OSAKA (Kyodo) -- A startup in Tokyo on Tuesday applied for approval from the Japanese government to manufacture and sell heart muscle sheets derived from stem cells known as iPS, the company said.

It was the first application in Japan submitted to the Ministry of Health, Labor and Welfare over the commercialization of regenerative medicine products prepared from human iPS cells. The sheets were developed by a team led by Yoshiki Sawa, a professor emeritus of the University of Osaka, according to Cuorips Inc.

iPS cardiomyocytes are designed for transplants for patients with severe heart failure who have no effective alternatives other than heart transplant or venticular assist devices. The team hopes the treatment will become a new standard of care in Japan, where a severe shortage of heart donors persists, according to the team.

"We were able to make a fresh step to treat people around the world," Sawa said.

iPS, or induced pluripotent stem cells, were generated by Shinya Yamanaka, director emeritus at Kyoto University's Center for iPS Cell Research and Application, for which he won the Nobel Prize in Physiology or Medicine in 2012.

The University of Osaka team began a clinical trial on ischemic cardiomyopathy using sheets of iPS cardiomyocytes in January 2020, so far treating a total of eight patients with severe heart failure at the University of Osaka, Tokyo Women's Medical University and Kyushu University, among others.

Since the outcome of the trial was successful, the company said it has decided to apply for the approval of manufacturing and sales of the products.

During the treatment, sheets of iPS cardiomyocytes are placed on the surface of the heart, where they promote the formation of new blood vessels underneath and help restore heart function, according to the company.

The transplant surgery usually ends in an hour and the physical impact of surgery on patients is relatively light, Sawa said.

The iPS-derived heart muscle sheets will be on display at a World Exposition pavilion, run by the Osaka city government during the global event running from April 13 to Oct. 13.