Celularity's Regenerative Medicine Platform Accelerates Regulatory Momentum: Multi-Product FDA Pathway Gains Traction Ahead of 2024 Submissions

Celularity Inc. (Nasdaq: CELU), a biotechnology innovator focused on placental-derived cellular and biomaterial therapeutics, has secured significant regulatory validation for its expanding product portfolio. The company received preliminary clearance from the FDA’s Office of Combination Products that FUSE—its investigational bone void filler—should be classified and regulated as a medical device under the FDA’s Center for Devices and Radiological Health (CDRH). This decision paves the way for a 510(k) pre-market notification submission scheduled for early 2024.

Strategic Regulatory Win for Bone Regeneration Technology

FUSE represents a breakthrough in passive osteoconductivity, designed for use across multiple clinical settings including pelvic reconstruction, extremity repairs, and posterior-lateral spinal fusion procedures. The technology fills skeletal defects without requiring chemical intervention—a critical advantage in biomaterial design. The FDA’s preliminary assessment was based on Celularity’s comprehensive October 2022 Pre-Request for Designation submission, which demonstrated 100 percent biochemical characterization. The company’s proprietary processing methodology systematically removes cells, nucleic acids, growth factors, and inflammatory mediators, aligning precisely with FDA Class II Special Controls guidelines.

The global bone void filler market—valued at $3.2 billion in 2021—is projected to expand to $7.3 billion by 2031, driven by rising orthopedic disease prevalence (osteoarthritis, osteoporosis, bone infections) and an aging global population. This 8.5% compound annual growth rate presents substantial commercialization opportunities for Celularity’s biocompatible, absorbable FUSE technology.

Interfyl and Broader Biomaterial Portfolio Advance in Parallel

This regulatory progress complements Celularity’s broader regenerative medicine strategy. The company’s established biomaterial suite—including Interfyl (placental-derived connective tissue matrix for integumental repair), Biovance (decellularized amniotic membrane), Biovance 3L (tri-layer amniotic products for surgical and ocular applications), and CentaFlex (umbilical cord-derived surgical barrier)—demonstrates the company’s multifaceted approach to tissue regeneration. Interfyl, already indicated for wound and trauma repair in the U.S. market, exemplifies how Celularity leverages its 15+ biomaterial patent families to create diversified revenue streams while funding continuous R&D advancement.

The February announcement that Celularity’s investigational Tendon Wrap received similar FDA preliminary device classification reinforces this momentum, with a 510(k) submission targeted for end-of-2023, further validating the company’s cellular and biomaterial platform versatility.

Geographic Expansion Unlocks Emerging Market Opportunities

Complementing regulatory progress, Celularity recently finalized exclusive distribution agreements for Middle Eastern and North African markets. Through partnerships with AD Ports Logistics and CH Trading Group LLC, the company will distribute its biomaterial portfolio across the UAE, Qatar, Bahrain, Oman, Kuwait, and Egypt. These agreements capitalize on Celularity’s Halal-certified regenerative medicine products, creating a scalable channel for geographic diversification and establishing the company’s biomaterial products as a sustainable revenue engine to support its ongoing cellular medicine development in cancer, immunological, and degenerative disease indications.

CEO Robert J. Hariri, M.D., Ph.D., underscored the strategic coherence: “Our unique placental technology platform generates two independent but complementary product opportunities—cellular therapeutics and biomaterials—each driving value creation and supporting the next generation of placenta-derived therapeutics.”

What 510(k) Submissions Mean for Market Access

The 510(k) regulatory pathway—a pre-market notification mechanism required 90 days before device commercialization—allows Celularity to demonstrate substantial equivalence to predicate devices and accelerate time-to-market. Unlike more complex approval pathways, successful 510(k) clearance typically enables faster commercial launch, reducing barriers to entry in both orthopedic and surgical markets.

With FUSE positioned for 2024 market entry and the Tendon Wrap approaching year-end submission, Celularity is consolidating a multi-product regulatory strategy that leverages its proprietary placental biology to address significant unmet clinical needs while diversifying revenue across cellular medicine and biomaterial commercialization segments.