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Heartseed, World's First Clinical Trial of Catheter Administration of iPSC-Derived Cardiomyocyte Spheroids: First Patient Dosed

Business

Heartseed, World's First Clinical Trial of Catheter Administration of iPSC-Derived Cardiomyocyte Spheroids: First Patient Dosed
Business

Business

Heartseed, World's First Clinical Trial of Catheter Administration of iPSC-Derived Cardiomyocyte Spheroids: First Patient Dosed

2026-06-12 13:02 Last Updated At:13:10

TOKYO--(BUSINESS WIRE)--Jun 12, 2026--

Heartseed (Heartseed Inc.), a Tokyo-based biotechnology company, today announced the successful dosing of the first patient in its domestic Phase I/II EMERALD study of HS-005, allogeneic iPS cell-derived cardiomyocyte spheroids administered via catheter, targeting severe heart failure caused by ischemic heart disease or dilated cardiomyopathy.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611923545/en/

This study marks the world's first clinical trial to administer iPS cell-derived cardiomyocyte spheroids using a catheter. The administration to the first patient suffering from dilated cardiomyopathy was successfully completed at Shinshu University Hospital in late March 2026. The patient's postoperative course has been generally uneventful, and the patient has already been discharged. Furthermore, the independent Safety Monitoring Committee evaluated the 4-week data and approved the study to continue in dilated cardiomyopathy cohort.

"Catheter administration enables the minimally invasive delivery of cardiomyocytes", said Keiichi Fukuda, CEO of Heartseed. "The inclusion of patients with dilated cardiomyopathy as a new target is a highly significant milestone in our goal to save more patients with severe heart failure.”

About HS-005 and EMERALD Study

While Heartseed's lead pipeline, HS-001 requires open-heart surgery, HS-005 enables next-gen, minimally invasive cardiac regenerative medicine by endocardial catheter delivery. The administered cardiomyocytes are expected to engraft into the patient's myocardium, improving cardiac contractility by remuscularization and promoting neovascularization. The EMERALD study aims at treating severe heart failure with reduced ejection fraction (HFrEF) caused by ischemic heart disease or dilated cardiomyopathy. The study plans to enroll 7 patients in each cohort, for a total of 14 patients to evaluate the safety and efficacy of the therapy.

About Heart Failure

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body’s needs. It affects more than 65 million people globally. Aside from heart transplantation, there are no radical treatment options, creating a strong demand for innovative therapies.

About Heartseed

Heartseed Inc. was founded in 2015 to realize cardiac remuscularization therapy, and it was listed on the Tokyo Stock Exchange Growth Market in July 2024 (Stock Code: 219A). Heartseed has proprietary technologies throughout the entire manufacturing process of the cardiomyocyte cell product, including iPSC production, purification, and cell delivery.
For more information, visit heartseed.jp, LinkedIn and YouTube.

For details: https://heartseed.jp/en/news.html

Cardiomyocyte spheroids

Cardiomyocyte spheroids

GUADALAJARA, Mexico (AP) — Hwang In-beom scored a goal and set up another as South Korea rallied to defeat the Czech Republic 2-1 in the second match of the 2026 World Cup on Thursday night.

After a lackluster first half in which both teams were jeered as they left the field, the Czech Republic took the lead in the 59th minute on a header by captain Ladislav Krejci after a long throw-in into the penalty area.

South Korea equalized in the 67th, when Hwang scored after faking a shot with a nifty move to clear two Czech players. The midfielder who plays for Dutch club Feyenoord then made the cross from the right flank for Oh Hyeon-gyu's decisive strike in the 80th in a match played in front of hundreds of empty seats at Guadalajara Stadium.

The South Korean squad celebrated with its fans behind one of the goals after the final whistle. Players later posed for a photo with the fans behind them.

“It was our first game and a very difficult one,” South Korea coach Hong Myung-bo said. “The win itself makes me happy, but what’s even more positive is that our boys won by not giving up. I knew that we were more than capable of winning, so at 1-1, I told the boys to keep playing the way we’ve been playing.”

It was South Korea's first opening World Cup win since it beat Greece in 2010 in South Africa. South Korea beat European opponent in the tournament for a third straight time, following wins over Portugal in 2022 and Germany in 2018.

Let by star forward Son Heung-min, South Korea controlled possession and outshot the Czechs, who were making their first World Cup appearance since 2006. The Koreans, ranked 25th by FIFA, had most of the significant scoring chances against the 38th-ranked Czechs but failed to capitalize early.

Son was looking to become South Korea’s top goal scorer at the World Cup and the Asian player with the most goals in the tournament. The 33-year-old former Tottenham star, who now plays for Los Angeles FC of Major League Soccer, entered Thursday having scored three goals over three prior World Cups.

Appearing in his fourth World Cup, Son had a couple of good opportunities to add to his tally but missed wide in the first half and had a close-range shot saved in the second.

The Czechs thought they had retaken the lead with another set piece in the 77th, but Tomas Soucek was ruled offside on his header.

Czech Republic coach Miroslav Koubek said “probably the better team won.” But he said his team could have had a better outcome if it weren’t for “some mistakes.”

“We played very well, it could have been a draw and we could have won as well,” Koubek said.

The announced attendance was 44,985 at the 45,664-capacity Guadalajara Stadium, a crowd that included FIFA President Gianni Infantino. Sections in the middle of the stands had many unoccupied seats and there were other empty seats scattered across the stadium.

South Korea is making its 11th straight World Cup appearance and 12th overall, the most of any Asian country. Its best result was a fourth-place finish at the tournament it co-hosted with Japan in 2002. Since then, the South Koreans have never gone beyond the round of 16.

In the other Group A match on Thursday, co-host Mexico defeated South Africa 2-0 in the tournament opener in Mexico City.

AP World Cup coverage: https://apnews.com/hub/fifa-world-cup

Fans look on during the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Moises Castillo)

Fans look on during the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Moises Castillo)

South Korea players celebrate after the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Moises Castillo)

South Korea players celebrate after the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Moises Castillo)

Czechia's Ladislav Krejci reacts after scoring against South Korea in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Dolores Ochoa)

Czechia's Ladislav Krejci reacts after scoring against South Korea in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Dolores Ochoa)

South Korea's Hwang In-beom gestures to the crowd as he is substituted during the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Matias Delacroix)

South Korea's Hwang In-beom gestures to the crowd as he is substituted during the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Matias Delacroix)

South Korea's Hwang In-beom, right, shoots and scores a goal against Czechia goalkeeper Matej Kovar during the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Moises Castillo)

South Korea's Hwang In-beom, right, shoots and scores a goal against Czechia goalkeeper Matej Kovar during the World Cup Group A soccer match between South Korea and Czechia in Zapopan, near Guadalajara, Mexico, Thursday, June 11, 2026. (AP Photo/Moises Castillo)

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