RCS-01

As Seen In
Canadian Technology and Innovation: making strides in the global cell therapy landscape
Another cell therapy rising star, RepliCel Life Sciences, is harnessing the healing properties of hair...
As Seen In
Company Uses Patients' Own Cells to Put an End to Baldness, Aging Skin and Tendon Degeneration
Company Uses Patients' Own Cells To Put An End To Baldness, Aging Skin And Tendon...
As Seen In
Regenerative medicine: Interview with a game-changing leader
Regenerative medicine is a game-changing area of medicine. It has the potential to fully heal...
As Seen In
Analyst Says Cell Therapy Company’s Move Decreases Risk
Click here to read the full article as it appears in the Streetwise Reports (08/23/17)....
As Seen In
Your Hair Follicles May Hold the Key to Younger Looking Skin
Click here to read the full article as it appears in the New York Daily...
Press Release
Prominent Skin Aging Researcher Provides Insights into RepliCel’s Clinical Data
“We believe that this novel therapy has the potential to rejuvenate skin in a way...
As Seen In
Skin in the Game
To read the full article as it appears on DDN News (08/08/17), click here. ...
As Seen In
Poised for Success with Positive Clinical Results
To read the full interview as it appears on Costmeticosbr.com.br, click here (7/6/17).
As Seen In
The Latest in Biocellular Regeneration
To read the full article as it appears on TheAestheticChannel.com by Lisette Hilton, click here...
As Seen In
Exclusive Interview with RepliCel Life Sciences President and CEO Lee Buckler
To read the full article as it appears on SmarterAnalyst.com by Julie Lamb, click here....
Press Release
RepliCel CEO Provides Company Outlook
A data-rich 2017 positions RepliCel for maturity through the next phase of its product development,...
As Seen In
RepliCel Developing Autologous Cell Therapies For Skin, Hair and Tendon Regeneration
To read the full interview as it appears on MedicalResearch.com, click here. (4/22/17)
As Seen In
String of Positive Trial Results Boosts RepliCel’s Profile
To read the full article as it appears on thelifesciencesreport.com, click here. (04/12/17)
As Seen In
RepliCel – Stem Cell Therapies Using Your Own Cells
To listen to Podcast and View Transcript on Future Tech Podcast, click here
Press Release
Positive Results from RepliCel’s RCS-01 Phase I Skin Trial are the Company’s Most Compelling to Date
Interim trial results lead researchers to conclude that the injection of RCS-01 is not only...
As Seen In
RepliCel – Using Cells for Healing
View featured company Article on Advisor Access click here
As Seen In
RepliCel CEO Lee Buckler talks to Cantech Letter
View Article by Nick Waddell on Cantech Letter click here (1/11/2017)...
Press Release
RepliCel Life Sciences conducts formal consultation review with Japan’s PMDA and receives unprecedented review fee reduction
Japan’s Pharmaceuticals and Medical Devices Agency reviews RepliCel’s pre-clinical, quality, and manufacturing data for its...
Press Release
RepliCel Life Sciences Finishes Enrolment for its Tendon Repair and Skin Rejuvenation Clinical Trials
Results from both trials will support commercialization initiatives, partner discussions and continued clinical developmentVANCOUVER, BC...
Press Release
RepliCel Announces CEO Update
Milestones for 2016 include two clinical trial readouts, finalizing RCI-02 for a 2017 product launch,...
{
  "items": [
    {
      "id": 1943,
      "url": "/news/canadian-technology-and-innovation-making-strides-in-the-global-cell-therapy-landscape",
      "parentid": 1929,
      "lastupdateddate": "2019-08-01T06:20:54",
      "AMPContent": "",
      "Author_name": null,
      "Author_url": null,
      "Author": 0,
      "CanonicalLink": "",
      "CodeEditor": false,
      "CreatedByMemberId": 0,
      "Description": "

Another cell therapy rising star, RepliCel Life Sciences, is harnessing the healing properties of hair follicles to address unmet medical needs in acute, chronic and genetic conditions. RepliCel’s product pipeline features a diverse portfolio spanning tendinopathies, pattern baldness, skin damage, and dermal injector medical devices.
READ FULL ARTICLE

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 1030219, "Image": "/Blog/2018/Screen Shot 2018-11-09 at 8.48.23 AM.png", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "Canadian Technology and Innovation: making strides in the global cell therapy landscape", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2018-08-15T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "canadian-technology-and-innovation-making-strides-in-the-global-cell-therapy-landscape", "Weighting": 0 }, { "id": 1957, "url": "/news/company-uses-patients-own-cells-to-put-an-end-to-baldness-aging-skin-and-tendon-degeneration", "parentid": 1929, "lastupdateddate": "2019-08-01T06:20:58", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Company Uses Patients' Own Cells To Put An End To Baldness, Aging Skin And Tendon Degeneration

By Robin Seaton Jefferson

Forbes Magazine. September 29, 2017.

Hollywood has made movies about it. Industries have made billions from it. And if the volume of scripture is any indication, the Almighty God must have placed great value on his creation of the head of human hair. After all, He gave Samson—the strongest man of whom the Bible tells—his immense strength through his hair and declared a woman’s hair \"a glory unto\" her in the 11th chapter of 1 Chorinthians.

Is it any wonder men and women obsess over their hair? And though we may get wiser as we age (a good thing), most of us don’t get hairier—at least not in the places we want to (not a good thing).

But there is a Canadian company who has been working diligently to change that.

To read the full article, please go to the Forbes Magazine article.

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 993247, "Image": "/Blog/2017/Forbes-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "Company Uses Patients' Own Cells to Put an End to Baldness, Aging Skin and Tendon Degeneration", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-09-28T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "company-uses-patients-own-cells-to-put-an-end-to-baldness-aging-skin-and-tendon-degeneration", "Weighting": 0 }, { "id": 1958, "url": "/news/regenerative-medicine-interview-with-a-game-changing-leader", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:15", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Regenerative medicine is a game-changing area of medicine. It has the potential to fully heal damaged tissues and organs. To find out more about this innovative medical technology we spoke with RepliCel’s CEO, Lee Buckler. Click here to read the full article

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 994208, "Image": "/Blog/2017/dj-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Tendon", "Hair", "Skin", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "Regenerative medicine: Interview with a game-changing leader", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-09-20T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "regenerative-medicine-interview-with-a-game-changing-leader", "Weighting": 0 }, { "id": 1962, "url": "/news/analyst-says-cell-therapy-company-s-move-decreases-risk", "parentid": 1929, "lastupdateddate": "2019-08-01T06:20:49", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Click here to read the full article as it appears in the Streetwise Reports (08/23/17).

