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

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.

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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

GLASGOW, Scotland (AP) — The Scottish Football Association has handed new Rangers manager Derek McInnes a four-match ban for his critical comments about a disputed penalty that benefited Celtic in last season's title race.

Then-Hearts coach McInnes had called the stoppage-time penalty decision “actually quite disgusting" after Celtic beat Motherwell 3-2 in the penultimate game to put it on course for its record 56th Scottish league title.

On Wednesday, the Scottish FA issued the four-match touchline ban with one suspended until the end of the 2026-27 season.

Rangers responded by saying it would appeal the ruling.

“We do not believe Derek’s view on a match-defining decision amounted to an attack on the competence or integrity of match officials,” the Glasgow club said in a statement. “His comments were directed at the decision, rather than representing any broader criticism of officials. Considered fairly and in context, Derek’s comments did not allege bias, incompetence or dishonesty.

“Although the comments pre-dated Derek’s appointment, the club believes the issue at stake is important and must be challenged,” Rangers added.

Deep into stoppage time in the second-to-last round, Celtic was tied 2-2 at Motherwell. A penalty was awarded on video review for what the officials eventually judged was handball by a Motherwell player. Celtic forward Kelechi Iheanacho scored from the spot in the 99th minute.

The victory set up a title-deciding match at Celtic Park on the last day of the season. Hearts needed at least a draw to clinch its first Scottish league title since 1960 but Celtic got a late go-ahead goal and won 3-1.

Rangers, which hired McInnes in June, play Dundee United on July 31 to open the new league season.

McInnes, a former Rangers midfielder, previously coached at Kilmarnock and Aberdeen.

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FILE - Aberdeen coach Derek McInnes looks on from the bench during the Europa League third qualifying round soccer match between Sporting CP and Aberdeen at the Alvalade stadium in Lisbon, Sept. 24, 2020. (AP Photo/Armando Franca, File)