A novel regenerative medicine for a severe cardiovascular disease indication initially granted a conditional approval in Japan almost a decade ago has hit a roadblock due to challenges meeting the terms of this regulatory approach.
Major Japanese medtech firm Terumo Corporation is now preparing to withdraw from the market HeartSheet, an autologous skeletal myoblast-derived cell sheet conditionally approved and launched in 2015 for severe heart failure due to ischemic
Eligible recipients must have New York Heart Association class III or IV heart failure, with a resting left ventricular ejection fraction of over 35%