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992274, "Image": "/Blog/2017/swr-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "Analyst Says Cell Therapy Company’s Move Decreases Risk", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-08-24T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "analyst-says-cell-therapy-company-s-move-decreases-risk", "Weighting": 0 }, { "id": 1961, "url": "/news/your-hair-follicles-may-hold-the-key-to-younger-looking-skin", "parentid": 1929, "lastupdateddate": "2019-08-01T06:22:24", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Click here to read the full article as it appears in the New York Daily News(08/24/17).

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992275, "Image": "/Blog/2017/ny-dailynews-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Skin", " RCS-01" ], "MetaDescription": "", "Name": "Your Hair Follicles May Hold the Key to Younger Looking Skin", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-08-24T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "your-hair-follicles-may-hold-the-key-to-younger-looking-skin", "Weighting": 0 }, { "id": 1964, "url": "/news/prominent-skin-aging-researcher-provides-insights-into-replicel-s-clinical-data", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:12", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

“We believe that this novel therapy has the potential to rejuvenate skin in a way we’ve never seen before”, states key opinion leader in dermatology research

Dusseldorf, Germany – August 10, 2017 – Following an interview with Prof. Dr. med Jean Krutmann, one of the world’s leading researchers on skin aging, RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) (“RepliCel” or the “Company”) is pleased to provide the following insights regarding the data from RepliCel’s recent clinical study of RCS-01 for aging and sun-damaged skin.

Q: In your center, a phase 1 trial has been performed to assess the safety of an autologous cell product against skin aging. Can you tell us why, in your opinion, the data from this trial suggests to you that such a cell treatment has the potential to treat signs of skin aging?

Prof. Dr. med Jean Krutmann: I am personally very interested in this approach because it represents, to the best of my knowledge, the first cell-based treatment option for skin aging. I had the privilege to oversee the conduct of the phase 1 trial of this product in our Institute. In addition to the results indicating that the therapy is safe to use in humans, we observed in the data from this study that several molecular biomarkers of skin aging significantly improved in areas treated with the cell therapy, as compared to placebo-treated skin.

Q: What do you see as the advantage of cell treatment, compared to other modalities?

Prof. Dr. med Jean Krutmann: The novelty of this cell treatment is that it directly affects and interacts with the dermis and is capable of modulating gene expression in the treated skin. For us this means we expect it will likely show long-term effects on the aesthetic effects of skin aging – in other words, positively impact the skin wrinkles and appearance.

Q: In addition to safety parameters, expression of several molecular markers was assessed as well. What was the purpose of this?

Prof. Dr. med Jean Krutmann: The molecular markers assessed in this study were all related to skin aging. The data suggests the cell therapy can affect the marker expression in a way which indicates that skin aging can be counteracted by being treated with this product. In other words, we believe the data indicates the effects of skin aging can potentially be reversed.

Q: Could you give us your expert opinion about the results?

Prof. Dr. med Jean Krutmann: As a scientist specializing in skin aging and having studied a wide variety of different types of products, I am struck by the efficacy of the treatment. Although the number of study participants was limited, we obtained significant results as compared with placebo-treated skin. For example, we looked for Collagen-1 transcripts in cell-treated versus placebo-treated skin and found a remarkable, statistically significant up-regulation (increase) of collagens in the cell-treated skin. This is very remarkable to see in such a small trial and suggests to me that this product might be very effective in countering the effects of skin aging.

Q: What would be in your view the next steps?

Prof. Dr. med Jean Krutmann: The next natural step is a phase 2 study to directly look at the efficacy of the cell therapy for the treatment of pre-existing clinical signs of skin aging. One of the things being considered is accompanying the clinical study with a research study to provide further insights into the underlying anti-aging mechanisms. Already plans are being finalized for both projects. We believe that this novel therapy has the potential to rejuvenate skin in a way we’ve never seen before.

About Aging and UV-damaged Skin Markets
Ultra-violet (UV) light exposure from the sun is responsible for up to 80% of visible facial skin aging. According to statistics from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in 2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures are growing over 15% annually.

About the RCS-01 Study
The clinical trial cited by Prof. Dr. med Jean Krutmann is a randomized, double-blind, placebo-controlled, single-centre, phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin. Recently, statistically and clinically significant positive data was released from the interim analysis of this phase I study. The data revealed a nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin. Further details are available at http://replicel.com/20170404/.

About Prof. Dr. med Jean Krutmann
Prof Dr. med Jean Krutmann is Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf. He is a coordinator of the Leibniz Research Alliance “Healthy Aging” (a strategic alliance of 23 Leibniz institutes). His research is in the field of derma-toxicology and immune-dermatology with special emphasis on environmentally-induced skin diseases and skin aging. Prof. Krutmann is author or co-author of more than 400 papers. He is the recipient of the International Arnold-Rikli-Award, the Albert Fleckenstein Award, the Paul Gerson Unna Award, the Oscar Gans Award, the C.E.R.I.E.S. Research Support Award, the Dermopharmacy Innovation Award and the Xu Guang Qi Lecturer Award. He is a visiting and adjunct professor at the Nagoya City University, Japan, Case Western Reserve University, Cleveland, Ohio, University of Alabama, Birmingham, AL, USA, and Fudan University, Shanghai, China. He is a member of the National Academy of Science of Germany. He is a clinical consultant to RepliCel Life Sciences, Inc.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company 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 is also developing a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / info@replicel.com

Forward-looking information
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the potential effects of RCS-01 on skin aging. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the anti-aging potential of RCS-01, its ability to show long term aesthetic effects on skin aging; its ability to counteract skin aging and revise the effects of skin aging; the Company’s expectation that significant changes to gene expression markers are expected to correlate with increased collagen fibers; that increased collagen production and reduced collagen degradation should potentially lead to fewer wrinkles and the repair of sun-damaged skin; that the RCS-01 therapy is a novel therapy that has the potential to rejuvenate skin in a way never seen before; the potential correlation between changes in biomarkers and clinically important endpoints; that the Company will conduct a phase 2 study; the potential application for other aesthetic products; and the expected timing of return of trial participants for analysis and the process to be undertaken in connection with same. 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: the risk that there will be delays enrolling clinical trial participants; 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; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; 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, 2015 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.

 

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. 

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 989690, "Image": "/Blog/2017/RP-press-release.jpg", "ItemCategories": [ "News - Press Release" ], "ItemTags": [ "Skin", " RCS-01" ], "MetaDescription": "", "Name": "Prominent Skin Aging Researcher Provides Insights into RepliCel’s Clinical Data", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-08-09T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "prominent-skin-aging-researcher-provides-insights-into-replicel-s-clinical-data", "Weighting": 0 }, { "id": 1965, "url": "/news/skin-in-the-game", "parentid": 1929, "lastupdateddate": "2019-08-01T06:22:16", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To read the full article as it appears on DDN News (08/08/17), click here.

