2. Description of the Company
◦ Advanced Preservation Technologies, LLC (to be formed) is
a new technology development company that intends to
either license, design, market, and eventually manufacture
its products.
◦ In June of 2009, we obtained an exclusive worldwide license
of a preservative that was used in the space program by
NASA.
◦ We are also negotiating a license from a major University of
a bio-polymer that preserves samples for extended periods
of time.
◦ We have already established relationships with reference
laboratories and medical supply houses whom have
expressed an interest in purchasing said products upon
completion of successful research and/or validation.
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3. NASA Preservative
◦ The specific field of use is to preserve urine, blood, plasma and
serum (largest markets). However, it also preserves saliva, tears,
sweat, vaginal fluids, semen, feces, mucous, breast milk, ascites,
lymph, pleural effusion, synovial fluid, bone marrow, spino-cerebral
fluid, and washings from bodily cavities (e.g., lung washings).
Biopolymer
◦ Preserves samples for extended periods of time (12 – 18 months and
longer) at room temperature. It puts the sample in a dormant state
and is reconstituted with the addition of a rehydration solution. This
system is compatible with many biological samples including
proteins, DNA, RNA, receptors, antibodies, antigens, bacteria,
mammalian cells, cell surfaces, enzymes and tissues. The polymer is
also effective in protecting the biological materials on the surfaces of
biosensors. Most importantly, it keeps cells alive (very important
attribute). This product has a short path to commercialization as no
510K approvals are required for research applications. We are
currently negotiating a sales and distribution arrangement with a
major supply house for an exclusive arrangement.
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4. Our goal is to initially outsource our production until manufacturing
facilities can be arranged. This will give us an almost immediate
revenue stream. We have already identified Original Equipment
Manufacturers (OEM) to make, bottle, label, and package SUBJECT
DATA.
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5. Urine
◦ We conducted a research program to verify that the preservative preserves clinically
important urine analytes. We focused mainly on Pheochromacytoma patients as it
was believed that if we preserved those samples that the others should follow suit.
The latest test results gave us 2 days of preservation using the recommended
2ml/100ml of urine. Our desired results are six days. Hence, we need to modify the
product as it relates to 24hr urines. We also would like to run test to see how the
product performs on routine uA’s and urine cultures. This product has the interest of
two very large reference laboratories as well as Becton Dickinson.
Blood, Plasma and Serum
◦ Earlier this year, one of the major reference laboratories performed testing on the
blood tubes and the results were very good. In fact, they have stated that if we make
these tubes that they would be interested in becoming a customer. This particular
company buys 230 million tubes annually. This product has the potential to be a
game-changer as blood tubes would no longer require refrigeration and/or to be
kept frozen for analysis.
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6. Current Applications Future Applications
◦ Our immediate focus will be to go ◦ The beauty of both our product is
after the low hanging fruit which that they have the potential for
would be the applications that has numerous applications to include
the shortest path to revenue forensics, biodegradable
generation and build from there. We packaging, agriculture, oral vaccines
believe that the biopolymer provides and food science. Our advisory
this opportunity as product is simple board will determine which
to make and no FDA approvals are applications / markets should be
required for research applications. given priority.
This will give use a revenue stream
while we bring the blood and urine
products to practical applications.
◦ We have identified a blood tube
manufacturer that can produce our
tube while we test and apply for
510K and setup our own
manufacturing facilities.
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7. Easy to Prepare and Use - Both solutions are stable and
easy to prepare. It is also easy for the average person to
use and is capable of coating an aliquot tube.
Inexpensive - This technology is inexpensive to produce.
In addition, since samples may be stored at room
temperature, the costs which would normally be incurred
for the refrigeration and freezing of samples is eliminated.
Refrigeration Not Required - Samples may be collected in
remote settings where it was not previously feasible to do
so.
Non-toxic and Maintains pH - Preservatives does not alter
the pH of a sample. In addition, unlike hydrochloric acid,
boric acid, thymol and thymerasol, this preservative is
non-toxic.
