3-D Matrix, Ltd.
PureLift Approval Clearance Submission | June 2026
Our company obtained regulatory approval in 2021 and submitted the approval clearance document for PureLift, which was reimbursed in 2022, but the approval has since expired. Domestic supply has been discontinued, and delays in establishing a new manufacturing system have occurred. Meanwhile, development of endoscopic mucosal injection materials based on self-assembled peptide technology is being promoted for the U.S. market. Shipping in the Japanese market is limited, with no impact on performance.
Key Figures
- Regulatory approval expiration notice submitted
- Domestic supply discontinued
- Development of products for the U.S. market underway
AI要約
Overview of Business Activities
Our company obtained regulatory approval for PureLift in 2021, and reimbursement was approved in 2022. Subsequently, we submitted an approval clearance document, leading to expiration of the regulatory approval. Domestic supply has been discontinued, and there are delays in establishing a new manufacturing system. Meanwhile, we are continuing sales promotion and product development for endoscopic mucosal injection materials based on self-assembling peptide technology, which are considered to have high business potential in the U.S. market. In Japan, shipments are limited, and there is no impact on performance.
Future Outlook and Impact on Shareholders
While the delay in establishing domestic manufacturing systems continues to result in supply discontinuation, we are focusing on product development and sales expansion for the U.S. market. Based on development progress and overseas approval status in Japan, future business strategies will be considered. The approval clearance submission will not have a short-term impact on financial results, and we will continue to expand overseas markets and develop new products with the goal of long-term growth.
Three D Matrix Co., Ltd.
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