CTBE Initiates Randomized Controlled Cohort in Corporate Clinical Trial for Knee Anterior Cruciate Ligament Reconstruction Treatment

CoreTissue BioEngineering Co., Ltd. (Headquarters: Yokohama City, Kanagawa Prefecture, hereinafter referred to as CTBE, Representative Director: Yoji Shirokura) announces the completion of the safety evaluation in the safety evaluation cohort and the initiation of a randomized controlled cohort to verify safety and efficacy for its corporate clinical trial targeting knee anterior cruciate ligament reconstruction with its medical device under development, "Tissue Regenerative Ligament" (development code: CT-ACL001). This randomized controlled cohort will use the standard treatment of knee anterior cruciate ligament reconstruction using the patient's own hamstring tendon as a comparative control group. It will be conducted at six facilities nationwide, including Tokyo Women's Medical University Hospital, where Professor Ken Okazaki, the trial coordinating physician, is affiliated, as well as Kobe University Hospital, Juntendo University Hospital, Hirosaki University Hospital, Hiroshima University Hospital, and Hokkaido University Hospital (in alphabetical order).

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

Overview of the Randomized Controlled Cohort (Please refer to public clinical trial information for details)

Investigational product: Tissue Regenerative Ligament (development code: CT-ACL001)

Target disease: Knee anterior cruciate ligament injury (requiring reconstruction surgery)

Target number of cases: 38 cases for the CT-ACL001 reconstruction group, 19 cases for the autograft reconstruction group

Scheduled start date: May 2026

Future plan: Application for manufacturing and marketing approval of the developed product after completion of the clinical trial

The research and development of this investigational product, including this clinical trial, is supported by the Medical Research and Development Innovation Platform Creation Project (CiCLE) of the Japan Agency for Medical Research and Development (AMED).

<Public Clinical Trial Information>

jRCT (Japan Registry of Clinical Trials: Clinical Research Submission/Publication System) Clinical Trial Implementation Plan Number: jCRT2032240214 https://jrct.mhlw.go.jp/latest-detail/jRCT2032240214

ClinicalTrials.gov (World's largest clinical trial registration 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 where the ligament is regenerated by the patient's own cells, using the graft (transplant) as a scaffold for reconstruction treatment.

[Company Profile]

CoreTissue BioEngineering Co., Ltd.

Date of establishment: November 29, 2016

Head office location: 1-1-43 Suehirocho, Tsurumi-ku, Yokohama City, Kanagawa Prefecture, Life Science Research Center 301

Representative Director: Yoji Shirokura

Business activities: Development, manufacturing, and sales of tissue-regenerative medical devices using animal tissues.

<Contact for this release>

CoreTissue BioEngineering Co., Ltd.

〒230-0045

1-1-43 Suehirocho, Tsurumi-ku, Yokohama City, Kanagawa Prefecture, Life Science Research Center 301

045-642-5455

Kanemoto: mitsuhide.kanemoto@coretissue.com