Cryo Cell International Inc (NYSE: CCEL)

Cryo-Cell International Inc., or CCEL, operates in the cellular processing and cryogenic storage industry. The company, headquartered in Oldsmar, Florida, was incorporated in 1989 and is renowned as the world's first private cord blood bank. Cryo-Cell International Inc. is organized into three reportable segments: cellular processing and cryogenic storage for family use, the manufacture of PrepaCyte CB Processing System units, and cellular processing and cryogenic storage of umbilical cord blood stem cells for public use.

Cryo-Cell International Inc.'s primary business activities revolve around the collection, processing, and storage of umbilical cord blood stem cells. These activities are carried out in three segments, as previously mentioned. The company's offerings include cord blood stem cell preservation, cord tissue preservation, and public banking services. These services are available in various countries, with the company's PrepaCyte CB Processing System being a crucial component. This system, which is 510(k) cleared as a Class II device, is used to process and store total nucleated cells (TNC) from human umbilical cord blood before banking.

The company's revenue is primarily generated from the aforementioned services and the sale of PrepaCyte CB Processing System units. The customer base for these services is diverse, encompassing expectant parents, medical caregivers, and hospitals. Cryo-Cell International Inc.'s position within the industry is strengthened by its status as the world's first private cord blood bank, its cGMP- and cGTP-compliant facility, and its AABB and FACT accreditations. These factors, coupled with a value-based pricing strategy and a robust marketing program, provide the company with a competitive edge over approximately 25 other national private cord blood banks.

CCEL's marketing program is multifaceted, including internet marketing, advertisements in clinical journals, and telemarketing activities. The company believes that its longevity and experience, value-based pricing strategy, superior customer service, premier technical and operational expertise, state-of-the-art facilities, and innovative marketing programs will continue to provide a competitive advantage.

Cryo-Cell International Inc. is subject to regulations by the FDA, which requires the company to register and list its HCT/Ps, comply with current Good Tissue Practice (GTP) and current Good Manufacturing Practice (GMP), and label its products in accordance with FDA regulations. The company is also subject to local, state, and federal laws and regulations relating to safe working conditions, laboratory and manufacturing practices, and the use and disposal of hazardous or potentially hazardous substances.

In addition to its primary operations, Cryo-Cell International Inc. has entered into a Patent and Technology License Agreement with Duke University. This agreement grants CCEL an exclusive license to make, have made, use, import, offer for sale, sell and otherwise commercially exploit certain licensed products and to practice certain licensed processes. The agreement also requires CCEL to pay Duke a license fee and royalties based on a portion of the net sales.

Furthermore, the company has entered into a Master Services Agreement with Emmes Biopharma Services LLC to conduct a phase 3 clinical trial infusing allogeneic umbilical cord blood into children with cerebral palsy. Cryo-Cell International Inc. has also entered into revenue sharing agreements with various third and related parties, which provide for the sharing of a percentage of the company's future revenue derived from the annual storage fees related to a certain number of specimens that originated from specific geographical areas.