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About Cryo-Cell International Inc. (CCEL)
Cryo-Cell International Inc., founded in 1989, is a pioneering company in the biotechnology and healthcare sectors, specializing in cellular processing and cryogenic storage. As the first cord blood bank to separate and store stem cells in 1992, Cryo-Cell has established itself as a leader in the field of regenerative medicine. The company’s mission revolves around providing families and public health organizations with cutting-edge solutions for the collection, processing, and preservation of stem cells derived from umbilical cord blood, cord tissue, and menstrual stem cells. With a global client base exceeding 270,000, Cryo-Cell is a trusted name in stem cell banking, known for its unwavering commitment to quality and innovation.
Core Business Areas
- Private Family Cord Blood Banking: Cryo-Cell offers families the opportunity to preserve stem cells from umbilical cord blood and tissue for potential future medical use. These stem cells are stored in the company’s state-of-the-art cryogenic facilities, ensuring long-term viability and accessibility.
- Public Cord Blood Banking: The company also engages in public cord blood banking, facilitating the collection and storage of stem cells for broader medical and research applications. This segment supports advancements in regenerative medicine and provides critical resources for public health initiatives.
- PrepaCyte CB Technology: Cryo-Cell manufactures and markets PrepaCyte CB, a proprietary processing technology designed to enhance the efficiency and quality of umbilical cord blood stem cell processing. This technology underscores the company’s commitment to innovation and excellence in cellular processing.
Competitive Positioning
Cryo-Cell’s competitive edge lies in its vertically integrated operations, which allow the company to maintain complete control over every step of the processing, testing, and cryopreservation process. This ensures the highest quality standards and reliability for its clients. Additionally, the company’s long-standing history and track record of 100% specimen viability upon thaw set it apart from competitors in the cord blood banking industry. By combining advanced technology with decades of experience, Cryo-Cell has positioned itself as a trusted partner in the evolving field of regenerative medicine.
Industry Context and Market Relevance
The stem cell banking industry is a vital component of the broader biotechnology and healthcare sectors, driven by advancements in regenerative medicine and personalized therapies. Cryo-Cell operates at the intersection of these trends, offering services that address the growing demand for stem cell-based treatments. Its focus on both private and public banking diversifies its revenue streams and enhances its relevance in multiple market segments. As awareness of the potential applications of stem cells continues to grow, Cryo-Cell is well-positioned to capitalize on these opportunities while navigating challenges such as regulatory compliance and competitive pressures.
Commitment to Quality and Innovation
Cryo-Cell’s dedication to quality is evident in its state-of-the-art facilities and rigorous processes. The company’s ability to ensure 100% viability of specimens upon thaw highlights its expertise and reliability. Furthermore, its investment in proprietary technologies like PrepaCyte CB demonstrates a commitment to staying at the forefront of innovation in cellular processing. These factors contribute to Cryo-Cell’s reputation as a leader in the stem cell banking industry.
Conclusion
In summary, Cryo-Cell International Inc. is a trailblazer in the field of cellular processing and cryogenic storage, offering comprehensive solutions for stem cell preservation. With a strong emphasis on quality, innovation, and customer trust, the company plays a pivotal role in advancing regenerative medicine and personalized healthcare. Its dual focus on private and public banking, coupled with its proprietary technologies, positions it as a key player in the biotechnology landscape.
Cryo-Cell International has announced plans for its Institute for Cellular Therapies after securing an exclusive license from Duke University. This partnership provides commercial rights to a range of FDA regulatory data and intellectual property related to cord blood and cord tissue-derived cell therapies that passed Phase 1/Phase 2 trials. The company aims to conduct further Phase 2 and Phase 3 trials focusing on conditions like hypoxic ischemic encephalopathy, cerebral palsy, and autism. Successful trials could lead to FDA licensure and commercialization.
On October 15, 2021, Cryo-Cell International (CCEL) reported Q3 2021 results, showing revenue of $7.5 million, an 8% decline from $8.1 million in Q3 2020. Processing and storage fees contributed $7.3 million. Net income was $857,000 ($0.10 per share), up from $784,000 in the prior year. Expenses increased, primarily due to costs related to the Cryo-Cell Institute and patent expenses. Despite revenue decline, the company emphasized solid results amid its transition to a vertically integrated cellular therapy entity.
