of conservatively 60M in 2021 and 100M in 2022. Additionally, as we increase the funds raised, our timeline shortens for each condition, as the business model has us running each condition in a series with overlap. That said, we we are able to run R+D, clinicals and manufacturing concurrently, this will greatly speed up our timeline.
Revenue Model
Revenue will be simple. Each device will range from $10-$40, depending on the condition and projected sales amount. The devices are single use, disposable and OTC. This provides recurring revenue, as long as the ailments exist. Additionally, we have identified both chronic and accute conditions that will help smooth out revenue once all of our products are out to market.
Competitors
At this point in time, we are only able to identify a few potential competitors. For the concussion space, a company called Medicortex is behind us, but entering into the space. All blood diagnostics companies could be seen as competitors. Additionally, there are a few boutique businesses that are focusing on saliva, but most are lab diagnostics and not point of care/OTC.
Traction
We have been in discussions with the National Football League, US Military and the UK Armed Forces for the mTBI device. Regarding COVID-19, the whole world is interested and a potential customer.
Due Diligence Docs
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Matthew Kwok is a business executive that has run a range of different businesses. From sports broadcast to event staffing to medical diagnostics, he has ...
