Clinical Development of Regenerative Medicine … ª式会社セルシード JASDAQｸﾞﾛｰｽ証券コード：7776 Clinical Development of Regenerative Medicine Products Based

株式会社セルシードJASDAQｸﾞﾛｰｽ証券コード：7776

Clinical Development of Regenerative Medicine

Products Based on Cell Sheet Engineering

Technology in Japan and Europe

Setsuko Hashimoto, Ph.D.

President and CEO

Copyright © 2015 CellSeed Inc. All Rights Reserved.

Universities Source of

innovation

Hosp

itals

Patie

nts

products

Research collaborataion

seeds fee

therapy

Product development

Approval

Manufacturing

Business collaboration

partner companies

fee

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Missions of CellSeed

To bring regenerative medicine to the patients

To introduce our unique platform technology for regenerative medicine,

“cell sheet engineering” globally To initiate health innovation by providing safe and high quality products


Corporate overviewEstablishment May, 2001Basic technology Cell-sheet engineering using temperature-responsive polymers Business • Cell Sheet Regenerative Medicine

• Intelligent cell culturewareHead office Katsura Bldg., 4F, 3-61 Haramachi, Shinjuku-ku, Tokyo 162-0053

Directors President and CEO Setsuko Hashimoto, Ph.DExecutive Director Katsumi KatayamaExecutive Director Hiroshi YoshidaExecutive Director Eiji TakagiAuditor（External） Teruo Okano, Ph.DAuditor Ichiro KobayashiAuditor（External） Noriko SawaiAuditor（External） Toshio Yamaguchi

Fiscal year January - DecemberNo. of employees 30 (as of April 30, 2015）Publicly listed on JASDAQ (in 2010)

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Core competence: Cell sheet engineeringTemperature-responsive polymers allow recovery of intact cells in a sheet form. Developed by Prof. Teruo Okano, Tokyo Women’s Medical University, Japan

Intelligent surface of the cultureware37℃ hydrophobic ⇔ 20℃ hydrophilic

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Copyright © 2015 CellSeed Inc. All Rights Reserved. 4

Advantages of Cell Sheet: Autonomously Functioning Bioengineered Tissue

Isolated cells (Used in conventional regenerative

medicine and cell therapy)

● Isolated cells not functioning as tissue

● Lost “extra-cellular matrix”

1. Functioning as a basic unit of biological tissue/organ• Low safety risk• Immediately becomes part of the

body

2. Extra-cellular matrix preserved

• Graft possible with no sutures• Remains and continues to produce

factors that aid tissue regeneration over the long term

3. Multiple layering possible= 3D tissues/organs construction possible

Cell Sheet

● Very difficult to construct 3D tissues/organs


Cell Sheet Regenerative Medicine Pipelines

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角膜

Prioritized business for 2015

•Epithelial cell sheet for

esophageal regeneration

•Regenerated cartilage sheet

Promote our own

development

• Cell Sheet for periodontal

tissue generation sheet

Explore possibility for

joint development

•Epithelial cell sheet for

corneal regeneration

•Regenerated cardiac patch

Explore cooperation

with partner(s)

Starting clinical trial sponsored by CellSeed


Treatment method to prevent esophageal stricture after removal of esophageal epithelial cancer developed by Tokyo Women’s University

Transplant the cultured autologous oral mucosal epithelial cell sheet in the intelligent cultureware on the ulceration after endoscopic surgery

CellSeed develops devices for transplanting cell sheets

Cell Sheet Regenerative MedicineEpithelial cell-sheet for esophageal regeneration

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Copyright © 2015 CellSeed Inc. All Rights Reserved. 7

Clinical development of epithelial cell sheet for esophageal regeneration

Japan CellSeed

Tokyo Women’s Medical University

Europe

Japan： Tokyo Women’s Medical University 20 patients

Sweden：Karolinska University Hospital 10 patients

Clinical research in academia

Company sponsored clinical trial


Establishment of a subsidiary in Sweden

Company name： CellSeed Sweden AB

Establishment：May 6, 2015

Location: Vollmervägen 12, SE-187 36 Täby, Sweden

Business：Cell-sheet regenerative medicine products in Europe

Capital： 6,800,000 SEK

Chairman of the board： Setsuko Hashimoto, Ph.D.

Board members : Erik Walden, Helena Nilshans

Country Manager: Camilla Huse Bondesson

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Promoting epithelial cell sheet for esophageal regeneration business in Europe


Cell sheet regenerative medicine for Regenerated cartilage sheet

In collaboration with Prof. Masato Sato, MD, Ph.D., Dept. of Orthopedic Surgery, Tokai University

Completed pilot clinical research with autologous cells with 8 patients (2011 – 2014)To start clinical trial in 2016 in Japan

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Multi-layered cell sheetsRegeneration of cartilage

3D tissues/organs construction

Prevent proteoglycan to diffuseProtect from catabolic factorsSources of growth factor secretion

“cell sheet” consisting of intact cellswith extra-cellular matrix

Multi-layered

Indication： cartilage defect, knee osteoarthritis


CellSeed business based on cell sheet engineering Covering all value chain of regenerative medicine business

Culture cell sheetTreatment with

regenerative medicine

Production ＆ delivery of cell sheet

Regenerative medicine

Culture cells

Intelligence culatureware

Body cells・Stem cellsiPS cells

Temperature-responsive cell culatureware

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This presentation material has been prepared by CellSeed Inc. for information purposes only. Copyright

2014 CellSeed Inc. All rights reserved.

The information and opinions contained in this material have been obtained from sources believed to be

reliable, but no representations or warranties, express or implied, are made that such information is

accurate or complete and no responsibility or liability can be accepted by CellSeed for errors or omissions

or for any losses arising from the use of this material.

This information also contains forward-looking statements concerned with plans, strategies and forecasts

on future business performance of CellSeed group. CellSeed wishes to alert readers that such statements

involve risks and uncertainties, including, without limitation, risks inherent in the development and

commercialization of potential products, reliance on collaborators, need for additional capital, uncertainty

of clinical trial results or regulatory approvals or clearances, maintenance of our intellectual property rights,

changes in the business and economic environment and other factors. Actual results may differ materially

from the results anticipated in these forward-looking statements. CellSeed disclaims any duty to update

information provided herein. No part of this material shall be reproduced or redistributed in any form or by

any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission

of CellSeed Inc.

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Thank you for your attention.

Contact : Setsuko Hashimoto, Ph.D., President & CEO,CellSeed Inc. [email protected]://www.cellseed.com

mailto:[email protected]

http://www.cellseed.com/

Documents

Clinical Development of Regenerative Medicine … ª式会社セルシード JASDAQｸﾞﾛｰｽ証券コード：7776 Clinical Development of Regenerative Medicine Products Based