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.
- Biovance®3L 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.
“The SFDA’s Minimally Manipulated Biological Product classification establishes a clear regulatory pathway for the importation of our Halal Certified biomaterial products into Saudi Arabia,” said Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and Founder of Celularity. “As such, SFDA classification marks the achievement of another important step in launching product sales with our commercial partners in the region, including Tamer Group, with which we announced an exclusive distribution agreement earlier this year for Celularity’s branded biomaterial products in Saudi Arabia. This is a critical milestone in Celularity’s globalization strategy to bring our technologies to important markets in the Islamic world and beyond.”
Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular and regenerative medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. These therapeutic programs target indications in autoimmune, infectious, and degenerative diseases. In addition, Celularity develops, manufactures, and commercializes innovative biomaterial products also derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.
This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include statements regarding Celularity’s ability to obtain an importation license from the SFDA; the ability to commercialize its technologies in Saudi Arabia, the MENA region and the broader Islamic markets; and other commercial risks associated with the Tamer Group and other distribution partners, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including the inherent risks in biotechnological development, the risks associated with Celularity’s current liquidity, developments relating to the biotechnology industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. These risks and uncertainties may be amplified by current economic situations, including inflation, supply chain issues and overall economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
To learn more, visit celularity.com
Celularity Media/Investor Contact:
Carlos Ramirez, SVP Investor Relations [email protected]
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