Delayed Market Launch of an Irrigated Ablation Catheter
First written in FY2017-Q2. 11 of 31 entries say "Worsened", first in FY2017-Q3. Latest entry: FY2026.
0 other companies' latest entry also says "Dropped".
- FY2026DroppedAnnual report
「We recorded ¥410 million in inventory valuation losses and other charges associated with discontinuing certain products whose competitiveness had declined, including the cholangioscope system and endoscopic laser ablation catheters.」
The discontinuation of HeartLight and other endoscopic laser ablation catheters, together with the recognition of inventory valuation losses and other charges, was disclosed, moving the previous market launch delay theme to the discontinuation stage. - 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 disclosed that there had been no material change in the risk of a delayed market launch for irrigation-enabled ablation catheters. - FY2024-Q3MitigatedAnnual report
「Although supply shortages of the endoscopic laser ablation catheter “HeartLight X3 (HeartLight X3)” from the supplier-manufacturer showed some improvement in the third quarter, sales remained sluggish.」
Although delays in the market launch and sales of HeartLight X3 caused by supply shortages remain, procurement conditions showed some improvement in the third quarter. - FY2024-Q2MitigatedAnnual report
「The endoscopic laser ablation catheter “HeartLight X3 (HeartLight X3)” was affected by product shortages resulting from raw-material shortages at the supplier-manufacturer. Although procurement conditions showed some improvement in the second quarter, sales remained sluggish.」
Although delays in the market launch and sales of HeartLight X3 caused by supply shortages continue, procurement conditions showed slight improvement in the second quarter. - FY2024-Q1WorsenedAnnual report
「The endoscopic laser ablation catheter “HeartLight X3 (HeartLight X3)” continued to be affected by raw-material shortages at the supplier-manufacturer, and adequate product supplies remained unavailable. As a result, sales were conducted under constraints, including curbing expansion into new facilities.」
The continuing shortage of HeartLight X3 constrained its market launch and sales expansion at new facilities. Revenue from ablation catheters decreased 29.0% year on year. - FY2023WorsenedAnnual report
「Sales of ablation catheters decreased from the previous fiscal year because sales of the endoscopic laser ablation catheter HeartLight X3 remained sluggish. Sales were affected because product supplies from suppliers were intermittently disrupted from July 2022 onward against the backdrop of the global shortage of raw materials.」
Sales of HeartLight X3 remained sluggish because of intermittent supply disruptions caused by the global shortage of raw materials, resulting in lower sales of ablation catheters. - FY2023-Q3WorsenedAnnual report
「This situation was temporarily resolved in September, but supply problems arose from October onward because of shortages of other raw materials. In response, we limited sales to existing facilities and took other measures, causing the number of new sales facilities to fall behind plan.」
The supply problem for HeartLight X3 recurred from October after being temporarily resolved in September. As sales were limited to existing facilities, the number of new sales facilities is behind plan. - FY2023-Q2WorsenedAnnual report
「Although sales resumed in September, as of the end of the second quarter of the consolidated accounting period, the number of newly adopting facilities was behind plan.」
HeartLight X3 resumed sales in September, but the number of newly adopting facilities is behind plan because of supply delays caused by the global shortage of raw materials. - FY2023-Q1WorsenedAnnual report
「The endoscopic laser ablation catheter generated a significant increase in sales following the introduction of the next-generation HeartLight X3. However, product deliveries have been delayed due to the global shortage of raw materials, and progress against the plan is somewhat behind schedule.」
Sales increased significantly due to the launch of HeartLight X3, but progress against the plan is somewhat behind schedule because of supply delays caused by a global shortage of raw materials. - FY2022MitigatedAnnual report
「In July 2021, the company launched the next-generation HeartLight X3. The product was highly rated for significantly shorter procedure times than the previous model, and sales were strong during the period.」
Although adoption of HeartLight at new facilities had continued to be delayed, sales of HeartLight X3 ramped up faster than expected after its launch, easing the market adoption stagnation. - FY2022-Q3AdvancedAnnual report
