About Cryo-Cell International

Cryo-Cell International, Inc. engages in cellular processing and cryogenic storage for family use, with a focus on the collection and preservation of umbilical cord blood and tissue stem cells. The company engages in the manufacture of PrepaCyte CB Processing System (PrepaCyte CB) units, the processing technology used to process umbilical cord blood stem cells. The company also involves in cellular processing and cryogenic storage of umbilical cord blood stem cells for public use. The Company, in combination with its global affiliates, stores nearly 500,000 cord blood and cord tissue specimens worldwide for the exclusive benefit of newborn babies and possibly other members of their families. The company has expanded its research and development activities to develop technologies related to stem cells harvested from sources beyond umbilical cord blood stem cells. During fiscal 2011, the company introduced the advanced new cord tissue service, which stores a section of the umbilical cord tissue. The company offers the cord tissue service in combination with the umbilical cord blood service. This service is growing; however, the umbilical cord blood service continues to be the company’s main focus. Segments The company is organized in three segments: The cellular processing and cryogenic storage of umbilical cord blood and cord tissue stem cells for family use. Revenue is generated from the initial processing and testing fees and the annual storage fees charged each year for storage (the Umbilical cord blood and cord tissue stem cell service). The manufacture of PrepaCyte CB units, the processing technology used to process umbilical cord blood stem cells. Revenue is generated from the sales of the PrepaCyte CB units (the PrepaCyte CB). The cellular processing and cryogenic storage of umbilical cord blood stem cells for public use. Revenue is generated from the sale of the cord blood units to the National Marrow Donor Program (MDP), which distributes the cord blood units to transplant centers located in the United States, and around the world. Cord Blood Stem Cell Storage Services The company enters into storage agreements with its clients under which it charges a fee for the processing and testing and first year of storage of the umbilical cord blood. Thereafter, the client is charged an annual fee to store the specimen, unless the client has entered into an 18-year pre-paid storage plan or a lifetime pre-paid storage plan. The company’s corporate headquarters are located in a nearly 18,000 square-foot state-of-the-art current Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility. Food and Drug Administration (FDA) 21 CFR Part 1271, effective in May 2005, requires human cellular and tissue-based products to be manufactured in compliance with good tissue practices (cGTPs). The company’s laboratory processing facility contains a Class 10,000 clean room and Class 100 environments for the processing of cord blood stem cells and other cellular tissues. In addition, the cellular products cryogenic storage area has been designed as a bunker, with enhanced provisions for security, building fortification for environmental element protection and back-up systems for operational redundancies. Cord Tissue In August 2011, the company introduced its advanced new cord tissue service, which stores a section of the umbilical cord tissue. Approximately six inches of the cord tissue is procured and transported to the company’s laboratory for processing, testing and cryopreservation for future potential use. Umbilical cord tissue is a rich source of mesenchymal stem cells (MSCs). MSCs have many unique functions including the ability to inhibit inflammation following tissue damage, to secrete growth factors that aid in tissue repair, and to differentiate into many cell types, including neural cells, bone cells, fat cells and cartilage. MSCs are increasingly being researched in regenerative medicine for a wide range of conditions, including heart and kidney disease, ALS, wound healing and auto-immune diseases. MSCs from several different tissues are being tested in clinical trials for efficacy. Specifically, cells derived from cord tissue are currently being used in many clinical trials. Disorders being treated include cardiomyopathy, ulcerative colitis, diabetes, anemia, autism and cirrhosis of the liver. Public Banking In June 2018, the company acquired substantially all of the assets (the Cord Purchase) of Cord:Use Cord Blood Bank, Inc., a Florida corporation (Cord:Use), in accordance with the definitive Asset Purchase Agreement between Cryo-Cell and Cord:Use (the Purchase Agreement), including without limitation Cord:Use’s inventory of public cord blood units existing as of the closing date (the Public Cord Blood Inventory). The Public Cord Blood Inventory creates a large, ethnically diverse, high quality inventory of available cord blood stem cell units for those in need of life saving therapy. The company collects cord blood units at hospitals in Florida, Arizona, California, Michigan and Washington. The company’s public inventory is stored in North Carolina, and the cord blood units are sold through the National Marrow Donor Program (NMDP) located in Minnesota, who ultimately distributes the cord blood units to transplant centers located in the United States, and around the world. Umbilical Cord Blood and Cord Tissue Services The company markets its cord blood stem cell preservation services directly to expectant parents and by distributing information through obstetricians, pediatricians, childbirth educators, certified nurse-midwives and other related healthcare professionals. The company has a national sales force to increase its marketing activities with its clinical referral sources, including physicians, midwives and hospitals. Promotional activities also include advertisements in clinical journals and telemarketing activities. In addition, the company exhibits at conferences, trade shows and other meetings attended by medical professionals. Significant portions of client referrals to the company are from medical caregiver professionals. To increase awareness among expectant parent audiences, the company continues to promote its service through internet marketing. The company’s client support team advisors are available by telephone to enroll clients and educate both expectant parents and the medical community on the life-saving potential of cord blood stem cell preservation. License Agreement with Duke University On February 23, 2021, the company entered into a Patent and Technology License Agreement (the Duke Agreement) with Duke, pursuant to which Duke has granted to the company an exclusive license to make, have made, use, import, offer for sale, sell and otherwise commercially exploit (with the right to sublicense) certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of certain diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, subject to Duke’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes. Through this Agreement, the company intends to expand to a triad of core business units to include its cord blood bank and other storage services; cord blood and cord tissue infusion clinic services initially under the FDA’s Expanded Access Program and in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain BLA approvals for new indications; and biopharmaceutical manufacturing if BLA(s) are approved by the FDA. Due to equipment delivery delays, the company is projecting to open the Cryo-Cell Institute for Cellular Therapies and begin infusing patients during fiscal 2024. Research, Development and Related Engineering Expenses For the year ended November 30, 2022, the company’s research, development and related engineering expenses included $384,789. Government Regulation The company is required to register with the Food and Drug Administration (FDA) under the Public Health Service Act because of its ongoing cellular storage business and is subject to FDA inspection. This requirement applies to all establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of any Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) or the screening or testing of a cell or tissue donor. In addition, with the purchase of the manufacturing rights to the PrepaCyte CB Processing System on June 30, 2015, Cryo-Cell is required to register this product as a Medical Device under the Federal Food, Drug, and Cosmetic Act, which is also subject to FDA inspection. As of November 30, 2022, the company was in compliance with these requirements. The division of FDA, which regulates HCT/Ps is the Center for Biologics Evaluation and Research (CBER). The section of FDA Code of Federal Regulations (CFR) pertaining to cord blood is 21 CFR 1271. 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. These laws include the Occupational Safety and Health Act (OSHA), compliance with good tissue practices (cGTPs), current Good Manufacturing Practice (cGMPs), Environmental Protection Act, and those of the local Department of Health. History Cryo-Cell International, Inc. was founded in 1989. The company was incorporated in 1989 in the state of Delaware.