Investment in the United States

  • The U.S. is falling behind other countries in advancing the science and use of cell therapies.

  • In 2014, Japan implemented a conditional approval system for cell therapies that allows a path to reimbursement while clinical trials are ongoing.

  • The European Union has a regulatory exemption that allows patients to access cell therapies in hospitals under the exclusive professional responsibilities of treating physicians.

  • Many patients are forced to receive treatments overseas, and companies are taking their investments to other parts of the world, due to the FDA’s outdated regulatory framework.