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992276, "Image": "/Blog/2017/ddn-news-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Hair", "Skin", " RCH-01", " RCS-01" ], "MetaDescription": "", "Name": "Skin in the Game", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-08-08T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "skin-in-the-game", "Weighting": 0 }, { "id": 1969, "url": "/news/poised-for-success-with-positive-clinical-results", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:12", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To read the full interview as it appears on Costmeticosbr.com.br, click here (7/6/17).

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992279, "Image": "/Blog/2017/RP-recent-coverage.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "Poised for Success with Positive Clinical Results", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-07-05T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "poised-for-success-with-positive-clinical-results", "Weighting": 0 }, { "id": 1972, "url": "/news/the-latest-in-biocellular-regeneration", "parentid": 1929, "lastupdateddate": "2019-08-01T06:22:19", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To read the full article as it appears on TheAestheticChannel.com by Lisette Hilton, click here (6/20/17). Read full article

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992283, "Image": "/Blog/2017/aestheticchannel-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Hair", "Skin", " RCH-01", " RCS-01" ], "MetaDescription": "", "Name": "The Latest in Biocellular Regeneration", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-06-19T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "the-latest-in-biocellular-regeneration", "Weighting": 0 }, { "id": 1975, "url": "/news/exclusive-interview-with-replicel-life-sciences-president-and-ceo-lee-buckler", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:00", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To read the full article as it appears on SmarterAnalyst.com by Julie Lamb, click here. (6/8/17)

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992285, "Image": "/Blog/2017/smarter-analyst-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "Exclusive Interview with RepliCel Life Sciences President and CEO Lee Buckler", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-06-07T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "exclusive-interview-with-replicel-life-sciences-president-and-ceo-lee-buckler", "Weighting": 0 }, { "id": 1978, "url": "/news/replicel-ceo-provides-company-outlook", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:26", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

A data-rich 2017 positions RepliCel for maturity through the next phase of its product development, research programs, and revenue generation
VANCOUVER, BC – May 25, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a regenerative medicine company addressing large-market opportunities with innovative technologies in aesthetics and sports injury/orthopedics, today unveiled its go-forward strategy.

In the first few months of 2017, the Company made pivotal announcements based on data collected from all three of its cell therapy programs. Furthermore, RepliCel continues to make significant progress on its nearest-term commercial asset, the dermal injector (RCI-02).

Building on a decade of the Company’s discovery, pre-clinical work, and successful first-in-human clinical data, RepliCel has formulated a strategic plan for 2017 through 2019 focused on maturing its assets through three distinct pillars:

– Commercializing the Company’s dermal injector;
– Research and development to enhance clinical efficacy, optimize manufacturing, and strengthen the Company’s intellectual property portfolio; and
– Preparing and launching phase II clinical trials.

The plan includes several key milestones anticipated to be part of the Company’s next 30 months including:

– Building and testing the commercial-grade prototypes of RepliCel’s next-generation dermal injector;
– Preparing the RCI-02 device for marketing approval in Europe (CE-mark);
– Executing an application-focused commercialization agreement for RCI-02 with a multi-national partner, including the payment of non-dilutive licensing/milestone fees and ongoing sales royalties;
– Launching and executing a molecular marker study anticipated to add significant value to the Company’s intellectual property, manufacturing technologies, and the enhancement of clinical efficacy;
– Completing ongoing research related to the manufacture of dermal sheath cup cells as a precursor to phase II clinical trials of RCH-01; and
– Preparing for phase II clinical studies of the RCT-01 (tendinopathy) and RCS-01 (skin aging) clinical programs.

Further details on each of the programs are expected to be released in the coming few weeks.

“The first decade of RepliCel’s growth was focused on moving our initial discoveries through pre-clinical research, diversification, and achieving proof-of-concept data in first-in-human clinical trials. Now we are presented with the exciting opportunity to mature the Company and its assets through device commercialization, next-phase clinical trials, and partnerships,” stated RepliCel’s President & CEO, R. Lee Buckler.

“Given the near-term commercial status of our dermal injector development and the nature of the discussions underway, we remain confident we will secure a revenue-generating, commercialization partnership for this asset next year,” continued Buckler. “Additionally, we are currently engaged in a number of early-stage partnership and collaboration discussions for each of our cell therapy programs. While we have already commenced planning preparation for our next-phase clinical trials, these discussions may influence how we prioritize and finance these studies. Shareholders should expect a series of releases over the next few weeks providing more clarity on each of these programs.”

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on aesthetics and sports injury applications.

As its nearest-term commercial asset, RepliCel is developing a next-generation dermal injection device (RCI-02) designed to optimize aesthetic injections. The Company’s cell therapy product pipeline is comprised of three clinical-stage products: RCT-01 for tendon regeneration, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration which is being co-developed under exclusive license by Shiseido Company 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.

Visit www.replicel.com for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / info@replicel.com

Forward-looking information
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements (i) that it obtain the approvals required to commercialize its initial dermal injector; (ii) that its research and development will enhance clinical efficacy, optimize manufacturing and strengthen the Company’s intellectual property portfolio; (iii) that it will prepare and launch phase 2 clinical trials; (iv) that it will finish building and testing the commercial-grade prototypes of its next-generation dermal injector; (v) that it will prepare the RCI-02 device for marketing approval in Europe (CE-mark); (vi) that it will execute a commercialization agreement for RCI-02 with a multi-national partner and generate revenue in the next year, including the payment of non-dilutive licensing/milestone fees and ongoing sales royalties; and (vii) that it launch and execute one or more molecular market studies to add significant value to the Company’s intellectual property, manufacturing technologies, and the enhancement of clinical efficacy. 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: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals; the risk that the Company’s patents will not be granted or validated in one or more countries; the risk that its phase 2 clinical trial programs are not approved by the applicable regualtory authorities; the risk that there will be delays enrolling clinical trial participants; 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; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks with identifying and coming to an agreement to commericalize its dermal injector; 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, 2015 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.

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.
 

