Press Release

Press Release
Arbitration decision
RepliCel Life Sciences Announces Arbitration Decision VANCOUVER, BC – October 16, 2023 - RepliCel Life...
Press Release
RepliCel Announces DermaPrecise™ Development Milestone, Updates Arbitration Proceedings
RepliCel Announces DermaPrecise™ Development Milestone, Updates Arbitration ProceedingsVANCOUVER, BC, CANADA – September 13, 2023 –...
Press Release
David Kwok is appointed Chief Financial Officer
RepliCel announces the passing of long time Chief Financial Officer Simon Ma; David Kwok is...
Press Release,Product - RCI-02
RepliCel Announces Material Patent Milestones
New DermaPrecise™ patent application and patents granted for tendinopathy and skin rejuvenation technologies in key...
Press Release
RepliCel Files Notice of Arbitration against Shiseido Company to Resolve its License Agreement Dispute Regarding its Androgenetic Alopecia Cell Therapy
After several unsuccessful attempts to settle the dispute, RepliCel has filed an arbitration claim seeking...
Press Release
RepliCel and University of Victoria Collaboration Leads to Bioengineering Innovations, Funding, and Patents
Canadian granting agency MITACS commits to three years of funding for the project’s second stage...
Press Release
Replicel Postpones Filing of Annual Financial Statements and MD&A Due to COVID-19 Related Delays
VANCOUVER, BC – 22 April, 2020 – Replicel Life Sciences Inc. ("Company" or "Replicel") has...
Press Release
RepliCel Provides 2019 Year-End Update
RepliCel Provides 2019 Year-End UpdateNotable Milestones for the Company’s ProgramsVANCOUVER, BC, CANADA – 26 November 2019 – RepliCel...
Press Release
RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy for its Automated Dermal Injector
RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy...
Press Release
RepliCel Reignites its First-in-Japan Strategy
RepliCel Reignites its First-in-Japan StrategyNext-stage trials in Japan present market launch opportunities for RepliCel’s skin...
Press Release
RepliCel CEO Provides 2019 Shareholder Update
With a new strategic plan, RepliCel prioritizes focus on commercial revenueVANCOUVER, BC, CANADA – 5 March, 2019 –...
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RepliCel Life Sciences Announces Arbitration Decision

\n \n VANCOUVER, BC – October 16, 2023 - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: \n P6P2), (“RepliCel” or the “Company”).

On Monday, October 16, 2023, RepliCel received the Final Award \n related to its ongoing arbitration proceedings with Shiseido Co. Ltd. (“Shiseido”). The Tribunal dismissed \n RepliCel’s claims finding that Shiseido validly terminated the Collaboration and Technology Transfer \n Agreement dated effective as of July 9, 2013. Management is currently considering the impact of the \n decision and assessing its options. \n \n For more information, please contact:\n Andrew Schutte, CEO and President\n info@replicel.co\n

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RepliCel Announces DermaPrecise™ Development Milestone, Updates Arbitration Proceedings

VANCOUVER, BC, CANADA – September 13, 2023 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing novel, next-generation injection technologies as well as regenerative medicine products in aesthetics and orthopedics, provides development update.

RepliCel is pleased to announce the delivery of the User Requirement Specification from our primary vendor, A.M.I. “We have received testing data, confirming the device will function according to our designated parameters. DermaPrecise™ has illustrated its value proposition by controlling injections based on volume, depth and sheer force” Schutte stated. “We believe this comprehensive testing data will be key in business development efforts going forward.” RepliCel anticipates completing the development phase in 2023. The next step will be securing a contract manufacturer in North America. A complete timeline for approval will be articulated at the Annual General Meeting. RepliCel intends to provide updates as development milestones are achieved.

RepliCel further provides an update regarding the ongoing ICDR proceedings with the Shiseido Group. In response to numerous inquiries, the Company refers to the ICDR rules Article 40, which stipulates that the parties must keep arbitration proceedings confidential; however, the Company is required, by law, to disclose material events. The Company confirms that an award will be a material event to be disclosed in a timely manner, in accordance with applicable securities laws. 

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated but is the subject of an arbitration regarding Shiseido’s rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. 

MainPointe Pharmaceuticals has an exclusive distribution agreement for the DermaPrecise™ device and consumables in the United States, subject to income. MainPointe is expected to fund the FDA approval process in the United States. Please visit replicel.com for additional information.

For more information, please contact: Andrew Schutte, CEO and President 604-248-8693

info@replicel.com

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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RepliCel announces the passing of long time Chief Financial Officer Simon Ma; David Kwok is appointed Chief Financial Officer

VANCOUVER, BC – August 17, 2023 - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2), (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announces Chief Financial Officer transition.

 With great sorrow, RepliCel Life Science announces the passing of Simon Ma, our long tenured Chief Financial Officer. “Simon Ma has been a valuable member of the team for many years, Simon’s deep commitment to the company was always evident. We spent many late nights engaged on projects together. Simon’s commitment was unwavering, and he left an enduring impact on our team and his legacy of integrity and leadership will continue to inspire us.” President & CEO Andrew Schutte stated. 

 David Kwok steps into the Chief Financial Officer role with a clear financial vision for the company’s success. His extensive expertise, honed while working with numerous public companies, positions RepliCel Life Sciences for the future. “David Kwok’s experience and expertise position him well to assume the role of Chief Financial Officer, David’s experience with public companies for over 15 years, will prove invaluable.” Andrew Schutte stated. David Kwok has been a Certified Professional Accountant for over 15 years and is a member of the Certified Professional Accountant of British Columbia since January 2008.