Biopolymer – Keeps cells alive
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8. The global IVD market was valued at $44 billion in the year 2011, growing at a
CAGR of 7.8% from 2011 to 2016. The U.S. represented the biggest market for the
IVD equipments accounting for a share of 47% of the total IVD market in the year
2011.
Sixty percent (60%) of testing is conducted a hospital laboratories, Thirty-three
percent (33%) at commercial labs and the remainder (7%) at Physician labs.
According to Quest, 100% of the urine samples require the use of a preservative
and Lab Corp says 85% of their urinalysis requires a preservative. Hence, we used
an average number of 93% of urinalysis, urine cultures and molecular diagnostics
require the use of a preservative from commercial laboratories. Currently
hematology, chemistries and immunoassays do not require a preservative.
However, some of those test requires that samples be kept frozen and/or
refrigerated. Hence, our approach would be to offer preservations for these
applications as well. Storing samples at room temperature could reduce shipping
costs as well as save needed space. This gives us a total market of over $8.4
billion dollars not to mention any of the other applications not included like the
Bard bags. Hospitals could also be targeted as samples are sometimes
inadvertently left unrefrigerated and have to be thrown out and retesting is
needed. Our product would alleviate this problem as our samples can be stored
on the shelf at room temperature for 6 -7 days..
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9. Urinalysis $569 million
Urine $300 million
Cultures
Hematology $1.8 billion
Molecular $2.6 billion
Diagnostics Hospitals $16,445,988,202 60%
Chemistries $11.8 billion
Commercial $9,045,293,511 33%
Immunoassay $10.2 billion Labs $8,412,122,965
Total $27.4 billion Physician Labs $1,918,698,624 7%
Market
Of the $27.4 billion dollar market potential available for our product, our numbers reflect only commercial
laboratories. Hospitals are the largest markets and it is our goal to penetrate these markets. Chemistries,
hematology and Immunoassays do not require the use of a preservative, but some testing require samples to be
frozen. With our product, all samples could be handled the same way and kept unrefrigerated, further streamlining
operations. We have also identified other untapped markets to include urinalysis collection bags (Bard bags) and
hormones.
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10. Projected Company Financials Year 1 Year 2 Year 3 Year 4 Year 5
Revenue
Urine Tubes $0.400 $0.400 $0.400 $0.400 $0.400
Units Sold (manufactured) 5,000,000 30,000,000 40,000,000 50,000,000 75,000,000
Blood Tubes 0.10 0.10 0.10 0.10 0.10
Units Sold (manufactured) 1 60,000,000 230,000,000 250,000,000 500,000,000
Projected Sales (Blood) $0.00 $ 6,000,000 $ 23,000,000 $ 25,000,000 $ 50,000,000
Projected Sales (Urine) $2,000,000 $12,000,000 $16,000,000 $20,000,000 $30,000,000
Total Sales $2,000,000 $18,000,000 $39,000,000 $45,000,000 $80,000,000
We believe that our numbers are extremely conservative as one major reference laboratory that we
know of buys 20 million urine tubes and 230 million blood tubes annually.
Note: Our projections do not include the bioploymer
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11. ◦ The potential customers are both domestic and foreign.
Domestic customers include managed care groups, hospital
buying groups, physician groups, independents,
catalogues, reference laboratories and medical supply
houses. Managed care groups dominate the market. These
groups make more that 50% of all purchases of medical
devices. The foreign market includes many of the above
segments but also include key distributors. For example,
distributors are required to penetrate the European, Middle
Eastern, African, Central and South American and Japanese
markets. These distributors are being identified.
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12. Worldwide Exclusive license
Immediate applications as no FDA approvals
required for biopolymer and some urine
applications.
Captured interests of the two largest clinical
laboratories in the country
Enormous upside potential as product has several
applications
Advisory Board with 70 years of experience in the
commercialization of medical technologies
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13. Biopolymer – No FDA approvals required for research applications.
