Feb. 27 at 5:00 PM
$MDXG $ORGO there are only four PMA skin substitutes per CMS classification and none belong to MDXG: Dermagraft, Apligraft, Trancyte (ORGO) and Integra.
Starting 2027, CMS will reimburse this category at a different rate than the 510 clearance products such as Epifix. IF Renu gets FDA approval by December 2026 (good chance with RMAT designation and current FDA administration), based on being first to market and target volume (30 million moderate -severe arthritis) estimated target price will range between
$15-
$24.
