RepliCel Life Sciences Appoints Leading CEO of Regenerative Medicine Industry in Japan as Strategic Advisor

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Kunihiko Suzuki, One of the Leading Pioneers of the Emerging Regenerative Medicine Industry in Japan, Commits to Serving as Senior Strategic Advisor to RepliCel Board of Directors

VANCOUVER, BC / ACCESSWIRE / October 12, 2021 / RepliCel Life Sciences Inc. (OTC PINK: REPCF) (TSXV: RP) (FRA: P6P2) (“RepliCel” or the “Company”), a company developing next generation technologies in aesthetics and orthopedics, is pleased to announce that Kunihiko Suzuki has accepted an appointment as Senior Strategic Advisor to its Board of Directors with a particular focus on the development of the company’s business in Japan.

“We are delighted that someone of the industrial stature of Mr. Suzuki brings their strategic advice, expertise and network to the value we aim to create in our Japanese therapeutics pipeline and business,” said the President. and CEO of RepliCel, R. Lee Buckler. “Kunihiko is a longtime colleague in the industry and I am delighted that he is available to help us through a critical period in the delivery of our programs in Japan. I know that his contributions will provide us with unmatched value for reach our milestones over the next 24 months. “

The company, in collaboration with industry leaders CJ Partners and the clinical research organization Accerise, is currently preparing to support clinical research studies of the next phase of its Skin Rejuvenation Cell Therapy (RCS- 01) and its Tendon Regeneration Cell Therapy (RCT-01) in Japan under the Regenerative Medicine Safety Act (ASRM) which, once its goals are met, could lead to a commercial launch of the products in Japan.

About Kunihiko Suzuki, MBA

Kunihiko Suzuki is one of the leading regenerative medicine / cell and gene therapy (RM / CGT) business leaders in Japan. Kunihiko started his business career at an American oil company in Tokyo / Kyoto and spent around 20 years at one of Japan’s leading financial institutions, doing investment banking in Tokyo, commercial banking in London. and the fiduciary bank in Luxembourg. He joined the RM / CGT sector in 2006 as a member of the management team (board member, CBO, CEO and other positions) of MEDINET Co., Ltd., one of the first focused companies on immune cell therapies and contract development. and manufacturing services (CDMO).

In addition, Kunihiko was one of the founding committee members of the Japanese industry association, the Forum for Innovative Regenerative Medicine (FIRM), which acts as the country’s industry advocacy group, at the like the United States-based Alliance for Regenerative Medicine (ARM). He has been a member of the board of directors and vice-president of FIRM since 2014 and, in April 2021, was invited to lead the FIRM specific cellular products working group.

In April 2020, Kunihiko became a member of the Bio-Industry Sub-Committee of the Trade, Distribution and Information Committee for the Industrial Structure Council of METI (Ministry of Economy, Trade and industry) of Japan to publish the report “The Fifth Industrial Revolution” Cultivated With Biotechnology. Recently, Kunihiko also served as Co-Chair of ISCT Melbourne 2019 Annual Meeting Organizing Committee as well as ISCT Asia Regional Treasurer for the 2020-2023 term.

In December 2020, Kunihiko became an advisor to Cyfuse Biomedical KK, a company producing regenerative medical products with its own unique 3D bioprinting technology (the KENZAN method), and was appointed to the board of directors of Cyfuse in March 2021. In May 2021, Kunihiko became an associate member of New York-based consultancy Cell One Partners, responsible for advising clients on their RM / CGT activities in the Japan / Asia markets.

Kunihiko holds an MA in Economics from Waseda University and an MBA from Keio University.

About RepliCel’s first strategy in Japan

RepliCel was one of the first foreign regenerative medicine companies to have a Japanese partnership in 2013. In 2015, RepliCel was one of the first foreign regenerative medicine companies to launch a consultation process, under the new regulation of regenerative medicine products, with PMDA (Pharmaceuticals and Medical Devices Agency). In 2016, RepliCel’s licensee, Shiseido Company, was one of the first companies to fund and manufacture a product for use in a clinical study under the new Regenerative Medicine Safety Act ( ASRM).

RepliCel aims to be one of the first foreign regenerative medicine companies based outside of Asia to directly engage in a clinical study of a cell therapy product as part of the ASRM regulatory pathway to commercialization. RepliCel will also be one of the first such companies to seek certification from a manufacturing facility outside of Asia for the production of a cell therapy product to be imported for use in a clinical study governed by the ASRM regulations.

About RepliCel’s programs in Japan

RepliCel is currently preparing for clinical testing and commercialization of three additional technologies in Japan. These include two cell therapies – one for skin rejuvenation and one for tendon regeneration – and a next-generation dermal injector for cosmetic treatments involving a wide variety of injectable substances including cells, PRP, muscle paralysis toxins, fillers, enzymes, drugs and other biologicals. , etc.

RepliCel cell therapy technology, which is the subject of active and ongoing partnership discussions in Japan, has already been the subject of two successful consultations with the Japan Pharmaceutical and Medical Device Agency (PMDA). Planning for clinical research studies under Japan’s Regenerative Drug Safety Act (ASRM) is already underway. Manufacturing of the clinical product will be carried out by a Japanese subcontractor who is now preparing for PMDA certification in accordance with the applicable guidelines of the Japanese Ministry of Health, Labor and Welfare (MHLW). The conduct of clinical research studies will be managed by a high quality Japanese clinical research organization.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for cosmetic and orthopedic conditions affecting what the company estimates to be approximately one in three people in industrialized countries, including aging / sun damaged skin, baldness and chronic degeneration of the tendons. These conditions, often associated with aging, are caused by a deficit of healthy cells necessary for normal tissue healing and function.

Based in Canada with a base of operations in Europe, RepliCel has existing partnerships in the United States, Japan and China.

The Company’s cell therapy product portfolio includes RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. All of RepliCel’s cell therapy product candidates are based on RepliCel’s innovative technology, using cell populations isolated from a patient’s healthy hair follicles. RepliCel’s three cell therapy products have now been tested in over 100 patients in four countries on three continents and successfully reviewed by three different regulatory bodies.

RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and which can be used with other dermatological applications. Certain commercial rights for RCI-02 have been licensed to YOFOTO for Greater China and exclusive, limited-time distribution to MainPointe for the United States.

Commercial rights for RCH-01 for most of Asia have been licensed exclusively to Shiseido. Although the legal status of this license is currently the subject of disagreement between the parties, Shiseido continues to fund the development of the licensed product based on RepliCel technology in their territories. Commercial rights for RCT-01 and RCS-01 have been exclusively licensed to YOFOTO (China) Health for Greater China. YOFOTO also undertakes to finance the co-development of these products on their territory.

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For more information please contact:
Lee Buckler, CEO and Chairman
[email protected]

THE SOURCE: RepliCel Life Sciences, Inc.

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