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Initial Report
Human BioSystems
Rating: Speculative • Human BioSystems is targeting the multi-billion dollar market opportunities for the
OTCBB: HBSC preservation of human blood platelets and organs for transplantation. The company
has seen good successes thus far with its patented, proprietary technologies and is
currently moving toward additional trials.
• Over the past few decades there have been few advances in the technology for blood
Joseph Noel
platelet storage. Each year, platelets worth hundreds of millions of dollars are
jnoel@emerginggrow.com discarded after the maximum shelf life is reached. The company’s proprietary
Emerging Growth Research technologies offer a way to increase the shelf life, potentially saving significant sums
San Francisco, California for the worldwide healthcare industry.
925.922-2560
• The recent failure of a major study targeted at increasing the shelf life of blood
platelets has focused additional attention on this issue and has shown the healthcare
industry the significant cost savings that can be gained by even moderate increases in
platelet shelf life.
• Organ transplant rates are on the rise as are the recipient waiting lists. The need for
kidneys is especially severe. Organs also have a very limited window of viability and
the healthcare industry is actively seeking way to improve shelf life in order to reduce
Analyst Certification
deaths of those on the waiting lists and to reduce costs. The company’s technologies
I, Joseph Noel, hereby
certify (1) that the views show strong promise relative to these areas.
expressed in this research
company report accurately ♦ While highly speculative, shares of Human BioSystems are likely to see significant
reflect my personal views price appreciation as trials are successfully completed and as the company moves
about any or all of the
toward FDA and other government approvals.
subject securities or issues
reflected in this company
report, and (2) no part of my
compensation was, is, or Market Data Financial Summary
will be directly or indirectly
related to specific Market Cap (MM) $1.3 Revenue FY 09E (MM) Pre-
recommendations or views Shares Outstanding (MM) 136 Revenue
expressed in this company Float 121 Cash end of Last Quarter (MM) Nil
report. Dividend Yield n/a Total Assets (MM) Nil
52-Week Range $0.01-$0.14 Long-Term Debt (MM) None
Shareholders Equity (MM) Negative
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HUMAN BIOSYSTEMS
HUMAN BIOSYSTEMS
H
U Executive Summary savings that were available if only a two day extension in platelet life
could be achieved.
The company is concentrating on two main markets. The first, and the most
important relative to near-term business prospects, is a technology that extends
the shelf life of blood platelets. Platelets, which are also known by their
formal name of thrombocytes, are the cells circulating in the blood that are
primarily involved in the mechanics of forming blood clots, but also perform
other functions. A variety of medical conditions can result in a low platelet
count, a condition which physicians call thrombocytopenia. When such a
condition exists normal clotting of blood is not possible, which could lead to
severe blood loss upon injury or other trauma. Platelets, while vital to the
function of blood clotting, are also important because they potentially
modulate the inflammatory process by interacting with other types of blood
cells and additionally provide some other more minor functions. Please see
Figure 1 for a photo of thrombocytes, (human platelets), leukocytes (white
blood cells), and RBCs (Red Blood Corpuscles).
Figure One Human Blood Cells (left, platelets; top white blood cell; bottom right red blood cell)
Source: American Medical Association
While some of the blood collected during the donation process is preserved in
its whole form in order to be used for direct transfusion into other people, a
large percentage of this blood is processed via a centrifuge, which breaks the
blood down into its individual components, such as, red blood cells, plasma,
and platelets. These separate components can then be used to benefit many
different patients with a variety of different diseases or conditions.
Please see Figure One, which shows the breakdown of the components of
whole blood.
Figure Two Main Components of Human Blood Source: Adams Labs, Inc.
Whole blood and its individual components have limited shelf life and must be
used within a specific amount of time in order to ensure patient safety.
Typically, blood platelets used for transfusion are used within a few days of
donation with five days being the traditionally accepted maximum before the
platelets must be discarded. Because of this limited shelf life, blood
processing and platelet replacement is mainly a local business with transfusion
and processing of blood product usually occurring in the same general
geographic area where the recipient patient is located. Having many local
blood processing centers is very expensive for the healthcare industry and for
many years there has been extensive research into methodologies to improve
the shelf life of blood and blood related products in order to reduce these costs
and to provide better patient care.
