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CBAI AT A GLANCE

 

 

 

 

 

 

Cord Blood America's product is similar to an insurance policy, providing strong peace of mind. The company preserves and stores umbilical cord blood of infants at birth specifically for the donating family. Besides current uses, medical research is ongoing on how to use these cells to combat heart disease, Parkinson's disease, spinal cord injuries, sickle cell anemia, cancer and other difficult diseases to treat. Researchers postulate that the cells they remove from the umbilical cord blood can someday be turned into every single tissue in the body, making, for instance, the repair of a damaged heart possible, or facilitating recovery from a stroke by turning stem cells into brain cells.^[1]

Business Overview

Cord Blood America, Inc. (OTCBB: CBAI), through its subsidiaries, provides private cord blood stem cell preservation services to families in the Untied States. The company also engages in the collection, testing, processing, and preservation of peripheral blood and adipose tissue stem cells, which allows individuals to privately preserve their stem cells for potential future use in stem cell therapy. In addition, it engages in the collection, transportation, testing, and preservation of umbilical cord blood. The company was founded in 2003 and is headquartered in Santa Monica, California.^[2].

CBAI and its subsidiaries engage in the following business activities:

• Cord specializes in providing private cord blood stem cell preservation services to families.
• BodyCells is a developmental stage company and intends to be in the business of collecting, processing and preserving peripheral blood and adipose tissue stem cells allowing individuals to privately preserve their stem cells for potential future use in stem cell therapy.
• Rain specializes in creating direct response television and radio advertising campaigns, including media placement and commercial production.

Business Segments

Cord

The umbilical cord blood stem cell preservation operations provide umbilical cord blood banking services to expectant parents throughout all 50 United States. The company's corporate headquarters are located in Los Angeles, CA. Cord also maintains offices in Philadelphia, Pennsylvania. Cord earns revenue through a one-time enrollment and processing fee, and through an annually recurring storage and maintenance fee. Cord blood testing, processing, and storage is conducted by its outsourced laboratory partner, formerly Bergen Community Regional Blood Services, located in Paramus, New Jersey. On August 1, 2007, CBAI entered into an agreement with Progenitor Cell Therapy, LLC, (PCT) for testing, processing and storage of cord blood samples. The Company believes this transition from Bergen to PCT will provide additional leverage to operating costs and efficiencies while maintaining the highest of quality standards. Cord provides the following services to each customer. In addition, some storage services are provided by ThermoFisher of Rockville, Maryland.

• Collection Materials. Cord provides a medical kit that contains all of the materials necessary for collecting the newborn’s umbilical cord blood at birth and packaging the unit for transportation. The kit also provides for collecting a maternal blood sample for later testing.

• Physician And Customer Support. Cord provide 24-hour consulting services to customers as well as to physicians and labor and delivery personnel, providing any instruction necessary for the successful collection, packaging, and transportation of the cord blood & maternal blood samples.

• Transportation. Cord coordinate the transportation of the cord blood unit to its laboratory partner, Progenitor Cell Therapies, immediately following birth. This process utilizes a private medical courier, Airnet, for maximum efficiency and security.

Contents 1 Business Overview 2 Business Segments 2.1 Cord 2.2 Rain 2.3 BodyCells 3 Key Trends and Forces 3.1 Positive Stem Cell Findings Increases Investment Dollars 3.2 Advances in Stem Cell Research 3.3 Acceptance of Umbilical Cord Blood Banking 4 About Umbilical Cord Blood 4.1 Harvesting Umbilical Cord Blood 4.2 Difference Between Cord Blood Banking and Stem Cell Research on Human Embroys 4.3 Controversy 5 Competition 6 Business Financials 7 References

• Comprehensive Testing. At the laboratory, the cord blood sample is tested for stem cell concentration levels, bacteria and blood type. The maternal blood sample is tested for infectious diseases. Cord reports these results to the newborn’s mother.

• Cord Blood Preservation. After processing and testing, the cord blood unit is cryogenically frozen in a controlled manner and stored in liquid nitrogen for potential future use. Data indicates that cord blood retains viability and function for at least fifteen years when stored in this manner and theoretically could be maintained at least as long as the normal life span of an individual.

Rain

Rain provides advertising and direct marketing customers a range of services including:

• the placement of advertising in television, radio, on-hold and motor sports outlets;
• the production of advertising content, including television commercials and radio copy, which is outsourced to third party production companies; and
• advertising and marketing consulting services which can include assistance in not only developing an advertising program, but helping the client to develop the particular product or service, determine the appropriate market and design and implement an overall marketing program and strategy.

