October 1, 2021

Fujimori Kogyo Co., Ltd.

Sales of T-TAS® 01 (Total Thrombus-formation Analysis System)

to launch in Japan

Fujimori Kogyo Co., Ltd. (Head Office: Bunkyo-ku, Tokyo, Representative Director and President: Eishi Fuyama) has enter into a distributorship agreement with FINGGAL LINK CO., LTD. (Head Office: Taito-ku, Tokyo, Representative Director: Masaaki Nagone) for T-TAS® 01 in Japan. As the manufacturer and distributor of T-TAS® 01, FINGGAL LINK CO., LTD., will begin selling the system in Japan starting in October 2021.

T-TAS® (Total Thrombus-formation Analysis System) applies a new measurement principle independently developed by our company and is the world's first system designed to quantitatively observe thrombus forming ability in the bloodstream. The T-TAS plus research model has been sold in Japan, Europe, and the United States since 2015, and has been well received by medical professionals.

Following the release of T-TAS® plus, we developed T-TAS® 01 as an easier to operate model. This model received the European CE Mark in December 2018 and US Food and Drug Administration (FDA) approval in February 2020 as a medical device. We began selling, and continue to sell, T-TAS® 01 in the European and North American regions ahead of Japan.

In Japan, we registered this model as a medical device with the Pharmaceuticals and Medical Devices Agency (PMDA) in September 2021. We will develop the Japanese market for this system in concert with FINGGAL LINK CO., LTD., by providing solutions to medical sites in the fields of thrombosis and hemostasis.

Brand Name: T-TAS 01 Total Thrombus-formation Analysis System

Classification: Class I Controlled medical devices requiring special maintenance

Marketing authorization number: 13B1X10181000056

Manufacturer and distributor: FINGGAL LINK CO., LTD.

Product introduction "T-TAS® 01 Total Thrombus-formation Analysis System"

GUI guidance for easy operation

Simultaneous measurement of up to

Graphical User Interface

T-TAS® 01

Websites: Product Information

https://www.zacros.co.jp/products/ttas.shtml?c=15

T-TAS® Special Website https://www.t-tas.info/

■Contact information for this matter Fujimori Kogyo Co., Ltd. General Affairs Department TEL: 03-5804-4221

URL: https://www.zacros.co.jp/contact.shtml

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Fujimori Kogyo Co. Ltd. published this content on 01 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 October 2021 07:11:03 UTC.