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 989692, "Image": "/Blog/2017/RP-press-release.jpg", "ItemCategories": [ "News - Press Release" ], "ItemTags": [ " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel CEO Provides Company Outlook", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-05-24T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-ceo-provides-company-outlook", "Weighting": 0 }, { "id": 1982, "url": "/news/replicel-developing-autologous-cell-therapies-for-skin-hair-and-tendon-regeneration", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:28", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To read the full interview as it appears on MedicalResearch.com, click here. (4/22/17)

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992290, "Image": "/Blog/2017/RP-recent-coverage.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel Developing Autologous Cell Therapies For Skin, Hair and Tendon Regeneration", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-04-21T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-developing-autologous-cell-therapies-for-skin-hair-and-tendon-regeneration", "Weighting": 0 }, { "id": 1983, "url": "/news/string-of-positive-trial-results-boosts-replicel-s-profile", "parentid": 1929, "lastupdateddate": "2019-08-01T06:22:18", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To read the full article as it appears on thelifesciencesreport.com, click here. (04/12/17)

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992291, "Image": "/Blog/2017/swr-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Skin", " RCS-01" ], "MetaDescription": "", "Name": "String of Positive Trial Results Boosts RepliCel’s Profile", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-04-11T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "string-of-positive-trial-results-boosts-replicel-s-profile", "Weighting": 0 }, { "id": 1984, "url": "/news/replicel-stem-cell-therapies-using-your-own-cells", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:15", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

To listen to Podcast and View Transcript on Future Tech Podcast, click here

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992292, "Image": "/Blog/2017/future-tech-podcast-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel – Stem Cell Therapies Using Your Own Cells", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-04-09T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-stem-cell-therapies-using-your-own-cells", "Weighting": 0 }, { "id": 1986, "url": "/news/positive-results-from-replicel-s-rcs-01-phase-i-skin-trial-are-the-company-s-most-compelling-to-date", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:12", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Interim trial results lead researchers to conclude that the injection of RCS-01 is not only very safe, but also has the potential to reverse effects of aging skin, representing a natural alternative to existing anti-aging treatments

VANCOUVER, BC – April 4, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”) is pleased to report statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.

The primary objective of this trial was to establish a complete safety profile for intradermal injections of RCS-01 (RepliCel’s type 1 collagen-expressing, hair follicle-derived fibroblasts [“NBDS cells”]) at six months post-injection. Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product’s potential for skin rejuvenation.

The study was neither powered for, nor was expected to show statistically significant results of efficacy. However, the nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01, was so profound with a single RCS-01 injection, that the results are considered statistically significant. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin.

“This type of positive effect on TIMP gene expression, which is related to protection against collagen degeneration, is rarely observed. In my experience, after decades of performing these tests, this is an exceptional finding, particularly for a safety trial with a small sample size,” stated Prof. Dr. med Jean Krutmann, Scientific Manager of the IUF Leibniz Research Institute for Environmental Medicine where the study was conducted. “The promising results demonstrate the potential of RCS-01 to promote skin rejuvenation. An increase in collagen markers of this nature would be expected to translate into clinically measurable and aesthetically visible effects.”

Krutmann concluded: “Replication of these results in a larger trial would confirm our view of the product’s potential as a more natural alternative to Botulinum toxins and fillers that only temporarily prevent and reverse the signs of aging.”

“This study not only showed an excellent safety profile, but also provides compelling proof-of-concept that RepliCel’s RCS-01 cells are, by nature, very good collagen producers in the skin,” stated Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer. “We are highly encouraged by the findings and eager to demonstrate the correlation between the change in these biomarkers and clinically important endpoints such as wrinkle depth, in a larger multi-centre trial studying optimal dose and treatment frequency.”

“As a practicing dermatologist,” Hoffmann continued, “the potential of RCS-01 represents a leap-forward in the way we look at skin anti-aging, especially for the fine wrinkles in UV-damaged skin where we have no long-lasting treatment today. Of importance is the fact that, because RCS-01 is comprised of cells derived from tissue at the back of the patient’s scalp, these cells are not only very good collagen producers, but also UV- protected and therefore more functionally active.”

“In my opinion,” Hoffmann concluded, “this is the first example of a treatment potentially capable of rejuvenating UV-damaged skin.”

“This is the most compelling data we have announced to date,” stated RepliCel CEO and President, R. Lee Buckler. “Longer term, this data is very complementary to our focus on commercializing a next-generation dermal injector and its targeted application not only with RCS-01, but also with other aesthetic products on the market today. We look forward to discussing these findings and the potential of our products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in our programs.”

About Aging and UV-damaged Skin Markets

Ultra-violet (UV) light exposure from the sun is responsible for up to 80% of visible facial skin aging. According to statistics from the American Society for Plastic Surgeons, $2.5 billion was spent on facial aesthetics in 2013 and this is predicted to grow to over $5.4 billion by 2020. Dermal filler procedures are growing over 15% annually.

About the RCS-01 Study
The clinical trial was a randomized, double-blind, placebo-controlled, single-centre, phase I safety study of intradermal injections of RCS-01 in healthy subjects. The primary endpoint was to assess the local safety profile by recording and evaluating adverse events reported at the treatment evaluation sites. Secondary safety measures related to any reporting of systemic adverse events and assessment of histopathological abnormalities of the treatment sites. Secondary endpoints also included evaluating any changes in expression of numerous genetic markers (using real-time PCR) related to intrinsic skin aging, skin wrinkling and solar degeneration of skin.

After trial inclusion, all participants provided a biopsy from the scalp from which RCS-01 was prepared at a central GMP manufacturing site. Study participants were randomized to one of two treatment subgroups that received intradermal injections of either RCS-01 or placebo. Each participant had four treatment evaluations sites identified on their buttocks, two on each side to allow for a within-subject comparison of single and triple injections of RCS-01 with placebo respectively. Participants in the RCS-01 Subgroup received injections of RCS-01 or placebo or a ‘sham’ injection (a needle penetration without injection of liquid). Participants in the Placebo Subgroup were randomized to receive only injections of placebo or sham injections to compare the systemic safety profile to the RCS Subgroup.

Baseline evaluations of subjects’ overall health and skin condition at treatment sites on their buttocks were performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites received intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four and eight weeks after Day 0 according to a randomization schedule for a total of three injections per treatment site.

All participants returned/will return to the clinic for at least nine visits to monitor safety. Assessment of the local safety profile was performed by the investigator before each injection visit, two to four days after injection, and 12 and 26 weeks after injection. The investigator was asked to examine each treatment site for the presence or absence of local adverse events and grade them with respect to relatedness to treatment, severity and seriousness. Other study assessments included recording of vital signs at each visit and routine laboratory assessments at screening, injection visits and at the Week 26 time point. At the 12-week time point, nine randomly selected participants provided biopsies from all injection sites for gene expression analysis of skin markers related to aging. At Week-26 (cut-off date of the interim analysis), the remaining participants provided biopsies of all injection sites for histopathological analysis.

All reported pre-defined local adverse events related to injection or sham were transient and mainly mild in intensity only. No other related local or systemic adverse events were reported. No clinically relevant abnormal laboratory results or abnormal vital signs were reported up to the cut-off date of this interim analysis. Histopathological assessments of treatment evaluation site biopsies were all judged to be normal by a blinded investigator.

