Company Profile
CoreTissue BioEngineering Inc. is a Japan-based medtech startup developing tissue-regenerative ligaments for anterior cruciate ligament (ACL) reconstruction, headquartered in Yokohama, Kanagawa, Japan. Founded in November 2016 as a spin-out from Waseda University, the company operates as an independent private entity led by CEO Yoji Jokura, Ph.D. and founder Kiyotaka Iwasaki, Ph.D., serving orthopedic surgeons and sports medicine centers in Japan and the United States. The company maintains a US office in Palo Alto, California.
Core Products & Technologies
Tissue-Regenerative Ligament System
• CT-ACL001 Tissue-Regenerative Ligament: Implantable decellularized bovine tendon graft for ACL reconstruction, designed to achieve strength comparable to human tendon and ligament-level thickness while eliminating cellular components that trigger immune or inflammatory responses
• Microwave Decellularization Technology: Proprietary process using microwaves to vibrate water molecules, enabling cell-membrane dissolving solutions to penetrate deep into thick tendon tissue without damaging collagen structure — the first in the world to achieve this for ligament-scale tissue
Manufacturing & Development Pipeline
• Mass-Production Equipment: Verification unit under joint development with Microwave Chemical Co., Ltd. to scale up microwave-based decellularization for commercial production targeted for 2028
• Clinical Trial Infrastructure: Company-sponsored investigator-initiated trial network spanning six top-tier Japanese university hospitals
Market Position & Certifications
CoreTissue BioEngineering holds a pioneering position in the decellularized biological ligament segment, competing with Neoligaments (Cousin Biotech) and Shanghai Pine ＆ Power Biotech in the global artificial ligament market. Key strengths include:
• World-first microwave decellularization: Unique ability to process thick tendon tissue while preserving mechanical strength and collagen architecture
• Regulatory milestones: Class I medical device manufacturing and marketing license obtained in Japan (July 2023); FDA Pre-Submission completed (2020); product not yet approved in any country pending pivotal trial completion
• Clinical validation: First-in-human treatment performed in December 2024; safety cohort completed and randomized controlled cohort initiated in May 2026
• Government support: Research and clinical trials funded by Japan Agency for Medical Research and Development (AMED) and NEDO Deep-Tech Startups Support Program (JPY 494 million, 2025–2027)
Corporate Timeline
2016 — Founded as a Waseda University spin-out in Yokohama to commercialize decellularized tissue ligaments
2019 — Received first investment from Waseda University Official Fund; granted Ogasawara Foundation research funding
2020 — Adopted to AMED's 5th CiCLE grant program; completed FDA Pre-Submission meeting
2021 — Elected to J-Startup national support program; obtained highly controlled medical device manufacturing and marketing authorization in Japan; raised JST SUCCESS program funding
2022 — Obtained medical device manufacturing license; featured on NHK WORLD "Medical Frontiers"; selected for Yokohama City US Life Science Market Development Support Program
2023 — Completed Series A funding of approximately JPY 560 million; obtained Class I medical device license in Japan; selected for AMED Advanced Medical Devices and Systems Development Project
2024 — First patient treated with CT-ACL001 regenerative ligament in December; selected as coworking member of Japan Innovation Campus in Silicon Valley; accepted into accelerator backed by Mitsubishi Corporation (Americas) and Fogarty Innovation
2025 — Raised approximately JPY 600 million from Nippon Ham and Mitsui Sumitomo Insurance Venture Capital; commenced mass-production equipment development with Microwave Chemical; selected for 8th NEDO-DTSU Support Project
2026 — January: Began developing mass-production equipment with Microwave Chemical. May: Safety cohort completed; randomized controlled cohort initiated across six Japanese university hospitals; initial results presented at ESSKA Congress
Target Markets & Applications
• ACL Reconstruction Surgery: Primary ligament graft for patients requiring anterior cruciate ligament repair, offering an alternative to autologous hamstring tendon harvest
• Sports Medicine: Treatment for athletes with ACL injuries to enable early return to competition and restore peak performance
• Revision ACL Surgery: Graft option for re-rupture cases where insufficient autologous tendon remains for reconstruction
• Future Orthopedic Expansion: Potential application to other ligament injuries and rotator cuff reconstruction under exploratory development
Contact Information
Global Headquarters
Address: Life Science Research Center 301, Suehirocho 1-1-43, Tsurumi-ku, Yokohama, Kanagawa 230-0045, Japan
Tel: +81-45-642-5455
Email: info@coretissue.com
Website: coretissue.com
US Office
Address: Japan Innovation Campus, 212 Homer Avenue, Palo Alto, CA 94301, USA
Corporate Structure
CoreTissue BioEngineering Inc. operates as an independent private company with no publicly traded parent company.
CEO: Yoji Jokura, Ph.D.
Founder: Kiyotaka Iwasaki, Ph.D.
Key Investors: WERU Investment (Waseda University affiliated), Nippon Ham, Mitsui Sumitomo Insurance Venture Capital
Investor Relations: Not applicable — privately held startup with no publicly traded stock.
