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CRYO-CELL International – on a mission to collect the umbilical cord blood cells of all newborn babies and maintain affordability

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 Healthcare
Medical Equipment & Supplies
NASD: CCEL

CRYO-CELL International, Inc.

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Daniel D. Richard
Chairman and
Chief Executive Officer

3165 McMullen Booth Rd., Bldg. B
Clearwater, FL 33761
Phone: 727-723-0333

Interview conducted by:
Walter Banks,
Co-Publisher

CEOCFOinterviews,com
July 2001

BIO OF CEO

Background Information

Daniel D. Richard, Founder, Chairman and Chief Executive Officer CRYO-CELL International, Inc. Although not a M.D. or researcher, Mr. Richard's background in the cryopreservation and stem cell field is extensive.  

·         Co-inventor of world’s first computer-controlled, robotically operated, laser scanning, long-term cryopresevation unit.

·         Founder and CEO of CRYO-CELL International, Inc., America’s fastest growing and largest exclusive autologous/sibling umbilical cord blood cryopreservation program 11 years ago.

·         Pioneered affordable, commercial, fractionated U-Cord™ blood stem cell preservation program.

·         Founded CCEL Bio-Therapies 8 years ago.  This subsidiary of CRYO-CELL is involved in providing U-cord™ blood to the University of South Florida for conversion to neural cells for research in treating neuro-degenerative diseases such as stroke, Parkinson’s, Alzheimer’s and severed spinal columns.  The research agreement with the University of South Florida (USF) a leader in research in the neural transplantation field.  Research team includes Dr. Paul Sanberg, Dr. Juan Sanchez-Ramos, and Dr. Allison Wheeling).  Dr. Sanberg recently presented at the American Association for the Advancement of Science (AAAS) in San Francisco.

·         Negotiated world marketing rights for any pharmaceuticals developed by USF utilizing cord blood from their research program.  Funded initial research, co-inventor on joint patent application utilizing cord blood for developing therapies to treat neuro-generative diseases. 

·         Co-inventor of worlds largest capacity, computer-controlled, robotically operated, laser scanning DNA cellular storage system.

·         Founded Stem Cell Preservation, Inc. which will be involved in dealing with adult peripheral stem cells.

·         Negotiated and signed all agreements for CRYO-CELL’s expansion into Europe, Mexico and Central America.  Advised CRYO-CELL Europe management to approach insurance companies to provide coverage for their expectant parent policyholders committed to and invested U.S. $1,000,000 once the insurance companies agreed to provide this maternity coverage and  also invested one million euros.

·         Negotiating other license agreements in South America, and Asia.

·         Founder and first Director and Officer of Marrow Tech, Incorporated (now Advance Tissue Science) a firm currently involved in skin replication.

·         Created the National (and soon to be International) “Save the Stem Cells” program.

·         He made tremendous in-roads in developing alliances with groups and organizations serving the African-American communities after the announcement of the first successful treatment of a sickle-cell anemia patient.  This is imperative since 97% of all sickle cell patients are African-American or other people of color.

About CRYO-CELL
International, Inc.

CRYO-CELL International, Inc. is a cellular storage company specializing in preserving newborn babies' umbilical cord (U-Cord™) blood stem cells at the Company's state-of-the-art laboratory in Clearwater, Florida. They are committed to keeping their prices affordable to make it easy for expectant parents to store for their family first. At CRYO-CELL, every U-Cord specimen is professionally processed, thoroughly tested and cryopreserved under closely monitored conditions.

CRYO-CELL is also dedicated to developing patented technology to serve the medical and scientific communities. They have pioneered several technologies that allow  specimens to be stored long-term in a computer controlled, robotically operated cryogenic environment. 

CEOCFOinterviews - Mr. Richard, can you give us a brief history of CRYO-CELL International?

Mr. Richard: "We started the company in 1989, and have developed and patented the world's first computer controlled, robotically operated, long-term, cellular storage unit. I was literally going to be in the machine business because people were not comfortable with long-term storage of specimens since opening and closing the cryo chambers over a period of years might threaten the viability of the stored specimens. 

In 1990, I first learned of a child suffering from Fanconi’s anemia that had been saved in France with an umbilical cord blood transplant. All of a sudden I realized that I had to change the course of our company to then become a long-term U-Cord™ cellular storage company.  We now cryopreserve umbilical cord blood from newborn babies only for the benefit of that baby, their siblings and other members of the family. When you preserve for a newborn it is a perfect match for the entire life of the baby and a 1 in 4 match or better for any sibling in the family."

