3-D Matrix,Ltd.

Through an exclusive license agreement (with sublicensing rights) entered into with MIT in 2003, US-based 3-D Matrix, Inc. holds exclusive worldwide usage rights to self-assembling peptide technology in the medical, life science, and cosmetics fields. As a chemically synthesized product containing no biologically-derived raw materials, it offers technical advantages including high safety with no risk of viral infection, and the ability to mass-produce with uniform quality.

US revenue for FY2025 (ending April 2025) doubled to ¥3,152 million (up 106.4% year on year), setting new quarterly record highs each quarter. In addition to expanded usage by existing customers, the number of new customer acquisitions has been increasing at a faster pace than expected, and the US subsidiary achieved profitability on a financial accounting basis during the period. Sales personnel expansion measures have driven revenue growth that exceeds the associated cost increases.

The company has sequentially obtained approvals in Europe (CE marking in 2014), Australia (2016), Japan (2020), and the US (510(k) in 2021), establishing a sales structure across four regions. For FY2025 (ending April 2025), business revenue showed increasing regional diversification, with ¥3,152 million from the US, ¥2,052 million from Europe, ¥1,234 million from Japan, and ¥478 million from Australia.

Plans call for U.S. sales of ¥8,590 million in FY2027 (ending April 2027), up 37% year on year. Sales team resources were strengthened and reorganized at the end of the previous fiscal year, and sales per representative are expected to increase. In the gastrointestinal endoscopy field, sales activities will continue to balance new customer acquisition, retention of existing customers, and expansion of usage volume per customer.

Preparations are underway for U.S. approval applications covering multiple new indications, including hemostasis in pediatric cardiac surgery, tonsillectomy, post-biopsy hemostasis, surgery for benign prostatic hyperplasia, radiation cystitis, mucosal wound healing (De Novo application in preparation), and the bone filling material. The company aims to file applications leveraging existing clinical data or data that can be obtained in the short term.

For the next-generation hemostat, which obtained approval in Europe in December 2025, PMCF (post-market clinical follow-up) studies are being planned to obtain data for approval applications in the U.S. and Japan. The product has indications across multiple fields, including neurosurgery, the gastrointestinal tract, cardiovascular applications, and solid organs, and is expected to become a new revenue source upon approval.

In Europe, while maintaining the distributor model in the gastrointestinal endoscopy and cardiac fields, the company is deploying additional resources to the otolaryngology field and expects growth of around 30%. High growth is also expected to continue in new fields such as urology through a small-scale direct sales structure. Overall European sales are planned to grow 12% to ¥2,922 million in FY2027 (ending April 2027).

An approval application for the Wound Healing Material (Mucosal Wound Healing) was submitted in Europe in March 2026. In the U.S., following discussions with the FDA, the company is preparing to resubmit as a De Novo application. Upon formal regulatory approval, the company aims to establish and expand a new product category following the hemostat business.

The note regarding the going concern assumption was resolved following the full redemption and conversion of the convertible bonds with stock acquisition rights. The company secured an equity ratio of 66.7% and cash balance of ¥2,830 million, and also established a new overdraft facility and expanded its commitment line. This significantly reduced financing risk and secured capacity for business investment.