Latest news with #regenerativeMedicine
Globe and Mail
3 days ago
- Business
- Globe and Mail
Celularity Receives Nasdaq Notice Regarding Form 10-Q
FLORHAM PARK, N.J., May 30, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) ('Celularity' or the 'Company'), a cellular and regenerative medicine company, today announced that on May 28, 2025, Nasdaq notified the Company that it did not timely file its Quarterly Report on Form 10-Q for the period ended March 31, 2025. Based on this latest notice, the Company is not in compliance with Listing Rule 5250 (c)(1), which requires the Company to timely file all required periodic financial reports with the Securities and Exchange Commission. The Notice received from Nasdaq has no immediate effect on the listing or trading of the Company's shares. Nasdaq has provided the Company 60 calendar days to submit a plan to regain compliance. If Nasdaq accepts the Company's plan, then Nasdaq may grant the Company an exception until November 17, 2025, to regain compliance with the Nasdaq Listing Rules. The Company continues to work diligently to complete its Form 10-Q for the period ended March 31, 2025, after which the Company anticipates maintaining compliance with its SEC reporting obligations. About Celularity Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information, visit Forward-Looking Statements This press release includes 'forward-looking statements' (as defined under Federal securities laws). These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'can,' 'could,' 'continue,' 'expect,' 'improving,' 'may,' 'observed,' 'potential,' 'promise,' 'should,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks,' and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption 'Risk Factors' in Celularity's annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity's current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity's views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Associated Press
3 days ago
- Business
- Associated Press
Celularity Receives Nasdaq Notice Regarding Form 10-Q
FLORHAM PARK, N.J., May 30, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) ('Celularity' or the 'Company'), a cellular and regenerative medicine company, today announced that on May 28, 2025, Nasdaq notified the Company that it did not timely file its Quarterly Report on Form 10-Q for the period ended March 31, 2025. Based on this latest notice, the Company is not in compliance with Listing Rule 5250 (c)(1), which requires the Company to timely file all required periodic financial reports with the Securities and Exchange Commission. The Notice received from Nasdaq has no immediate effect on the listing or trading of the Company's shares. Nasdaq has provided the Company 60 calendar days to submit a plan to regain compliance. If Nasdaq accepts the Company's plan, then Nasdaq may grant the Company an exception until November 17, 2025, to regain compliance with the Nasdaq Listing Rules. The Company continues to work diligently to complete its Form 10-Q for the period ended March 31, 2025, after which the Company anticipates maintaining compliance with its SEC reporting obligations. About Celularity Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information, visit Forward-Looking Statements This press release includes 'forward-looking statements' (as defined under Federal securities laws). These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'can,' 'could,' 'continue,' 'expect,' 'improving,' 'may,' 'observed,' 'potential,' 'promise,' 'should,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks,' and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption 'Risk Factors' in Celularity's annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity's current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity's views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Carlos Ramirez Senior Vice President, Celularity Inc. [email protected]
Associated Press
26-05-2025
- Business
- Associated Press
Chair of Sernova Biotherapeutics Resigns
LONDON, Ontario and BOSTON, May 26, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today announced the resignation of its Chair. Mr. Ross Haghighat tendered his resignation on May 24th and it was accepted by the Sernova Board. The Board of Directors of Sernova thanks Ross for his service as a trusted leader and sincerely wishes him luck in the future. ABOUT SERNOVA BIOTHERAPEUTICS Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem-cell derived islet like clusters in collaboration with Evotec to create Bio-hybrid Organs to treat T1D. A Bio-hybrid Organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues to restore or enhance the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on T1D and thyroid disorders. FOR FURTHER INFORMATION, PLEASE CONTACT: David Burke VP, Investor Relations (917) 751-5713 Email: [email protected] Website: The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release.
Yahoo
19-05-2025
- Business
- Yahoo
Cellino's iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation
AMT Designation Positions Cellino to Accelerate the Development of Scalable, Personalized Regenerative Medicines CAMBRIDGE, Mass., May 19, 2025--(BUSINESS WIRE)--Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) has received the FDA's Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER). This prestigious designation highlights the transformative potential of Cellino's automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies. The FDA encourages the adoption of advanced manufacturing technologies (AMTs) that improve manufacturing reliability, product quality, and production scale. The AMT designation accelerates timelines for therapies manufactured using Cellino's optical biomanufacturing technology, offering higher priority within the FDA, along with earlier and more frequent interactions during Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) processes for a faster path to market. "We are honored to receive the AMT designation for our proprietary technology stack," said Nabiha Saklayen, Ph.D., CEO and Co-Founder of Cellino. "This recognition affirms our commitment to revolutionizing the production of patient-specific iPSCs, enabling faster and more consistent clinical and commercial-scale manufacturing. It's a pivotal moment in our mission to deliver personalized regenerative therapies that can scale globally, transforming healthcare for millions." Autologous iPSC manufacturing has long been one of the most complex challenges in biomanufacturing, involving labor-intensive processes like manual passaging and colony picking that only a limited number of experts worldwide can perform. These hurdles have slowed progress, preventing