Komori
Other Disclosures219AHeartseed Inc.Pharmaceuticals

Notice Regarding the Acquisition of a Marketing Authorization for Regenerative Medicine Products

The Tokyo Metropolitan Government granted the Company a license to manufacture and market regenerative medicine products in Japan. This establishes the foundation for a system that will enable the Company to sell development products in Japan in the future once marketing approval has been obtained.

Worth reading
48Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
—
Displayed only when the document provides numerical figures.
Wording
Conditional
How definitive the wording is.

Announced details

Allogeneic iPS cell-derived cardiac spheroids for severe heart failure
Applicable field (uses covered by this announcement)

Treatment of severe heart failure, domestic commercialization and launch

Relationship between the counterparty and the company
Heartseed Inc.219A
Relationship with the Company

Our company applied to the Tokyo Metropolitan Government for a license to manufacture and market regenerative medicine products and obtained the license from the Tokyo Metropolitan Government.

CounterpartyTokyo Metropolitan Government

Tokyo Metropolitan Government. The application and licensing authority for a license to manufacture and market regenerative medicine products. Other details: Not disclosed

Award/certification name

License to market regenerative medical products

Awarding / certifying body

Tokyo Metropolitan Government

Impact on Business Performance

No revision has been made to the earnings forecast for the fiscal year ending December 2026.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredAllogeneic iPS cell-derived cardiac spheroids for severe heart failure
CounterpartyTokyo Metropolitan Government
Counterparty overviewTokyo Metropolitan Government. The application and licensing authority for a license to manufacture and market regenerative medicine products. Other details: Not disclosed
Relationship with the CompanyOur company applied to the Tokyo Metropolitan Government for a license to manufacture and market regenerative medicine products and obtained the license from the Tokyo Metropolitan Government.
Applicable areaTreatment of severe heart failure, domestic commercialization and launch
Award/certification nameLicense to market regenerative medical products
Awarding / certifying bodyTokyo Metropolitan Government
Impact on Business PerformanceNo revision has been made to the earnings forecast for the fiscal year ending December 2026.
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historySource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To accelerate the establishment of a practical framework for future domestic commercialization and launch, and to promote compliance with laws and regulations governing pharmaceuticals and related products.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice Regarding the Acquisition of a Marketing Authorization for Regenerative Medicine Products | Heartseed Inc. (219A) timely disclosure | Komori