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Celularity & Fountain Life Announce Partnership to Deliver Stem Cell Therapies Under New Florida Law
GlobeNewswire News Room· 2025-07-09 12:30
Fountain Life operates four flagship longevity centers, including two in Florida, where a new state law effective July 1, 2025, authorizes licensed physicians to administer stem cell therapies to members with conditions in orthopedics, wound care, and pain management. FLORHAM PARK, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it entered into ...
Celularity Hails New Florida Law Opening Patient Access to Stem Cell Therapies
Globenewswire· 2025-07-01 12:30
Core Viewpoint - A new Florida law effective July 1, 2025, allows physicians to provide investigational stem cell therapies for orthopedics, wound care, and pain management, with strict safety and ethical standards in place [1][2]. Group 1: New Legislation - The law permits the use of stem cell therapies not yet approved by the FDA, with strict limits on the sources of stem cells, which must come from FDA-registered facilities [2][4]. - Physicians are required to obtain informed consent from patients before administering these therapies [2]. Group 2: Company Positioning - Celularity Inc. is prepared to supply ethically sourced stem cells for these treatments and has a facility that complies with the new law's requirements [2][4]. - The company has extensive knowledge and real-world data from clinical trials related to the therapies authorized under the new law [3][4]. Group 3: Industry Impact - The Florida Medical Association was involved in crafting the legislation to balance public protection against ineffective therapies and avoid overregulation of physicians [4]. - The law is seen as a potential model for other states, emphasizing the role of physicians in assessing the best therapeutic approaches for patients [4]. Group 4: Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on placental-derived cell therapies and advanced biomaterial products [5]. - The company aims to address significant unmet global needs for effective and affordable therapies by utilizing the unique biology of the placenta [5].
Celularity Announces Chief Financial Officer Transition
Globenewswire· 2025-06-10 20:15
Core Points - Celularity Inc. has terminated its Chief Financial Officer, David Beers, effective immediately, without cause, and this decision is not related to the company's financial performance or reporting practices [1] - Joseph DosSantos, the current Senior Vice President of Finance, has been appointed as the interim CFO while the company searches for a new CFO [2] - The company has retained CFO Squad, a financial and business advisory firm, to provide outsourced accounting and consulting services during this transition period, focusing on SEC and financial reporting support [3] Company Overview - Celularity Inc. is a regenerative and cellular medicine company that develops and commercializes advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, utilizing the postpartum placenta [4]
Celularity Announces Full Year 2024 Operating and Financial Results
Globenewswire· 2025-05-09 13:15
Core Viewpoint - Celularity Inc. reported significant growth in net revenues for the year ending December 31, 2024, totaling $54.2 million, which represents an increase of $31.4 million or 138.1% compared to the previous year, driven primarily by strong sales in wound care applications [1][3]. Financial Performance - Net revenues for 2024 were $54.2 million, an increase of $31.4 million or 138.1% from the prior year, with product sales in wound care applications rising by $22.2 million, reflecting a growth of 168.7% [1][3]. - Total operating expenses decreased to $92.6 million, down by $122.5 million or 57.0% compared to 2023, mainly due to the absence of goodwill and in-process research and development impairments [4][6]. - Loss from operations for 2024 was $38.4 million, a decrease of $153.9 million or 80.1% from the previous year, attributed to higher revenues and lower operating expenses, which improved gross margin [4][6]. Product and Market Development - The company experienced strong sales growth in its Biovance® product line, which is expected to continue contributing positively to revenue in the upcoming quarters [2]. - Celularity received recommendation letters from the U.S. FDA Tissue Reference Group for new additions to its portfolio of human placental-derived advanced biomaterial products, indicating a commitment to innovation in the wound care sector [2]. Balance Sheet Overview - As of December 31, 2024, total assets were $132.7 million, a decrease from $143.9 million in 2023, with current assets amounting to $20.6 million [8][9]. - Total liabilities increased to $123.8 million from $102.9 million in the previous year, with current liabilities at $53.7 million [8][9]. Company Background - Celularity Inc. is focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies, aiming to address significant unmet global needs for effective and affordable therapies [10].
Celularity Welcomes CMS Action on Medicare Local Coverage Determination for Skin Substitutes Products
Globenewswire· 2025-04-14 12:00
Core Points - The Centers for Medicare & Medicaid Services (CMS) has revised the effective date of the Medicare Local Coverage Determination (LCD) for skin substitute products to January 1, 2026, which is used to treat diabetic foot ulcers and venous leg ulcers [1][3] - This action follows a January 2025 executive order by President Trump that froze all regulatory guidance not yet in effect, leading to a previous delay of the LCD's effective date by sixty days [3] - Celularity Inc. expressed support for CMS's decision, highlighting the importance of access to skin substitute products for Medicare patients to avoid serious health complications [4] Company Overview - Celularity Inc. is a regenerative and cellular medicine company focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies [5] - The company aims to leverage the unique biology of the placenta to create effective, accessible, and affordable therapeutic solutions for significant unmet global health needs [5]