The issue of the shelf life of blood, blood products and platelets is more than
simply a cost issue, but also one of saving human life. During periods of mass
casualties from events natural disasters, such as the recent earthquakes in
China and the tsunamis in southern Asia and during times of war, there are
often severe shortages of blood and blood products. The implementation of
technologies that would allow for long-term storage of these products to be
used during times of peak demand would have a significant positive impact on
survivability rates and reduce suffering.
For the past few decades the normal method to preserve blood platelets for
later donation has been to store the platelets in blood plasma. This method of
preservation has seen little advancement over the past 30 years. Up until very
recently, within the United States, after approximately 5 days, which is the
shelf life mandated in 1986 by the Food and Drug Administration (FDA),
blood banks, hospitals and clinics simply discard the materials. Typically,
within the European Union and Japan a timeframe of fewer than five days is
very strictly enforced.
Because of this very short three-day window for usage of blood platelets, it is
estimated that industry-wide approximately 15% to 25% of all processed blood
platelets are ultimately discarded, costing the healthcare industry throughout
the United States, Europe, and Japan well over $1 billion per year. While no
accurate estimates currently exist, it is likely the worldwide figure could be
close to $2 billion per year, or higher.
For many years there has been a desire to increase the shelf life of platelets
beyond the FDA's mandated five day standard and beyond the even shorter
periods generally enforced throughout the European Union and Japan. While
technologies to extend platelet life beyond 14 days are still thought to be well
off into the future, it is becoming increasingly clear that technologies to extend
the shelf life to 10 to 14 days are extremely viable and will likely be coming to
the market over the next few years.
The ability for hospitals, clinics and blood banks to even moderately extend
the life beyond the five day US FDA mandated platelet shelf life would yield
significant cost savings for the industry and a huge opportunity for the
company or individuals that would be able to supply such technology to the
industry.
In 2007 the US FDA approved a longer storage of seven days for certain types
of blood platelets products in very specific cases under a study called
PASSPORT, which stands for Post Approval Surveillance Study of Platelet
Outcomes, Release Tested. The seven day storage required 100% bacterial
screening and participation in a surveillance study to help evaluate the effects
of the longer holding. Only certain laboratories, hospitals and clinics were
eligible for participation in the three-year study. Under the program donated
products were held only for 24 hours to allow any bacteria that may be present
to reach detectable levels, which effectively provided for a five to six-day long
period of effective usage of the platelets.
The study was voluntarily terminated in early 2008 by the two companies that
conducted the study due to concerns of patient safety. Early interim analysis
of the PASSPORT study, along with the review of other studies, determined
that up to 50% of the bacterial contaminated platelets may escape detection
using the shorter 24-hour holding period. Upon termination of the program all
participants in the study were advised to revert to the normal procedures,
including resumption of the five-day maximum holding.
With the blood industry suffering a major setback relative to the PASSPORT
study it has become increasingly clear among most within the industry that a
reduction in the 48 hour holding period for blood is not a viable solution to
extending the period for which platelets can be viably transfused into patients.
As a result, many within the industry believe the alternative will be to find
technologies that will significantly the timeframe for viability of the platlelets.
Even though the PASSPORT study was a failure, in our opinion, there was
clearly a positive outcome in some regards. Those hospitals and clinics that
had participated in the study were able to demonstrate the significant cost
savings available to them as a result of only a two-day increase in the standard
platelet holding period. We believe the desire for the industry to renew these
cost savings is significant and will likely make it easier for companies with
technologies to extend the life of blood platelets to be taken seriously in the
future.
Currently, within the United States alone there are more than 100,000 men,
women and children waiting for organ transplantation. Approximately 75% of
these people are waiting for a kidney transplant. Generally speaking a person
with malfunctioning kidneys can be kept alive for a considerable amount of
time due to advances in dialysis treatments. Therefore, it is quite common for
such people to remain on the waiting list for an extended period of time. The
growing diabetes epidemics in North America and within the European Union
are making kidney failure much more prevalent leading to an even greater
demand for donating kidneys. The waiting list for donated livers is the next
longest with more than 15,000 patients in the U.S. currently on the list,
followed by more than 2500 patients waiting for hearts, approximately 2,000
patients waiting for a lung and around 1500 patients waiting for a pancreas.
