Philosophy & History
Vision
EXTENDING LIFE and ENHANCING QUALITY of LIFE by ENABLING MOBILITY
Arteriosclerosis stands as one of the leading causes of death worldwide. Among its manifestations, Lower Extremity Artery Disease (LEAD), which has seen a surge in patient numbers recently, is a life-threatening condition. Once it progresses to a severe stage necessitating amputation, the 5-year survival rate is lower than that of certain cancers. It is estimated that tens to hundreds of millions of people globally suffer from gait impairment due to arteriosclerosis.
In the coronary intervention field, stent implantation has been established as a standard revascularization therapy. However, for the lower limbs, particularly in the below-the-knee (BTK) arteries, no definitive device currently exists that can withstand the harsh mechanical environment of flexion, torsion, and deformation associated with walking while maintaining long-term patency. Consequently, the challenge of "restenosis" remains unresolved.
To address this unmet need, we are developing the BioStealth™ Stent, a next-generation scaffold equipped with "stealth" properties designed to minimize recognition as a foreign body within the vessel.
Through this development, we aim to restore compromised blood flow and realize a future where the fundamental happiness of "walking with vitality" is preserved in our aging society.
Mission
To deliver the latest treatments to patients as soon as possible
Fusion of Advanced Materials Engineering and Clinical Medicine Unattainable by Existing Technologies
In the progress of medicine, challenges remain that cannot be solved merely by extending existing technologies. In particular, treatment in the harsh environment of Below-the-Knee (BTK) arteries—which are extremely narrow with slow blood flow—has long been a major barrier in global intervention.
To break through this barrier, we have conducted research for over 20 years since 2003 within the "Medical-Engineering Collaboration Research Group (Hasebe Research Group)" of Keio University Faculty of Science and Technology and Tokai University School of Medicine, integrating experts in materials engineering, mechanical engineering, and clinical medicine.
Unique Development System Starting from Basic Materials Research
In medical device development, basic research at a university is not always mandatory. However, our challenge—the "search for the optimal biological solution in the fusion domain of organic and inorganic materials" and development returning to the micro, nano, and atomic levels—required a vast amount of time and an academic foundation beyond the scope of conventional corporate frameworks. Our strength lies in the vertical integration of development phases starting from the basic research level: precision materials engineering by the Faculty of Science and Technology, extraction of needs through close communication with the School of Medicine, and rapid technology evaluation cycles.
Breaking Through Barriers to Commercialization Ourselves
We do not let our research results end as mere academic reports. To ensure delivery to the clinical field as a tangible product, we have built a unique commercialization structure that seamlessly connects medicine, science/engineering, and manufacturing in a one-stop process without fragmentation. By overcoming every hurdle from development to commercialization ourselves, we guide innovative technologies to rapid social implementation.
Translating Science from Bench to Bedside
The core technology "BioStealth™," honed over 20 years, has reached the solid milestone of initiating clinical trials in Japan in 2025. It is our unwavering mission to deliver scientific evidence backed by advanced materials engineering to patients as soon as possible, ensuring a future where "walking" remains a fundamental right.
History
Jun. 2025
Submission of Clinical Trial Notification
Submitted the Clinical Trial Notification (CTN) for the Investigator-Initiated Clinical Trial (IIT) of the BioStealth™ Stent under development (Registry No. jRCT2032250267). Participating as the investigational device provider.
Apr. – Jun. 2025
Series B Round
Raised a total of 1.0 billion JPY through third-party allotment
Mar. 2024 – Mar. 2025
Completion of Non-Clinical Studies in the US
Conducted animal studies at a GLP-compliant facility in the US to acquire FDA-compliant non-clinical data. Completed the necessary non-clinical studies for the domestic clinical trial.
Oct. 2024
Series A Extension Round
Raised a total of 320 million JPY through third-party allotment
Sep. – Nov. 2023
Series A Round
Raised a total of 1.17 billion JPY through third-party allotment
Apr. – Jun. 2023
Seed Round
Raised 280 million JPY through third-party allotment to "DMC No. 1 Investment Limited Partnership" operated by Diamond Medino Capital.
Mar. 2023
FDA Pre-Submission
Completed the US FDA Pre-Submission process toward US approval. The framework for the non-clinical testing package was finalized.
Dec. 2022
Establishment of Global Vascular Co., Ltd.
Incorporated the design and development operations related to this project; Bito and Maegawa assumed the positions of Representative Directors.
Sep. 2022 – Present
Selected for AMED FY2022 Translational Research Program (Seeds F)
Launched "Practical application research of a long-term patency stent system for fine arteriosclerotic lesions in the below-the-knee (BTK) region" with Tokai University as the Principal Investigator institution, and Global Vascular Inc. (from FY2023), BioZone Medical, Yamashina Seiki, and Keio University (until FY2023) as participating institutions.
Apr. 2019 – Present
Initiated Joint Research with Biozone Medical Co., Ltd.
Established a spin-out lab at Biozone Medical Co., Ltd. based on Hasebe Research Group's technology to commercialize the lower limb artery stent. CEO Bito and CTO Maegawa led the technology development.
Oct. 2018 – Mar. 2022
Selected for AMED FY2018 Advanced Measurement and Analysis Technology/Equipment Development Program
Launched "Development of a long-term patency stent system for fine arteriosclerotic lesions in the below-the-knee (BTK) region" with Tokai University as the Principal Investigator institution, and Yamashina Seiki and Keio University as participating institutions. The project was selected for the AMED Translational Research program. Developed a prototype and demonstrated the concept of "in vivo suppression of foreign body reaction" through animal studies.
2005 – 2015
Establishment and Refinement of Basic Coating Technology
Reported the hemocompatibility of fluorine-doped diamond-like carbon (F-DLC), the fundamental structure of BioDiamond™ technology, for the first time globally. Hasebe earned a Ph.D. (Engineering). Research results were published in international journals and presented at conferences, receiving numerous academic awards.