According to the below, the company is one of 11 with 2 RMAT designations from the FDA, respectively in regard to Rexlemestrocel for CLBP and Revascor for end stage heart failure patients with LVADs. They were granted in early 2023 and end of 2017 respectively. Revascor for end-stage HF with LVAD also has an orphan drug designation - wonder if they had applied for an ODD voucner as they did (and were approved) for HLHS for kids.
https://bioinformant.com/product/rmat-designations/#:~:text=Additionally%2C%2011%20companies%20(Abeona%20Therapeutics,designations%20from%20the%20U.S.%20FDA.
https://www.mesoblast.com/product-candidates/cardiovascular-diseases/congestive-heart-failure#:~:text=Pilot%20trial%20results%20formed%20the,diseases%20and%20life%2Dthreatening%20conditions
The conditions for qualifying for accelerated approval under an RMAT umbrella are outlined on p.10 of this 2019 FDA guidance document for the RMAT designation, with AA being the pathway that has been clearly guided by the FDA in their March quarter meeting with the company as something for it to pursue:
https://www.fda.gov/media/120267/download
Cell Therapy News/Articles, page-17784
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