The struggle for these people to continue their lives depends on a complex and
technologically advanced organ transplant allocation system that links patients
with organs donated by strangers. Please see Figures Three and Four, which
shows how the waiting list has grown significantly over the past few years and
the number of organ transplants versus the waiting list.
Figure Four Transplants Performed Versus the Waiting List Source: Lifesharers
During the 1980s, the United States federal government passed the national
organ transplant act, which established the organ procurement and transplant
network, a national organ sharing system to guarantee the fairness in the
allocation of organs for transplant. Under the act, the Department of Health
and Human Services was authorized to contract for services to ensure fairness
in the organ allocation process. Since 1984 a nonprofit organization called the
United Network for Organ Sharing has served this function for the United
States by maintaining a centralized computer database with all the names of
the patients waiting for a kidney, heart, liver, lung, intestine, pancreas, and
multiple organ transplantation. These actions have significantly increased the
level of fairness in organ allocation, by setting up a complex set of waiting list
rules based on medical urgency, blood, tissue and size match with the donor,
among other criteria.
Within the United States and Western Europe there has also been a concerted
effort by government and private entities to increase organ donation. From the
period of 2002 to 2006 alone, the total rate of organ donations was up over
30%. During 2006, the most recent year for which statistics are available, a
total of approximately 29,000 organ transplant operations occurred within the
United States with nearly 80% of the donated organs coming from deceased
donors and approximately 20% coming from living donors. Several recent
studies, including a recent study conducted by the Gallup Organization,
indicate that Americans continue to strongly support the donation of organs
and tissues for transplantation. This clearly shows that there is a significant
trend for an increasing number of Americans to take personal actions to
become personal organ donors.
Even though there has been significant efforts on the part of both government
and private organizations to ensure fairness in the organ transplantation
process and to increase the pool of available organs for transplantation, severe
shortages still exist. Each year, according to the US Health Resources and
Services Administration, more than 6,000 to 7,000 people die each year within
the United States waiting for a replacement organ that never arrives. Please
see Figure Five for additional information relative to these statistics.
Figure Five Death While Waiting for Organ Transplantation (2006-most recently available data)
Source: LifeSharers
There are several reasons why so many people die each year waiting for organ
transplants. First, is a severe shortage of donated organs. While the rates of
organ donation have increased significantly over the past few years, the pool
of available organs is still relatively small compared to the actual demand. In
order for organ to be useful for transplantation the donor must die in a very
specific manner - usually referred to as brain death where the majority of the
organs continued to function normally until the donor is taken off life support
systems. Such death accounts for less than 1% of all deaths each year,
resulting in only a small pool of available organs for donation. Within the
United States, Canada and the European Union approximately 60% of those
who die in this manner have either previously personally consented to organ
donation or their families consent upon the person’s death.
An additional reason that many people die waiting for organ transplantation is
simply the logistics of transporting the organs from the location where they are
harvested to the location where they can be transplanted. During the donation
surgery and just prior to the removal of the donated organ, ice cold
preservation solutions are flushed into the organ, which starts the process of
preservation. When the organ is removed from the donor's body it is packed in
several layers of sterile containers and cooled with an icy slush mixture, which
significantly cools the organ but does not actually cause freezing. The
solutions that are currently used mimic the fluid contained within the cells of
the organ itself. While the science relative to how the solution actually works
is not yet proven, it is thought to reduce the amount of damage and limit the
swelling of the organ that would otherwise occur. There have been very few
advances in such procedures over the past few years, with the exception of the
preservation of kidneys. Occasionally, donated kidneys are placed on a special
machine that continuously pumps the preservation solution through the organ.
This procedure is still relatively uncommon, however.
Please see Figure Six for additional information relative to this issue.
Figure Six Human Organ Transport and Storage Times Source: The Scientific Registry
The company's initial product emphasis is on a technology that will allow for
the extension from the five-day period for platelet utilization to seven to ten
days. The company's platelet preservation system utilizes a proprietary
process to store platelets in a solution under refrigeration. The process
maintains cell functionality for an extended period of time. Typically,
platelets are highly sensitive to temperature variations and have not been able
to tolerate refrigeration.