About Prof. Dr. med Jean Krutmann
Prof Dr. med Jean Krutmann is Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf. He is a coordinator of the Leibniz Research Alliance “Healthy Aging” (a strategic alliance of 23 Leibniz institutes). His research is in the field of derma-toxicology and immune-dermatology with special emphasis on environmentally-induced skin diseases and skin aging. Prof. Krutmann is author or co-author of more than 200 papers. He is the recipient of the International Arnold-Rikli-Award, the Albert Fleckenstein Award, the Paul Gerson Unna Award, the Oscar Gans Award, the C.E.R.I.E.S. Research Support Award and the Dermopharmacy Innovation Award. He is a visiting and adjunct professor of dermatology at the Nagoya City University, Japan, Case Western Case Western Reserve University, Cleveland, Ohio and University of Alabama, Birmingham, AL, USA. He is a member of the National Academy of Science of Germany and Xu Guang Qi Lecturer, Shanghai Institute for Biological Sciences (CAS), Shanghai, China.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company 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 is also developing a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

Forward-looking information
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the RCS-01 Phase 1 skin trial. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the anti-aging potential of RCS-01, its ability to promote skin rejuvenation, and its potential as a more natural alternative to Botulinum toxins and fillers; the Company’s expectation that significant changes to gene expression markers are expected to correlate with increased collagen fibers; that increased collagen production and reduced collagen degradation should potentially lead to fewer wrinkles and the repair of sun-damaged skin; that RepliCel’s RCS-01 cells are by nature very good collagen producers in the skin; the potential correlation between changes in biomarkers and clinically important endpoints; that the potential of RCS-01 represents a leap-forward in skin anti-aging; the potential application for other aesthetic products; and the expected timing of return of trial participants for analysis and the process to be undertaken in connection with same. 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: the risk that there will be delays enrolling clinical trial participants; 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; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; 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, 2015 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.

 

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. 

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 989694, "Image": "/Blog/2017/RP-press-release.jpg", "ItemCategories": [ "News - Press Release" ], "ItemTags": [ "Skin", " RCS-01" ], "MetaDescription": "", "Name": "Positive Results from RepliCel’s RCS-01 Phase I Skin Trial are the Company’s Most Compelling to Date", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-04-03T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "positive-results-from-replicel-s-rcs-01-phase-i-skin-trial-are-the-company-s-most-compelling-to-date", "Weighting": 0 }, { "id": 2002, "url": "/news/replicel-using-cells-for-healing", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:15", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

View featured company Article on Advisor Access click here

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992300, "Image": "/Blog/2017/advisor-access-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel – Using Cells for Healing", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-01-15T16:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-using-cells-for-healing", "Weighting": 0 }, { "id": 2003, "url": "/news/replicel-ceo-lee-buckler-talks-to-cantech-letter", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:25", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

View Article by Nick Waddell on Cantech Letter click here (1/11/2017)

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992301, "Image": "/Blog/2017/cantech-letter-logo.jpg", "ItemCategories": [ "News - As Seen In" ], "ItemTags": [ "Media", "Tendon", "Hair", "Skin", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel CEO Lee Buckler talks to Cantech Letter", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2017-01-10T16:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-ceo-lee-buckler-talks-to-cantech-letter", "Weighting": 0 }, { "id": 2017, "url": "/news/replicel-life-sciences-conducts-formal-consultation-review-with-japan-s-pmda-and-receives-unprecedented-review-fee-reduction", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:41", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Japan’s Pharmaceuticals and Medical Devices Agency reviews RepliCel’s pre-clinical, quality, and manufacturing data for its non-bulbar dermal sheath (NBDS) platform

VANCOUVER, BC – April 25, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced that it met this month with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in Tokyo. The meeting was a formal consultation review of the company’s pre-clinical, quality, and manufacturing data related to its non-bulbar dermal sheath (NBDS) platform technology. This review is a required step in the process to obtain PMDA consent to perform a clinical trial in Japan.

“We have been very encouraged by the PMDA’s collaborative approach and yet the absolute high standards of safety they maintain”, stated R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. “The conduct of this consultation meeting moves the clinical-stage products (RCT-01 tendon repair; RCS-01 skin rejuvenation) being developed from our NBDS platform closer to the launch of Japanese clinical trials and partnerships”, he added.

Furthermore, each consultation performed by the PMDA at the formal request of a potential clinical trial sponsor, carries with it associated fees which are lowered for academic institutions, hospitals, and small/medium enterprises. Additionally all documentation created for the consultation must be provided in Japanese.

Without any known precedent for doing so, RepliCel, on the advice of CJ Partners Inc., applied for the reduced-fee designation based on its small size and the pre-revenue nature of its business. The company was successfully awarded a reduced fee status which represents approximately one-tenth of the otherwise applicable fees.

“To the extent that CJ Partners knows, this is the first time that a foreign regenerative medicine company has qualified for the reduced price status with the PMDA”, commented Colin Lee Novick, Managing Director of CJ Partners Inc.

“RepliCel continues to pioneer foreign participation in cell therapy development in Japan”, said Buckler. “We are committed to early commercialization of our products in Japan and entering into a Japanese-based partnership for each product in our cell therapy portfolio.”

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company 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. The Company 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:

CORPORATE:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

MEDIA/INVESTOR RELATIONS:
Jacqui Specogna
Telephone: 604-248-8730 / js@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.

Forward-Looking Statements

Certain statements in this press release related to the Program are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “will”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding the number of Warrant Holders that may participate in the Program, the use of proceeds and final regulatory approval. Such forward-looking statements should therefore be construed in light of such factors, and the Company is not under any obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 989718, "Image": "/Blog/2017/RP-press-release.jpg", "ItemCategories": [ "News - Press Release" ], "ItemTags": [ "Tendon", "Hair", " Financing", "Skin", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel Life Sciences conducts formal consultation review with Japan’s PMDA and receives unprecedented review fee reduction", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2016-04-24T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-life-sciences-conducts-formal-consultation-review-with-japan-s-pmda-and-receives-unprecedented-review-fee-reduction", "Weighting": 0 }, { "id": 2018, "url": "/news/replicel-life-sciences-finishes-enrolment-for-its-tendon-repair-and-skin-rejuvenation-clinical-trials", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:43", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Results from both trials will support commercialization initiatives, partner discussions and continued clinical development

VANCOUVER, BC – April 20, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that it has enrolled its final patients for both its RCT-01 and RCS-01 clinical trials. This ensures clinical data for both trials will be analyzed and released near year-end. Positive safety data will allow the company to move forward with phase 2 trials for both products in 2017. Data pertaining to the products’ effects post-injection will inform and guide the company’s product development and clinical trial strategy for both tendon repair and skin rejuvenation applications.

