Komori
Other Disclosures219AHeartseed Inc.Pharmaceuticals

Notice Regarding the Application for a Marketing Authorization for Regenerative Medicine Products

In preparation for the future commercialization and launch of regenerative medical products, the Company applied to the Tokyo Metropolitan Government for a license to manufacture and market regenerative medical products. Following the grant of the license, the Company has moved to the stage of establishing the quality control and post-marketing safety management systems that will be required.

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Announced details

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

Regenerative medicine for severe heart failure

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

Licensing authority to which the application was submitted

CounterpartyTokyo 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
CounterpartyTokyo Metropolitan Government
Relationship with the CompanyLicensing authority to which the application was submitted
Applicable areaRegenerative medicine for severe heart failure
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 (13)
Counterparty overviewContract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration 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 establish systems compliant with Good Quality Practice (GQP) and Good Vigilance Practice (GVP), in anticipation of future applications for manufacturing and marketing approval and commercialization and launch in Japan.

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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice Regarding the Application for a Marketing Authorization for Regenerative Medicine Products | Heartseed Inc. (219A) timely disclosure | Komori