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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 ...
Celularity Receives Preliminary Assessment of Product Classification and Jurisdiction for Its Investigational Celularity Tendon Wrap (CTW) to be Regulated as
About this update from Celularity Inc.
[{"type":"text","content":"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) \n 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...