A majority of Rain's revenues are earned via direct response media buys and per inquiry campaigns. For direct response, Rain currently buys television and radio schedules for clients on a national and local level. It's national television outlets include Directv, DISH Network, Comcast Digital, national cable networks and various local cable interconnects. Rain buys time with numerous national radio networks including Premiere Radio, Clear Channel, Westwood One and Jones Radio Network, along with a variety of local radio stations. For per inquiry advertising, Rain focuses on national campaigns. The placements are made using the company's internal media buyers and other agencies with which management has formed strategic marketing alliances. Rain also generates revenues through the commercial production aspect of its business using production partners in Florida and California. Rain's on-hold advertising is placed on a client’s telephone system. Production is outsourced to AudioMenu of Fort Lauderdale, FL. Motor sports sponsorship is placed on vehicles in various motor sports circuits. Most advertising has been placed with BAM Racing, LLC. In January of 2008 Rain entered in a non-exclusive agreement with BAM Racing, LLC. The agreement compensates for sales of sponsorship of NASCAR Sprint Cup Team #49.^[3]

In December, 2007, Rain made a significant shift in its business development strategy. Rain’s revenues prior to 2008 were largely reliant on a few customers. Rain decided that a business model with smaller contracts and a larger volume of customers would better serve the marketplace and steady the large swings in revenues for the segment.^[4]

BodyCells

BodyCells exists to facilitate the collecting, processing and preserving of peripheral blood and adipose tissue stem cells allowing individuals to privately preserve their stem cells for potential future use in stem cell therapy. The subsidiary is currently suspended pending the identification of an alternative lab to partner.^[5]

Key Trends and Forces

Positive Stem Cell Findings Increases Investment Dollars

An article in the February 27th volume of The Journal of the American Medical Association entitled, "Clinical Applications of Blood-Derived and Marrow-Derived Stem Cells for Nonmalignant Diseases" studied a broad array of clinical studies conducted between January 1997 and December 2007 and concluded that there was evidence that stem cells harvested from blood or bone marrow did appear to provide disease-ameliorating effects in certain auto- immune diseases and cardiovascular disorders. The article also highlighted that the vast majority of human stem cell trials have focused on clinical applications for hematopoietic and/or mesenchymal stem cells, both of which may be obtained from peripheral blood, bone marrow, or umbilical cord blood and placenta.^[6]

The National Institutes of Health lists more than 1,500 clinical trials currently underway in the US investigating adult stem cell use as potential breakthrough therapies for a myriad of diseases, including, cancer, diabetes, heart and vascular disease, and autoimmune disorders such as lupus, multiple sclerosis and arthritis. More than 500 of these are for autologous use, meaning the stem cells come from your own body.

Advances in Stem Cell Research

Recent advances in stem cell research - including the technique for reprogramming ordinary skin cells to behave like embryonic stem cells - could put human evolution on a pace that's much faster and wilder than we can handle, according to a pioneer in the field.^[7]

Scientists are seeking to harness the marvelous ability of embryonic stem cells to transform themselves into virtually any tissue in the body - which could lead to new treatments for maladies ranging from spinal-cord injuries to heart attacks and Parkinson's disease. Other types of cells, such as adult stem cells and umbilical-cord cells, have some of these abilities, but embryonic cells are seen as "the gold standard" for future therapies.

Observers are expecting stem cell research to surge now that President Obama has moved into the White House. Just last month, the Food and Drug Administration gave California-based Geron Corp. the go-ahead to begin the world's first medical study of a treatment based on human embryonic stem cells.

Acceptance of Umbilical Cord Blood Banking

The American Academy of Pediatrics (AAP) issued recommendations to guide clinicians on responding to questions about cord blood banking programs and cord blood transplantation for children with various disorders. Theguidelines, aiming to dispel confusing and sometimes incorrect information about public and private banking of umbilical cord blood, were published in the February 2007 issue of Pediatrics.^[8]

These recommendations, which are the first update of guidelines initially offered by the AAP in 1998, encourage parents to donate to public cord blood banks and discourage them from using private cord blood banks, unless they have an older child that could benefit from cord blood transplantation.

Because umbilical cord blood contains a rich source of hematopoietic stem and progenitor cells, it has been effective as an alternative allogeneic donor source in a variety of pediatric genetic, hematologic, immunologic, and oncologic disorders. The use of less-than-completely matched human leukocyte antigen cord blood stem cells may be less risky in terms of causing graft-vs-host disease than mismatched cells from either a related or unrelated donor, although this has not yet been substantiated. Although gene-therapy research involving modification of autologous cord blood stem cells for treatment of childhood genetic disorders remains experimental at present, it may ultimately prove to be beneficial.^[9]

About Umbilical Cord Blood

Umbilical cord blood is up to 180mL of blood from a newborn baby that is returned to the neonatal circulation if the umbilical cord is not prematurely clamped. In some obstetric and midwifery practices, physiological extended-delayed cord clamping protocol, as well as water birth, allows for the cord blood to pulse into the neonate for 5-20 minutes after delivery.