 In light of Simon Ma’s sudden passing, RepliCel Life Sciences will apply for a Management Cease Trade Order (MCTO) as the company completes a transition process and endeavours to file its second quarter financials in a timely manner.

 

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

 The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. MainPointe Pharmaceuticals has an exclusive distribution agreement for the DermaPrecise™ device and consumables in the United States, subject to income. MainPointe is expected to fund the FDA approval process in the United States. Please visit replicel.com for additional information.

 

Please visit www.replicel.com for additional information.

For more information, please contact: Andrew Schutte, CEO and President info@replicel.com

 

 

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New DermaPrecise™ patent application and patents granted for tendinopathy and skin rejuvenation technologies in key markets

 VANCOUVER, BC, CANADA – 10 January 2022 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing novel, next-generation injection technologies as well as regenerative medicine products in aesthetics and orthopedics, is pleased to announce the filing of a new patent application covering novel aspects of the DermaPrecise™ product portfolio as well as the granting and/or allowance of three patent applications in key markets.

The DermaPrecise™ Injector is an electronic injection system designed to offer new levels of control over any injection into the dermal and subcutaneous layers for which precision of depth, dose and/or delivery matters. The new provisional patent application, filed on November 11, 2021 covers new commercial embodiments of certain technologies related to its dermal injector product portfolio which are not covered in previous patent applications.  

“As we continue to innovate the DermaPrecise™ injector, control unit and consumables, we will continue to file patents protecting all aspects of this product portfolio,” stated RepliCel President and CEO, R. Lee Buckler. “The testing being conducted on the DermaPrecise™ injection system is generating new ideas, innovations, and specifications which will lead to more patent filings covering new technologies and applications as we march toward commercialization of the DermaPrecise™ product line.”

With respect to the newly granted and allowed patents, RepliCel has been issued a key patent in Japan related to the Company's RCT-01 cell therapy for the treatment of chronic tendinopathy and two patents, one in Brazil and another in Mexico, relating to its RCS-01 regenerative cell therapy for skin rejuvenation. 

About the DermaPrecise Product Line

The DermaPrecise™ Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation prior to injection. The proprietary consumables include two different multi-needle heads, syringe cartridges, and liners. 

High-value market applications for the device include the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Other potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles. 

Commercial, clinical-grade units of the consumables and injector are now in production and testing for the purpose of gathering all necessary data to complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by other markets globally.

The DermaPrecise™ injection system is supplied with single-use cartridges and multi-needle heads for use with injectables of varying viscosity including highly viscose products such as some of the newer crosslinked hyaluronic acid-based dermal fillers and antibody therapeutics.

About RepliCel's Skin and Tendon Programs 

RepliCel is currently preparing for the clinical testing and commercialization of two cell-based regenerative medicines in Japan - one for skin rejuvenation (RCS-01) and one for tendon regeneration (RCT-01). RepliCel’s partner in Greater China, YOFOTO China Health Company, is currently preparing for phase 2 studies in China of these same therapies in collaboration with RepliCel. Both RCT-01 and RCS-01 have been the subject of successful phase 1 clinical studies.. 

Both products are the subject of active, ongoing partnership discussions in Japan and have already been the subject of two successfully completed consultations with Japan's Pharmaceutical and Medical Devices Agency (PMDA). Planning for clinical research studies under Japan's Act for the Safety of Regenerative Medicines (ASRM) is underway. Manufacturing of the clinical product will be performed by a Japanese-owned contract manufacturer preparing now for PMDA-certification under Japan's Ministry of Health, Labour, and Welfare (MHLW) applicable guidelines. Conduct of the clinical research studies will be managed by a high-quality Japanese clinical research organization.  

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 under the ASRM regulatory pathway to commercialization. RepliCel will also be one of the first such companies to apply for certification of 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 Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated but is the subject of an arbitration regarding Shiseido’s rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit replicel.com for additional information.

Notable Facts:

  • RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents. 
  • RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide. 

For more information, please contact:
 
Lee Buckler, CEO and President
 604-248-8693

info@replicel.com

 

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After several unsuccessful attempts to settle the dispute, RepliCel has filed an arbitration claim seeking Shiseido’s full compliance with the agreement or return of the license and all collaboration data and innovations related to its cell therapy treatment for male and female pattern hair loss.

 VANCOUVER, BC, CANADA – 18 October 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has retained Aceris Law LLC, a law firm specialized in international arbitration, to pursue the resolution of its disagreement with Shiseido Company Limited (“Shiseido“). 

The Company further announced that its legal counsel has now filed a Notice of Arbitration and provided a copy to Shiseido in accordance with the International Center for Dispute Resolution (ICDR) Rules, which are the arbitration rules that govern all disagreements between the parties.  

The dispute between Shiseido and RepliCel is related to a license for Asia, acquired by Shiseido, to RepliCel’s cell therapy technology for androgenetic alopecia, which is the leading cause of male and female pattern hair loss.  

In accordance with the ICDR rules, once an arbitrator is selected and the parties have filed their claims and responses, the arbitrator will accept evidence and arguments in support of a ruling on whether or not either party materially breached the license agreement and what relief should be awarded as a result of the ruling including enforcement of the license agreement, return of the license, and/or payment of damages including the equivalent of all reasonably expected future milestone and royalty payments.

