Description
The world’s only searchable, sortable database of RMAT designations that is continuously updated on a daily basis.
To date, 46 RMAT designations have been publicly announced. However, the FDA states it has received 146 requests and issued 52.
The most recent addition to this list was the RMAT awarded to Athersys on September 23, 2020, for use of MultiStem in the treatment of ARSD. Prior to that, Medeor Therapeutics received an RMAT for its cell therapy, MDR-101, in the prevention of kidney transplant rejection.
Thus far, only two companies (Abeona Therapeutics and Athersys) have received two RMATs from the U.S. FDA.
RMAT stands for “Regenerative Medicine Advanced Therapy” designation. Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
While cell and gene therapies have been the most common recipients of RMAT awards, tissue engineering and combination products have also received them.
RMAT Designations
Since the RMAT designation was introduced, BioInformant has maintained a searchable, sortable database of approvals that is updated daily by our dedicated team of analysts.
It was originally developed in-house for our own purposes, but we had more and more clients requesting access to it.
The database presents all known RMAT recipients, including:
- Company Name
- Product Name
- Medical Indication
- Date of Approval
- Product Category (Cell Therapy, Gene Therapy, Tissue or Combination Product)
- Company Website
- Link to RMAT Announcement
Because RMAT designations allow for faster, more streamlined approvals of regenerative medicine products within the U.S., this database reveals the identities of 44 of the most innovative competitors within the marketplace.
In addition to identifying products under development and the conditions they treat, the database is searchable and sortable, allowing you to assess the rate of increase in RMAT designations over time.
Because it is an essential resource within our company, we’re confident it will be a valuable resource for you too.
For a brief time, you can claim this comprehensive RMAT Database for only $37 (25% off).
Act now, before this offer expires and receive this database instantly as an Excel download.
Of course, your investment is backed by a Greater than 100% Money Back Guarantee.
Last Update: September 25, 2020.