Harvesting Umbilical Cord Blood

Cord blood banking is controversial in the medical and parenting community. Blood collected this way takes up to 180mL from the neonate (sometimes up to half of the total blood volume) which is a highly controversial subject in perinatal medicine. Cord blood is rich in hematopoietic stem cells, however, The American Academy of Pediatrics 2007 Policy Statement on Cord Blood Banking[1] states that:

Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood;^[11]

New parents have the option of storing their newborn's cord blood at a private cord blood bank or donating it to a public cord blood bank. The cost of private cord blood banking is approximately $2000 for collection and approximately $125 per year for storage, as of 2007.^[12]

After the first sibling-donor cord blood transplant was performed in 1988, the National Institute of Health (NIH) awarded a grant to Dr. Pablo Rubinstein to develop the world's first cord blood program at the New York Blood Center (NYBC),^[13]in order to establish the inventory of non embryonal stem cell units necessary to provide unrelated, matched grafts for patients.

In 2005, University of Toronto researcher Peter Zandstra developed a method to increase the yield of cord blood stem cells to enable their use in treating adults as well as children.^[14]

Difference Between Cord Blood Banking and Stem Cell Research on Human Embroys

The type of stem cell most often discussed in the news is an embryonic stem cell. During fertilization, a sperm cell unites with an egg cell, and begins to reproduce by dividing into different cells. These cells begin to arrange themselves into an outer ring of cells that enclose an inner cell mass called a blastocyst. Researchers have collected these inner cells and discovered that they can be made to develop into many types of specialized cells in the body.^[15]

These cells from the inner cell mass contain embryonic stem cells, which is an accurate term because they do come from the first stages of an embryo. But once these cells are removed from the inner cell mass, they are not able to develop into an infant.

Because embryonic stem cells have such great potential, they are now being looked at by the international medical community as a possible cure for many diseases. For example, one promising use is to replace the damaged or missing nerve cells in patients with Parkinson's or Alzheimer's disease. It is important to understand the difference between embryonic stem cells and umbilical cord blood stem cells. Umbilical cord blood stem cells come from the unused blood leftover in the umbilical cord after the baby is born. They are only collected from fully developed humans.

Controversy

While there is general support in the medical community for public banking of cord blood, the question of private banking has raised objections from many governments and nonprofit organizations. The controversy centers on varying assessments of the current and future likelihood of successful uses of the stored blood. In March 2008, a paper was published by Nietfeld et al.[4] in the journal Biology of Blood and Marrow Transplantation which computed the lifetime probability (up to age 70) that an individual in the US would undergo a stem cell transplant. The likelihood of an autologous transplant using your own stem cells is 1 in 435, the likelihood of an allogeneic transplant from a matched donor (such as a sibling) is 1 in 400, and the net likelihood of any type of stem cell transplant is 1 in 217.

The National Marrow Donor Program estimates that by the year 2015, there will be 10,000 cord blood transplants world-wide per year using publicly banked cord blood. It is therefore vitally important to build public repositories of cord blood donations throughout the world. In the United States, the Health Resources and Services Administration (HRSA) of the US Dept. of Health and Human Services is responsible for funding national programs to register marrow donors and bank cord blood donations.^[16] The European Union Group on Ethics (EGE) has issued Opinion No.19 ^[17] titled Ethical Aspects of Umbilical Cord Blood Banking. The EGE concluded that "[t]he legitimacy of commercial cord blood banks for autologous use should be questioned as they sell a service, which has presently, no real use regarding therapeutic options. Thus they promise more than they can deliver. The activities of such banks raise serious ethical criticisms." However, in the final section of their Opinion, the EGE admits that: "if in the future regenerative medicine developed in such a way that using autologous stem cells became possible, then the fact to have one's own cord blood being stored at birth could increase the chance of having access to new therapies."^[18]