Legal counsel for RepliCel issued several demand letters to Shiseido to comply with the terms of its license agreement which RepliCel alleges Shiseido has now breached which, if not cured, could result in the return of the license to RepliCel for re-licensing to other partners in Asia.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company Limited. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit www.replicel.com for additional information.

Notable Facts:

  • RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents. 
  • RepliCel now has key strategic partners in the United States, China, and Japan each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.  

For more information, please contact:
 
Lee Buckler, CEO and President
 604-248-8693

info@replicel.com

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "Press Release" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Item_Rating": 0, "Image": "/Blog/2017/RP-press-release.jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "Press Release", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 2938, "Name": "RepliCel and University of Victoria Collaboration Leads to Bioengineering Innovations, Funding, and Patents", "Url": "/news/replicel-and-university-of-victoria-collaboration-leads-to-bioengineering-innovations-funding-and-patents", "Url_List": [ "/news/replicel-and-university-of-victoria-collaboration-leads-to-bioengineering-innovations-funding-and-patents" ], "UrlSlug": "replicel-and-university-of-victoria-collaboration-leads-to-bioengineering-innovations-funding-and-patents", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-09-16T06:00:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "
  • Canadian granting agency MITACS commits to three years of funding for the project’s second stage to optimize certain proprietary microcarrier technologies for use in RepliCel’s cell therapy manufacturing  
  • RepliCel signs an Option to License agreement related to a filed US patent application

VANCOUVER, BC, CANADA – 16 September 2021 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that the first-stage of a research project with the University of Victoria Centre for Biomedical Engineering (“UVic”) has led to significant milestones in terms of technology advancements, patent filings, grant funding, and a license option agreement.
 
As a result of the innovations coming out of the collaboration to-date, RepliCel has signed a Technology Evaluation and Option to License agreement pertaining to a patent filed with the US Patent Office (“USPTO”) on “multifunctional microcarriers with thermal-responsive biomaterials coatings”. The agreement grants RepliCel an option to license the patent and related technologies for global applications related to therapeutic cell culture in RepliCel’s fields of interest.
 
Additionally, the parties have now executed a new research collaboration agreement intended to optimize the innovations for use with RepliCel’s technologies and are pleased to announce that this next phase of the collaboration has been awarded new grant of funding over three years from the Mitacs Accelerate program.
 
“Based on the success of the NSERC-funded first phase of this collaboration, we are very pleased to have now procured significant funding support from the Mitacs Accelerate Program which focuses on scientific innovations with significant industrial or commercial application. This is a tremendous endorsement of our innovations, progress, and the technology’s potential utility,” stated RepliCel’s President and CEO, R. Lee Buckler.
 
“We are also very pleased to continue this collaboration with Dr. Akbari and his team at UVic. He is one of the world's emerging experts on biomedical engineering and the employment of advanced materials and micro-technologies for cell and tissue culture. The collaboration represents a unique opportunity to leverage his expertise and non-dilutive grant funding to innovate around RepliCel's technologies in ways expected to improve the Company's commercial-scale manufacturing”.
 
The UVic-RepliCel Micocarrier Cell Culture Project
 
The first phase of the two-year RepliCel-UVic project, announced in late 2018 and extended due to COVID-19 implications, was performed at the University of Victoria Centre for Biomedical Engineering,  Laboratory for Innovations in Microengineering under the leadership of Dr. Mohsen Akbari with input from RepliCel Chief Scientific Officer, Dr. Kevin McElwee. The project was co-funded by RepliCel Life Sciences and a grant from the Natural Science and Engineering Research Council of Canada (\"NSERC\") under the NSERC Collaborative Research and Development (\"CRD\") program. This first phase of the project resulted in further development of a proprietary microcarrier technology which is the subject of a U.S. patent application, employing certain advanced materials and properties designed as an innovative platform for adherent cell culture in small volumetric footprints with the potential to reduce media consumption, culture time, and/or the use and disposal of single-use plastics.
 
This newly launched second phase of the collaboration will focus on approaches to optimize therapeutic cell culture platforms, such as those employed in RepliCel's cell therapy manufacturing, for eventual commercial-scale production. This phase of the project will focus on optimizing the proprietary microcarrier technology for use in culturing RepliCel’s therapeutic cell therapy products as part of RepliCel’s vision for its next-generation manufacturing. This phase of the project will be co-funded by RepliCel and the Mitacs Accelerate program and co-led by Dr. Mohsen Akbari, Associate Professor at the University of Victoria and Director of the Laboratory for Innovations in Microengineering (LiME), and RepliCel’s Dr. Kevin McElwee.
 
About Dr. Mohsen Akbari
 
Dr. Mohsen Akbari received his PhD (2011) in Applied Sciences from Simon Fraser University (Vancouver, British Columbia). He also conducted research from 2012-2015 as a postdoctoral fellow at Brigham and Women's Hospital (Boston, USA), Harvard Medical School, and Wyss Institute for Biologically Inspired Engineering. Dr. Akbari is currently an Associate Professor of Mechanical Engineering at the University of Victoria, Canada. He is also affiliated with the Centre for Advanced Materials and Related Technology (CAMTEC) at the University of Victoria, International Collaboration on Repair Discoveries, and the Djavad Mowafaghian Centre for Brain Health. His research lies at the interface of cellular biology, biomaterials, and microtechnologies with a focus on the biofabrication of engineered tissue substitutes for regenerative medicine, development of biomimetic tissue models using microengineering techniques for disease modeling and drug discovery, and development of advanced drug delivery systems for therapeutic applications.
 