Urine preservative - According to the FDA, no 510K approvals are
required for routine uA’s or 24hr urines. However, 510K approvals
are required for urine cultures. (We have gotten mixed messages on
this and are currently waiting to hear back from the FDA)
Blood tubes – Anything having to do with blood tubes will require
510K approval.
As there are similar products already on the market, the approval
process is about 90 days after you submit your package to the FDA.
This is considered a “me too type” application according to the FDA.
I am figuring 6 months tops from start to finish.
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14. NASA Preservative
◦ Currently patients who are required to provide a 24 hour void of urine are required to
take home a container that contains the toxic hydrochloric acid and/or boric acid.
This is a liability issue for the laboratories and is of great concern. Our product
would alleviate that concern.
◦ The product could also be used to reduce the cost of shipping as current samples
have to be rushed to a laboratory. The use of our product would allow for more
affordable shipping methods which could literally save millions of dollars.
◦ Samples that are inadvertently left on the shelf for prolonged periods of time have to
be discarded. Those samples could still be used if preserved with our product saving
time and money as no retesting would be required.
◦ Additionally, our product allows samples to be stored on the shelf, freeing up space
in the refrigerator for other applications.
◦ Some blood samples (chemistries and hormones) are required to be kept frozen. Our
customers have identified this as a huge problem and our product would alleviate
that requirement. We believe that this will be very disruptive to the industry.
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15. Biopolymer
◦ Various methods for the preservation of biological specimens have evolved over the years. Modern
specimen preparation techniques for microbiology and electron microscopy typically include
dehydration and immobilization, both of which are irreversible and often damage the integrity of
the specimen.
◦ Dehydration using chemicals or freezing temperatures typically causes structural damage to
biological tissues. Chemicals may destroy the overall quality of the specimen, including the
particular characteristics of interest to the scientist. Rapid freeze-drying often produces crystalline
structures that are destructive to most biological tissues. The result of dehydration is a biological
sample that has been significantly altered, beyond repair, from its natural state.
◦ Immobilization of a biological sample within a polymer typically involves curing, using elevated
temperatures or ultraviolet radiation, both of which are detrimental to specimen quality. The
polymers are resins typically used for sample preparation today form a hard plastic when cured.
Once a sample has been cured, the biological material cannot be restored to its isolated state.
◦ Biological specimen preservation techniques are of particular concern in the preparation of
biosensors. Biosensors are used in the health and environmental sciences for rapid detection of
specific substances. Biosensors are currently used to detect the presence of pesticides, herbicides,
and other compounds; to detect the presence of organic compounds such as alcohols, ammonia,
and metals; and, to detect the presence of specific bacteria including algae, fungi, and pathogenic
organisms such as Escherichia coli (E. coli) and Salmonella. Potential applications for biosensors
include sensing pollution and microbial contamination of air and water, clinical diagnosis of
medical conditions, fermentation analysis and control, monitoring and analysis of industrial gases
and liquids, monitoring of mining conditions and sensing toxic gases.
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16. Biopolymer
◦ Biosensors often have a very short shelf life because the antibody or other biological receptor
degrades rapidly when exposed to the environment. Like other biological samples, biological
receptors need isolation and protection from the environment until ready for use. In field
applications especially, a variety of biological receptors may be needed at any time, depending on
the conditions.
◦ There is an unsatisfied need in the art for biological samples that can be protected and preserved
without the altering or destroying the biological tissue. The demand for safe transport and
prolonged storage of biological samples today requires preservation techniques that maintain the
integrity and quality of the biological sample. Sensitive biological receptors used in biosensors
need to be isolated from the environment, without damaging the receptor, until ready for use.
None of the specimen preparation techniques in the art currently meet these needs.
◦ There is also a need in the art for biological samples that can be restored to their isolated or
prepared state after immobilization, with minimal damage, for later study or use. The current
techniques of dehydration and immobilization are irreversible and destroy sample viability.
