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Celularity (CELU) - Prospectus
2025-12-31 21:15
As filed with the Securities and Exchange Commission on December 31, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CELULARITY INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 83-1702591 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 170 Park Aven ...
Celularity CEO Comments on Centers for Medicare & Medicaid Services' Withdrawal of Skin Substitute Local Coverage Determinations
Globenewswire· 2025-12-26 13:30
Core Viewpoint - Celularity Inc. welcomes the withdrawal of the Local Coverage Determinations (LCDs) for skin substitute products by the Centers for Medicare & Medicaid Services (CMS), which were set to take effect on January 1, 2026, while ensuring that its Biovance® and Biovance 3L products remain eligible for Medicare coverage [1][2] Group 1: CMS Actions - On December 24, 2025, CMS announced the immediate withdrawal of LCDs for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, which would have affected coverage starting January 1, 2026 [2] - The withdrawn LCDs eliminated Medicare coverage for 158 skin substitute products from other companies, while Celularity's products remained unaffected [2] Group 2: Company Insights - Dr. Robert J. Hariri, CEO of Celularity, highlighted the substantial real-world evidence supporting the effectiveness of Biovance® in treating chronic wounds across diverse patient populations [3] - Biovance® has shown a reduction in steroid use in about 50% of treated patients, which may help decrease pro-inflammatory factors and enhance the body's natural healing process [3] - The new Medicare payment policy, effective January 1, 2026, will reimburse skin substitute applications at a flat rate of $127.28 per square centimeter, which Celularity is prepared to operate under due to its efficient manufacturing process [3] Group 3: Company Overview - Celularity Inc. is focused on developing, manufacturing, and commercializing advanced biomaterial products and cell therapies derived from postpartum placenta, addressing significant unmet needs in regenerative medicine [4] - The company aims to leverage the unique biology of the placenta to create effective and affordable therapies targeting aging mechanisms such as cellular senescence and chronic inflammation [4]
Celularity (CELU) - Prospectus
2025-12-19 21:15
As filed with the Securities and Exchange Commission on December 19, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (State or other jurisdiction of incorporation or organization) Delaware 2834 83-1702591 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 170 Park Avenue Florham Park, New Jersey 07932 (908) 768-2170 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CELULARITY INC. (Exact ...
Celularity and DefEYE, Inc. Partner to Advance Growth of Regenerative Therapies in Eye Care
Globenewswire· 2025-10-30 12:00
Core Insights - Celularity Inc. has formed a strategic partnership with DefEYE, Inc., focusing on regenerative therapies in eye care through an exclusive license and pricing arrangement [1][3] - DefEYE aims to leverage Celularity's expertise and biologics portfolio to enhance its offerings in the ophthalmic market, with a significant sales growth of nearly 70% in 2024 compared to the previous year [2][3] - The partnership is expected to facilitate the launch and scaling of decellularized biologic solutions for eye care, with Celularity serving as the exclusive contract manufacturer for DefEYE's products [2][5] Company Overview - Celularity Inc. specializes in regenerative and aging-related cellular medicine, developing advanced biomaterial products and cell therapies derived from postpartum placenta [5] - DefEYE, Inc. is focused on transforming therapeutic approaches in eye care, delivering innovative decellularized biologic solutions for various ocular conditions [6] Strategic Implications - The collaboration is seen as a strategic opportunity for both companies, aligning their capabilities to drive innovation in the eye care sector [3][5] - Celularity's investment and licensing agreement reflect its commitment to expanding into new markets and enhancing its portfolio of commercial products [3][5]