Celularity Announces Commercial Biomaterial Products Receive Saudi Food and Drug Authority (SFDA) Product Classification
October 18 2023 - 9:00AM
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.”
About Celularity
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.
Forward-Looking Statements
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
carlos.ramirez@celularity.com
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