Celularity Announces Commercial Biomaterial Products Receive Saudi Food and Drug Authority (SFDA) Product Classification

SFDA Classification Establishes Clear Regulatory Pathway for Importation
 of Celularity’s Commercial Biomaterial Products into the Kingdom of Saudi Arabia

FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia. The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:

• Biovance, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound-healing process.
  
• Biovance3L and Biovance 3L Ocular are tri-layer human amniotic membrane products focused on the wound care, surgical, and ocular markets and available in both sheet and disk form.
  
• Interfyl, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is used by a variety of medical specialists to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
  
• CentaFlex, a decellularized human placental matrix derived from the umbilical cord that can be used as a surgical covering, wrap, or barrier to protect and support the repair of damaged tissue.
  

In December 2022, Celularity announced that it received Halal Certification of its business models, commercial-stage advanced biomaterial products, and clinical and investigational stage cellular therapeutic programs, indicating that they have undergone rigorous assessment to determine that they are permissible or acceptable in accordance with Islamic law or Sharia. Halal Certification underpins Celularity’s ability to serve Islamic markets globally, including previously announced initiatives in the Middle East North Africa (MENA) region and in furtherance of our partnership with Genting Innovation PTD LTD in Southeast Asia.