Cryo-Cell International Receives FACT Re-accreditation, Setting the Longest Independently Validated Quality Track Record Among U.S. Private Cord Blood Banks
Cryo-Cell International Receives FACT Re-accreditation, Setting the Longest Independently Validated Quality Track Record Among U.S. Private Cord Blood Banks
foundation for the accreditation of cellular therapyregulatory
A foundation for the accreditation of cellular therapy is a formal program or organization that evaluates and certifies clinics and laboratories that make or administer cell-based treatments, ensuring they meet consistent safety, quality and record-keeping standards. For investors, accreditation reduces clinical and regulatory risk, supports wider patient and payer acceptance, and can speed commercialization—similar to how a trusted inspection stamp on a factory reassures buyers and regulators about product reliability.
fact accreditationregulatory
Fact accreditation is an independent verification that specific claims or figures in a corporate announcement are true and supported by evidence, similar to an inspector’s stamp on a safety report. For investors, it matters because accredited facts reduce the risk of relying on false or misleading information, helping to judge a company’s credibility and make more confident decisions about buying, holding, or selling securities.
netcord-fact standardsregulatory
NetCord-FACT standards are an internationally recognized set of rules and quality checks used to certify public and private umbilical cord blood banks and related cellular therapy services. They ensure that cord blood is collected, processed, tested, stored and shipped in a reliable, safe way—like a restaurant health code for biological materials—so investors can judge whether a provider meets trusted safety, regulatory and partnership expectations that affect reputation, legal risk and long-term revenue potential.
cgmP-/cgtp-compliantmedical
cGMP-/cGTP-compliant means a facility and its processes meet government quality rules for making and handling biological or cell-based products: cGMP covers consistent, controlled manufacturing and record-keeping, while cGTP covers safe sourcing, testing and tracking of human tissues or cells. For investors this matters because compliance lowers the chance of product recalls or regulatory shutdowns, supports product approvals and commercial sales, and is like having a certified, inspected kitchen that buyers and regulators trust.
national marrow donor programmedical
A national marrow donor program is a centralized registry and coordinating service that finds compatible bone marrow or blood stem cell donors and arranges transplants for patients with blood cancers and other life‑threatening disorders. Think of it as a national matchmaking and logistics system for lifesaving cellular donations; investors watch it because its operations, funding, and partnerships affect demand for related medical technologies, hospital services, drug development, and nonprofit or government healthcare spending.
fda-registeredregulatory
An FDA-registered facility or product is one that has been listed with the U.S. Food and Drug Administration as required for certain medical devices, manufacturers, or establishments — like being entered in an official government directory. It does not mean the FDA has approved or certified safety or effectiveness, but it does mean the operation is subject to inspections and regulatory rules, which affects market access, investor risk assessment, and credibility with customers and partners.
fda 510kregulatory
A 510(k) is a submission to the U.S. Food and Drug Administration that demonstrates a medical device is essentially similar in safety and performance to another device already legally sold in the U.S. It matters to investors because a cleared 510(k) typically offers a faster, lower‑cost route to market, reducing regulatory risk and shortening timelines for sales and revenue — like proving a new model works like a trusted product so retailers will carry it.
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OLDSMAR, Fla.--(BUSINESS WIRE)--
Cryo-Cell International, Inc. (NYSE American LLC: CCEL) (the “Company”), the world’s first private cord blood bank, has been granted renewed Foundation for the Accreditation of Cellular Therapy (“FACT”) Accreditation for Cord Blood Collection, Banking, and Release for Administration (Related and Unrelated) Donations. Originally accredited in 2014, the Company’s latest FACT re-accreditation extends for three more years, with the latest renewal effective through April 3, 2029.
The FACT accreditation was issued after Cryo-Cell International, Inc. demonstrated compliance with the NetCord-FACT Standards for Cord Blood Banking — the most rigorous internationally recognized quality framework in cellular therapy.
Accreditation Scope and Verification
The FACT certificate confirms that Cryo-Cell International, Inc., having met the NetCord-FACT Standards for Cord Blood Banking, is granted FACT Accreditation for Cord Blood Collection, Banking, and Release for Administration (Related and Unrelated) Donations.
To verify the official FACT accreditation and other licenses, visit:
FACT is an independent, internationally recognized accrediting body. Its standards are used by the nation’s leading transplant and cancer centers when selecting cord blood units from public banks.
Cryo-Cell International, Inc. was the first U.S. private (family-use) cord blood bank to receive FACT accreditation — a pioneering commitment to peer-reviewed, expert-developed standards that exceed regulatory minimums, and have been independently validated through continuous accreditation for more than a decade.
FACT accreditation requires a rigorous on-site inspection by qualified experts, comprehensive documentation review, and demonstrated compliance across collection, processing, testing, storage, and release protocols.
Executive Statement
“FACT accreditation is the standard used by the world’s leading transplant centers for evaluating public cord blood banks. Earning and renewing this credential for private banking demonstrates that the Company operates at that same level of rigor — giving families and their physicians an independently verified quality benchmark they can trust.”
— David Portnoy, Co-CEO, Cryo-Cell International, Inc.
Cryo-Cell’s Commitment to Quality and Safety
In addition to FACT accreditation, Cryo-Cell International, Inc.’s facility is:
FDA-registered and cGMP-/cGTP-compliant
AABB accredited as a cord blood banking facility
Licensed in all states requiring licensure
National Marrow Donor Program (NMDP) network cord blood bank
The Company holds exclusive rights to PrepaCyte-CB, an advanced FDA 510k cord blood processing technology designed to maximize stem cell recovery and viability.
About Cryo-Cell International, Inc.
Founded in 1989, Cryo-Cell International, Inc. is the world’s first private cord blood bank. The Company, together with its global affiliates, stores more than 250,000 cord blood and cord tissue specimens for the exclusive benefit of newborn babies and their families. In addition to its private bank, Cryo-Cell International, Inc. has a public banking program in partnership with Duke University. Cryo-Cell’s public bank has provided cord blood for more than 900 transplants and operates a cord blood donation site at one of the country’s most prominent hospitals, Cedars–Sinai Hospital in Los Angeles, California. Cryo-Cell’s facility is FDA-registered, cGMP-/cGTP-compliant, and licensed in all states requiring licensure. In addition to AABB accreditation as a cord blood facility, Cryo-Cell was the first U.S. private (family-use) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. Cryo-Cell holds exclusive rights to PrepaCyte-CB, the industry’s most advanced cord blood processing technology. Cryo-Cell’s mission is to provide clients with the premier cord blood and cord tissue cryopreservation service and to aid in the advancement of regenerative medicine.
