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Home » Products » Database of U.S. FDA RMAT Designations (53)
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RMAT Designation

Database of U.S. FDA RMAT Designations (53)

Category: Stem Cells Tag: RMAT
  • Description

Description

The world’s only searchable, sortable database of RMAT designations that is continuously updated.

To date, 53 RMAT designations have been publicly announced. However, the FDA states it has received 165 requests and issued 62, which means that a handful are not yet public knowledge.

Discover class-defining bioproduction tools.

To date, three companies (Abeona Therapeutics, Athersys, and Rocket Pharmaceuticals) have received multiple RMAT designations from the 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 in 2017, BioInformant’s team of analysts have maintained a searchable, sortable database of every approval.  

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 the most innovative competitors within the marketplace.

In addition to identifying products under development and the conditions they treat, the database allows you to assess the year-over-year 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 $49 (20% 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.

$59 $49

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