CTBE and Microwave Chemical Begin Developing Mass-Production Equipment for a Novel “Regenerative Ligament” for ACL Reconstruction ― Aiming for practical application in sports medicine by leveraging the world’s first microwave decellularization technology ―

CoreTissue BioEngineering Inc.
Microwave Chemical Co., Ltd.

CoreTissue BioEngineering Inc. (“CTBE”) and Microwave Chemical Co., Ltd. (“Microwave Chemical”) have begun development of mass-production equipment (the “Equipment”) that applies a unique microwave-based decellularization technology toward commercialization of a “regenerative ligament” intended for anterior cruciate ligament (ACL) reconstruction procedures.

After Microwave Chemical delivers the Equipment to CTBE, CTBE will use it to identify technical issues required for commercial-scale equipment development and to verify mass-production conditions. The companies aim to implement the process toward commercial production of the development product in 2028.


■Background
ACL injuries frequently occur in sports settings and are serious orthopedic conditions that can affect athletes’ careers. Each year, approximately 19,000 ACL reconstruction surgeries are performed in Japan and around 175,000 in the United States.

At present, reconstruction surgery with tendon autograft —harvesting a tendon from another part of the patient’s body—is the standard approach. However, this method places an additional physical burden on the patient due to removal of healthy tendon tissue, and it may also be difficult to secure sufficient tendon tissue in the event of re-rupture.

One potential solution is the use of bovine or porcine tissues as alternatives to autografts. To enable transplantation into humans, decellularization technology is required to remove cells and other components that may cause immune or inflammatory responses. Conventional decellularization methods are generally limited to thin membrane-like tissue of only several hundred micrometers or less, and chemical agents used to dissolve cells may damage collagen structures, making it difficult to achieve the thickness and mechanical strength needed for ligament reconstruction.


■Overview
To address these challenges, CTBE focused on the ability of microwaves to vibrate water molecules and thereby enable cell-membrane dissolving solutions to penetrate deep into thick tendon tissue. CTBE’s technology is the first in the world to remove only cellular components without deteriorating the tissue structure, achieving both strength comparable to human tendons and the thickness required for a ligament construction.

The regenerative ligament developed using this technology (the “Development Product”) was used for the first time to treat a patient in December 2024 as part of a company-sponsored clinical trial^※1, and a clinical trial to evaluate its safety is currently underway.

In order to establish mass-production technology for the Development Product, CTBE will collaborate with Microwave Chemical, which has strengths in scaling up microwave equipment, to manufacture a verification unit for optimizing mass-production conditions. After completion and delivery of the Equipment, CTBE will use it to validate stable multi-unit manufacturing of the Development Product.


■Outlook
CTBE will continue preparing for clinical trials with a view to expanding its business in the United States, while establishing mass-production technology toward commercialization. CTBE aims to implement the process toward commercial production of the development product in 2028. In addition, CTBE will explore applications beyond the knee—such as other ligament injuries and rotator cuff reconstruction—to drive innovation in sports medicine worldwide.

Through fabrication of the Equipment, Microwave Chemical will accumulate knowledge in the medical field and expand its microwave technology platform, broadening the scope of future applications.


■Note
1: A company-sponsored clinical trial is a study conducted at the request of a pharmaceutical, medical device, or other development company and carried out by medical institutions/physicians to evaluate the safety and efficacy of a new drug, medical device, or similar product, with the aim of obtaining approval from the regulatory authority.


■Company Profiles
CoreTissue BioEngineering Inc.
A medical device startup spun out of Waseda University in 2016. With the mission of help athletes around the world return to competition early and regain their best performance, CTBE is pioneering the development and commercialization of innovative regenerative ligaments for ACL reconstruction.

Microwave Chemical Co., Ltd.
In 2014, Microwave Chemical became the first in the world to succeed in developing manufacturing processes for large-scale chemical plants heated using microwaves. The company provides innovative electrified processes across a range of industries, enabling energy-saving, high-efficiency, and compact manufacturing processes.