CoreTissue BioEngineering

What CoreTissue BioEngineering does

CoreTissue BioEngineering is a clinical-stage Japanese medical device company spun out of Waseda University in November 2016 to commercialize proprietary decellularization technology for regenerative orthopedic applications. Its lead pipeline product, CT-ACL001, is a tissue regenerative ligament for anterior cruciate ligament (ACL) reconstruction surgery that uses decellularized biological tissue combined with freeze-drying and sterilization processes to create a scaffold enabling native tissue regeneration. The company addresses limitations of current ACL reconstruction — which requires harvesting the patient's own hamstring or patellar tendon, causing donor site morbidity and limiting graft availability for revision or multi-ligament cases — by offering a regenerative off-the-shelf alternative that targets the global ACL reconstruction market of over 800,000 procedures annually (approximately 20,000 in Japan and 200,000 in the US).

The underlying technology is differentiated from approximately 40 existing decellularized tissue medical devices by its ability to process thick tendon tissue while maintaining mechanical strength suitable for ligament reconstruction. In January 2026, CoreTissue partnered with Microwave Chemical Co., Ltd. to develop proprietary microwave-based decellularization equipment aimed at commercial-scale manufacturing by 2028. The company is also developing a rotator cuff reconstruction device under an AMED Advanced Medical Devices project providing up to ¥575M over five years, expanding its tissue regenerative platform into additional orthopedic indications.

CoreTissue operates a pre-commercial revenue model: it is not yet generating product sales and is funded primarily through equity (approximately ¥1.16 billion across Series A and Series A Extension rounds) and non-dilutive government grants (AMED, JST SUCCESS, NEDO DTSU). Its go-to-market is enterprise field sales to hospitals and orthopedic surgery centers performing ACL reconstruction procedures, initially in Japan upon PMDA approval and subsequently in the US via the FDA pathway. The company maintains headquarters in Yokohama, a US branch at the Japan Innovation Campus in Palo Alto, and is led by President and CEO Yoji Jokura with founder Kiyotaka Iwasaki serving as Chief Scientific Advisor. Six Japanese university hospitals are currently enrolling patients in its pivotal clinical trial (jRCT2032240214), with the randomized controlled cohort initiated in May 2026.

Name

CoreTissue BioEngineering

Legal name

CoreTissue BioEngineering株式会社

Website

https://coretissue.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

CoreTissue BioEngineering is a clinical-stage Japanese medtech developing CT-ACL001, a decellularized tissue regenerative ligament for ACL reconstruction surgery, targeting the global market of over 800,000 annual ACL procedures and currently enrolling patients in a pivotal Japan trial.

Ownership category

akta.pro rank

Product category

Orthopedic Regenerative Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)

akta.pro secondary industries

Acellular/Decellularized Matrices & ECM Products (HLAAAGAF), Tissue-Engineered Constructs & Scaffolds (natural/synthetic biomaterials) (HLAAAGAB)

Keywords

• Regenerative ligament devices
• Decellularization technology
• ACL reconstruction products
• Tissue engineering medical devices
• Orthopedic biomaterial solutions

Headquarters

HQ city

Tsurumi

HQ country

Japan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales (Tissue Regenerative Ligament): Revenue will be generated through the sale of the tissue regenerative ligament (CT-ACL001) to hospitals and surgical centers performing ACL reconstruction procedures. The product is positioned as a premium medical device offering superior biocompatibility compared to autografts, targeting the global ACL reconstruction market of over 800,000 annual procedures.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

CoreTissue BioEngineering develops, manufactures, and will sell CT-ACL001, a tissue regenerative ligament for anterior cruciate ligament (ACL) reconstruction surgery, using a proprietary decellularization technology that processes thick biological tissues while maintaining mechanical strength. The product serves as a regenerative scaffold that allows patient cells to infiltrate and replace the implant with native ligament tissue, eliminating the need to harvest the patient's own hamstring or patellar tendon. The company is commercializing the device for hospitals and surgical centers in Japan with plans for US market entry.

Product overview

CoreTissue BioEngineering is a medical device startup developing regenerative medical products centered on its lead pipeline product CT-ACL001 (Tissue Regenerative Ligament), a decellularized tissue-based medical device for anterior cruciate ligament (ACL) reconstruction surgery. The company also offers an AI-powered chatbot service (Jorus Medical AI Chatbot Service) as a patient support tool for its clinical trials. The product portfolio centers on solving the limitations of current ACL reconstruction methods by enabling tissue regeneration without requiring harvest of the patient's own tendons.

