Announcement of Sales Launch for New Product "CAP" (Compact Folding Pipettor)

Cyfuse Inc. (Headquarters: Minato-ku, Tokyo; Representative Director: Shizuka Akie; hereinafter referred to as "Cyfuse") is pleased to announce that it has developed and commenced sales of a new device product, the "CAP (Compact Automated Pipettor)" (hereinafter referred to as the "Device"), a compact folding pipettor that automates the advanced cell culture expertise cultivated through its regenerative medicine pipeline development and other activities.

1. Background of Development and Future Prospects

The global regenerative medicine market is experiencing rapid growth, with many cell-processed products transitioning from research and clinical development stages to commercial production as regenerative medicine products. Amidst this trend, "automation and standardization of manufacturing processes" to ensure high-quality, low-cost, safe, and stable supply of products has become one of the most critical challenges for the industrial development of the regenerative medicine field.

In particular, with the promotion of "Advanced Manufacturing" led by the U.S. Food and Drug Administration (FDA), which drives global standards for pharmaceuticals and regenerative medicine products, and the penetration of the international concept of "Quality by Design (QbD)" for scientifically assuring quality throughout the manufacturing process, the regenerative medicine field is increasingly seeking the establishment of innovative manufacturing systems that do not rely on traditional manual labor dependent on individuals. In other words, automation and standardization of manufacturing processes not only enable stable supply after product approval but also serve as a crucial business foundation supporting corporate competitiveness and business growth in the future regenerative medicine sector.

Cyfuse, aiming to establish a commercial production system for its products, has been engaged in the development of new devices that quickly respond to market demands for reduced manufacturing costs and enhanced mass production and scalability (scalability) by leveraging the cell culture technology and manufacturing know-how accumulated through research and development and manufacturing process development of regenerative medicine products.

Recognizing the global trend towards automation and standardization as a significant business opportunity, the newly developed product "CAP" automates the process of high-precision seeding (dispensing) into each container while maintaining uniform cell concentration in cell suspensions. Furthermore, it is capable of handling various suspensions, including cell suspensions, and boasts the industry's smallest class compactness for an automated cell suspension pipettor, making it a groundbreaking device that sets itself apart from conventional pipetting equipment.

This product is envisioned for use in a wide range of manufacturing sites in the regenerative medicine and life science fields, from research to clinical development and commercial production. By improving manufacturing process efficiency and homogenizing product quality, it significantly contributes to achieving both overall cost reduction and quality stabilization.

As a leading company supporting the "industrialization of regenerative medicine," Cyfuse will continue to create next-generation manufacturing platforms that realize mass production, high quality, and low cost for cell products, thereby contributing to the development of the regenerative medicine industry and enhancing global market competitiveness.

While the impact on the current fiscal year's performance is expected to be minor at this time, Cyfuse plans to expand its peripheral devices, including this Device, in addition to its bio-3D printers. This will accelerate the mechanization and automation of the entire cell product manufacturing process, diversify revenue structures beyond equipment sales, and further promote the enhancement of corporate value in the medium to long term.

2. Features of the New Product

(1) High-precision automation of conventional manual operations

For the manufacturing of cell preparations such as cell suspensions containing live cells and other components, this device automates high-precision cell dispensing operations comparable to those of skilled technicians, while maintaining sterility and uniform cell concentration.

(2) Industry's smallest class compactness and versatility

Featuring an industry-leading lightweight design and a revolutionary folding structure similar to a laptop PC, it can be installed within safety cabinets, enabling highly flexible and versatile operation.

(3) Optimized for clinical settings

It incorporates disposable consumables, decontamination of the main unit, and a low-dust-generating drive mechanism, ensuring the safety and quality required for clinical applications while significantly improving operational efficiency.