In mid 2001 the company filed a provisional patent to cover this improved
platelet preservation methodology and in July of 2002 received his first patent
on the technology and methodologies. In August of 2003, the company filed
an additional patent application covering a more sophisticated platelet
preservation methodology and this patent was approved in May of 2006.
Since this time the company has developed additional technologies, which it
plans on patenting in the near future.
While the company believes that even longer (beyond seven days) storage of
platelets is possible utilizing hydrostatic pressure technology to prevent the
platelets from freezing under sub zero temperatures, the management team
believes that a significant enough market opportunity exists for the currently
The company has seen good results in the testing that has been conducted thus
far. Using the company's proprietary solution and protocol for storage and
testing, the company has indicated that after 24 hours of refrigeration up to
68% of platelets maintained their original disk shaped with up to 13% of
platelets remaining viable after five days of storage. Subsequent tests
demonstrated that up to 78% of platelets stored under refrigeration for a full 10
days survived with 20% maintaining full functionality. Because platelets are
very susceptible to extremes and temperature - either hot or cold - these results
are viewed by most in the blood industry as being highly significant.
The company began research on kidney preservation in 2002 and has since
developed a solution that may allow for preservation for well over 30 hours,
which is well beyond the normal storage and transport period. A major
emphasis at the company will be to target the market for kidney storage, as this
is the most popular transplant surgery in the Western world with a significant
number of individuals on the waiting list. The company's goal is to extend the
shelf life for donated human kidneys for up to 72 to 96 hours at above freezing
temperatures, which will allow the industry to perform vastly superior donor-
recipient matching likely yielding significantly less organ rejection.
The company has conducted studies on rats where they have successfully
transplanted a rat kidney that had been frozen at a temperature of -80°C for a
period of three months using the company's subzero solution. At the end of
2005 the company successfully completed its initial phase of the survivability
study in small animals and will now likely turn its attention to additional
studies using larger animal species, before applying for FDA clearance to
conduct human trials.
Management
Harry Masuda
Former president and Founder of high tech companies Piiceon, Inc. and HK
Microwave. He successfully negotiated acquisitions for both companies.
David Winter, MD
President (74)
Paul Okimoto
ADVISORY BOARD
Jose A. Venzor
Bryan Flaherty
Competition
There are quite a few significantly sized corporations involved in areas related
While it is apparent that the disposal of old blood platelets costs the healthcare
industry hundreds of millions of dollars per year, it is a cost that has been built
into the overall cost structure for many years. Just because a company is able
to demonstrate that it is able to save an industry money is not a guarantee that
the money-saving products will be implemented. The healthcare industry is
often slow moving and Human BioSystems could complete development of its
technology and still face significant lead times for implementation.
Government Regulation
This company will need FDA and/or other government approvals to market its
products to hospitals, blood banks and clinics. The approval process is often
lengthy and outcomes are uncertain.
The company still has development work to complete and will need to undergo
a potentially lengthy process of receiving FDA and other government
approvals before its products can be marketed to the industry. We believe it is
likely the company will need to raise additional capital in order to complete
the product development and approval processes.
Competition
The market for blood platelet preservation is a significant one and one that is
likely to attract a great deal of competition. Several other companies are
currently working on technologies for this purpose and there can be no
assurance that Human BioSystems will emerge as an industry leader. Our
initial research into the industry, however, does indicate that the company's
products have significant potential. With the proper direction and capital we
believe the company could develop an early industry-leading position.
We believe a very viable market exists for technologies that will allow
hospitals, clinics, and blood banks to even marginally extend the life of
platelets to be used in transfusions. The recent implementation and subsequent
failure of the PASSPORT study, which allowed for a very modest two day
increase (from five days to seven days) was a highly significant event for the
blood industry within the United States. The fact that the US FDA approved
the study, in our opinion, showed that there is a significant need to address the
issue of limited shelf life of donated platelets. Additionally, those healthcare
facilities that participated in the study were able to demonstrate significant cost
savings as a result of only a two day increase in allowable platelet shelf life.
We believe the industry's experience with the PASSPORT study has shed
additional light on the issue of platelet storage and will likely make it easier for
new technologies to be trialed and ultimately implemented by the industry.