Dr. Akbari has published more than 90 peer-reviewed articles in high-impact journals including Small, Science Translational Medicine, Advanced Functional Materials, Advanced Science, Nature Microtechnologies and Nanoengineering, Biotechnology Advances, and Advanced Materials. He has also published 7 book chapters, 3 patent applications/disclosures, and more than 50 conference presentations in prestigious conferences such as µTAS, World Biomaterials Congress, IMECE, and ASME. He has been cited +5300 times according to Google Scholar and has an h-index of 35. Dr. Akbari is the recipient of several institutional, national, and international awards such as the British Columbia Innovation Award, the Natural Sciences and Engineering Research Council of Canada (NSERC) postdoctoral fellowship, and the Kaiser Foundation Award. Recently, he was recognized as a rising Canadian star in global health. He also serves on the editorial board of Micromachines, Gels, and Transactions of Canadian Society for Mechanical Engineering (CSME), and is the chair of the micro and nanotechnology technical committee at CSME.
 
About RepliCel Life Sciences
 
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration.  These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function.  
 
Headquartered in Canada with a base of operations in Europe, RepliCel has existing partnerships in the United States, Japan and China as well as long-standing and ongoing research collaborations with the University of Victoria and the University of British Columbia.
 
The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. All RepliCel’s cell therapy product candidates are based on RepliCel’s innovative technology, utilizing 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 agencies.  
 
RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Certain commercial rights for RCI-02 have been licensed to YOFOTO for Greater China and a limited-term exclusive distributorship to MainPointe for the United States.
 
The commercial rights for RCH-01 for most of Asia have been exclusively licensed to Shiseido Company. Though the legal status of this license is currently the subject of some disagreement between the parties, Shiseido continues to finance the development of the licensed product based on RepliCel’s technology in their territory. The commercial rights for RCT-01 and RCS-01 have been exclusively licensed to YOFOTO (China) Health for Greater China. YOFOTO is also committed to financing the co-development of these products in their territory.  
 
For more information, please visit www.replicel.com or contact:
 
For more information, please contact:
Lee Buckler, CEO and President
info@replicel.com
 

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VANCOUVER, BC – 22 April, 2020 – Replicel Life Sciences Inc. (\"Company\" or \"Replicel\") has postponed filing its annual financial statements and management's discussion and analysis, for the year ended December 31, 2019, due to logistics and delays caused by the COVID-19 pandemic.

Replicel is relying on exemptive relief recently granted by Canadian securities regulatory authorities that allows it to delay the filing of its annual documents required by sections 4.2 and 5.1(2) of National Instrument 51-102 by April 29, 2020. In response to the coronavirus disease 2019 pandemic, securities regulatory authorities in Canada have granted a blanket exemption allowing issuers an additional 45 days to complete their regulatory filings.

Replicel estimates that its 2019 annual documents will be available for filing at its earliest opportunity, which is expected to occur on or before June 13, 2020. Until such time as the 2019 annual documents are filed, Replicel’s management and other insiders are subject to a trading blackout that reflects the principles contained in section 9 of National Policy 11-207 - Failure-to-File Cease Trade Orders and Revocations in Multiple Jurisdictions.

There have been no material business developments since the date of the last interim financial statements, filed on December 2, 2019; however, the Company has issued news releases subsequent to November 27, 2019, copies of which are available on SEDAR at www.sedar.com.

For more information, please contact:

Telephone: 604-248-8693 / info@replicel.com 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding the estimated date of filing of the Company’s 2019 annual documents. 

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks that the COVID-19 pandemic and associated consequences will result in additional delays in the preparation of the Company’s 2019 annual documents and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2018 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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RepliCel Provides 2019 Year-End Update

Notable Milestones for the Company’s Programs

VANCOUVER, BC, CANADA – 26 November 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to provide an update to shareholders.

Today RepliCel announced significant progress across all its priority programs including:

  • recent receipt of the final fully functional dermal injector prototype (to be showcased in a dedicated announcement shortly);
  • near-completion of two-thirds of the regulatory reviews needed in Japan for the tendon and skin clinical programs;
  • launch of a partnership program in Japan to identify strategic partners to co-invest in development and commercialization of the tendon, skin and device products in Japan;
  • completion of the hair loss clinical study in Japan and demand for data delivery; and
  • completion of YOFOTO's cell therapy manufacturing facility in China, launch of tech transfer training, and initiation of cell manufacturing validation runs.

\"We are pleased with the rapid progress made in China this year, very encouraged by the positive regulatory reviews we have had to-date in Japan on our tendon/skin cell therapy products, and excited  by the potential we are seeing for a high-value investment/partnership deal in Japan next year,\" stated RepliCel President and CEO, R. Lee Buckler. 

Earlier this year, RepliCel announced the development and launch of a three-prong strategy focused on early commercialization and near-term revenue-generation. Today RepliCel management and the Board reported that the Company is tracking well against the strategic plan the Board adopted for the Company’s direction priorities over the next 24-36 months encompassing 2019-2021.  At the core of this plan is:

  1. initial market launch of the RCI-02 device and consumables in countries accepting CE mark regulatory designation for commercialization in 2020.
  2. clinical development of the skin and tendon products in China with YOFOTO;
  3. clinical development and commercialization of the NBDS product line (RCT-01 for chronic tendinopathy and RCS-01 for aging and sun-damaged skin) in Japan including the necessary partnership structure to enable market launch of both products potentially after a single, successful clinical study in Japan.

The primary driver for this strategy is to drive the Company toward revenue and the Board’s objective of minimizing the need for capital and dilution until the Company is revenue-generating. 

