Celularity Receives Preliminary Assessment of Product Classification and Jurisdiction for Its Investigational Celularity Tendon Wrap (CTW) to be Regulated as a Device Within U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH)
Celularity Inc. (Nasdaq: CELU) has announced intentions to submit a 510(k) pre-market notification to the FDA for its investigational Celularity Tendon Wrap (CTW). The FDA has agreed to regulate CTW as a device, based on the company's recommendation. The CTW is designed for tendon injuries without substantial tissue loss, serving as a surgical mesh. The global tendon repair market was valued at $2.1 billion in 2021, with a projected CAGR of 7.5% through 2030. Celularity also has exclusive agreements for distributing its biomaterial products in over 100 countries. The submission is expected by year-end with planned product launch in 2024.
- FDA agreement to regulate CTW as a device indicates potential pathway to market.
- 510(k) submission intended for 2023 could expedite commercialization.
- Significant market potential in the tendon repair market, valued at $2.1 billion in 2021.
- FDA feedback is preliminary and non-binding, indicating potential uncertainties in approval.
- Dependence on successful 510(k) application poses regulatory risks.
Celularity’s Pre-Request for Designation (Pre-RFD) is based on data showing
CTW contains 100 percent extracellular matrix
Celularity to submit 510(k) pre-market notification to
the FDA Center for Devices and Radiological Health (CDRH)
FLORHAM PARK, N.J., Feb. 01, 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, in response to its October 2022 Pre-Request for Designation (Pre-RFD) for its investigational Celularity Tendon Wrap (CTW), the U.S. Food and Drug Administration (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 Radiological 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 depend on chemical action to mediate this effect, to be classified as a surgical mesh.
“We are delighted to receive this feedback from the FDA on preliminary CTW product classification and CDRH jurisdiction,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “Our unique business model continues to generate innovative therapeutic products from the biomaterials and stem, progenitor and immune cells derived from the placenta. We have had a history of developing and commercializing products for degenerative diseases and see great potential to use this part of our business as a revenue engine to help support continue research and development as well as enhance the value proposition for our investors. We will work with the FDA to provide the appropriate pre-clinical data to support a 510(k) pre-market notification submission later this year, and expect to launch our product in 2024.”
As part of its CTW Pre-RFD submission, Celularity also provided supporting data demonstrating that its proprietary processing steps are designed to remove from CTW 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.
The global tendon repair market 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. Most recently, the Company announced an exclusive territory agreement with CH Trading Group, an international import, export, and trading company, to distribute Celularity’s branded regenerative biomaterial products -- which are Halal-Certified under globally recognized Circle H International Inc. standards -- in more than 100 countries.
Celularity’s advanced biomaterial products include:
- 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.
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 CTW product from the FDA; expected commercialization of its CTW product; and the size and growth of the global tendon repair market, 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, 2022, as amended on July 15, 2022, 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 Media Contact:
Paul Graves SVP, Chief Communications Officer
Celularity Inc.
paul.graves@celularity.com
Celularity Investor Contact:
Carlos Ramirez SVP, Investor Relations
Celularity Inc.
carlos.ramirez@celularity.com
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