Patho Care – a -point-of-care-testing system for COVID-19 and other respiratory diseases with real-time results at 97% accuracy – may save tens of thousands of lives.
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About our project
The problem we solve: COVID-19 statistics are horrifying. This worst pandemic in more than a century will undoubtedly continue to afflict the United States and the world for quite some time. Before vaccines can achieve prevention, millions more will become infected and die.
National and global responses to date have unquestionably been highly fractionalized and largely ineffective. Comprehensive responses involving interrelated systems of testing, tracing and treating Covid-19 are essential to curbing the spread.
There is a desperate need for a programmable, mobile and reusable point-of-care-testing (POCT) system for rapid detection and characterization of respiratory infections. Patho Care, LLC, with its PathoProbes and PathoWAND, can remedy this. Its early detection capability, with results in less than 10 seconds and up to 97% accuracy, will not only greatly help patients and save lives, but also render contact tracing faster and easier.
About our solution:
The Patho Care system utilizes programmable, mobile and reusable POCT devices for detection and characterization of COVID-19 and other bacterial and viral respiratory infections. Results are available within 10 seconds, with 97% accuracy.
Patho Care relies on RAMAN Spectroscopy to determine the spectral pattern of fluoresced emitted light. This microorganism unique pattern is analyzed by Artificial Intelligence (AI) Deep Learning Neural Networks (DLNN) for the presence or absence of a particular pathogen.
AI DLNN algorithm processing requires high-speed supercomputers. Patho Care has three configurations: PathoProbe I and II (clinical & institutional environments) and PathoWAND (individual use). The first uses a smartphone to link to server farm supercomputers. The second uses a local supercomputer to execute the algorithms. The third links a personal or home-use wand resembling a tongue depressor to the server farm via a smartphone or laptop.
Progress to
date:
The Patho Care system has shown great promise. The PathoProbe and PathoWAND should be ready for clinical trials in early 2021, contingent on financing.
There has already been highly favorable response from medical and other communities. Cecil F. Motley, MD, PhD, a biomedical engineer and principal on the project, has been invited to address the Food and Drug Administration Patient Engagement Advisory Committee (PEAC). Several other medical institutions are also showing interest in the Patho Care potential for real-time, highly accurate POCT. In addition, at least two pharmaceutical companies have inquired about producing, marketing and distributing the devices.
Patho Care principals have also done numerous Zoom and webinar presentations to prospective investors and affiliates in both the for-profit and non-profit sectors. Some negotiations are underway, and the company has also made preparations for crowdfunding.
The Patho Care system has shown great promise. The PathoProbe and PathoWAND should be ready for clinical trials in early 2021, contingent on financing.
There has already been highly favorable response from medical and other communities. Cecil F. Motley, MD, PhD, a biomedical engineer and principal on the project, has been invited to address the Food and Drug Administration Patient Engagement Advisory Committee (PEAC). Several other medical institutions are also showing interest in the Patho Care potential for real-time, highly accurate POCT. In addition, at least two pharmaceutical companies have inquired about producing, marketing and distributing the devices.
Patho Care principals have also done numerous Zoom and webinar presentations to prospective investors and partners in both the for-profit and non-profit sectors. Some negotiations are underway, and the company has also made preparations for crowdfunding.
About Our Team
Creator: Cecil Motley
Location: California
Education: BSEE: U of Houston; others: USC
Bio: Cecil F. Motley, MD PhD (Biomedical Engineer) has over 45 years of experience in electrical engineering, biomedical engineering and medical device development. He has numerous patents and is a specialist in artificial intelligence, machine intelligence and deep learning neural networks. He also has 20 years of experience in UV based systems and devices. Dr. Motley is currently the Manager of Cardiometric Medical Systems LLC, Patho Care, LLC and Neb Care, LLC.
Hospital Affiliation: Cardiometrics Medical Systems, LLC, Patho Care, LLC & Neb Care, LLC
Title: Program Manager
Advanced Degree(s): BSEE, MSEE, MSBME, MD, PhD
About Team Members
Randall Maxey
Clinical Trials Principal Investigator, BS, MD, PhD Biography: Randall W. Maxey, MD PhD (Cardiovascular Pharmacology, Internal Medicine Nephrology) has over 47 years of experience in medicine. He is a PhD in Pharmacology and an MD from Howard University College of Medicine. He has served as Director of Nephrology at Daniel Freeman Memorial H ospital, Robert F. Kennedy Med. Center, the Pacific Coast Dialysis Center and Guam Renal Care. He is currently a practicing physician and CEO and is Board Chair of American Alliance Dialysis Holdings LLC and Biometrics Partners Corp. Dr. Maxey served as President of the National Medical Association (2003-2004).