We see clear evidence that the market for viable technologies in this area are
easily worth hundreds of millions of dollars in the US alone in likely two or
three times this amount on a worldwide basis.
We believe the market for organ preservation is also viable with the market for
kidney preservation being significantly larger than probably all of the other
markets combined. The rate of kidney disease continues to increase in the
United States, Western Europe and Japan partially as a result of the growing
diabetes epidemic being experienced in these areas. As a result of these factors
and due to the aging demographics of the Western world, all of the organ
donation related agencies and foundations are forecasting rising rates of kidney
transplantation over the coming years. Kidney transplantation continues to be
a localized industry due to the limitations of survivability of the organ after
harvest. Technologies that are able to extend this survivability by even a
marginal amount are likely to be highly desirable to the healthcare industry.
One of the factors that we believe is exciting relative to this developing market
opportunity, and to Human BioSystems in particular, is that even modest
increases in this survivability of both platelets and human organs are likely to
yield significant dividends both in terms of human survivability and in cost
savings to the healthcare industry.
While it still appears that long-term storage of human blood, blood products
and organs is still many years, or perhaps decades away, it appears that long
awaited advancements in short-term storage technologies are on the immediate
horizon. We believe companies that are able to capitalize on this opportunity
stand to make considerable sums of money over the coming years.
Analyst Certification - I, Joseph Noel, hereby certify (1) that the views expressed in this research company report accurately
reflect my personal views about any or all of the subject securities or issuers referred to in this company report and (2) no part
of my compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed in this
company report.
Analyst:
Joseph Noel is a 29-year veteran of small cap technology and healthcare investment industries. Joe was recently a senior
analyst at Pacific Growth Equities, LLC, where he tracked small cap stocks and the advanced industrial sector. Prior to Pacific
Growth, he covered both the telecommunications equipment and services industries at Hambrecht & Quist and was employed
by Gartner/Dataquest as a communications industry analyst. Before becoming an analyst, Mr. Noel received solid industry
experience at a number of telecommunications carriers, including MCI, where he was responsible for the frame relay product
marketing launch; and British Telecom, where he was involved in strategic planning for the company’s Internet access
service. He was also employed by various Bell Operating Companies in both marketing and technical roles for nearly ten
years. Mr. Noel received his MBA in finance from Wake Forest University, and holds a BS in business and economics. A
four-time Wall Street Journal All-Star Analyst, Joe specializes in emerging growth companies in the communications, Internet
and advanced industrial equipment sectors.
The coverage analyst uses a relative rating system in which stocks are rated as; BUY or SPECUATIVE, SELL, or HOLD.
Stock Ratings:
BUY or SPECULATIVE - the stock is expected to outperform the unweighted expected total return of the sector over a 12-
month investment horizon.
SELL - the stock is expected to underperform the unweighted expected total return of the sector over a-12 month time horizon
HOLD - the stock is expected to perform in line with the unweighted expected total return of the sector over a 12-month
investment horizon.
______________________________________________________________________________________________________________________________
Information, opinions, or recommendations contained in this research report are submitted solely for informational purposes. The information used in statements of fact made has been obtained from sources
considered reliable, but we neither guarantee nor represent their completeness or accuracy. Such information and the opinions expressed are subject to change without notice. This research report is not intended
as an offering or a solicitation of any offer to buy or sell the securities mentioned or discussed. The firm, its principles, or the assigned analyst may or may not own or trade shares, options, or warrants of this
covered company. Emerging Growth Research, LLP, has received, or will receive, monetary compensation for the production of this report and other related services. Additionally, the analyst responsible for
the production of this report may common stock and/or warrants in the subject company. The views expressed in this research company report accurately reflect the analyst’s personal views about any or all of
the subject securities or issuers referred to in this company report, and no part of the analyst’s or the firm’s compensation was, or will be directly or indirectly related to the specific recommendation or views
expressed in this report. Opinions expressed herein reflect the opinion of Emerging Growth Research, LLP and are subject to change without notice. We claim no responsibility to update the information
contained in this report. Investors should consider the suitability of any particular investment based on their ability to accept certain levels of risk, and should not rely solely on this report for information
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without the written permission of Emerging Growth Research, LLP.
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