Greetings from President & CEO

Setsuko Hashimoto, Ph.D.President and CEO, CellSeed Inc.

Continuing to Move Forward for Commercialization
- Pursuing Commercialization of Cell Sheet Regenerative Medicine and Challenges for Sustainable Growth -
Setsuko Hashimoto, Ph.D. President and CEO, CellSeed Inc.

The year of 2017 saw several great achievements for CellSeed. First of all, we are very glad that our Epithelial Cell Sheet for Esophageal Regeneration was designated as a “SAKIGAKE product” under the Ministry of Health, Labour and Welfare’s SAKIGAKE Designation System.*1 Taking full advantage of this great opportunity, we plan to accelerate the development in Japan and obtain marketing approval in 2019.

Secondly, we entered into a partnership with MetaTech (AP) Inc. in Taiwan, which has been licensed the exclusive right to develop, manufacture, and market cell sheet regenerative medicine products (our Epithelial Cell Sheet for Esophageal Regeneration, and Regenerated Cartilage Sheet). MetaTech took a full swing of their development since they started and their cell sheet development activities have been progressing rapidly in Taiwan. To increase our sales and generate profits, we will explore business partnerships with other overseas companies for expanding cell sheet engineering, platform technology pioneered in Japan to the world.

In addition, we launched HydroCell Flask, a new type of low cell binding cultureware in the end of year 2017, and will expand sales of our intelligent cell cultureware globally in a positive manner.

The year 2018 marks the 18th anniversary of the establishment of CellSeed, Inc. We plan to start “contract manufacturing” of cell sheet products when our collaborative partner, Tokai University starts advanced and specialized medical care*2 with our Regenerative Cartilage Sheet for osteoarthritis of the knee patients. Our Cell Processing Facility has already acquired a business license to manufacture specified cell products and we are preparing for manufacturing products for these patients, to start with.

While we initiate “contract manufacturing” of cell sheet products, we have prepared to provide various contract services to assist research and development of regenerative medicine products. Under the Act on the Safety of Regenerative Medicine, enforced in 2014, we actively support the research and development of regenerative medicine products based on our experiences.

Bringing cell sheet products to as many patients as possible, as soon as possible – this is CellSeed’s constant aim. Your continued support is greatly valued and appreciated.

*1) SAKIGAKE Designation System aims to shorten premarket review periods to 6 months, cutting the standard review period in half, for the medical products for diseases in urgent need of innovative therapy having firstly developed in Japan and prominent effectiveness at early phase of clinical trials. The designation enables the developer various prioritized consultations for commercialization of the designated product.

*2) Advanced and Specialized Medical Care is the specific therapies using high level of medical technology. Every therapy has to be approved by the Ministry of Health, Labour and Welfare. Patients can be treated in combination with the insured therapy at the approved medical institution.

Setsuko Hashimoto

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