「Meanwhile, for the new endoscopic laser ablation catheter HeartLight X3, launched in August 2021, benefits including shorter procedure times than the previous model were well received. The product had a stronger-than-expected launch, and sales were well above the level of the same period of the previous year.」
For HeartLight, for which delays in adoption at new facilities had been reported, an earlier-than-expected initial sales ramp and sales significantly above those in the same period of the previous year were reported following the launch of the next-generation HeartLight X3. - FY2022-Q2MitigatedAnnual report
「Meanwhile, sales of HeartLight, an endoscopic laser ablation catheter, significantly exceeded those in the same period of the previous year, partly because we focused on expanding sales ahead of the launch of the next-generation HeartLight X3 in August 2021.」
Although delays in adoption of HeartLight at new facilities had been reported, sales significantly exceeded those in the same period of the previous year through sales expansion and the August 2021 launch of HeartLight X3, easing the delay risk. - FY2022-Q1MitigatedAnnual report
「Meanwhile, sales of HeartLight, an endoscopic laser ablation catheter, significantly exceeded those in the same period of the previous year, partly because we focused on expanding sales ahead of the launch of the next-generation HeartLight X3 in August 2021.」
HeartLight, whose adoption at new facilities had continued to be delayed, recorded sales significantly above those in the same period of the previous year as a result of sales expansion initiatives, and moved into the rollout phase ahead of the launch of the next-generation HeartLight X3 in August 2021. - FY2021WorsenedAnnual report
「Sales of HeartLight, a one-of-a-kind endoscopic laser ablation catheter, decreased from the previous fiscal year, partly because development of new facilities was delayed. HeartLight X3, the next-generation product scheduled for launch in the second quarter of the fiscal year ending March 2022, is expected to significantly shorten procedure times, and we will continue efforts to establish it in clinical practice.」
Sales of HeartLight decreased from the previous fiscal year because adoption at new facilities was delayed. The planned launch of the next-generation product HeartLight X3 in the second quarter of the fiscal year ending March 2022 was announced. - FY2021-Q3WorsenedAnnual report
「Sales of HeartLight, a one-of-a-kind endoscopic laser ablation catheter, decreased from the same period of the previous year, partly because adoption at new facilities was delayed.」
HeartLight had been gaining acceptance in clinical practice after its launch, but adoption at new facilities was delayed by COVID-19 and other factors, resulting in a year-on-year decline in sales. - FY2021-Q2WorsenedAnnual report
「Sales of ablation catheters decreased from the same period of the previous year because adoption of HeartLight, an endoscopic laser ablation catheter, at new facilities did not progress due to the impact of COVID-19, while sales volumes of radiofrequency ablation catheters decreased partly because of the impact of competing products.」
Adoption of HeartLight at new facilities did not progress because of the impact of COVID-19, while sales volumes of radiofrequency ablation catheters also decreased because of the impact of competing products. - FY2021-Q1WorsenedAnnual report
「Among ablation catheters, sales of HeartLight, an endoscopic laser ablation catheter, remained at the same level as in the same period of the previous year, partly because the impact of COVID-19 hindered adoption at new facilities.」
Even after its sales launch and the end of PMS, HeartLight's adoption at new facilities did not progress because of the impact of COVID-19, leaving sales at the same level as in the same period of the previous year. - FY2020AdvancedAnnual report
「Adoption of HeartLight, an endoscopic laser ablation catheter, progressed further in clinical practice, and sales volumes increased from the previous fiscal year.」
Following its sales launch and the end of PMS, HeartLight gained further acceptance in clinical practice, and sales volumes increased year on year. - FY2020-Q3AdvancedAnnual report
「Sales volumes of HeartLight, an endoscopic laser ablation catheter launched in July 2018, increased from the same period of the previous year.」
HeartLight's sales volumes increased year on year, marking progress from the market launch delay stage to the stage of gaining acceptance in clinical practice. - FY2020-Q2AdvancedAnnual report
「Meanwhile, sales volume increased for the endoscopic laser ablation catheter HeartLight, which was launched in July 2018. By combining an endoscope with a laser, the product enables precise treatment tailored to each case, and the company continues efforts to achieve further adoption in clinical practice.」