Restoration is particularly critical for the biological receptors in biosensors, which are especially
sensitive. There is a need, therefore, for a preservation technique that is both harmless and
reversible.
◦ The above and other needs are met by the present invention which, stated generally, provides a
method of using Acacia gum to isolate and preserve biological material without damage to the
specimen. The present invention further provides reversible techniques for using Acacia gum that
maintains the integrity and viability of biological specimens, even after prolonged storage at room
temperature.
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17. Randall Fitzgerald will serve as CEO and offers a
unique blend and extensive breath of experience
relative to this venture. Randall has served in the
U.S. Air Force/Georgia National Guard for 22
years and also spearheaded a $2.5 million dollar
joint venture that opened a family entertainment
center where he served a Co-owner/General
Manager. He has already begun to form a
working relationship with Quest Diagnostics,
NASA, Emory University, Georgia Center of
Innovation for Life Sciences, Validation
Laboratories and Biosure.
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18. Carl Fitzgerald will serve as Vice-President of Corporate
Development. He is the current Chairman and CEO of
Spotlite Enterprises, Inc. and holds several board seats on
multinational companies. He brings a strong
concentration in finance, marketing and global
development. Additionally, he is also the Ambassador
Designee for Liberia.
Deborah Mcneil will serve as CFO. She is experienced in
international investments, management and financial
advisory. She has provided her expertise in the areas of
the private sector finance, project development,
environmental studies, economic studies, project planning
and funding, policy writing/implementation and
evaluation, feasibility studies, and financial consulting to
several start-up companies worldwide.
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19. Organizational Structure
◦ The importance of having those skilled in the art as a
part of our team is well-known. An experienced V.P. of
Sales and Marketing is currently being sought. The
desired profile is for someone experienced in the
medical marketing/distribution arena, ideally someone
who was a part of a previous start-up venture that grew
to exceed a minimum $20 million in sales. It is also
imperative for us to add a clinical scientist to our staff as
soon as funding will allow. Some of our tasks can also
be handled by outside consultants in the early going.
Additionally, the management team will also include an
advisory board which is currently being assembled. The
Board of Directors is currently open.
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20. Marc G. Rioult, PhD, MBA, MS - Experience in business development and
technology commercialization, including strategic planning, valuation, deal
structuring, and negotiations. Skilled in competitive environment analysis,
marketing, and sales channel management. Over ten years experience
working as a consultant with organizations ranging from start-ups to
Fortune 500 corporations in the U.S. and overseas. Fifteen years experience
in academic research or with government or corporate research labs in the
U.S. and in Europe. He was formerly a commercialization specialist at MIT.
Donald Rhodes, Area Director, The University of Georgia Small Business
Development Center
B.A. in Economics, Mercer University
M.S.A. in Management, Georgia College and State University
ED.S. in Educational Leadership, The University of Georgia Area Director in
Macon
Mr. Rhodes has an extensive background in operations, customer service,
and accounting. He acquired comprehensive experience in management and
business operations with two heating and air conditioning contracting firms.
Prior to joining the Small Business Development Center, he was employed by
Barge Management Services as their service manager. His areas of interest
include sales, service, and family-owned businesses.
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21. Dean P. Remy, MT (ASCP, NCA)
President & CEO SCiSOURCE, Inc. and LLC and Cofounder Nexur LLC
A Life Sciences commercialization professional with 20+ years dedicated to
this industry. Dean Remy has held numerous positions in Sales, Sales
Management, Business Development, Marketing, and Product Management in
both the Life Science and Clinical Diagnostics marketplace for 2 decades. He
has worked with companies ranging from Start-Up conceptual to worldwide
global leaders with hundreds of thousands of products to support.
John Maclennan, Ph.D., MBA
Dr. Maclennan has had an extensive career in separations technologies and
their application to the biological, pharmaceutical and diagnostic markets.
He has 30 years of experience in separations companies such as
Waters, where he had marketing and product management responsibility for
the consumables product lines, as well as companies, such as Dyax where he
was responsible for marketing and selling the company’s affinity
chromatography business to companies manufacturing biopharmaceuticals.