CEOCFOinterviews - What diseases are treatable from the stem cells that are preserved?

Mr. Richard: "That is an excellent question. There have been over twenty-five hundred transplants now, where you can use cord blood stem cells for patients with cancer, leukemia and certain types of anemia. However, everyday they are developing new uses for them. The cord blood stem cells may be converted into other types of stem cells.  This is why stem cell research is the way of the future.  They could be convertible into brain cells, heart muscle and other cells. Just recently for example, there was an article about a boy in Toronto, who was blind in both eyes caused by cancer which spread to his spinal fluid.  The Toronto Globe and Mail stated that the doctor performed a pioneer procedure using the boy’s umbilical cord blood stem cells to do an autologous transplant.  He was successfully treated and in a short time left the hospital with his immune system being rejuvenated.  His parents stated they wanted their son to be a model for all expectant parents to know that storing their baby’s umbilical cord blood is “like gold!”

We also have a subsidiary, CCEL Bio-Therapies, which is working closely with the research team at the University of South Florida who is developing therapies to treat neuro-degenerative diseases.  CRYO-CELL provided the cord blood donated for research and they converted them to brain cells. At the American Society for Advancement of Science meeting, Dr. Paul Sanberg disclosed the significant success they had in treating laboratory animals with stroke.  The research team took the cord blood stem cells and after converting them to neural cells, did a cranial invasive procedure and transplanted the cells directly into the brain.  This showed great promise.  Then in cooperation with Michael Chopp of Henry Ford Hospital in Detroit, they tried something new.  For the first time they injected the neural cells intravenously and they migrated to the damaged area of the brain. This is the reason they believe that someday Parkinson's, Alzheimer’s and other diseases might be treated through intravenous injection of neural cells. 

I think one of the most important things is the first announced successful treatment of a sickle-cell anemia baby done in Georgia. As a result, I have been focusing my attention now in dealing with the African American people who make up 97% of all the sickle-cell patients. I have been invited in September to address the Sickle-Cell Anemia Foundation of Palm Beach which is conducting a medical forum.  We have met with an official of the National Counsel of Black Churches as well, and I have pending appointments with Ms. Cathy Hughes, owner of the largest individual radio station network in America.  What we are trying to do is heighten the awareness of all expectant parents that they have alternatives and they should ‘save the stem cells’."

CEOCFOinterviews - What does the stem cell offer people with other diseases?

Mr. Richard: "After the baby is born and the cord has been cut, the doctor or caregiver inserts a  needle into the umbilical vein; the blood goes into a closed system bag and is shipped to us.  There is no risk or pain to the mother or child.   We preserve the cells that can rebuild the immune system.  People with cancer many times do not die of that cancer. By treating the cancer with chemotherapy or radiation to kill the wildly growing cancer cells, it could simultaneously kill the immune system cells. Thus by storing the baby’s own cord blood which is rich in stem cells, the doctors can use a heavier dose of chemotherapy or radiation, because they know they have the preserved cells to rebuild the immune system and it will have a reduced incidence of graft vs. host disease post transplant.

One of the reasons the researchers have been asking for fetal, embryonic or aborted stem cells is that they are non-committed cells and can be converted into other cells.  However, we all know that there is a great controversy out there about people using aborted cells because they think that it is morally wrong. They are afraid that people will encourage some women to have babies and after an abortion use the cells. Yet, the cord blood stem cells taken from the blood of a baby brought to full-term has no controversy attached to them. We are proud of the fact that the Vatican has just announced they support starting a cord blood bank in Italy at the San Raphaelo Hospital.. Therefore, we believe we can provide the researchers some of the stem cells needed to develop therapies to treat diseases which are now incurable." 

CEOCFOinterviews - How widely is your activity known?

Mr. Richard: "We have launched our National ‘Save The Stem Cells’ program to assist those researchers pleading to Congress for funding.  If we could get into the hospital bio waste bins and get over 3.9 million of those umbilical cords, everyone would benefit.   This would include private banks, public banks and research scientists, but most important of all, parents would have a peace of mind knowing that they have provided the maximum potential future medical benefit for their newborn and/or siblings.

