A novel regenerative medicine for a severe cardiovascular disease, initially granted a conditional approval in Japan almost a decade ago, will exit the market due to challenges meeting the terms of the regulatory pathway.
HeartSheet's Challenges And Withdrawal Hurt Japan's Cell Therapy Hopes
Despite it’s initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges gaining full approval in Japan, potentially offering lessons for other regenerative medicine developers.
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