Title: Clinical Trials Principal Investigator Advanced Degree(s): BS, MD, PhD
Ethelyn Motley
Project CFO, BSCHE Biography: Ethelyn Motley, a chemical engineer, is the principal designer of the PathoProbe and PathWAND devices. She is also a member of Cardiometric Medical Systems, LLC, Patho Care, LLC and Neb Care, LLC.
Title: Project CFO Advanced Degree(s): BSCHE
Ida Muorie
Project Financial Consultant, BA, JD Biography: Ida R. Mourie is a seasoned financial professional. With over 25 years in the industry, she has done hedge funding, private equity, wealth managing and trading. She has a JD from Howard University School of Law. Ms. Muorie is the Project Financial Consultant for Cardiometric Medical Systems, LLC and Patho Care, LLC on this project – and should be the main contact for present purposes. She can be reached by phone at 941-228-4288.
Title: Project Financial Consultant Advanced Degree(s): BA, JD Twitter:https://twitter.com/IdaRMuorieJD LinkedIn:https://www.linkedin.com/in/idamuoriejd1374b71b/
About Our Company
Patho Care, LLC
Location: 4609 Palos Verdes Drive N. Rolling Hills Estates, CA 90274
Patients will be able in an easier, faster, more accurate and cheaper manner to determine whether or not they have COVID-19 or another viral or bacterial respiratory infection. Families, coworkers and others will be able to do the same. This will save lives.
How We Help Physicians
Doctors, nurses and other health providers will be able in an easier, faster. more accurate and cheaper way to determine whether or not they have COVID-19 or another viral or bacterial respiratory infection. Clearly, this will help save their lives -- in addition to those of their patients and their families, coworkers and others. This will save lives.
How We Help Hospitals
Hospitals and other medical institutions will perhaps be the greatest beneficiaries of Patho Care. They will be able in an easier, faster. more accurate and cheaper way to determine whether or not their patients and staffs have COVID-19 or another viral or bacterial respiratory infection. This will save lives.
How We Help Partners
Partners are anticipated to earn a great return. In addition, particularly during a pandemic when we must all look out for others as well of ourselves, individuals and institutions will have the benefit and satisfaction of doing their parts. They will be saving lives.
Innovation Details
Intellectual Property Summary
Patho Care devices are protected by U.S. Provisional Patent No. 63/069,761. In addition, the POCT device is a component of the Neb Care, LLC RespirClear Treatment system, which is protected by Provisional Patent 63/014,606.
Patent Link
N/a (provisional)
Clinical Information
Phase 1 thru 3 Clinical Trials should be performed. Phase 1 trials are to prove the efficacy and safety of the POCT devices in the testing of human subjects infected with microorganisms such as COVID-19. Phase 2 involves small human trials (<250 subjects). Phase 3 is a full human trial (3000+ subjects) to establish statistical accuracy of the POCT devices which should lead to FDA approval. The POCT device trials will have a wide range of participant subjects (men, women, and children of all ages, races, and ethnic groups). The sequence for the Programmable Pathogen Test Unit (PPTU) is as follows:
Clinical Trial Milestones – Projected Duration of 16 Months
PPTU Safety Validation
PPTU Efficacy
PMA (Pre-Market Approval) & EUA (Emergency Use Authorization) Approved
Phase 1 Clinical Trials Complete
Phase 2 Clinical Trials Complete
Phase 3 Clinical Trials Complete
FDA Certification
Using traditional projections, the cost for the first year is projected to be $6,000,000, essentially through Phase 1. I may double in the second year.
The PathoProbes and PathoWAND are believed to qualify for application for “Emergency Use Authorization” (EUA) under Section 564 of the Food, Drug and Cosmetics Act (FD&C Act), 21 U.S.C. §360bbb-3. As indicated above, Patho Care hopes to apply for EUA after safety and efficacy have been established, perhaps after 6 months. In addition, Patho Care hopes to be above to file and application for "Premarket Approval" (PMA) (a) pursuant to FD&C Act §§515 and 515A, 21 U.S.C. §360e.
Regulatory Status
As previously indicated, the PathoProbe and PathoWAND devices should be ready for clinical trials in early 2021, contingent upon financing. Patho Care is currently doing presentations and negotiating with several potential investors and partners in both the for-profit and non-profit sectors. Probable clinical investigators have been identified. The principals of Cardiometrics have been through this process before.