Sales volumes of HeartLight have increased, and the product remains in the stage of gaining acceptance in clinical practice following the market launch delay. - FY2020-Q1RestatedAnnual report
「Meanwhile, we are working to establish the endoscopic laser ablation catheter HeartLight in clinical practice, as its combination of an endoscope and laser enables precise treatment tailored to each case.」
HeartLight remains in the stage of gaining acceptance in clinical practice after its sales launch, and efforts to expand the product continue following resolution of the market launch delay. - FY2019-Q3AdvancedAnnual report
「Sales of HeartLight, an endoscopic laser ablation catheter launched in July 2018, began after the PMS (post-marketing surveillance study) ended in November 2018, and adoption at medical institutions is progressing.」
Following the end of PMS after sales began, HeartLight reached the stage of adoption at medical institutions, marking progress from the market launch delay stage. - FY2019-Q2AdvancedAnnual report
「Sales of HeartLight, an endoscopic laser ablation catheter launched in July this year, are progressing smoothly, with adoption at medical institutions.」
HeartLight has reached the sales launch stage, and adoption at medical institutions is progressing smoothly. It has moved from the previous market launch delay stage to the sales and adoption stage. - FY2019-Q1MitigatedAnnual report
「We began sales of HeartLight, an endoscopic ablation system using balloon technology, in July this year.」
Sales of HeartLight, whose launch had been delayed even after regulatory approval, began in July 2018, easing the market launch delay. - FY2018RestatedAnnual report
「We also obtained regulatory approval last July for HeartLight, an endoscopic ablation system that uses the same balloon technology. Because the product enables precise laser treatment while viewing endoscopic images, we will continue preparations aimed at beginning sales in July this year.」
HeartLight has not yet been launched despite obtaining regulatory approval, and preparations continue with the aim of beginning sales in July this year. - FY2018-Q3RestatedAnnual report
「We also obtained regulatory approval last July for HeartLight, an endoscopic ablation system that uses the same balloon technology and enables precise laser treatment while viewing endoscopic images. We will continue preparations for a launch in the first half of the next fiscal year.」
Following regulatory approval, preparations for a launch in the first half of the next fiscal year are continuing. The risk of a market launch delay before sales begin remains, but the timing has become more specific. - FY2018-Q2WorsenedAnnual report
「We are also preparing to launch HeartLight, an endoscopic ablation system that uses the same balloon technology and enables precise laser ablation while viewing endoscopic images. We obtained regulatory approval for the product in July this year. However, because it is highly novel and insurance coverage is expected to take time, sales are now expected to begin in the next fiscal year.」
Although HeartLight obtained regulatory approval in July 2017, the expected time required for insurance coverage means that its sales launch is expected to be pushed back to the next fiscal year, making the market launch delay concrete. - FY2018-Q1RestatedAnnual report
「In addition, sales volumes of ablation catheters decreased because the full-scale market launch of irrigation-enabled products has not progressed.」
The full-scale launch of irrigation-enabled ablation catheters has not progressed, and the impact continues to be reflected in lower sales volumes. - FY2017RestatedAnnual report
「For ablation catheters, sales decreased from the previous fiscal year because the full-scale market launch of products with irrigation functionality was delayed compared with competitors.」
While the market launch delay was confirmed in the full-year decline in sales, preparations are under way for the launch of the endoscopic ablation system HeartLight. - FY2017-Q3WorsenedAnnual report
「For ablation catheters, sales decreased from the same period of the previous year because the full-scale market launch of irrigation-enabled ablation catheters has been delayed.」
As the market launch delay continued, it was reflected this time in a year-on-year decline in sales, compared with sales at the same level as the same period of the previous year in the prior quarter. - FY2017-Q2First statedAnnual report
「For ablation catheters, sales were at the same level as in the same period of the previous year because the full-scale market launch of irrigation-enabled ablation catheters has been delayed.」
The delay in the full-scale launch of irrigation-enabled ablation catheters has resulted in sluggish sales growth.