RCS-01: Skin Rejuvenation

RCS-01 is a proprietary cell-therapy product comprised of non-bulbar dermal sheath (NBDS) which are type 1 collagen-expressing fibroblasts derived from the hair follicle. The phase 1, single-centre trial currently ongoing in Dusseldorf, Germany, is investigating injections of RCS-01 as a treatment for UV-damaged and aged skin. The trial had projected enrollment at 30 participants; 15 male and 15 female. While the female cohort of the trial has been completely enrolled, the slow pace of male enrolment combined with an anticipation that this product will be largely targeted for female consumers, led to the decision to finish enrolment at the 17 participants already enrolled. The complete data set of the female cohort will permit study analysis for this subset of subjects as originally planned.

RCT-01: Tendon Repair

RCT-01 is a proprietary cell-therapy product comprised of non-bulbar dermal sheath (NBDS) which are type 1 collagen-expressing fibroblasts derived from the hair follicle. The phase 1/2, single-centre trial currently ongoing in Vancouver, British Columbia, is investigating the use of RCT-01 as a treatment for chronically injured ankle (Achilles) tendons otherwise called Achilles tendinopathy or tendinosis. The original targets for this trial were 28 participants to be injected by the end of Q1 2016 such that data would be available from this trial near year-end 2016. In order to ensure data near year-end 2016, the company decided to complete enrolment at the 10 patients currently enrolled.

“We have adjusted our plans for the RCT-01 clinical trial in part because it started later in 2015 and enrolled slower than originally anticipated. While the trial did not meet projected enrolment targets, we are confident the safety and preliminary efficacy data obtained by year-end will provide a signal of the product’s potential to regenerate chronically injured tendon that has failed to respond to other treatments. This will allow our teams to effectively plan larger phase 2 trials in 2017 which are powered to be statistically significant for clinical efficacy (evidence the product works as intended)”, stated Vice-President of Clinical Affairs, Darrell Panich.

“Future trials involving products from our non-bulbar dermal sheath (NBDS) platform will be designed to investigate the efficacy of these products at different dose levels and treatment frequencies while continuing to collect other data that will be used to support eventual RCS-01 and RCT-01 marketing applications by our commercial partners.”

“The delivery of clinical data when promised is important to management”, said R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. “We have made critical decisions to keep our commitment to the financial community and we believe the data from these trials will facilitate us closing a licensing and co-development deal on one or both of these products similar to the kind we have in place with Shiseido Company for our RCH-01 product”, he added.

About RepliCel’s NBDS Fibroblast Platform

RepliCel’s NBDS fibroblast platform has the potential to address numerous indications where impaired tissue healing has been stalled due to a deficit of active fibroblast cells required for tissue remodeling and repair. RepliCel’s proprietary NBDS fibroblast cells, isolated from healthy hair follicles, are a rich source of fibroblasts unique in their high-level expression of the necessary proteins, such as Type I collagen, required to jump-start the stalled healing cycle. The company is developing a series of products from this platform that have the potential to address large commercial markets in the areas of musculoskeletal and skin-related conditions. To learn more about RepliCel’s RCT-01 treatment for chronic tendinosis please watch our video: www.youtube.com/watch?t=23&v=kaa0hiJyeV4

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company 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. The Company 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:

CORPORATE:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

MEDIA/INVESTOR RELATIONS:
Jacqui Specogna
Telephone: 604-248-8730 / js@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.

Forward-Looking Statements

Certain statements in this press release related to the Program are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “will”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding the number of Warrant Holders that may participate in the Program, the use of proceeds and final regulatory approval. Such forward-looking statements should therefore be construed in light of such factors, and the Company is not under any obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 989719, "Image": "/Blog/2017/RP-press-release.jpg", "ItemCategories": [ "News - Press Release" ], "ItemTags": [ "Tendon", "Skin", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel Life Sciences Finishes Enrolment for its Tendon Repair and Skin Rejuvenation Clinical Trials", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2016-04-19T17:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-life-sciences-finishes-enrolment-for-its-tendon-repair-and-skin-rejuvenation-clinical-trials", "Weighting": 0 }, { "id": 2024, "url": "/news/replicel-announces-ceo-update", "parentid": 1929, "lastupdateddate": "2019-08-01T06:21:18", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "

Milestones for 2016 include two clinical trial readouts, finalizing RCI-02 for a 2017 product launch, and initiation of Shiseido’s pattern baldness trial in Japan

VANCOUVER, BC – February 16, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (“RepliCel” or the “Company”), a clinical-stage regenerative medicine company focused on the development of autologous cell therapies, is pleased to provide an update to shareholders from its new President and CEO, Mr. R. Lee Buckler.

Dear Shareholders,

In my initial communication to you as RepliCel’s CEO, I want to convey what we look to accomplish in the coming 12 months.

First a word about what you can expect from me as CEO. Expect my management to be dictated by an urgency to deliver on data and deals, my communication style to be driven by frank transparency, and every decision we make to be driven through strict analysis of how we can best deliver and preserve maximum shareholder value in the shortest possible period without sacrificing our commitment to quality.

As you would expect, I am currently critically reviewing all programs including product development, clinical trials, overhead costs, and opportunities related to non-dilutive capital.

Our first priority is to balance our fundraising activities with managing our finances and burn rate to ensure we are sufficiently capitalized to result in us obtaining the kind of data and achieving milestones that will result in our next licensing and co-development deal with the associated injection of non-dilutive capital.

I intend to ensure we complement further equity-based fundraising and anticipated deal-flow revenue with the pursuit of non-dilutive grant and licensing funding. We are also investigating a number of cash-positive strategic transactions that could be synergistic and mutually beneficial to the shareholders of both companies.

A Little Perspective
In mid-2013 the Company had one product and a recently-signed deal with Shiseido. Since then, the past 30 months have been focused on three critical programs:

  1. Rebuilding the RCH-01 (androgenic alopecia) program with Shiseido after one of our critical manufacturing reagents was pulled from the market forcing the Company to reinvent, retool, and re-validate our manufacturing of that product.


  2. Diversifying the Company’s product portfolio by building our NBDS platform (discovery, in vitro testing, animal testing, patent filings, regulatory submissions, and establishing manufacturing protocols) to move two products from that platform (RCT-01 (chronic tendinosis) and RCS-01 (aging & sub-damaged skin)) into clinical trials.

  3. Design, development and patent filings around a next-generation dermal injector (RCI-02) which now represents the Company’s nearest-term commercial opportunity.

Our delivery on the goals we set in 2015 has positioned RepliCel in a unique and exciting position among biotech companies.