Differentiator

Problem solved

Functional benefit

Products and services

• CT-ACL001 (Tissue Regenerative Ligament) A tissue-engineered ligament manufactured by CoreTissue BioEngineering using proprietary decellularization technology and freeze-drying/sterilization processes. Made from biological tissue, it serves as a regenerative scaffold enabling patient cells to infiltrate and ultimately replace the implant with native ligament after ACL reconstruction surgery. It is designed for hospitals and orthopedic surgery centers performing ACL reconstruction for athletes and active individuals, and is intended to eliminate the need to harvest the patient's own hamstring or patellar tendon.

Quantifiable outcome

• Over 800,000 ACL reconstruction procedures performed annually worldwide
• +2 more outcomes

Named customers6 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Microwave Chemical Co., Ltd.coreTechnology or Integration · 13 January 2026Partnership for development of mass-production equipment applying unique microwave-based decellularization technology. After equipment delivery, CTBE will use it to identify technical issues and verify mass-production conditions with target of commercial production implementation in 2028.
• Mitsubishi Corporation (Americas)coreStrategic or Co-development Partner · 30 July 2024R Accelerator Program partner providing approximately 6 months of support in Silicon Valley including business development, regulatory strategy, and reimbursement strategy formulation for US market entry.
• Fogarty InnovationcoreStrategic or Co-development Partner · 30 July 2024Non-profit MedTech incubator providing full-contact mentoring and strategic guidance to help CTBE navigate US market regulatory complexities. Located at El Camino Hospital campus in Mountain View, California.
• Waseda UniversitycoreStrategic or Co-development Partner · 7 April 2023Collaborating institution in AMED Advanced Medical Devices project for rotator cuff reconstruction device development. Professor Kiyotaka Iwasaki serves as professor at Waseda University and is the company's founder.
• Tokyo Sports & Orthopedic ClinicminorStrategic or Co-development Partner · 7 April 2023Collaborating clinical institution in AMED Advanced Medical Devices project for rotator cuff reconstruction device development, providing clinical expertise and trial site.
• Kievit ScientificminorImplementation/ SI/ Consulting Partner · 1 November 2022Program partner providing support for US Life Science Market Development Support Program 2022 sponsored by Yokohama City Americas Office.

Scale indicators4 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• LifeNet Health: Non-profit tissue bank offering decellularized and processed allograft products for orthopedic and sports medicine, including ligament reconstruction. Directly comparable to CoreTissue BioEngineering as a tissue-based regenerative medical device provider targeting the same surgeon customers in ACL reconstruction.
• MTF Biologics: Major tissue procurement and graft provider supplying allografts (including for ACL reconstruction) to orthopedic surgeons. Comparable as a tissue-based graft competitor in the same sports medicine surgical workflow.
• RTI Surgical (Novabone): Developer and manufacturer of tissue-based and regenerative implants including sports medicine grafts (now operating under Novabone). Comparable as a commercial decellularized/regenerative tissue peer in the orthopedic space.
• JRF Ortho: Specialty orthopedics company supplying allograft tissue for ligament reconstruction and other sports medicine procedures. Directly comparable as a tissue graft competitor in ACL reconstruction.

Broad incumbents

• Arthrex: Large privately-held orthopedic device company with a comprehensive sports medicine portfolio including ACL reconstruction products (grafts, fixation devices, instruments). Comparable as a broad incumbent serving the same surgeon customers with overlapping solutions.
• Smith & Nephew: Global medical device company with a sports medicine franchise that includes grafts, fixation, and instrumentation for ACL reconstruction. Comparable as a broad incumbent offering overlapping capabilities in the same surgical procedure category.
• Conmed: Public medical device company with a dedicated sports medicine franchise supplying instruments, fixation, and biologics for ACL reconstruction. Comparable as a broad incumbent serving the same surgical procedure category.

Emerging players

• MiMedx: Regenerative medicine company developing placental tissue-based and other biologic products for orthopedic and wound healing applications. Comparable as an emerging regenerative medicine peer using biologic tissue processing, with partial overlap in musculoskeletal indications.
• Organogenesis: Commercial-stage regenerative medicine company with biologics for wound care and surgical applications. Comparable as an emerging regenerative medicine peer leveraging biologic tissue processing, though focused on wound/skin rather than ligament applications.
• Vericel: Commercial-stage regenerative medicine company with sports medicine and cartilage repair products (MACI). Comparable as an emerging peer in regenerative sports medicine, with overlapping customer base of orthopedic surgeons despite a cartilage rather than ligament focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/coretissue-bioengineering-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds4 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CoreTissue BioEngineering