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ViaCell Reproductive Health
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Products & Pipeline>> ViaCell Reproductive Health
ViaCell Reproductive Health

ViaCell’s reproductive health business is responsible for marketing and sales of ViaCord, cord blood banking and research, and the development of ViaCyte

ViaCord: umbilical cord blood cryopreservation
ViaCyte: oocyte cryopreservation

ViaCord®

Our ViaCord Cord Blood Banking product involves the collection, testing, processing and preserving of umbilical cord blood. Our customers are expectant parents who choose to collect and store umbilical cord blood at the birth of their child for potential use in a hematopoietic stem cell transplantation for the donor and family members. We have established a leading position in this emerging field of private umbilical cord blood preservation.

Over the past three years, the number of customers in this industry has grown significantly. Family cord blood preservation is growing in acceptance by the medical community and has become increasingly popular with families. We believe the total available target market could grow to 30% of US births driven by:

• increased awareness about the availability and benefits of preserving cord blood;

• growing endorsement by the medical community;

• new applications for cell therapy; and

• potential for expanding the number of stem cells in a single unit of cord blood, making it possible to treat larger, adult patients or multiple patients within a family.

To date, ViaCord has performed facilitated collections at over 2,000 hospitals in the United States, and currently stores over 130,000 cord blood units for customers.

The following services are provided to each customer:
Collection. We provide a kit containing all the materials necessary for collecting the newborn's umbilical cord blood at birth and packaging the unit for transportation. The kit also provides for the collection of a maternal blood sample for later testing.

Comprehensive TestingAt the laboratory, we conduct several tests on the cord blood unit which are essential in the event the unit is ever needed for transplant. These tests include volume collected, number and viability of nucleated cells, sterility, blood typing and the percent of stem cells. The maternal blood sample is tested for infectious diseases.

Processing. At our state-of-the-art laboratory, we process the cord blood using a process designed to maximize the number of stem cells preserved.

Cryopreservation. After processing and testing, we freeze the cord blood unit in a controlled manner and store it using liquid nitrogen. Published data indicates that cord blood retains viability and function for 15 years, and potentially longer, when stored in this manner.

All of our processing and storage of cord blood products is handled at our own cord blood processing and storage facility located in Hebron, Kentucky.

ViaCord complements our ability to deliver cellular medicines by providing:

     • experience in providing banked umbilical cord blood for stem cell transplantation, with more than 25 of our
       customers' umbilical cord blood units used in transplantations to date; 

     • strong relationships in the cell therapy community, including leading transplant centers; 

     • expertise in cord blood collection, testing and preservation; and 

     • overall financial stability.

Oocyte Cryopreservation Program

ViaCell is committed to offering innovative options to patients and physicians related to reproductive health, and believes the current limitations associated with cellular therapy for treatment of infertility can be overcome by effectively preserving and storing oocytes.

ViaCyteSM, an investigational product being studied for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology, represents a potentially significant breakthrough in the area of reproductive medicine, which may provide women with the opportunity to extend or protect their fertility, or obtain donor oocytes for IVF. ViaCell has exclusively licensed a patented method from Galileo Research Laboratories.

Women choosing to extend their fertility represent a large segment of our potential market opportunity. In the United States and elsewhere in the world, more women are choosing to have children later in life: the average age for a woman having her first child is almost 25, increasing from age 21 in 1970, according to the Center for Disease Control and Prevention. This trend is driven in part by rising birth rates for women in their 30's and 40's. Despite this trend, female fertility actually begins to decline at around age 26 and declines more rapidly after age 35. Declining oocyte viability due to the natural aging process is one of the major factors contributing to compromised fertility in women. Cryopreservation stops the aging of cells, and could allow a woman to have a child later in life, using one of her own younger and potentially healthier oocytes. 

ViaCyte, may also address currently unmet needs of female cancer patients who, as a result of chemotherapy and radiation treatment, may be at risk of compromised fertility. Women diagnosed with cancer could preserve their oocytes prior to undergoing or immediately following chemotherapy or radiation in order to preserve their ability to have a child in the future. Other significant market opportunities for oocyte cryopreservation include using our product candidate to aid women (or couples) who require IVF, but who have ethical concerns about embryo cryopreservation and those individuals seeking donor oocytes, but for whom the logistics of coordinating a donor-recipient cycle presents a challenge.

In March 2007, ViaCell commenced a pivotal trial to evaluate the safety and efficacy of ViaCyte.  Approximately 300 healthy women, age 21 to 35, who are currently seeking fertility treatment, are expected to enroll at multiple sites.  ViaCell expects the trial to be completed in 2009, and if the results are positive, the Company expects to file for regulatory clearance in the United States.