We are pleased to announce that Medico’s Hirata Inc. (Headquartered in Osaka, Japan, President: Masataka Hirata; referred to below as "Medico’s Hirata"), a pioneer in minimally invasive treatments with over 100 years of history in the medical device industry, and Gellycle Co., Ltd. (Headquartered in Tokyo, Japan, CEO: Kosuke Masui; referred to below as "Gellycle"), a bio-venture company with Tetra gel technology originating from the University of Tokyo, have expanded the framework of their joint development and have concluded a new agreement to utilize Tetra gel in the treatment of blood circulation disorders and vascular diseases.

Medico’s Hirata and Gellycle have been working on the joint development project of a hemostatic agent medical device since the agreement was concluded in February 2021. In light of the recent progress in R&D of hemostatic agents, they have decided to expand the scope of the project and enter into a further joint development agreement.

This wider collaboration will enable Medico’s Hirata to develop various medical devices using Gellycle's Tetra gel and to expand into the fields of blood circulation disorders and vascular disease therapies.

The new joint development is aimed at the treatments of varicose veins in lower limb and aortic dissection, among various treatments of blood circulation disorders and vascular diseases. Varicose veins is a disease so common that there are more than 10 million people in Japan suffering from the condition,*1 and one in two women*2 who have given birth also develop the disease. All existing treatments for varicose veins are highly invasive now. Gellycle's Tetra gel can achieve a less invasive treatment by a simple gel injection. We are diligently working on the joint development in order to obtain regulatory approval in 2026.

*1: Estimated by converting the number (9%) of varicose veins patients aged older than 40 in a specific region into the total population of Japan (the Nishiyo District Cohort Study in 2005, Professor Masamitsu Konishi et al.)

*2: “Varicose Veins in Pregnancy”, Japanese Journal of Phlebology 8(3) 255-261 in 1997. Masafumi Hirai, Atsuhiko Maki, Naokazu Hayakawa et al.

Note: Invasiveness can be measured by the amount of physical stress and impact on the patient’s body in medical treatment. A minimally invasive treatment is usually the first choice in testing, therapy and surgery.

[Gellycle’s Tetra gel technology]

Tetra gel technology is a new gel technology developed by Professor Takamasa Sakai of the Faculty of Engineering, the University of Tokyo. A mixture of two types of polyethylene glycol (PEG), which have a four-branched chain and different functional groups at the end of the prepolymer chain that react with each other, can produce a gel with homogeneous network structure.

The homogeneous network structure of Tetra gel now makes it possible to control and set all the properties individually. This control of the properties of gels was previously considered to be too challenging. This is the result of Prof. Takamasa Sakai's work including more than 10 years of research on Tetra gel and more than 100 papers published in national and international journals, such as Science and Nature Biomedical Engineering.

With these properties of Tetra gel, Gellycle is able to meet all the needs of clinical practice, whilst doing cooperative researches with many clinicians.

In this joint development project, we are targeting the practical use of Tetra gel in the treatment of blood circulation disorders and vascular diseases. We will continue to collaborate with many medical-related companies to jointly develop medical devices using this Tetra gel technology, and hope to spread medical products using this innovative technology to the rest of world.

[Message from Masataka Hirata, President of Medico’s Hirata Inc.]

I believe that the wider framework of the joint development using Gellycle's Tetra gel will bring about substantial benefits for varicose veins therapy, which Medico's Hirata has worked on for many years, and will provide even safer and more effective medical care to patients. This joint development can boost the advancement of minimally invasive medical care that we have been promoting. We will strive to promptly distribute developed products in medical practice not only in Japan but also to the rest of world based on our motto: “Our social mission is to contribute to the development of medical therapy”

[Message from Kosuke Masui, CEO of Gellycle Co., Ltd.]

We are very pleased to be able to further expand the partnership of Tetra gel with Medico’s Hirata. They have worked on varicose veins therapy for a long time. We believe that the signing of this agreement is the result of their deep trust in our technology and their professional evaluation of the superiority of Tetra gel. We will speed up the process and deliver our products to patients as quickly as possible.

[About Medico’s Hirata Inc.]

Founded more than 100 years ago, Medico's Hirata was one of the first companies in Japan to work on catheter intervention therapy, and has been a specialized trading company that provides safety and security to the medical community in Japan through the import, manufacture and sales of minimally invasive medical devices.

We are also actively promoting joint developments with domestic and overseas medical device manufacturers, and have been working on the hemostatic agent with the same venture spirit since our founding and a sense of mission of delivering advanced medical products.

[About Gellycle Co., Ltd.]

With the mission of revolutionizing medicine utilizing hydrogels "Find Better QOL with Hydrogels," Gellycle was founded in 2018 by Mr. Masui and Professor Takamasa Sakai of the Faculty of Engineering, the University of Tokyo, and their core technology is the Tetra gel technology that Mr. Masui researched in his master's program at the University of Tokyo.

Gellycle’s Tetra gel has made it possible to control the properties of gels, which had been considered difficult in the past, and is used by more than 20 advisory physicians, including Professor Yuichi Tei of the University of Tokyo, to promote research and development in the medical industry.

[Company information on Medico's Hirata Inc.]

Company name: Medico's Hirata Inc.

Headquarter: 3-4-3 Edobori, Nishi-ku, Osaka, Japan

Representative: Masataka Hirata

Established in January 1918

URL: http://www.medicos-hirata.co.jp/

[Company information on Gellycle]

Company name: Gellycle Co., Ltd.

Headquarter: 2F Sakae Building, 3-38-1 Hongo, Bunkyo-ku Tokyo, Japan

Representative: Kosuke Masui

Established on August 01, 2018

URL: http://gellycle.com/

Business: Research and development of medical devices and regenerative medicine using tetra hydrogel