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Looks like Rmat isn't accessible and a strategic partner will be required to get FDA approval. Good news is business is proposed to be busy.
The FDA recently published two draft guidances regarding Regenerative Medicine Advanced Therapies (RMAT). Based on these draft guidance documents, the FDA will continue to require a robust clinical trial program for these products, which typically costs hundreds of millions of dollars and years of studies. We have spent more than $100 million over two decades on both preclinical (animal) and clinical (human) trials for the MyoCell™ product. We have published many studies showing that the culture-expanded autologous stem cells directly injected into the heart can provide benefit to congestive heart failure patients. We will continue to work closely with the FDA to understand how these new draft guidances will affect our technologies and company, but our main focus as always is to offer stem cell therapies to all patients in need. USRM intends to take full advantage of this RMAT opportunity. We are actively seeking strategic partners to pursue commercialization of the MyoCell™ product and finalize RMAT designation based on the draft guidelines published.
While we are considering partnership opportunities, our current resources are best served focusing on our in-clinic programs that provide treatments to patients every day. Our phones are ringing off the hook with patients interested in pursuing these potentially life-changing therapies
