17/12/2025
NIKKISO CO.,LTD.

Nikkiso Co., Ltd. (hereafter "Nikkiso") is pleased to announce the launch of its hemodialysis machine "DBB-06 PRO" and dedicated bloodline set for the U.S. market from January 2026. This marks a significant step forward in accelerating our business expansion in the United States, which has the world's second-highest number of dialysis patients.

■Product Overview

Features of the "DBB-06 PRO"

The "DBB-06 PRO" is a dedicated equipment for hemodialysis (HD), the most common treatment method in U.S. dialysis care. It features simple operation and various monitoring functions, supporting improved treatment quality. Furthermore, it incorporates the "D-FAS" (Dialysis Full Assist System), the first full-assist function in the U.S. for an HD-dedicated device. By fully assisting pre-treatment priming operations and blood withdrawal/return procedures, it contributes to reducing the workload for healthcare workers and preventing human errors. "D-FAS" is already implemented in existing models for Japanese and European markets, where it has received high acclaim.

Regarding the Dedicated Bloodline Set

Sales of the bloodline set compatible with the "DBB-06 PRO" will also commence. This bloodline set is Nikkiso's proprietary "Arch Loop®" series, featuring a simple design for easy installation and reduced contact area between blood and air. The "DBB-06 PRO" is the first hemodialysis machine for the U.S. market to support the "Arch Loop®" system.

Manufacturing and Clearance Information

This hemodialysis machine and bloodline set received clearance from the U.S. Food and Drug Administration (FDA) in May 2025. The DBB-06 PRO is scheduled to be manufactured at the Kanazawa Plant, the primary domestic production site, while the bloodline set will be produced at manufacturing sites in Ho Chi Minh City and Quang Ngai Province, Vietnam. Additionally, some related products will be manufactured in Thailand.

■Future Developments in the U.S. Market

The United States, which has the second-largest number of dialysis patients worldwide--over 500,000 as of 2023--is projected to see continued growth in the number of patients receiving hemodialysis therapy. This trend heightens demand for advanced dialysis machines that alleviate the burden on healthcare workers and enhance treatment safety. Nikkiso will take the launch of the "DBB-06 PRO" as a significant opportunity to accelerate expand its dialysis business in the U.S. market. We will also continue preparations to broaden our lineup of dialysis-related products for the U.S. market.

Leveraging the technology and expertise cultivated through over 50 years of developing and providing dialysis-related products, Nikkiso will contribute to improving the quality of life for dialysis patients worldwide.

About Nikkiso

Since its establishment in 1953, Nikkiso has contributed to solving social issues by anticipating the changing times with world-first and Japan-first technologies and products. In the industrial business, Nikkiso has created new markets by developing products in the energy field, hemodialysis-related products in the medical business, and CFRP (carbon fiber reinforced plastic) aerostructures in the aerospace business.

Company Name: NIKKISO CO., LTD.

Head Office : YebisuGardenPlaceTower22nd　Floor,4-20-3,Ebisu,Shibuya-ku,Tokyo 150-6022, Japan

Date of Establishment: December 26, 1953

President & CEO : Koichi Kato

Business Overview : Nikkiso provides specialized pumps and systems in the Industrial Business, CFRP (carbon fiber reinforced plastic) aircraft parts in the Aerospace Business and hemodialysis related products in the Medical Business.

URL : https://www.nikkiso.com/

※This Press Information is intended to provide timely disclosure of information to our stakeholders, including members of the press, investors, and shareholders. The product information contained herein is not intended to provide medical information, including medical advice for the public, nor is it intended to solicit customers.

【For inquiries, please contact】

PR Section, Corporate Planning Department, Corporate Division, NIKKISO CO., LTD.

E-mail: nikkiso-pr@nikkiso.co.jp

The PDF version of this press release is available here.