Celularity

Celularity Inc. is a United States-based regenerative and cellular medicine company listed on the Nasdaq Capital Market under the ticker CELU. It is developing and commercializing advanced biomaterial products and allogeneic, cryopreserved cell therapies, all derived from the postpartum placenta, with the goal of targeting age-related and other serious diseases. The company describes its proprietary approach as harnessing the placenta's unique biology and ready availability to create therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. Celularity's scientific platform is built on two decades of research into placental-derived cells. Its allogeneic platform includes mesenchymal-like adherent stromal cells (MLASCs), natural killer (NK) cells, and T cells, which the company says offer greater expandability, persistence, and stem-ness. The company positions itself as a fully integrated cellular medicine manufacturer, following the principle that "the process is the product." Its pipeline spans both advanced biomaterials and clinical-stage cell therapies. The advanced biomaterials pipeline includes amniotic membrane allografts and tri-layer amniotic membrane allografts for wound care and ocular protection, a placental connective tissue matrix, the Celularity Tendon Wrap (CTW) for surgical tendon management, the FUSE Bone Void Filler for orthopedics, bone, spine, and dental applications, and the Celularity Placental Matrix (CPM) for soft tissue management. Several of these products are regulated under Section 361 of the Public Health Service Act as human cells, tissues, and cellular and tissue-based products (HCT/Ps), while others are expected to require 510(k) filings. The clinical research pipeline includes MLASC candidates such as PDA-001 and PDA-002, which have completed Phase 2 studies in autoimmune conditions including Crohn's disease and diabetic foot ulcers, pending an FDA end-of-Phase 2 meeting. The company reports more than 15 active and completed trials. Celularity's history traces back to Anthrogenesis, founded in 1998, which merged with Celgene in 2002. Celularity itself was spun out in 2017 and became a public company in 2021. The company is led by founder, chairperson, and CEO Robert J. Hariri, M.D., Ph.D., supported by a leadership team with experience across cellular and regenerative medicine, including Anna Gosiewska, Ph.D. (R&D, degenerative diseases), Sharmila Koppisetti, M.D. (clinical development, immunology and drug safety), and Tim Wilk (technical operations). Celularity is headquartered in Madison, New Jersey.

Celularity's corporate lineage begins with Anthrogenesis, founded in 1998. Anthrogenesis focused on the therapeutic potential of the postpartum placenta, a line of research that would become the scientific foundation of Celularity. In 2002, Anthrogenesis merged with Celgene, a larger biopharmaceutical company, giving the placental-derived cell research a broader corporate platform. Celularity was spun out as an independent company in 2017, allowing it to focus exclusively on placental-derived cellular medicines and biomaterials. The company built an allogeneic platform based on two decades of science, developing mesenchymal-like adherent stromal cells (MLASCs), natural killer (NK) cells, and T cells derived from the placenta. Its approach emphasizes off-the-shelf, cryopreserved therapies that can be delivered on demand, addressing barriers of scale, quality, and economics that have limited other cellular medicines. In 2021, Celularity became a public company, listing on the Nasdaq under the ticker CELU. As a clinical and commercial stage biotechnology company, it has pursued both a clinical research pipeline and a commercial advanced biomaterials business. Its clinical pipeline includes MLASC candidates such as PDA-001 and PDA-002, which have completed Phase 2 studies in autoimmune conditions including Crohn's disease and diabetic foot ulcers, pending an FDA end-of-Phase 2 meeting. The company reports more than 15 active and completed trials. On the commercial side, Celularity has developed a range of advanced biomaterials, including amniotic membrane allografts and tri-layer amniotic membrane allografts for wound care and ocular protection, a placental connective tissue matrix, the Celularity Tendon Wrap (CTW) for surgical tendon management, the FUSE Bone Void Filler for orthopedics, bone, spine, and dental applications, and the Celularity Placental Matrix (CPM) for soft tissue management. Several of these are regulated under Section 361 HCT/P pathways, while others are expected to require 510(k) filings. The company is headquartered in Madison, New Jersey, and is led by founder, chairperson, and CEO Robert J. Hariri, M.D., Ph.D. Its leadership team includes Anna Gosiewska, Ph.D. (R&D, degenerative diseases), Sharmila Koppisetti, M.D. (clinical development, immunology and drug safety), and Tim Wilk (technical operations). Celularity describes its mission as leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies at unparalleled scale, quality, and economics.

• 2021

  Celularity became a public company (NASDAQ: CELU)

• 2017

  Celularity spun out as an independent company

• 2002

  Anthrogenesis merged with Celgene

• 1998

  Anthrogenesis founded

Clinical and commercial stage biotechnology company leading the next evolution in cellular and regenerative medicine with off-the-shelf placental-derived allogeneic cell therapies and biomaterial products designed for serious unmet medical needs.

• Amniotic Membrane Allograft

  Wound care product regulated under 361 HCT/P.

• Tri-Layer Amniotic Membrane Allograft

  Wound care and ocular protective cover product regulated under 361 HCT/P.

• Placental Connective Tissue Matrix

  Wound care product regulated under 361 HCT/P.

• Celularity Tendon Wrap (CTW)

  Surgical tendon management product; expected 510(k) filing.

• FUSE Bone Void Filler

  Orthopedics / bone, spine, dental product; expected 510(k) filing.

• Celularity Placental Matrix (CPM)

  Soft tissue management product; expected 510(k) filing.

• PDA-001 / PDA-002

  MLASC candidates; Phase 2 studies complete in autoimmune (Crohn's) and DFU, pending FDA EOP-2 meeting.

1. 1Celularity – The Next Evolution in Cellular Medicinecelularity.com
2. 2About – Celularitycelularity.com
3. 3Pipeline – Celularitycelularity.com
4. 4Leadership – Celularitycelularity.com
5. 5Celularity (United States) – Wikidatawikidata.org
6. 6Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndromeprnewswire.com
7. 7LaSalle REIT acquires NJ life science property for $46M - Real Estate Weeklyrew-online.com