Subsequent to this, Dr. Maclennan has had a variety of sales roles into the
drug discovery, development, biomanufacturing, and the clinical & molecular
diagnostics segments.
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22. Steven Munevar, Ph.D., M.B.A.
President & CEO
Munevar & Associates, Inc.
Summary:
Focused on bridging innovations and discoveries from the
research bench to patient bedside through technology
development and commercialization by providing multidisciplinary
experience and expertise in biomedical science, bio-engineering
and business management
Background:
Ph.D. - Biomedical scientist with an emphasis on cellular and
molecular physiology and cell biology
M.B.A. - Business management with a focus on new venture
creation and commercialization
B.S. - Bioengineer with emphasis on biomedical devices and
biomimetic materials
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23. Winston Patrick Kuo, D.D.S., D.M.Sc.
Director, Harvard Catalyst - LITT, Harvard Medical School
Instructor, Department of Developmental Biology, Harvard School
of Dental Medicine
Munevar & Associates, Inc.
Dr. Kuo is currently a Biomedical Informatics Research Fellow in
several labs throughout Harvard Medical School: Decision
System’s Group at the Brigham and Women’s Hospital
(www.dsg.harvard.edu), Children’s Hospital Informatics Program
(www.chip.org), and the Department of Genetics
(http://genetics.med.harvard.edu/~cepko/). His research is
divided into technical and biological aspects in Genomics and
Bioinformatics (Computational Biology). He is currently evaluating
commercial and academic high-throughput technologies that
measure gene expression profiles, in terms of their accuracy,
comparability, sensitivity, specificity, and reproducibility that will
benefit the biomedical research community as this technology
becomes universally accepted.
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24. Advanced Preservation Technologies, LLC. will issue an unsecured convertible
note in increments of ____________________dollars to raise $300,000 in
funding to further develop the product.
For an investment of $________________ , Advanced Preservation
Technologies, LLC. will execute an unsecured convertible promissory note in
your favor. The principal plus 10% interest will be payable when financing is
obtained. You will have the option to convert the principal of
$_______________________ into equity in Advanced Preservation Technologies,
LLC. At the Company’s discretion, the Company may accept investments in
the Notes in an aggregate amount of more or less than the initially
anticipated amount of $300,000 unsecured which will be convert to Stock at
a rate equivalent to the per share price at which shares of the Stock are sold
in the Qualified Financing multiplied by 0.80 to compensate for the degree of
risk associated with the start up. None of the above may be realized if
financing is not secured. The funds will be at risks and investment is suitable
only for persons with the financial capability to make and hold long-term
investments not readily converted into cash. Investors must, therefore, have
adequate means of providing for their current and future needs and personal
contingencies. The funds will be used as described in the “Use of Proceeds
for startup capital”.
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25. Secure biopolymer and negotiate a sales and distribution agreement with supply house.
Modify, test and launch urine preservative
◦ Engage Dr. Gaul/Emory University to assist with achieving 6 days of preservation of
urine.
◦ Immediately market product for 24hr voids
◦ Determine other applications for urine i.e. Bard bags
Test blood, plasma and serum applications and publish data.
◦ Determine best methods of commercialization and marketing
Schedule
Secure Test blood,
agreement on Launch blood
plasma and tubes and urine Evaluate other
bio-ploymer. serum. tubes uses for products
Launch Outsource tubes, 3Q13 3Q13
bioploymer. get 510k
Complete approvals
modification of 1Q13
preservative
1Q13
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26. We believe we have a dynamic product with huge
potential. The beauty of our product is that:
No FDA approvals are required for research
applications. Therefore product has immediate
applications.
The In-Vitro Diagnostic market is enormous and
we have acquired worldwide exclusive rights to
product.
Captive audience of the two largest clinical
laboratories in the country awaiting our product.
We also have the bio-polymer serving as a safety
net for our investors.
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