Celularity Inc. announced 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.

As part of its FUSE pre-RFD submission, Celularity provided data to demonstrate that its proprietary processing steps are designed to remove all cells, cellular debris, residual nucleic acids, cytokines and chemokines, residual hormones, growth factors and other regulators of wound healing, scarring and fibrosis, and well as anti- and pro-inflammatory factors. These processing steps are fully aligned with stringent requirements defined within FDA's Class II Special Controls Guidance Documents for Industry and FDA Staff. FUSE has been designed as an absorbable, biocompatible, and osteo conductive in nature bone void filler.

Following placement in the bony void or gap, FUSE resorbs and is replaced with bone during the healing process. The global bone void filler market size was valued at $3.2 billion in 2021 and projected to reach $7.3 billion by 2031, growing at a compound annual growth rate (CAGR) of 8.5% from 2022 to 2031, according to a 2022 report by Allied Market Research (AMR). The growth of the market size for global bone void fillers is driven largely by an increase in prevalence of orthopedic diseases, such as osteoarthritis, osteoporosis, scoliosis, bone tumor and bone infection, as well as a surge in geriatric populations, according to the AMR report.