Theratome Bio


Theratome Bio is developing an innovative, injectable biologic comprised of the therapeutic factors secreted by adult stem cells. The lead indications for this product are ischemic brain injury and ischemic stroke. Ischemic brain injury is a significant complication of interventional cardiovascular procedures such as transaortic valve replacement (TAVR), and stroke is the fourth leading cause of death and the leading cause of disability. The addressable market for these indications exceeds $7 billion. In preclinical studies, our lead product has demonstrated significant reduction in death and cognitive loss and displays a 6x longer treatment window than tPA, the only approved drug for ischemic stroke. Theratome Bio has validated its GMP manufacturing plan and IND-enabling preclinical study designs with FDA in a pre-IND meeting and plans to initiate a phase I/IIa study in 2018 in patients undergoing TAVR. The design of this trial is extremely efficient due to the high volume of TAVR and the ability to potentially show a treatment effect based on quantitative MRI. Theratome Bio is also exploring additional clinical indications for its lead product to fully capture the value of this platform technology.