Of the secondary objectives announced earlier this year, the Company has prioritized and posted progress on the following:

  • Partnership discussions in Japan focused on our skin, tendon and dermal injector products;
  • Distributor discussions in Europe focused on the dermal injector and consumables; and
  • Clarifying Shiseido’s plans for RCH-01 in Japan and Asia. 

Below is a brief synopsis of recent progress, current status, and near-term milestones in relation to each of RepliCel’s programs:

RCI-02 and consumables – We will have a fully functional prototype of RepliCel’s dermal injector and related consumables at this year’s annual general meeting to be held on November 27 in Vancouver. A team of Replicel representatives including Buckler, Hoffmann, Schutte, Rueck, and King met at AMI’s facility in October with the engineers, project managers, regulatory specialists involved in the final stages of the device's development, production, testing, and regulatory approval. The Company continues to anticipate that commercial-grade prototypes will be available in Q4 to be immediately followed by the launch of functional and clinical testing. Detailed planning is now underway for CE mark submission and product launch next year.

RCT-01 – RepliCel’s cell therapy for the treatment of chronic tendon damage (Tendinopathy) has been the subject of a successful phase 1 trial. RepliCel is now planning to execute next-phase clinical trials of RCT-01 in Japan where, subject to PMDA approvals, such a trial could launch next year and be commercialized in Japan by late 2021/early 2022 following a trial with successful outcomes. Following several pre-consultations with the Japanese regulatory agency, the PMDA, we are now scheduled to complete, by the end of 2019, two of the three formal consultations necessary to launch clinical trials. We are now preparing for the development of clinical trial design and protocols to submit early next year. Co-development and partnership discussions have now commenced in Japan around this product.

RCS-01 – RepliCel’s cell therapy for the treatment of skin aging and sun damage has been the subject of a successful phase 1 trial. RepliCel is now planning to execute next-phase clinical trials of RCS-01 in Japan as soon as the RCI-02 device and consumables are available for use in Japan. Planning is now underway to launch a clinical study of this product in Japan next year involving RepliCel's dermal injector with the potential for it to be commercialized in Japan by late 2021/early 2022 following a study with successful outcomes. Co-development and partnership discussions have now commenced in Japan around this product.

RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 trial in Europe and a clinical study now complete in Japan. Shiseido is expected to announce soon whether it will commercially launch the product in Japan or conduct further development and clinical testing. RepliCel will not plan for a phase 2 clinical trial of this product until it has the RCI-02 injector commercially available to use in such a trial and it has clarity from Shiseido regarding its plans for the product in Japan.

Partnership with Shiseido – The dispute regarding the status of the agreement between Shiseido and RepliCel, for the license of RCH-01 in Asia, remains unresolved but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and has recently demanded that Shiseido share the data from the recently completed study of RCH-01 in Japan. With the completion of the Japanese RCH-01 study earlier this year, RepliCel is now actively engaging Shiseido to deliver the study data and reach a resolution to the dispute between the parties. RepliCel is eager to end the ongoing dispute and work with Shiseido to commercialize RCH-01.

Partnership with YOFOTO – YOFOTO recently completed the manufacture and validation of its cell manufacturing facility and is nearing completion of full technology transfer and training. Next steps are to obtain the necessary regulatory approvals of its manufacturing facility and proposed clinical trial protocols needed to launch clinical trials of the tendon and skin products in China.

Research and Development – The grant-funded research project aimed at manufacturing optimization being conducted at the University of Victoria continues on-track. The first stage of the research being conducted at the University of British Columbia has successfully completed (details to be announced shortly) and plans are being laid for the second stage. Further product and process development, aimed at manufacturing improvements, will be prioritized as funding permits.

Business Development – RepliCel's business development activities are now exclusively focused on pursuing two types of transactions in the coming months: (1) distribution and/or licensing of the dermal injector and consumables, and (2) licensing, investment, and/or the establishment of a joint venture focused on Japan where the Company is targeting partnerships for its tendon repair and skin rejuvenation cell therapy programs as well as its dermal injector. RepliCel anticipates one or more of these transactions will be announced in the next 6-12 months.

Announcements anticipated before year-end include:

  • audio-visual of the dermal injector demonstrating its functions and utility;
  • results from the first two formal consultations (of three required) with the Japanese PMDA;
  • first production run of the commercial-grade dermal injector ordered; and
  • further details regarding the dermal injector business plan.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration.  These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world.  RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it is CE marked. Please visit www.replicel.com for additional information.

For more information, please contact:
 
604-248-8693

info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding:

that the Company will launch its dermal injector (RCI-02) and the consumables in countries accepting the CE mark regulatory designation for commercialization by mid-2020; that the Company will launch clinical development of its NBDS products in China with YOFOTO in 2019/2020; that the Company will obtain approval to launch the next-phase clinical trials of its tendon product (RCI-01) and skin product (RCS-01) in Japan in 2020 and launch YOFOTO-sponsored trials in China; that the Company will continue its cell marker research at UBC; that the Company will prepare for phase 2 studies of NBDS products in Europe; that the Company will enter into partnership discussions (outside of greater China) for its RCI-01 device and cell therapy products; that the Company will clarify Shiseido’s plans for RCH-01 in Japan; that commercial grade prototypes of its dermal injector and related consumables will be available in Q4; that the Company will obtain CE mark approval next year; that the Company will launch its next-phase clinical trials of RCS-01 in Japan as soon as the RCI-02 device and consumables are available in Japan; that the Company will receive clinical data from Shiseido; that the Company will transition from being a pre-revenue development company to generating commercial revenue; and that the Company will be able to minimize dilution and maximize shareholder value.

