A startup launched at Osaka University announced Tuesday that it has applied for government approval to commercially sell heart muscle cell sheets developed using induced pluripotent stem (iPS) cells.

This is the world’s first application for the approval of a regenerative medical treatment product made from iPS cells.

The health care company Cuorips, whose research is led by Dr. Yoshiki Sawa of Osaka University, has submitted an application to the health ministry for approval to manufacture and sell its myocardial cell sheets.

The treatment involves transplanting a thin sheet — roughly 0.1 millimeters thick — into the heart. The sheets are composed of heart muscle cells developed from donor-derived iPS cells and are designed to act as an allogeneic cell-based medicine.

The government will now review the submitted clinical data to evaluate the treatment’s safety and effectiveness, with the review process expected to take about a year.

Cuorips is targeting patients suffering from severe heart failure for whom current treatment options are limited to heart transplants or artificial heart implantation. The company says the therapy could help improve cardiac function and promote recovery in cases where other interventions are ineffective.

A clinical trial was conducted between January 2020 and March 2023, with eight patients undergoing the procedure at four institutions, including Osaka University Hospital as the lead site. All patients underwent the procedure, which was shown to be safe and effective in improving symptoms, according to the company. Based on the success of the trial, Cuorips moved forward with the approval application.

In a statement announcing the regulatory filing, the company said it will “work closely with regulatory authorities to respond swiftly to the review process, and aim to obtain approval as soon as possible so that the myocardial cell sheet can be provided as a new treatment option for patients quickly.”