Cryo-Cell International, Inc. (Nasdaq:CCEL) has appointed Mark Portnoy and Daniel Mizrahi to its Board of Directors, following the resignations of George Gaines and Jonathan Wheeler, M.D. Gaines retires while Wheeler steps down for health reasons. Both new appointees bring extensive experience, with Portnoy having previously served on the board and Mizrahi leading a manufacturing company in Guatemala. The board expects to enhance shareholder value, particularly after the recent NASDAQ uplisting and a transformative agreement with Duke University.
Cryo-Cell International, Inc. (CCEL) has announced its common stock is listed on the Nasdaq Capital Market as of August 31, 2021. This milestone marks an achievement in meeting Nasdaq's stringent requirements and aims to enhance liquidity and broaden the shareholder base. Chairman David Portnoy expressed optimism that this uplisting will reduce the valuation gap between market and intrinsic value. Cryo-Cell is transitioning into a biopharmaceutical company, providing experimental treatments at the upcoming Cryo-Cell Institute for Cellular Therapies.
Cryo-Cell International (CCEL) has acquired an 8,326 sq. ft. facility in Durham, NC, for its Institute for Cellular Therapies, strategically located near the Raleigh-Durham International Airport. The clinic aims to provide FDA-approved clinical trials for patients in need of cord blood therapies by early 2022. This facility will employ advanced technology and child-friendly layout while adhering to COVID safety guidelines. The treatments target various conditions, including autism spectrum disorders and cerebral palsy.
Cryo-Cell International, the world’s first cord blood bank, announced that Chairman and Co-CEO, David Portnoy, will present at the Q3 Virtual Investor Summit on August 18, 2021, at 2:45 PM EDT. The 30-minute session will include a 20-minute corporate overview followed by a 10-minute Q&A. In February 2021, Cryo-Cell transformed into a vertically integrated cellular therapy company through a license agreement with Duke University, set to treat patients at its first infusion clinic opening in early 2022. The event can be accessed via registration.
Cryo-Cell International, Inc. (CCEL) reported its fiscal Q2 2021 results with a revenue decrease of 8% to $7.21 million, down from $7.87 million in Q2 2020. The company generated $7.16 million in processing and storage fees. Net income rose to $1.17 million, or $0.15 per basic share, from $953,000, or $0.13 per basic share in the prior year. Cost reductions in sales and administrative expenses contributed to net income growth despite lower revenues. Cryo-Cell continues to expand its operations and maintain quality standards with FDA registration and AABB accreditation.
Cryo-Cell International is conducting two pivotal clinical studies: MASC for COVID-19 related Acute Respiratory Distress Syndrome and MISTIC for children with Multisystem Inflammatory Syndrome associated with COVID-19. MASC has completed Phase 1 and is enrolling for Phase 2, while MISTIC is in Phase 1 enrollment. Both studies utilize human cord tissue derived mesenchymal stromal cells. The ongoing research underscores Cryo-Cell's commitment to advancing regenerative medicine and improving patient outcomes amid the ongoing pandemic.
Cryo-Cell International, Inc. (OTC: CCEL) reported its fiscal first quarter results for 2021, citing revenues of $6.86 million, a decrease from $7.62 million in Q1 2020. The revenue comprised $6.74 million from processing and storage fees, $38,000 from product sales, and $84,000 from public banking. Net income was approximately $694,000, consistent with the prior year. The company is optimistic about future opportunities tied to its licensing agreement with Duke University, despite challenges posed by the COVID-19 pandemic affecting birth rates.
Cryo-Cell International, Inc. (CCEL) has entered a collaborative licensing agreement with Duke University to utilize proprietary processes and regulatory data pertaining to cord blood and tissue. This agreement allows Cryo-Cell to explore potential treatments for conditions with limited FDA approved therapies, including cerebral palsy, autism, multiple sclerosis, and COVID-19. Cryo-Cell is focusing on expanding its core business units, including biopharmaceutical manufacturing, pending necessary FDA approvals. The partnership raises the possibility of uplisting the stock to NASDAQ.