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related YOFOTO spending the required amounts on RepliCel’s programs and related infrastructure over the next 5 years in Greater China; risk related to YOFOTO paying milestone payments and sales royalties; risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risk that the Company may not obtain any further data from Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2018 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy for its Automated Dermal Injector

Management strengthens its commitment to a successful upcoming market launch of RepliCel’s dermal injector and consumables product line by addition of Damien King

VANCOUVER, BC, CANADA – August 29, 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announces it has retained the services of Damien King, an aesthetic dermatology product specialist and former executive in several top-tier companies, to help build out the global commercial strategy for the Company’s automated dermal injector, RCI-02, and related consumables (the “RCI-02 Product Line”). RepliCel’s RCI-02 Product Line is expected to market launch next year in Europe and Hong Kong after receiving CE marketing approval in the first half of 2020.

Mr. King has more than 20 years of in-depth experience in the sales and marketing of pharmaceutical, biologic, and medical device products for some of the world’s largest life science companies. Most recently he was a Director of Sales and Franchise Development for Merz Pharmaceuticals with past experience including roles with Allergan, Purdue and Eli Lilly. Mr. King holds a Bachelor of Science and a Master of Business Administration from Cornell University. He currently sits on the Board of Directors for Aequus Pharmaceuticals and has recently launched Avari Medical to distribute emerging and innovative products in the aesthetic and dermatology sector to select markets. “Bringing Damien King on board along with his extensive consulting network of leading dermatology experts in clinical affairs, regulatory compliance, sales and marketing, and business analysis,” stated RepliCel President & CEO, R. Lee Buckler, “is a perfect complement to our existing team of experts including our Chief Medical Officer and practicing medical dermatologist, Dr. Rolf Hoffmann, our Head of Clinical and Regulatory Affairs, Dr. Petra Goessens-Rueck, and our medical device engineering partner, the Agency for Medical Innovations.”

“With the anticipated marketing approval of the products in RepliCel’s RCI-02 Product Line in the first half of next year, RepliCel management is currently heavily engaged in developing its global commercial strategy. Mr. King and team have been retained to provide critical insights and advice on all aspects of the business modelling and its execution including the targeted clinical applications, pricing, marketing, key opinion leader engagement, and sales and distribution,” Buckler summarized. 

About the RCI-02 Product Line

RepliCel’s RCI-02 injector was designed with input from dermatologists, industrial designers, and electronic and medical device engineers to improve the delivery of a variety of injectables in a controlled, precise manner, removing the risks and uncertainties of injection outcomes currently resulting from manually operated, single-needle syringes.

The RCI-02 Product Line is now in the final stages of development with final prototypes expected within the next few weeks after which the Company will transition to product manufacture, testing, and regulatory marketing approval. Upon successful delivery and assessment of the final device prototypes, a first production run of commercial-grade units of the RCI-02 injector and related consumables will be manufactured later this year to be used for both functional testing and clinical safety evaluation. 

RCI-02 dermal injector is the world’s first motorized injection device with programmable depth and volume, a built-in Peltier element for pre-injection numbing of the skin and interchangeable needle head configurations. It is designed to deliver a variety of injectable substances, including cells, dermal fillers, drugs or biologics intradermally (dermis) and subcutaneously (fat) via an array of needle configurations, starting with a 16-needle configuration (4×4) on one head. This needle head will be used to perform a variety of procedures, increase surface area coverage and speed-up procedure times.

RCI-02 automates and simplifies the injection process. Equipped with a touch screen on its accompanying docking station, the device’s programmability allows for the delivery of precise quantities of material, at specific depths, through fine-gauge needles, on a single plain or trailing through multi-plains, as the needle retracts through the skin.

Overall benefits of this next-generation dermal injector technology are anticipated to include improved handling, reduction or elimination of the need for pre-injection local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow and evenly-dispersed injections.

The Company anticipates marketing approval to launch sales of the initial RCI-02 Product Line next year. Management is committed to being fully prepared for market launch in Europe and Hong Kong in 2020 as it continues to plan for further product line innovation and pursue marketing approvals in the United States, Asia, and other key global markets. 

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.

For more information, please contact:

Lee Buckler, CEO and President

604-248-8693

info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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RepliCel Reignites its First-in-Japan Strategy

Next-stage trials in Japan present market launch opportunities for RepliCel’s skin and tendon products

VANCOUVER, BC, CANADA – 19 March, 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce the resumption of their First-in-Japan strategy.
 
The Company, working with industry leaders, CJ PARTNERS, have initiated a program in Japan to realize its goal of launching its cell therapy products in Japan sooner than would be possible anywhere else in the world. Because of this unique opportunity, the Company’s next-phase trials will be conducted in Japan.
 
Unlike anywhere else in the world, one well-designed cell therapy trial in Japan, approved by their regulatory authorities, has the potential to lead to product market launch. The strategy to bring its products to market first in Japan spans the Company’s entire portfolio. While the Company’s RCH-01 for hair loss due to androgenic alopecia may be launched in Japan much earlier if Shiseido decides to do so, current planning anticipates the potential for all four products to be on the market in Japan by 2022.
 