Our company wrote a letter to President Bush. CRYO-CELL never asked the government for any funds nor do we now.  We asked him to use the power and prestige of his office to educate expectant parents of their alternatives to having their babies’ umbilical cords “thrown away.”  Our company paid to have a copy of the letter we sent to President Bush hand-delivered to the office of every member of Congress.  One of our shareholders, a retired Major General sent a personal letter to the Deputy Surgeon General, saying that military people who are serving us should be served by getting information at every maternity ward in every single military installation around the world. 

We believe if the government can spend money to encourage people to eat American beef, drive American cars, or use cotton products, they surely could spend some informational dollars to inform the parents of the 4 million babies who will be born this year, to “save the stem cells” and not allow them to be discarded after the birth of the baby.

We believe that no “mother-to-be” in the world would allow her baby's cord blood to be discarded knowing that it could save a life, whether it be her own child, someone in the family, a stranger in need of a transplant or used for research.  Unfortunately, not only the parents are unaware, so are many of the doctors.   We are constantly striving to make the medical caregivers aware.  Recently we launched our ‘Save The Stem Cells’ program at our booth during the American College of Obstetricians and Gynecologists annual meeting.  Moreover, we were the sole sponsors and paid for a CD-ROM that went out to 40,000 ACOG members.   Currently there are approximately 15,500 doctors have supported their patients' decision to store with CRYO-CELL." 

CEOCFOinterviews - Do you have any competition in cord blood stem cell storage?

Mr. Richard: "Yes. There are number of private banks.  However, the two basic criticisms of private banking have been a) the concerns of the utilization of the preserved cord blood for the benefit of the newborn.  All expectant parents must be told that its a 1 in 4 chance (or better) to match a sibling.  This is vital information since 59% of all pregnant women have one or more children in the family.  This limited utilization concern is being dispelled every day with all the evolving medical technology, b)  The high cost for cryopreservation has also been questioned since a number of private cell banks charge $1000 to $1500 or more for their service, plus higher annual fees.  

CRYO-CELL’s mission is to maintain affordability and make it available to the average person.  Our fee is $275.00 and that includes the professional collection kit that the mother to be takes to the doctor to collect the cord blood, plus all the testing of the mother and the child, also the processing and preparation for long term storage and the first year storage fee as well. Thereafter, our storage fee is $50.00 a year and fixed in writing to remain the same for specimens already in storage.  We are proud to say we have never raised the price for our basic service since the inception of our company nearly twelve years ago.” 

CEOCFOinterviews - Which market is your primary focus?

Mr. Richard: "Our primary focus is and will always be the preservation of the umbilical cord blood, as we trade marked it, the U-Cord™ Preservation.  However, CCEL Bio-Therapies, our subsidiary mentioned earlier, which we own 80% of, is involved in research to develop therapies. We do own the world rights, because we are co-inventors on the patent application with them for the technology and therapies they believe can be developed for treating neuro-degenerate diseases.

The opportunity from a commercial point of view is impressive.  There are 4 million babies born every year. If we get one percent, that would be 40,000 mothers storing with us.  We are about half way there and new programs are currently being implemented to accelerate our reaching that goal.  For example, in supporting our ‘Save The Stem Cells’ program, iMaternity, a national chain of maternity stores with over 170 shops in the United States and Canada, are now cooperating with us to bring this information to the one million expectant parents who visit their stores.  I am sure that when they started the company selling pregnant women's fashions, they never dreamed that they could possibly save lives at the same time.  Their participation in heightening the awareness of their pregnant clients could well cause this to happen in the future without them even knowing it."  

CEOCFOinterviews - Do you invest any of the money you bring in into research and development?

Mr. Richard: "We are primarily a marketing company, however we are developing new equipment all of the time.  We have a patent on a new piece of equipment that will be able to store millions of specimen of DNA.  We just recently got a patent approved on a remote, small portable holder. When you take a vial out of the long-term cryogenic unit, you are taking it into ambient temperatures. In our new remote holder you can put up to 12 vials with liquid nitrogen at the bottom and a micro processor that will print out the temperature for people to actually work with the vials after they were removed from the storage unit. We are continually developing things such as new types of vials and applying for patents. We have applied for a patent on our CRYO-CELL long-term storage unit in Europe, Ireland and Canada and other countries of the world. Thus, for a small company we have spent a lot of money on protecting our proprietary products."

