Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products

FLORHAM PARK, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ:CELU) ("Celularity" or the "Company"), a regenerative and cellular medicine company, today announced that on December 19, 2024, it received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG, in response to the Company's requests regarding its Natalin and Acelagraft™ products confirming that each product "appears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271." FDA's recommendations reflect that each meets the criteria to be regulated solely under section 361 (21 CRFR Part 1271.10(a)) as a human cell, tissue and cellular and tissue-based product, or HCT/P, for given indication for use.

Natalin is a decellularized dehydrated amnion derived tri-layer graft and Acelagraft™ is a decellularized dehydrated amnion derived bi-layer graft. Both Natalin and Acelagraft™ are indicated for use in partial and full thickness acute and chronic wounds.

According to Nova One Advisor, the 2024 global Biological Skin Substitutes market was $347.75 million and projected to grow at a compound annual growth rate, or CAGR, of 8.83% through 2034 to reach $810.50 million. The chronic wounds segment, which includes diabetic foot ulcers, pressure ulcers and venous leg ulcers, is anticipated to grow at a 9.13% CAGR over the forecast period, the fastest of any segment. North America was the largest market accounting for 42.0% of the 2024 global market according to Nova One Advisor.

"We are extremely pleased to receive these TRG recommendation letters on important additions to our portfolio of human placental-derived biomaterials, which serves as a further testament to our commitment to innovate in the wound care sector and will further enable us to build on our commercial momentum," commented Dr. Robert Hariri, Chairman and CEO of Celularity.

About the Tissue Reference Group

The Tissue Reference Group, or TRG, is a working group within the FDA that responds to inquiries from manufacturers and sponsors regarding their existing, investigational, or proposed products containing or consisting of HCT/Ps. The TRG provides recommendation letters to inquiring stakeholders concerning, among other things, the application of the criteria in 21 CFR 1271.10(a) to the regulation of human cells, tissues and cellular and tissue-based products, or HCT/P, for given indication(s) for use and whether a submitted product appears to meet HCT/P regulatory requirements. A TRG recommendation letter referencing Section 361 of the Public Health Service Act is used by the Centers for Medicare and Medicaid Services, or CMS, and other agencies to confirm the regulatory status of an HCT/P and that it meets the criteria for regulation solely under Section 361 of the Public Health Services Act, versus requiring premarket approval as a drug or biologic. 

About Celularity

Celularity Inc. (NASDAQ:CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all 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. For more information, visit www.celularity.com.

Forward Looking Statements

This press release includes "forward-looking statements" (as defined under Federal securities laws). 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," "could," "expect," "forecast," "may," "plan," "project," "should," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including 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 July 30, 2024, and other filings with the SEC. 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 contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Carlos Ramirez

Senior Vice President, Celularity Inc.

[email protected]