Postponement of Product Launch Due to Delayed Insurance Coverage for Sutureless Bioprosthetic Valve
First written in FY2018-Q2. 9 of 10 entries say "Restated". Latest entry: FY2025-H1.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
4 other companies' latest entry also says "Restated".
- FY2025-H1RestatedAnnual report
「No new business or other risks arose during the current interim consolidated accounting period. In addition, there were no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The Company has disclosed that there has been no material change regarding the risk of postponement of the sales launch due to delays in obtaining insurance coverage for the sutureless bioprosthetic valve. - FY2024-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The Company has disclosed that there has been no material change regarding the risk of postponement of the sales launch due to delays in obtaining insurance coverage for the sutureless bioprosthetic valve. - FY2021-Q2RestatedAnnual report
「No new business or other risks arose during the six-month period ended [the second quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The Company has disclosed that there has been no material change regarding the risk of delays in obtaining insurance coverage and launching the sutureless bioprosthetic valve PERCEVAL. - FY2020-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The Company has disclosed that there has been no material change regarding the risk of delays in obtaining insurance coverage and launching the sutureless bioprosthetic valve PERCEVAL. - FY2020-Q2RestatedAnnual report
「No new business or other risks arose during the six-month period ended [the second quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The Company has disclosed that there has been no material change regarding the risk of delays in obtaining insurance coverage and launching the sutureless bioprosthetic valve PERCEVAL. - FY2020-Q1RestatedAnnual report
「No new business or other risks arose during the three-month period ended [the first quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The Company has disclosed that there has been no material change regarding the risk of delays in obtaining insurance coverage and launching the sutureless bioprosthetic valve PERCEVAL. - FY2019-Q1RestatedAnnual report
「The Company is preparing to introduce PERCEVAL, a new type of sutureless bioprosthetic valve, with a target launch in the second half of this year.」
PERCEVAL remains in the preparation stage for a launch targeted for the second half of this year, and the completion of the sales launch has not yet been reported. - FY2018RestatedAnnual report
「For PERCEVAL, a sutureless bioprosthetic valve that requires no suturing of the valve annulus and can shorten operating times, the Company will continue preparations for its introduction with a target launch in the second half of the next fiscal year.」
The Company continued preparations to introduce PERCEVAL and specified the launch timing as the second half of the next fiscal year, but sales had not begun during the current fiscal year. - FY2018-Q3RestatedAnnual report
「The Company is preparing to introduce PERCEVAL, a sutureless bioprosthetic valve that requires no suturing and is expected to make open-heart surgery less invasive by shortening procedure times, and will work toward an early launch.」
The Company continues preparations to introduce PERCEVAL and efforts toward an early launch, but the completion of the sales launch has not been reported. - FY2018-Q2First statedAnnual report
「The Company is preparing to introduce PERCEVAL, a sutureless bioprosthetic valve that requires no suturing and is expected to shorten procedure times, but as obtaining insurance coverage is expected to take time, the product launch is now expected to take place in the next fiscal year.」
The Company is preparing to introduce PERCEVAL but indicated that the product launch is expected to take place in the next fiscal year because obtaining insurance coverage is expected to take time.