When I joined the Company in Q4 2014, it was clear to me the Company had before it a two-year plan that had the potential to transform the Company. We are now mid-way through that timeline.

Last year, we announced plans to launch our chronic tendon injury and dermatology trials, lock-up the design of our dermal injector, benefit from initiation of independent analyst coverage, initiate regulatory review of our fibroblast platform technology by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and support Shiseido’s launch of their RCH-01 clinical trial in Japan. I am proud to say we accomplished our goals for 2015 and anticipate Shiseido’s trial launch in Q1 of this year.

A company in transition. RepliCel is transitioning from an early-stage biotech company to one with commercial products.

Today we sit as an early-stage biotech company but one with a rapidly maturing and diversified portfolio of products in development characterized by:

     

  • three products in active clinical trials, two of which (RCT-01 & RCS-01) are anticipated to generate clinical data by year-end,

  • a medical device (RCI-02) in late-stage development which is on-track to be launched to the market in 2017, licensing discussion with major international companies are underway, and

  • a major international licensing and co-development partnership in place around a product being co-developed with that partner which has the potential to be on the market in Japan in 2018.
  •  

2016 promises to be an important year for RepliCel. Over the next 12-15 months, everything we’ve been working on over the past 36 months has material milestones including:

     

  • clinical data from both our RCT-01 (chronic tendon injury) and RCS-01 (aging and sub-damaged skin) clinical trials in late 2016,

  • Shiseido launching their next-phase clinical trial of RCH-01 (pattern baldness) in Japan in early 2016. This is expected to be approximately a 20-month trial and has the potential to lead to a market launch in 2018 in Japan, and

  • filing a CE mark application for our dermal injector (RCI-02) seeking permission to sell the device in Europe with label approval for injection of hyaluronic acid-based dermal fillers.
  •  

Licensing Partnerships and Financing
We are currently in confidential licensing discussions with multi-national companies for our RCI-02 dermal injector and our RCT-01 tendon repair product.

As a matter of strategy, I am focused on positioning the Company such that we have an opportunity to fund our future programs heavily leveraging non-dilutive capital (deal-flow revenue, sale royalties, and grant funding) as a means of maximizing shareholder equity value.

In Japan, we are pleased with the ongoing collaborative nature of our partnership with Shiseido on RCH-01 and proud of their progress. We are also pushing very aggressively to secure a licensing/co-development partner for either RCT-01 or RCS-01 in Japan. With the recent regulatory changes in Japan, it is now possible to potentially develop and commercialize cell-based therapies faster than any other regulated country in the world making Japan an ideal place to develop products.

About RCI-02: Dermal Injector Device
In January, RepliCel was granted a patent by the European Patent Office for several key elements of its injection device technologies. We believe the intellectual property related to our dermal injection technologies will lead to several devices for various applications.

The first device being developed utilizing the RCI technologies is designed for the injection of hyaluronic acid (HA)-based dermal fillers, though it will be capable of being used for other products with similar injection profiles. The injector provides the user unparalleled control over injection depth, dose, and rate of deposition unlike any other device on the market. It also incorporates a feature which numbs the skin prior to injection thus reducing if not eliminating the need for local anesthetic injections.

The initial RCI-02 device promises a better patient experience, more consistent outcomes, the ability to delegate more injection procedures to lower-skilled technicians, and a reduction in procedure time and consumable cost. Additionally, perhaps the device’s most significant value is the enabling of dermal filler injections for the type of fine wrinkles across broad areas, including the fine wrinkles of the face, hands and décolleté, which current injector technologies do not currently enable.

We believe the RCI-02 dermal injector has the potential to significantly expand the number of dermal injection procedures currently including the approximately US$2 billion worth of HA-based dermal filler injections performed globally per year. In our opinion, the parties with the most to gain from commercializing our injector are the companies already selling approved injectable products, some of which we are already engaged with in licensing discussions.

About RCS-01: Skin Rejuvenation (Germany)
We anticipate clinical data from our RCS-01 trial in late 2016. Our RCS-01 skin rejuvenation study is a phase 1, single centre trial investigating our type 1 collagen-expressing, follicle-derived fibroblasts as a treatment for UV-damaged and aged skin.

We believe RCS-01 has the potential to be a natural, patient-derived, cell-based dermal filler alternative which would represent an industry game changer if clinical data supports our hypothesis of its potential to address fine wrinkle lines and UV-damaged skin with long-term, sustainable regeneration of the dermal extracellular matrix (ECM).

This trial may be the first clinical trial of a cell therapy product ever allowed by regulators to use healthy volunteers. This was important to us because we wanted to conduct pre- and post-injection biopsies of the injection sites. Despite the fact this trial is a phase 1 trial with safety data as the primary endpoint to be submitted to the regulators, we have designed this trial to also produce significant biological data measuring whether or not, and to what extent, we are accomplishing anything aesthetically meaningful in terms of rebuilding of the ECM under aging and sun-damaged skin. Quantitative data will be generated from histopathology and gene expression analysis of the biopsied tissue. We expect this kind of data to be critical to our decision as to whether or not this product is worth further investigation but also may be sufficient to excite potential licensing partners about investing in co-development of the product.

Market: In 2013, there was an estimated $2.5 billion spent on facial aesthetics, 6.7 million botox injections, 2.3 million soft tissue filler procedures, and 1.7 million injections of hyaluronic acid according to the American Society of Plastic Surgeons and GBI Research. We believe RCS-01 has the potential to both capture a good percentage of the existing market and also significantly grow the market for dermal injections because a material portion of the market not currently seeking such injections may be persuaded to do so if the injection is of a natural, cell-based dermal filler product that regenerates the ECM under their skin rather than artificially filling the ECM space. Similarly, we believe the RCI injector will be used for a significant number of these dermal injections and will help to grow the market faster.

About RCT-01: Tendon Repair (Canada)
Clinical data from our RCT-01 trial is anticipated in late-2016. Our RCT-01 tendon repair study is a phase 1/2 single-centre trial investigating the use of our type 1 collagen-expressing, follicle-derived fibroblasts as a treatment for chronically injured ankle tendons.

Based on clinical data published by one of our clinical collaborators from three phase 1 clinical trials involving the injection of fibroblasts in chronically injured tendons in the ankle, knee, and elbow, we firmly believe in the potential of RCT-01, when injected into the chronically injured tendon, to kick-start the stalled healing process and result in tendon regeneration.

This is a phase 1/2 trial with safety data as the primary endpoint to be submitted to the regulators. We have designed this trial to provide us with a number of efficacy measurements to give us a meaningful signal as to the product’s potential efficacy in healing chronically injured tendon for which nothing else works. These include function and pain scores and ultrasound imaging to measure blood flow, intratendinous tears, and rebuilding of tendon thickness among other things.

