Celularity Receives U.S. Food And Drug Administration (FDA) Preliminary Assessment For Celularity’s Investigational Fuse Bone Void Filler To Be Regulated As A Device By FDA’s Center For Devices And Radiological Health
Celularity Inc. (Nasdaq: CELU) announced that the FDA has conducted a preliminary classification of its investigational FUSE Bone Void Filler, recommending that it be classified as a device under its Center for Devices and Radiological Health (CDRH). This follows Celularity's Pre-Request for Designation (Pre-RFD) from October 2022. The company plans to submit its 510(k) pre-market notification to the FDA in early 2024. The global bone void filler market is expected to grow from $3.2 billion in 2021 to $7.3 billion by 2031, driven by factors such as an increase in orthopedic diseases and an aging population.
- FDA's preliminary classification of FUSE as a device paves the way for the 510(k) submission.
- Projected growth of global bone void filler market presents substantial revenue potential.
- Celularity's innovative use of placenta-derived products enhances its product offering.
- Preliminary FDA assessment is non-binding, introducing uncertainty.
- There are inherent risks in biotechnological product development and regulatory processes.
Celularity’s Pre-Request for Designation (Pre-RFD) is based on
data demonstrating 100 percent biochemical characterization of the product
Celularity intends to submit 510(k) pre-market notification to
the FDA Center for Devices and Radiological Health (CDRH) in early 2024
Today’s FUSE and February’s Investigational Celularity Tendon Wrap Regulatory Updates, Coupled with Celularity’s Growing Middle East Distribution Agreements, Highlight
Celularity’s Suite of Innovative Biomaterial Products
FLORHAM PARK, N.J., April 03, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that it received notice from the U.S. Food and Drug Administration (FDA) that the FDA’s Office of Combination Products (OCP) completed its preliminary product classification and jurisdictional assessment of Celularity’s investigational FUSE Bone Void Filler (“FUSE”). FUSE is being developed for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects that are not dependent on chemical action to mediate an effect.
The notification was in response to Celularity’s October 2022 Pre-Request for Designation (Pre-RFD). The OCP reviewed information provided by Celularity in its Pre-RFD, on the basis of which the OCP made a preliminary assessment that it agrees with Celularity’s recommendation that FUSE should be classified as a device regulated by the FDA’s Center for Devices and Radiological Health (CDRH). The OCP preliminary assessment is non-binding. Based on the OCP’s preliminary assessment, Celularity now intends to submit a 510(k) notification for FUSE in early 2024.
“We are delighted to receive the FDA’s feedback about the preliminary FUSE product classification and CDRH jurisdiction, on the basis of which we anticipate a 510(k) pre-market notification submission for FUSE in early 2024,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “Celularity’s unique technology platform is grounded in our use of the post-partum placenta as the source of cells and biomaterials for the development of therapeutics. This creates two independent but complimentary product opportunities in cellular and regenerative medicine. FUSE is an example of how Celularity develops innovative products from the placenta, leveraging our more than 15 biomaterial-related patent families and multiple issued patents. For Celularity, our suite of biomaterial products is a revenue engine that supports continuous new product research and development and enhances the value proposition for our investors.”
As part of its FUSE pre-RFD submission, Celularity provided data to demonstrate that its proprietary processing steps are designed to remove all cells, cellular debris, residual nucleic acids, cytokines and chemokines, residual hormones, growth factors and other regulators of wound healing, scarring and fibrosis, and well as anti- and pro-inflammatory factors. These processing steps are fully aligned with stringent requirements defined within FDA’s Class II Special Controls Guidance Documents for Industry and FDA Staff.
FUSE has been designed as an absorbable, biocompatible, and osteoconductive in nature bone void filler. Following placement in the bony void or gap, FUSE resorbs and is replaced with bone during the healing process.
The global bone void filler market size was valued at
About 510(k) Submission
A 510(k) submission refers to Section 510(k) of the Food, Drug and Cosmetic Act, which requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Pre-market Notification, also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.
Celularity’s Advanced Biomaterial Products
Celularity markets a suite of commercial placenta-derived biomaterial products, including:
- 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 is indicated for use in the United States as a natural scaffold to support the body’s wound healing process.
- Biovance® 3L and Biovance® 3L Ocular, tri-layer human amniotic membrane products focused on the 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 indicated for use in the United States 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 is indicated for use in the United States as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.
Recently, Celularity announced an exclusive distribution agreement with AD Ports Logistics (ADPL), a subsidiary of the Logistics Cluster, AD Ports Group, the leading global facilitator of trade, logistics and industry based in Abu Dhabi. In partnership with CH Trading Group LLC, an international import, export and trading company and the exclusive territories distributor of Celularity’s previously announced Halal-Certified regenerative medicine products within more than 100 countries, ADPL will distribute the Celularity’s biomaterial products in the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait and Egypt. “Celularity will continue to leverage global opportunities to distribute biomaterial products into untapped markets while aggressively advancing our cellular medicine candidates in clinical development in cancer, immunological and degenerative diseases,” added Dr. Hariri.
In addition, Celularity announced in February that, in response to its October 2022 Pre-RFD for its investigational Celularity Tendon Wrap (CTW), the FDA has reviewed information provided by the Company and other relevant available information, and agreed with the Company’s recommendation that its investigational CTW product be regulated as a device by the FDA Center for Devices and Radiologic Health (CDRH). The FDA feedback is preliminary and non-binding. Celularity intends to submit a 510(k) application for regulatory clearance to CDRH by the end of 2023. Celularity’s 510(k) submission to CDRH for CTW is intended to be for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue as a structural barrier for injured tendon tissue, and does not depend on chemical action to mediate this effect, to be classified as a surgical mesh.
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, and cancer. 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.
To learn more, visit celularity.com
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 express or implied statements regarding Celularity’s ability to timely submit a 510(k) submission and obtain regulatory clearance of its FUSE Bone Void Filler product from the FDA; expected commercialization of its FUSE Bone Void Filler product; the size and growth of the global bone void filler market; and Celularity’s ability to advance its cellular medicine candidates in clinical development in cancer, immunological and degenerative diseases; among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel biomaterial products and cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and 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.
Celularity Contact:
Paul Graves, Chief Communications Officer
Celularity Inc.
paul.graves@celularity.com
FAQ
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