RepliCel is leveraging a history of working in Japan which began in 2013 when the Company laid the foundation for its First-in-Japan strategy as one of the first foreign regenerative medicine companies to have a Japanese partnership. RepliCel followed that in 2015 as one of the first foreign regenerative medicine companies to initiate a consultation process, under the new regulations for regenerative medicine products, with Japan’s PMDA (Pharmaceuticals and Medical Device Agency).
 
Again 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 newly enacted Act for the Safety of Regenerative Medicine (ASRM).
 
While 2017 and 2018 saw RepliCel focus activity in Europe, Canada, and China, only weeks after the Board recently authorized a resumption of its First-in-Japan strategy, the Company has already initiated:

  • the continuation of its regulatory review process with the PMDA for the Company’s cell therapy platform;
  • planning for a clinical trial of its RCT-01 product for the treatment of tendinopathy;
  • planning for the clinical trial of its RCS-01 product for skin rejuvenation;
  • preparations to submit the application to the PMDA for approval to market the Company’s dermal injector (RCI-02) upon it being CE-marked.

 “With the regulatory reform for regenerative medicines now firmly entrenched,” states Colin Lee Novick of CJ PARTNERS, “there is an exciting maturity impacting the evolution of the cell therapy industry in Japan as never seen before. We are seeing another wave of foreign-domestic partnership, an emerging trend of foreign companies sponsoring their own clinical development in Japan, and a dramatic increase of domestic-sponsored clinical activity. This is beginning to materially impact patients, health care providers, investors, biopharma companies, and ancillary industries in ways which were only imagined in 2013 when the reforms were first drafted. It is an exciting time for both foreign and domestic stakeholders who decide to invest in Japan’s rapidly developing regenerative medicine sector.”
 
RepliCel’s First-in-Japan Strategy: A Portfolio View
 
RCT-01 for chronic tendinopathy - A Japanese clinical trial of RepliCel’s RCT-01 treatment for tendinopathy is aimed at obtaining conditional approval from Japan’s regulatory authority to market the product and obtain medical insurance reimbursement there for up to seven years before an application for final approval is required.
 
RCS-01 - A clinical study of the Company’s RCS-01 treatment for the rejuvenation of aging and sun-damaged skin is expected to lead to a launch of the product in Japan under the nation’s Act for the Safety of Regenerative Medicine.
 
RCI-02 - RepliCel’s next-generation, dermal injector, a medical device designed to deliver optimized and controlled injection of cell therapies and other injectables, is expected to be launched in Europe, Hong Kong, and other markets accepting CE mark approval next year. The marketing approval application for the injector will be submitted in Japan as soon as possible once the CE mark application is submitted.  The device will be marketed for the injection of various dermatology treatments but is expected to be critical to delivery of the Company’s RCS-01 treatment.
 
RCH-01 – A Japanese clinical study of RepliCel’s RCH-01 treatment for hair loss due to androgenic alopecia, approved by Japan’s Ministry of Health, Labour and Welfare, has been the subject of a clinical study recently completed at Tokyo Medical University Hospital and Toho University Medical Center Ohashi Hospital. The market is now keenly watching Shiseido Company, RepliCel’s licensee of the product for Asia, for any signal regarding its launch of that product in Japan.
 
Resources About Cell Therapy in Japan
 
Video: “Invest in Japan: Medical Industry” - https://youtu.be/lVym_W0ADYo
 
Video: “Has Japan's Regenerative Medicine Experiment Paid Off?” - https://youtu.be/eT8hjjzyuzI
 
Article: “Regenerative Medicine Environment ‐A Guide to Understand the Pathways to Get Approval in Japan” - https://firm.or.jp/_rmit/wp-content/uploads/2018/10/Japans-RM-Environment-2018.pdf
 
Article: “Japan’s regulatory gamble and what it means for the Industry” - http://www.cj-partners.com/en/news/files/000025_en_01.pdf
 
 
 
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration.  These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
 
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world.  RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
 
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information.
 
For more information, please contact:
Lee Buckler, CEO, and President
+1-604-248-8693
info@replicel.com

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With a new strategic plan, RepliCel prioritizes focus on commercial revenue

VANCOUVER, BC, CANADA – 5 March, 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to provide an update to shareholders from its President and CEO, Mr. R. Lee Buckler.

Dear Shareholders,

I am pleased to be providing this much-anticipated 2019 update. 

First, a quick recap of our Annual General Meeting held December 14, 2018 at which the shareholders elected a new slate of directors to RepliCel’s Board - some re-elected, some new. The Board now has higher shareholder representation as well as a duly-elected nominee of our new investor/partner in Greater China. 

Strategic Planning

Management and the Board have spent the past 60 days conducting an end-to-end analysis of the Company and its programs followed by comprehensive strategic planning to establish the Company’s direction and priorities for the next 24-36 months. 

A recent Board meeting solidified the analysis and strategic plan. We have emerged from this process with clarity around our strategy that we are eager to communicate with shareholders and the broader marketplace. 

Our core message is this: RepliCel’s strategy drives the Company toward revenue and the Board’s objective of minimizing the need for capital and dilution until the Company is revenue generating.

Transition to Commercial Revenue

RepliCel’s focus on its transition to commercial revenue leads the Company to prioritize commercialization of the Company’s dermal injector (and consumables) as well as clinical development of the tendon and skin programs in Japan where the pathway to commercial launch is the shortest due to its unique regulatory framework for cell therapies. 

RepliCel will also continue to support its partnership commitments to YOFOTO and Shiseido. With the progress YOFOTO has made in the past three months, RepliCel is encouraged YOFOTO will meet milestones in China in a timely way. With the clinical study of RCH-01 now successfully completed in Japan, RepliCel expects Shiseido to declare its near-term plans for RCH-01.

