Japanese Medtech Startup, CoreTissue BioEngineering, Initiates Randomized Controlled Cohort in the Clinical Trial for Anterior Cruciate Ligament (ACL) Reconstruction Treatment

YOKOHAMA, Japan--(BUSINESS WIRE)--CoreTissue BioEngineering Inc. (“CTBE”), a medical device start-up (Headquarters: Yokohama City, Kanagawa Prefecture, CEO: Yoji Jokura, Ph.D.) announces that the safety evaluation in the safety cohort of its clinical trial for anterior cruciate ligament (ACL) reconstruction with the medical device "Tissue Regenerative Ligament" (development code: CT-ACL001) sponsored by the company has been completed, and the randomized controlled cohort to verify safety and efficacy has been initiated. This randomized controlled cohort will use the standard treatment of ACL reconstruction using the patient's own hamstring tendon as the control group and will be conducted at six facilities nationwide: Tokyo Women's Medical University Hospital (where Professor Dr. Ken Okazaki, the clinical trial coordinator, is affiliated), Hirosaki University Hospital, Hiroshima University Hospital, Hokkaido University Hospital, Juntendo University Hospital, and Kobe University Hospital (listed in alphabetical order).

Furthermore, the initial results of the safety evaluation cohort will be presented by Lecturer Dr. Masafumi Ito of the Department of Orthopedic Surgery, Tokyo Women's Medical University at the 22nd Congress of the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA), held from May 20th of this year.

Summary of the Randomized Cohort (For details, please refer to the clinical trial public information)

• Investigational Device: Tissue-Regenerative Ligament (Development Code: CT-ACL001)
• Target Disease: Anterior Cruciate Ligament Injury (requiring reconstruction)
• Target Number of Cases: 38 cases in the CT-ACL001 reconstruction group, 19 cases in the autologous tendon reconstruction group
• Planned Implementation Period: Start in May 2026
• Future Plans: After completion of the primary endpoint of the trial, we plan to apply for manufacturing and marketing approval for a medical device in Japan.

This research and development, including this clinical trial, is supported by a grant from the Japan Agency for Medical Research and Development (AMED).

Clinical Trial Public Information

• ClinicalTrials.gov (World's largest clinical trial registry database operated by the U.S. National Library of Medicine (NLM)) Registration Number: NCT07129694 https://clinicaltrials.gov/study/NCT07129694

Glossary

Tissue Regenerative Ligament: A medical device based on a mechanism in which the ligament is regenerated by the patient's own cells using a graft (transplant) used in reconstructive treatment as a scaffold.

Company Overview

CoreTissue BioEngineering Inc. (CTBE)
CTBE is a medical device start-up founded in Japan focusing on the development of artificial ligaments derived from animal tissue for reconstruction surgeries of ligament and tendon.
URL : https://www.coretissue.com/english/