How we will use the funds raised
The funding and grants from this program are intended to be used for construction of initial PathoProbes and PathoWAND testing units and for Phase 1 Trials. Patho Care hopes to seek additional funding and grants for Phases 2 and 3. It is anticipated, however, that once the devices start to prove their merits, interest among pharmaceutical and other companies in financing, manufacturing and distributing the devices will increase significantly. As indicated earlier, such negotiations are already underway.
In addition, as also mentioned above, Patho Care hopes to be able obtain PMA and EUA from the FDA under the FD&C Act. If such approvals are obtained, they should both greatly accelerate the time to market and enhance funding opportunities. In addition, Patho Care is consulting with some non-profits to provide for supplies to disadvantaged, particularly vulnerable groups.
Thank You
To date there is no FDA-approved POCT device for COVID-19 and other bacterial and viral respiratory infections. Testing and tracing are critical to controlling spread and to reopening commercial venues and reviving the economy. Tests must have a very high accuracy ratee and provide results within seconds.
The PathoWAND is intended for personal testing. It can also be used by family members or other small groups with proper sterilization between tests. PathoProbes I and II are oriented toward institutional use. They are suitable not only for physician offices, clinics, hospitals, nursing homes and the like, but also for schools, transportation terminals, theaters, sports arenas and other large-group environments.
Please help save lives!
Investor Info
Market Size
Because of the unprecedented nature and out-of-control spread of the Covid-19 pandemic, the Total Market Opportunity for Patho Care is difficult to determine. The following are reasonably moderate projections for Patho Care device sales:
TOTAL ANNUAL $5,782,000 $14,994,000 $31,200,000 $392,340,000 $469,460,000
CASH ON HAND $218,000 $224,000 $1,024,000 $4,574,110 $278,417,990
ROI SHORT-TERM 526%
ROI LONG-TERM 7699%
Revenue Model
Projected costs and revenues from domestic and international sales of PathoProbes I & II and the PathoWAND are set forth under "Market Size" above. Total incremental funding for the project over three years (Phase 1 through 3 Clinical Trials) is anticipated to be $54,000,000. Projected percentages of founder, investor and other (broker, employee, etc.) ownership have not yet been determined. The ultimate goal is to sell to a major medical device company or to do an initial public offering.
Competitors
To date, the FDA has authorized nearly 300 tests for coronavirus. The vast majority require nasal swabs performed by health professionals at a healthcare facilities or testing sites. A handful of tests allow people to collect their own samples at home — nasal swabs or saliva — and to ship them to a laboratory, which typically means waiting days for results.
Earlier this month, the FDA did grant EUI to a home test kit from Lucira health. It is, however, a single-use test and it uses, making use of traditional nasal swabs for people to collect their own nasal samples. The sample is then swirled in a vial of laboratory solution that plugs into a portable device that displays results as lights labeled positive or negative. Neither the FDA or Lucira have provided any information on the accuracy of this test. It appears, however, to be a home version of the Abbott Laboratories test, as to which the FDA has issued a rare public warning about adverse incidents and false negatives. Based on independent studies, despite being much touted by the Trump White House, the Abbott test is believed to be only about 30% accurate.
In short, there is no test or testing device approved by the FDA or even apparently on the horizon with anything like the benefits of Patho Care devices. The Patho Care POCT devices are, to repeat, programmable, reusable and not dependent on swabs, reagents and other messy paraphernalia. Results can be had in under 10 seconds with 97% accuracy.
Traction
The Patho Care devices have not received FDA EUA or undergone Phase 1 through 3 Clinical Trials. Consequently, there have been no sales (traction) to date. Patho Care is, however, already generating considerable interest in medical and other communities. As mentioned earlier, Dr. Motley has been invited to address the FDA PEAC, and several medical institutions and pharmaceutical companies have approached Patho Care.
In addition, it should be mentioned that Patho Care is relying only on highly esteemed medical Institutions (e.g., UCLA and the Methodist Health System) and associated staff physicians for the Clinical Trials. This should help ensure wide acceptance of the Patho Care devices by the medical community. Patho Care has also already initiated a campaign to present papers and demonstrations at key medical conferences, both domestic and international, in support of its devices.
Due Diligence Docs
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Cecil F. Motley, MD PhD (Biomedical Engineer) has over 45 years of experience in electrical engineering, biomedical engineering and medical device developm...
Patho Care – a -point-of-care-testing system for COVID-19 and other respiratory diseases with real-time results at 97% accuracy – may save tens of thousands of lives.
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Progress to
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