Three-Part Strategic Focus

RepliCel’s Board has endorsed a three-part strategy prioritizing the following programs:

  1. Initial market launch of the RCI-02 device and consumables in countries accepting CE mark regulatory designation for commercialization by mid-2020

  2. Clinical development of the skin and tendon products in China with YOFOTO launching 2019/2020

  3. Regulatory review by Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) targeting approvals for RepliCel to launch the next-phase clinical trials of our tendon product (RCT-01) and skin product (RCS-01) in Japan in 2020 potentially leading to commercial launch upon completion

“The objective of our strategic planning process,” stated RepliCel’s Board Chairman, David Hall, “was to review the Company’s programs and identify ways to maximize shareholder value in a way which was minimally dilutive. We believe this will best be done by setting the Company on a path which prioritizes the pursuit of commercial revenue, allowing the Company to pursue its longer-term development projects when they can be financed through some combination of revenue, debt, and equity.”

  • Secondary emphasis will be placed on the following initiatives:

  • Continued cell marker research at UBC (as funding permits)

  • Support of the UVic cell culture biomaterials study (grant funded)

  • Preparing for phase 2 studies of NBDS products in Europe (as funding permits)

  • Partnership discussions in Japan focused on our skin, tendon and dermal injector products

  • Distributor discussions in Europe focused on the dermal injector and consumables

  • Clarifying Shiseido’s plans for RCH-01 in Japan and Asia

Below is a brief synopsis of how the new strategic plan impacts RepliCel’s programs:

RCI-02 and consumables – RepliCel’s dermal injector and related consumables are now in the final stages of development and prototype manufacture. New European regulations have impacted the commercialization timelines. The Company anticipates commercial-grade prototypes will be available in late Q3/early Q4 with the timeline dependent on final part sourcing and design changes currently being finalized. This put us on track for an anticipated CE mark approval and product launch next year. More details will be shared in another announcement shortly.

RCT-01 – RepliCel’s cell therapy for the treatment of chronic tendon damage (Tendinopathy) has been the subject of a successful phase 1 trial. RepliCel is now planning to execute next-phase clinical trials of RCT-01 in Japan where, subject to PMDA approvals, such a trial could launch early next year and be commercialized in Japan by late 2021/early 2022. 

RCS-01 – RepliCel’s cell therapy for the treatment of skin aging and sun damage has been the subject of a successful phase 1 trial. RepliCel is now planning to execute next-phase clinical trials of RCS-01 in Japan as soon as the Company can ensure the RCI-02 device and consumables are available in Japan for use in such a trial. Management is currently seeking clarity on this timeline and expects to announce it shortly. 

RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 trial in Europe and a clinical study now complete in Japan. Shiseido is expected to announce soon whether it will commercially launch the product in Japan or conduct further development and clinical testing. RepliCel will not plan for a phase 2 clinical trial of this product until it has the RCI-02 injector commercially available to use in such a trial and it has clarity from Shiseido regarding its plans for the product in Japan.

Partnership with Shiseido – The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and is communicating with Shiseido regarding its expectation of a release of data from the recently completed study of RCH-01 in Japan and clarity around Shiseido’s commercial plans for the product in Asia (the territory for the Shiseido license).

Partnership with YOFOTO – In the four months since completing the transaction with YOFOTO, good progress has been made in China in preparing for manufacture, technology transfer, and the regulatory review in China needed to launch clinical trials of the tendon and skin products in China.

Research and Development – The grant-funded research project aimed at manufacturing optimization being conducted at the University of Victoria continues on-track. The first stage of the research being conducted at the University of British Columbia has successfully completed (details to be announced shortly) and plans are being laid for the second stage. Further product and process development, aimed at manufacturing improvements, will be prioritized as funding permits.

A series of announcements are planned to provide more detailed updates on each of our programs over the coming weeks.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration.  These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world.  RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information.

For more information, please contact:
 
Lee Buckler, CEO and President
 604-248-8693

info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding:

that the Company will launch its dermal injector (RCI-02) and the consumables in countries accepting the CE mark regulatory designation for commercialization by mid-2020; that the Company will launch clinical development of its NBDS products in China with YOFOTO in 2019/2020; that the Company will obtain approval to launch the next-phase clinical trials of its tendon product (RCI-01) and skin product (RCS-01) in Japan in 2020 and launch YOFOTO-sponsored trials in China; that the Company will continue its cell marker research at UBC; that the Company will prepare for phase 2 studies of NBDS products in Europe; that the Company will enter into partnership discussions (outside of greater China) for its RCI-01 device and cell therapy products; that the Company will clarify Shiseido’s plans for RCH-01 in Japan; that commercial grade prototypes of its dermal injector and related consumables will be available in late Q3 or early Q4; that the Company will obtain CE mark approval next year; that the Company will launch its next-phase clinical trials of RCS-01 in Japan as soon as the RCI-02 device and consumables are available in Japan; that the Company will receive clinical data from Shiseido; that the Company will transition from being a pre-revenue development company to generating commercial revenue; and that the Company will be able to minimize dilution and maximize shareholder value.

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related YOFOTO spending the required amounts on RepliCel’s programs and related infrastructure over the next 5 years in Greater China; risk related to YOFOTO paying $4.5M CDN in milestone payments and sales royalties; risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risk that the Company may not obtain any further data from Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2017 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at http://www.sedar.com/.

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DISCLAIMER:
The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.

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