Announced details
Delivery and collection of various pharmaceuticals, including nucleic acid drugs, to and from target organs for treatment. The system can be applied to a variety of target organs.
The system may make it possible to deliver pharmaceuticals to target organs while avoiding systemic exposure to the pharmaceuticals. Quantitative figures: Not disclosed.
The Company has held a preparatory meeting for face-to-face consultation on medical devices and in vitro diagnostic products, as well as general consultations, with PMDA. The Company plans to proceed to a pre-development consultation.
An independent administrative agency responsible for ensuring the efficacy, safety and quality of pharmaceuticals and medical devices.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Perfusio, aibVIS |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA), an independent administrative agency |
| Counterparty overview | An independent administrative agency responsible for ensuring the efficacy, safety and quality of pharmaceuticals and medical devices. |
| Relationship with the Company | The Company has held a preparatory meeting for face-to-face consultation on medical devices and in vitro diagnostic products, as well as general consultations, with PMDA. The Company plans to proceed to a pre-development consultation. |
| Launch date | During fiscal 2026–2027 (target and planned start of sales) |
| Applicable area | Delivery and collection of various pharmaceuticals, including nucleic acid drugs, to and from target organs for treatment. The system can be applied to a variety of target organs. |
| Quantitative Effects | The system may make it possible to deliver pharmaceuticals to target organs while avoiding systemic exposure to the pharmaceuticals. Quantitative figures: Not disclosed. |
Items this document does not state (11)
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 clarify the regulatory approval process for adding new uses by combining existing catheters, in preparation for obtaining approval as a medical device required to commercialize Perfusio.