Competition

Company	Year Started	Laboratory	# Transplants	Blood Or MNC?	Bags Or Vials?	Accreditation	Collection Fee	Annual Storage
Cord Blood America	2003	Progenitor Cell Therapy	97	MNC	Bags	AABB / FACT	$1,800	$125
AlphaCord	Varies by Lab	Choice of 5 Labs	Varies by Lab	MNC	Bags	Varies by Lab	$775	$115
CordBancUSA	2008	Own	0	MNC	Bags	CA Biologics	$1245	$150
Cord Blood Registry	1995	Own	93	MNC	Vials/Bags	AABB	$1875	$125
Cord Blood Solutions	2005	Community Blood Services	150	MNC	Bags	AABB	$1495	$100
Cryobanks Intl.	1994	Own	14	MNC	Bags	AABB	$1749	$120
Cryo-Cell Intl.	1992	Own	16	MNC	Bags	AABB	$1595	$125
DomaniCell	2006	Progenitor Cell Therapy	92	MNC	Bags	AABB / FACT	$varies	$varies
Elie Katz	1996	Community Blood Services	150	MNC	Bags	AABB	$1350	$120
Family CB Services	1997	Own	2	MNC	Bags	AABB	$1530	$120
Family Link	2004	Own	2	Blood	Bags	AABB	$1600	$115
Genesis Bank	2005	Own	0	MNC	Bags	AABB	$1150	$100
HemaStem	2004	Community Blood Services	150	MNC	Bags	AABB	$499	$149
LifebankUSA	1998	Own	17	MNC	Bags	AABB	$1750	$115
LifeLine	2001	Own	0	MNC	Bags	AABB	$1200	$90
LifeSource	2007	Own	0	MNC	Bags	No	$unknown	$unknown
MAZE Labs	2004	NY Blood Center	0	MNC	Bags	AABB	$2010	$included
Neocells	2005	Reproductive Genetics Institute	0	MNC	Vials	No	$845	$95
Newborn Blood Banking	1997	Own	0	Blood	Bags	No	$946	$149
New England CB Bank	1995	Own	6	MNC	Bags	No	$1800	$124
RMI	2005	Community Blood Services	150	MNC	Bags	AABB	$unknown	$unknown
Safetycord	2005	Community Blood Services	150	MNC	Bags	AABB	$2100	$135
Securacell	2001	Unknown	0	MNC	Vials	No	$1495	$115
StemCyte	2004	Own	522	Blood	Bags	AABB / FACT	$1925	$125
Stork Medical	2006	Community Blood Services	150	MNC	Bags	AABB	$1700	$108
Utah Cord Bank	2007	Own	0	MNC	Vials	No	$940	$85
Viacord	1995	Own	39	MNC	Bags	AABB	$2050	$125
Vista Cord	2006	Own	0	MNC	Vials	No	$999	$99
Zytex	2008	Own	0	MNC	Bags	ISO	$1375	$100

Business Financials

On February 25, 2008 Cord Blood America announced an agreement with Shelter Island Opportunity Fund to restructure its current outstanding debt. In total, the company has reduced its long term debt by more than $1 million since the beginning of 2009.^[19]

Historically, the company has never achieved an annual profit from its core operations. Revenues totaled $5.8M for the fiscal year 2007 an increase of nearly 75% over the year prior.

Retained earnings exceed ($18M) and the company has historically funded operations through the issuance of shares of common stock. As of September 30, 2008 CBAI had 276,305,431 shares of Common Stock outstanding. An additional 41,266,667 shares has been issued and remains in the Company’s treasury.^[20]

The table below presents certain financial information by business segment for the nine months ended September 30, 2008 versus the nine months ended September 30, 2007:

	Umbilical Cord Blood 2008	Umbilical Cord Blood 2007	% Change	Radio/TV Advertising 2008	Radio/TV Advertising 2007	% Change
Revenue from External Customers	$2,623,463	$3,079,919	(15%)	$705,657	$2,617,782	(73%)
Interest Expense	$4,326,054	$2,910,818	PPP	$6,263	$1,575	297%
Depreciation & Amortization	$440,578	$374,089	(15%)	$0	$0	0%
Segment Income (Loss)	($5,560,284)	($4,421,592)	(20%)	$201,090	$233,714	(14%)
Segment Assets	$5,460,432	$5,771,093	(5.5%)	$32,018	$114,565	(72%)

References

1. ↑ [1]
2. ↑ Yahoo Finance, CBAI.ob
3. ↑ [2]
4. ↑ [3]
5. ↑ [4]
6. ↑ [5]
7. ↑ Future Shock
8. ↑ New Guidelines Issued On Umbilical Cord Blood Banking
9. ↑ New Guidelines Issued On Umbilical Cord Blood Banking
10. ↑ [6]
11. ↑ ^ 2007 Policy Statement on Cord Blood Banking, The American Academy of Pediatrics
12. ↑ [7]
13. ↑ ^ NIH data
14. ↑ ^ Raymer, Elizabeth (2005-10-14). "New strategy will boost cord blood stem cells". University of Toronto. Retrieved on September 20 2006.
15. ↑ Corcell.com FAQ
16. ↑ ^ Health Resources and Services Administration
17. ↑ Opinion N° 19, European Union Group on Ethics
18. ↑ Opinion N° 19, European Union Group on Ethics
19. ↑ Cord Blood Restructures Debt; Projects To Be Cash Flow Positive
20. ↑ [8]