many therapeutic programs from advancing past early-phase clinical trials. Cellino's proprietary optical bioprocessing technology overcomes these challenges by introducing precision, reproducibility, and scalability, ensuring reliable, high-quality iPSC production for both clinical trials and commercial stages. "This AMT designation underscores the scientific rigor and transformative potential of our technology," said Marinna Madrid, Ph.D., Chief Product Officer and Co-Founder of Cellino. "Automated, optical manufacturing is key to ensuring patient access to regenerative medicines. This milestone brings us closer to scaling therapies from Phase 1 through large-scale commercialization, aiming to address some of the world's most debilitating chronic degenerative diseases." Cellino intends to leverage the AMT designation to expedite the translation of personalized iPSC-derived therapies into clinical practice. With global chronic disease burdens rising and more than 100 million individuals in the U.S. alone who could potentially benefit from iPSC-derived therapies, Cellino's technology is poised to significantly expand patient access to next-generation living medicines. For more information on the FDA's Advanced Manufacturing Technologies Designation Program, visit the FDA AMT Guidance. About Cellino Cellino is a leader in advanced biomanufacturing technology, committed to making personalized cell, tissue, and organ replacements a reality for patients around the world. Learn more at and follow us on LinkedIn and X. View source version on Contacts Media Kimberly HaKKH Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Health
- Yahoo
Prof. Mike Chan's Precision Medicine Vision Validated by Landmark Human Cytology Study Mapping Over 400 Distinct Cell Types - with Special Focus on the Brain
HEIDELBERG, Germany, May 12, 2025 /PRNewswire/ -- A groundbreaking international study has mapped over 400 distinct human cell types, providing powerful validation for Prof. Mike Chan's longstanding vision of organ-specific, cell-specific regenerative medicine. This pivotal research [1], authored by Prof. Mike Chan and published by Genesis Biomedical Research Institute in collaboration with global universities, represents a transformative leap in precision healthcare, including the complex realm of brain regeneration. The landmark Human Cytology Atlas utilized single-cell RNA sequencing, high-dimensional cytometry, and bioinformatics to classify and quantify human cell types across various organs — including the intricate human brain. This cellular roadmap redefines how therapies must be developed: not generically, but tailored to match specific cell populations within targeted organs. "While precision medicine has gained widespread recognition, I have always believed that true healing demands an even deeper understanding — acknowledging that every stem cell is inherently unique. Each of the 400+ human cell types carries distinct molecular blueprints, comprising specific molecules, amino acid sequences, proteins, glycation rates, and transcription factors, all intricately tailored to the organs and tissues they sustain. This principle has been the cornerstone of my work in developing targeted, brain-and-organ-specific-precursor stem cell bioregenerative therapies," said Prof. Dr. Mike Chan. "For true regenerative success, A1 must match A1, B6 must match B6, Z10 must match Z10. There are no shortcuts when it comes to restoring the body's natural cellular balance." The Brain: A Complex Frontier for Cellular Medicine Among all organs, the brain exemplifies the need for cellular precision. As Prof. Chan noted, "To heal the brain, we must understand every cell within it." The Human Cytology Atlas revealed extraordinary specialization within brain structures such as the frontal lobe, hippocampus, pineal gland, prefrontal cortex, and substantia nigra. Each region contains unique cell types with distinct roles, underlining why regenerative therapies must match the exact cells to the corresponding brain area [2]. Prof. Chan's protocols at European Wellness emphasize this targeted strategy: Frontal lobe neurons for Alzheimer's disease Prefrontal cortex cells for autism Pineal gland cells for sleep disorders Hippocampal neurons for memory and emotional balance Substantia nigra cells for Parkinson's disease The Atlas's validation of cell diversity confirms that brain regeneration requires organ-specific, cell-specific therapies — reinforcing European Wellness' pioneering approach. 5 Key Breakthroughs from the Human Cytology Study Over 400 Cell Types Classified: First-ever complete catalog of human cell types with defined biological roles. Quantitative Mapping of Cells by Organ: Precision data on cell numbers and distribution enables anatomically tailored therapies. Discovery of Rare Functional Subtypes: New therapeutic targets for repair, immunity, and neuro-regeneration uncovered. Validation of Organ-Specific Cellular Identity: Proves that stem cells must be matched specifically to organ and tissue type. Recognition of Variable Regenerative Capacities: Enables smarter, prioritized treatment designs for aging and chronic diseases. European Wellness: Precision Medicine in Action For the first time, regenerative medicine has an exact cellular blueprint to follow. Instead of relying on generalized interventions, clinicians can now design therapies that match organ structure and cellular identity — fulfilling a vision Prof. Mike Chan and European Wellness have advocated for over four decades. European Wellness Biomedical Group continues to be at the forefront of precision regenerative medicine. Through targeted organ-and-brain-specific precursor stem cell therapies, they deliver individualized programs targeting liver disease, cardiac conditions, neurodegenerative disorders, and memory restoration. References: [1] Chan MKS, Jambo SA, Jumat MI, Landa F, Saili NS, et al. Human Cytology: Classification and Quantitative Cell Landscape with Numbers, Types and Functional Diversity. J Stem Cell Res. 6(1):1-42. [2] Mike KS Chan, Mohd Iskandar Jumat*, Florisa Landa, Nur Shafawati Saili, Siti Azmah Jambo, et al. Exploring the Complexity of the Human Brain: Cell Types, Numbers, and Lobar Functions. Am J Biomed Sci & Res. 2025 26(4) About European Wellness Biomedical Group European Wellness is an award-winning biomedical group specializing in advanced targeted organ-and-brain-specific precursor stem cell therapy, anti-aging, and regenerative protocols. The Group operates flagship centers in Germany, Switzerland, Greece, Malaysia and all over Asia. View original content to download multimedia: SOURCE European Wellness Biomedical Group Sign in to access your portfolio
