Announced details
Sites and organs where blood flow can be temporarily blocked, including the upper and lower limbs, kidneys, bladder and uterus. Administration of anticancer drugs for osteosarcoma and other conditions occurring in the limbs is also cited as an example.
No new animal or clinical studies are required. The review period is expected to be approximately 6 months.
The consultation counterpart for Perfusio®'s pre-development consultation
An independent administrative agency that provides consultation and advice on medical device development policies, the assessment items required for applications for marketing approval, and the need for clinical studies. Other information, including its location, representative, capital and year of establishment, is not disclosed.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Perfusio® |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An independent administrative agency that provides consultation and advice on medical device development policies, the assessment items required for applications for marketing approval, and the need for clinical studies. Other information, including its location, representative, capital and year of establishment, is not disclosed. |
| Relationship with the Company | The consultation counterpart for Perfusio®'s pre-development consultation |
| Launch date | During fiscal 2027 (scheduled; target for start of sales) |
| Applicable area | Sites and organs where blood flow can be temporarily blocked, including the upper and lower limbs, kidneys, bladder and uterus. Administration of anticancer drugs for osteosarcoma and other conditions occurring in the limbs is also cited as an example. |
| Quantitative Effects | No new animal or clinical studies are required. The review period is expected to be approximately 6 months. |
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.Through the pre-development consultation with PMDA, the company broadly obtained confirmation of the assumed development policy and confirmed that no new animal or clinical studies are required because the product qualifies as a general medical device.