CEOCFOinterviews - Right now, a great deal of spending is focused on the marketing of your company, is it not?

Mr. Richard: "Yes. We had to do that. Wanda D. Dearth was added as the new President of the Company’s management team.  She brought in a number of clinical educators to handle people interested in our service.  Thousands of women call us every month and we needed to be able to serve all of them.  We have bought new equipment and expanded our state-of-the-art laboratory in Clearwater Florida.  Dr. Geoffrey O’Neill, our lab director, formerly with Sloan-Kettering and with Dr. Robert Good who did the first successful bone marrow transplant in the world.  We continually enhance our Web site and Internet activities.  Our Information Technology Officers are preparing to make us into an e-commerce company where people can enroll on our Web site. Right now they can download the enrollment forms.  We deal with nine thousand Lamaze childbirth educators and, incidentally, we have exclusivity on their Lamaze ‘You and Your Baby’ video which was distributed to 60,000 Wal-mart baby departments. The childbirth educators use this video to train the expectant parents in their classes.  We have initiated an “Open House” program for both expectant parents and caregivers at our headquarters in Florida.

We believe in supporting the community wherever we can..  Several times a week in the conference room used by our Board of Directors, we remove the huge table and allow childbirth education classes to be held. 

We have launched the ‘Save The Stem Cells’ program.  We are not only going to all the media, we are going to our own shareholders and our own clients.  We have a Mother-to-Mother Network.  We have enrolled over 200 women that have stored their baby's cord blood with us or enrolled to store. They are now part of our educational network to go to their own doctors and tell them to help save the stem cells by just telling every patient about the affordable alternative that is available.

Recently, I was invited to speak by Congressman Christopher Smith who held a Press Conference at the U.S. Capitol.  I stated to the media that CRYO-CELL would be focusing in on its ‘Save The Stem Cells’ program.  We detailed our plans to ask government agencies, national and state agencies, hospital administrators, the Surgeon General as well as the President of the United States and members of Congress, to help educate expectant parents not to allow their baby’s cord blood stem cells to be discarded as hospital waste.  Someday, through a concerted effort, long-term storage of cord blood could become as commonplace as a vaccination. 

A number of years ago, in February 1995, the National Cancer Institute said that the collection of cord blood from the newborn and its storage would soon become as routine as it was unusual, at that time.  Along with CRYO-CELL’s management and dedicated staff, my mission in life is to help fulfill that prophecy."

CEOCFOinterviews What are your final thoughts to current shareholders and potential investors?

Mr. Richard: "We encourage them to visit our Web site at www.cryo-cell.com.  They will find that we are the fastest growing company in the country in our field and we are the largest exclusive autologous (self) storage company. We only store for the benefit of the baby and/or their siblings. We believe with all of the new programs we are implementing we can capture the dominant share of the private cord blood cryopreservation market.

As for our stock, we are currently a NASDAQ small cap company, which hopefully in the near future could become eligible for national NASDAQ.  We have expanded into five countries in Europe.  I  hope that some of your readers would go to www.cryoc.com to see the rapid expansion of our European license program.  They recently announced that an agreement had been signed with the Vatican-owned San Raphaelo Hospital in Milan, Italy to open a state-of-the-art lab.  We are growing throughout the world.  We have just signed a license agreement in Mexico and the countries in Central America and are negotiating licenses in South America and are awaiting a  medical team which is coming in from Asia for discussion.  Moreover, our growth is being accomplished without expending our own capital through our international licensing program.

Our financial position is excellent. We have reached a point of profitability.  Moreover, prior to September 30, 2001, we should have well over 2 million dollars in the bank and no debt, along with quarterly positive cash flow.  Consider that our financial position is after the investment of  U.S. one million dollars we paid for a 6 % equity in CRYO-CELL Europe.  It’s true, we sustained losses of about 6 million dollars through the years when we were doing our research and developing a program to educate expectant parents. This tax loss carry forward will be valuable to our company in the near future.  Our educational program has been very successful.  We now get as many calls in a one month as we used to get in couple of years.  The world has learned that stem cell preservation makes sense and will be the medical way of the future.  There is no question that … Saving Stem Cells … Means Saving Lives.

 727-723-0333
Expectant Parents call 1-800-STOR-CELL

Medical caregivers and expectant parents are invited to visit us during our Open Houses at our headquarters and state-of-the-art lab in Clearwater, Florida.

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