3-D Matrix PureLift Approval Withdrawal Announced by 3-D Matrix,ltd.

TOKYO, Jun 26 (Pulse News Wire) – 3-D Matrix,ltd. (7777.T) announced today that it submitted an approval withdrawal notice to the Ministry of Health, Labour and Welfare concerning PureLift, a medical device approved in May 2021 and recognized for insurance reimbursement in December 2022.

As a result, the product's approval will lapse. Domestic supply was halted due to contract termination with the domestic manufacturer, and sales had yet to commence. Despite efforts to establish a new manufacturing system domestically and internationally, the company received feedback indicating difficulties in commencing production amid increased cost pressures. PureLift, an endoscopic submucosal injection material based on self-assembling peptide technology, showed high commercial potential in the US market.

Sales trends of PureStat, an absorbable hemostatic agent sold in the US, indicated a larger market size and greater pricing flexibility compared to Japan. Additionally, there is higher demand for such products in the US market relative to existing offerings. Going forward, 3-D Matrix will focus on developing PureLift for the US market while evaluating future strategies for the Japanese market based on development progress and overseas regulatory approvals. The company stated that the limited pre-marketing activities conducted in Japan would not impact the market significantly.

There will be no impact on the company’s fiscal outlook or mid-term business plan revenue projections due to this decision.