January 21, 2021

The Niche

Trusted stem cell blog & resources

FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

Peter-Marks Regenerative Medicine Advanced Therapy Designation RMAT
A picture of Peter Marks from the blog post when RMATs first went live.

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain.

The numbers really jumped in the last month.

I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm names are to relevant press releases or other reference material.

A special thanks to some folks at ARM for helping me keep the list up to date.

You can stay up to date on the running total of RMATs in the public domain here.

You can see at right a picture of CBER Director Peter Marks from the original FDA blog post when RMATs first went live just about 2.5 years ago.

I wonder how many of these regenerative therapies will get full FDA approval in the end? My hope is quite a few, which would justify the RMAT program. I don’t believe it’ll be zero. This is one of the most important questions for the stem cell field.

Here’s the list updated as of September 24, 2019 with a remarkable 36 total:

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