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HOME >> Investor Relations >> Top Message >> Message Archive (June 25, 2015)

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To Our Investors - June 25, 2015 -

First, I would like to thank all the shareholders who attended the recent shareholders’ meeting and participated in the lively exchange of ideas. We sincerely hope that we will continue to have your support for many years to come. The following are some updates about Japan Tissue Engineering Co., Ltd. (J-TEC).

Opening Symposium Topics at Academic Conferences

Back in June, two academic conferences were held on the topics that were closely related to our business field. One of them is the 41st Annual Meeting of the Japanese Society for Burn Injuries held in Nagoya. An opening symposium on the first day in the main venue had a lineup of 9 presentations about the autologous cultured epidermis, JACE. The presenters, who were physicians specialized in burn injury treatment, discussed how to increase the life-saving rate of severe burn injury patients and how to improve the postoperative function, drawing on a number of real examples of using JACE, the first regenerative medicine product in Japan. JACE is a product as well as a treatment technique; and we could see that, through trial and error, medical care providers are actively exploring how to make the optimal use of JACE. As its manufacturer, we have the responsibility to meet the expectations of these medical care providers.

The second conference was the 7th Annual Meeting of the Japanese Orthopedic Society of Knee Arthroscopy and Sports Medicine (JOSKAS) in Sapporo. To our pleasant surprise, the topic of an opening symposium on the first day in the main venue was the “state-of-the-art of articular cartilage regeneration”. There were 7 presentations made with great enthusiasm about the efforts related to the state-of-the-art of articular cartilage regeneration including the use of the autologous cultured cartilage, JACC, as well as its competing techniques. We launched JACC onto the market two years ago. Since then, we have seen more newcomers (both academic and corporate) to the field, prompted by a significant change in the Japanese government’s regulations for regenerative medicine. Many of these newcomers regarded JACC as the benchmark. The competition will intensify. And the industrialization of regenerative medicine has begun in the field of orthopedics.

Regenerative medicine as an opening topic for Japanese academic conferences—it will be a trend that we expect to continue for a while. And my business goal is to make sure J-TEC will remain the leader of the pack.

Progress in Development of Corneal Epithelium

EYE-01M & Mr.Ozawa

As I briefly mentioned in the shareholders’ meeting, we are making good progress in the clinical trial of our 3rd pipeline product, autologous corneal epithelium (development code: EYE-01M). The development of this product is commissioned by Nidek Co., Ltd.; and this year, the clinical trial is commissioned by the Japan Agency for Medical Research and Development (AMED). It is conducted at 4 medical institutions and coordinated by Professor Koji Nishida of the Department of Ophthalmology, Osaka University. The patient recruitment is going smoothly. Various research studies are conducted worldwide in the field of corneal regenerative medicine. But when it comes to clinical trials, our EYE-01M seems to be the 3rd one in the world.

Actually, an autologous corneal epithelium product called Holoclar was approved by the European Medicines Agency (EMA) in December 2014. The main developers of this product are Profs. Michele De Luca and Graziella Pellegrini of Italy, who serve as our technical advisors. The product specifications are different between Holoclar and EYE-01M, yet the basic techniques are the same. Now, we simply must not let ourselves fall behind.

In order for patients with corneal epithelial stem cell deficiency to regain their eyesight, we are determined to demonstrate the efficacy and safety of EYE-01M through the clinical trial and to strive for careful yet fast-paced progress in this product development.

June 25, 2015
Yosuke Ozawa
President & CEO
Japan Tissue Engineering Co., Ltd.