Market: There is an estimated incidence rate of 656,211 new cases of mid-portion Achilles tendinopathy each year in North America alone, according to statistics published in the British Journal of Sports Medicine. If we can regenerate the tendon in ankles there is every reason to believe we can do so in the patellar tendon of the knee, both tendons of elbow, and the rotator cuff. There is also a distinct possibility that once there is a strong body of evidence that our cell therapy product heals chronic tendon injury that it will used by doctors for more acute injury and eventually the approved label expanded to include such treatments.

About RCH-01: – Hair repair, Shiseido (Japan)
We anticipate Shiseido will announce the start of their clinical trial of RCH-01 in Japan in the first quarter of 2016. Shiseido has invested a great deal of time and money in continuing to optimize the product and its manufacturing with RepliCel, building, validating, and obtaining PMDA certification of its facility purpose-built for this product, successfully completing the transfer of the manufacturing protocols and the product manufacturing validations, selecting the clinical site, training all related personnel, and submitting the clinical protocol for Ministry review.

We believe that Japan’s unique regenerative medicine regulatory and industry environment provides a unique opportunity to rapidly advance this product in their country and are excited that RCH-01 has the potential to be launched in the Japanese market by Shiseido as soon as 2018.

Clinical data from Shiseido’s trial will be shared with RepliCel, further strengthening the data package created on RCH-01. This can be used in submissions to other regulatory agencies and in negotiating the license for this product for the regions outside of Shiseido’s exclusive territory.

Market: $3.5 billion was spent on hair loss treatments in 2015 according to the Washington Post and $2.5 billion of this was spent on surgical procedures according to the International Society for Hair Loss. We believe RCH-01 has the potential to capture a good percentage of that surgical expenditure but also significantly grow the market because most hair loss sufferers still elect not to do surgery due to the invasiveness and variability associated with the procedure.

Closing
In closing, I want to thank our shareholders for their dedication and patience with the RepliCel story as it has unfolded. We have laid a tremendous amount of groundwork to get the Company to this point where we have a year unfolding in which so many exciting programs have the potential to culminate in exciting milestones and significant value creation.

I’m excited about the potential for 2016 to be a transformative year for RepliCel and its shareholders.

We recognize and appreciate your continued support, and look forward to sharing upcoming achievements with you.

As always, I welcome any questions or feedback you might have.

Sincerely,

Lee Buckler, CEO & President
Telephone: 604-248-8693 Email: lee@replicel.com

MEDIA & INVESTOR RELATIONS:

Tammey George, Director of Communications
Telephone: 604-248-8696 Email: tg@replicel.com

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: (i) the Company’s: proposed priorities, financing activities and financial management for the next 12 months; (ii) potential licensing and partnership agreements the Company may enter into; (iii) potential transactions the Company may pursue to improve the Company’s cash position; (iv) the benefits that shareholders may obtain from the Company’s activities; (v) the Company’s expected transition from an early-stage biotech company to one with commercial products; (vi) the expected timing of completion and generation of clinical data for the Company’s products in active clinical trials; (vii) the Company’s ability to source and obtain non-dilutive capital and to use such capital to fund its future programs; and (viii) specific statements regarding the Company’s different products, including:

     

  • with respect to the RCI-02 dermal injector device, that: the Company’s related intellectual property could potentially be used for several devices and various applications; it is on-track to hit the market in 2017, and licensing discussions with major international companies are underway in that regard; it will provide users with unparalleled control over injections; it will reduce if not eliminate the need for local anesthetic; it can improve patient experience and outcomes while controlling costs; it has the potential to signifciantly expand the number of dermal injection procedures; and a CE mark application for the injector is expected to be filed in the next 12 to 15 months;

  • with respect to the RCS-01 Skin Rejuvenation, that: clinical trials are anticipated to generate clinical data by year end; it has the potential to be a natural, patient-derived, cell-based dermal filler alternative which could represent an industry game changer; the data generated from clinical trials may excite potential licensing partners about investing in co-development of the product; and it has the potential to capture a good percentage of the existing market and significantly grow the market for dermal injections;

  • with respect to the RCT-01 Tendon Repair, that: clinical trials are anticipated to generate clinical data by year end; it has the potential to result in tendon regeneration; it could potentially be used by doctors for acute injury and be expanded for use in other treatments; and

  • with respect to RCH-01 Hair Repair, that: Shiseido will announce the start of their clinical trial in Japan in the first quarter of 2016; Japan provides a unique opportunity to rapidly advance this product; the product has the potential to be launched in the Japanse market as soon as 2018; and it has the potential to capture a good percentage of money currently spent on hair loss surgical procedures, as well as increasing that market significantly.
  •  

Such forward-looking statements and information are based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: failure to obtain CE mark clearance or necessary regulatory approvals; delays enrolling clinical trial participants; negative results from the Company’s trials; the effects of government regulation on the Company’s business; 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. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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.

", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 992136, "Image": "/Blog/2017/RP-press-release.jpg", "ItemCategories": [ "News - Press Release" ], "ItemTags": [ " Financing", " RCI-02", " RCH-01", " RCS-01", " RCT-01" ], "MetaDescription": "", "Name": "RepliCel Announces CEO Update", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ReleaseDate": "2016-02-15T16:00:00", "SeoPriority": "", "SEOTitle": "", "MetaTitle": "", "ShowPageForSearchEngine": true, "SocialMetaTags": "", "UrlSlug": "replicel-announces-ceo-update", "Weighting": 0 } ], "pagination": { "currentpage": 1, "itemsperpage": 20, "numberofpages": 2, "totalitemscount": 36 }, "params": {}, "parent": { "id": 1929, "url": "/news", "parentid": -1, "lastupdateddate": "2018-12-05T15:08:45", "AMPContent": "", "Author_name": null, "Author_url": null, "Author": 0, "CanonicalLink": "", "CodeEditor": false, "CreatedByMemberId": 0, "Description": "", "DisableForSiteSearch": false, "EnableAMP": false, "Enabled": true, "ExpiryDate": "2099-12-11T16:00:00", "ExternalId": 0, "ItemCategories": null, "ItemCategoryIdList": null, "ItemTags": null, "MetaDescription": "", "Name": "News", "OpenGraphProperties": { "title": "", "type": "", "url": "", "locale": "", "image": "" }, "ReleaseDate": "2018-11-27T16:00:00", "SeoPriority": "", "SEOTitle": "Replicel News", "MetaTitle": "Replicel News", "ShowPageForSearchEngine": false, "SocialMetaTags": "", "UrlSlug": "news", "Weighting": 0 } }

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.

THIRD PARTY CONTENT
Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.