HeartSheet's Challenges And Withdrawal Hurt Japan's Cell Therapy Hopes

 
• By Lisa Takagi
  
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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.

HeartSheet was heart to provide a new treatment option for severe heart failure to avoid heart transplant.
HeartSheet is a new option for severe heart failure in Japan, but challenges abound. • Source: Shutterstock

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.

Key Takeaways

  • Terumo’s HeartSheet could not convert its conditional approval in Japan to a full approval after failing to demonstrate efficacy and the company now is planning to pull it from the market.

Major Japanese medtech firm Terumo Corporation now is preparing to withdraw HeartSheet, an autologous skeletal myoblast-derived cell sheet, from...

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