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Celularity Receives U.S. Food And Drug Administration (FDA) Preliminary Assessment For Celularity’s Investigational Fuse Bone Void Filler To Be Regulated As A Device By FDA’s Center For Devices And Radiological Health
Celularity’s Pre-Request for Designation (Pre-RFD) is based on data demonstrating 100 percent biochemical characterization of the product Celularity intends
About this update from Celularity Inc.
[{"type":"text","content":"Celularity’s Pre-Request for Designation (Pre-RFD) is based on data demonstrating 100 percent biochemical characterization of the product Celularity intends to submit 510(k) pre-market notification to the FDA Center for Devices and Radiological Health (CDRH) in early 2024 Today’s FUSE and February’s Investigational Celularity Tendon Wrap Regulatory Updates, Coupled with Celularity’s Growing Middle East Distribution Agreements, Highlight Celularity’s Suite of Innovative Biomaterial Products FLORHAM PARK, N.J., April 03, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that it received notice from the U.S. Food and Drug Administration (FDA) that the FDA’s Office of Combination Products (OCP) completed its preliminary product classification and jurisdictional assessment of Celularity’s investigational FUSE Bone Void Filler (“FUSE”). FUSE is being developed for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects that are not dependent on chemical action to mediate an effect. The notification was in response to Celularity’s October 2022 Pre-Request for Designation (Pre-RFD). The OCP reviewed information provided by Celularity in its Pre-RFD, on the basis of which the OCP made a preliminary assessment that it agrees with Celularity’s recommendation that FUSE should be classified as a device regulated by the FDA’s Center for Devices and Radiological Health (CDRH). The OCP preliminary assessment is non-binding. Based on the OCP’s preliminary assessment, Celularity now intends to submit a 510(k) notification for FUSE in early 2024. “We are delighted to receive the FDA’s feedback about the preliminary FUSE product classification and CDRH jurisdiction, on the basis of which we anticipate a 510(k) pre-market notification submission for FUSE in early 2024,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “Celularity’s unique technology platform is grounded in our use of the post-partum placenta as the source of cells and biomaterials for the development of therapeutics. This creates two independent but complimentary product opportunities in cellular and rege...