The underlying science required for cell-based organ augmentation and replacement is advancing rapidly. The approaches to creating and growing populations of specialized cells, shaping more complex cellular structures and incorporating materials designed to minimize immune interactions have proliferated and grown increasingly sophisticated.

The FDA launched its regenerative medicine advanced therapy (RMAT) designation program, which stemmed from the 21st Century Cures Act, roughly one year ago. By now, at least 43 companies have applied for the new designation with more than a dozen recipients who can attest to the enhanced regulatory access and cooperation under the program.