RCT-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
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
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
RepliCel – Stem Cell Therapies Using Your Own Cells
To listen to Podcast and View Transcript on Future Tech Podcast, click here
As Seen In
Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis (ReaCT)
To read the full study as it appears on ClinicalTrials.gov, click here. Source: Clinical Trials....
Press Release
RepliCel’s Successful RCT-01 Tendon Repair Clinical Trial Shows Signs of Healing Chronic Tendon Problems
First-in-human clinical study meets primary endpoint demonstrating product safety and clinical potential for tendon regeneration...
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,...
As Seen In
5 Questions with David Hall
Click here to view the article on Cantech LetterVancouver-based RepliCel Life Sciences (TSXV:RP) concentrated on...
Press Release
RepliCel Life Sciences Enrolls First Participant in Phase 1/2 Clinical Trial of RCT-01 for Chronic Achilles Tendinosis
ReaCT Trial at University of British Columbia Treating Patients with Autologous CellTherapyVANCOUVER, BC – June...
Events
RepliCel Life Sciences Announces Participation in 23rd World Congress of Dermatology, Vancouver, BC
Conference program to include presentations on the clinical development of RepliCel’s skin rejuvenation, hair regeneration,...
Events
RepliCel to Present Unique Autologous Cell Treatment for Achilles Tendinosis at International Society for Cellular Therapy Conference
Clinical trial at the University of British Columbia now recruiting patients VANCOUVER, BC – May...
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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

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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.

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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

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

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

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

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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.
 

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

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

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To read the full study as it appears on ClinicalTrials.gov, click here. Source: Clinical Trials. gov (4/7/17)

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First-in-human clinical study meets primary endpoint demonstrating product safety and clinical potential for tendon regeneration and healing

VANCOUVER, BC – March 28, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”) is pleased to report compelling safety and clinical data from its phase 1/2 tendon repair study investigating the use of RepliCel’s type 1 collagen-expressing, hair follicle-derived fibroblasts (RCT-01) as a treatment for Achilles tendinosis.

The clinical trial met its goal of establishing a complete safety profile at 6 months and showed no serious adverse events related to the study treatment or injection procedure.
Additionally, each of the treated participants, all of whom suffered chronic tendon pain and loss of function over an extended period of time with no recovery from standard treatments, showed numerous clinically important improvements by various measures including tendon composition, blood supply, physical function and pain sensation.

“Chronic tendinosis is a state of tendon degeneration that is very difficult to reverse, as evidenced by the many therapies used to try and treat it,” stated Dr. Ross Davidson, an orthopedic surgeon, former clinical professor at the Department of Orthopaedics at the University of British Columbia, and past head physician and orthopaedic consultant for the Vancouver Canucks (of the National Hockey League (NHL)).

“This study shows exciting clinical improvements in patients with clinically diagnosed chronic Achilles tendinosis who were unresponsive to standard treatments, and who had suffered for many months (in some cases, years) with frequent pain and loss of function. Not only did the study show several clinically important improvements in pain and function scores, but several ultrasound measures clearly demonstrate a marked improvement in tendon structure; something rarely seen in patients with this condition,” said Davidson.

“With further clinical studies, this new technology could represent a cutting-edge advancement in kick-starting a healing process that results in tendon regeneration. For the first time, we may have a treatment that shows signs of reversing the underlying problem, versus just treating the symptoms. This could be a game-changer in sports medicine,” Dr. Davidson concluded.

The most clinically material improvements observed from the study are summarized as follows:

VISA-A Scale of Achilles Tendon Injury Severity
Participants treated with RCT-01 in the per protocol population who completed the VISA-A evaluation 6 months after receipt of injections showed clinically relevant signals of healing including an overall 15.3% improvement in total score compared to baseline. Two patients showed select measures of near-complete recovery in function (by VISA-A scoring).

VAS Scale of Pain Severity
Four out of five participants treated with RCT-01 who completed questionnaires 6 months after injection showed clinically relevant signals of improvement in pain on loading (running/jumping) based on VAS score. Average improvement in VAS score for the four participants was 62.9% over baseline VAS score.

Three out of five participants treated with RCT-01 who completed questionnaires 6 months after injection showed improvement in pain on palpation based on VAS score. Average improvement in VAS score for the three participants was 55.2% over baseline VAS score.

Two patients showed select measures of near-complete elimination of pain (by VAS scoring).

“This trial was to show the safety of injection of hair follicle-derived non-bulbar dermal sheath cells (NBDS),” stated RepliCel’s Chief Medical Officer, Dr. Rolf Hoffman, “as well as to repeat the landmark trials of our collaborators who injected skin-derived fibroblasts together with PRP (platelet-rich plasma) in different tendinopathies. We believe the cause of healing (mechanism of action) in those studies was the cellular collagen production and not the PRP which, in our view, has little clinical or commercial potential as a therapeutic product or treatment for tendon repair.”

“I am very pleased that in this trial we see some early signals of regenerative healing in some patients and because of its similar pathogenesis, there is every reason to believe the ability to heal Achilles tendons will extend to numerous applications including repairing the patellar tendon of the knee (jumper’s knee), both tendons of elbow (tennis elbow, golfer’s elbow), and the rotator cuff,” observed Dr. Hoffmann. “Furthermore,” he concluded, “when we have established that our cell therapy heals chronic tendon injury, it may then be used by physicians for more acute injury with the goal of an approved label for these additional treatments in the future.”

“This is a major step forward in the Company’s development of a series of products which leverage the exciting collagen-producing capacity of these cells,” stated RepliCel CEO, Lee Buckler. “Our management and clinical team are very excited about the data from this trial and the potential for further development and clinical testing of this product to treat patients without good options for the tendon degeneration, pain and loss of function they are experiencing.”

Buckler concluded: “We have captured the medical and investment communities’ attention and see the results of this much anticipated, proof-of-concept clinical study as an opportunity to advance therapies for patients and incrementally add value for shareholders in the months ahead.”

About Achilles Tendinopathy
Achilles tendinopathy is a condition that causes pain, swelling and stiffness of the Achilles tendon that joins your heel bone to your calf muscles. It is thought to be caused by repeated tiny injuries to the Achilles tendon. These may occur for a number of reasons, including overuse of the tendon; for example, in runners. Treatments range from physiotherapy, to anti-inflammatory medications, to surgery. For many people, symptoms of Achilles tendon injury usually clear within three to six months of starting treatment. However, for some people the injury does not respond to treatment and progresses to chronic tendinosis. 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.

About the RCT-01 Tendon Repair Study
The study was designed to demonstrate the safety of a single injection of RepliCel’s RCT-01 into the Achilles tendon. While the study was not designed to be statistically significant for efficacy, multiple measures of efficacy were incorporated to give insights into the product’s potential and to assist in guiding future development decisions. Measures of whether the product may be working included testing and scoring patient pain in various settings, evaluating overall function, blood flow changes in the tendon, and changes in the overall density and composition of the tendon as measured by ultrasound imaging. For further trial details see: https://www.clinicaltrials.gov/ct2/show/NCT02330146.

The first-in-human study involved patients clinically diagnosed with chronic Achilles tendinosis. The primary purpose of this single-centre, phase 1/2 randomized (3:1), double blind, placebo-controlled trial was to assess the safety profile of RCT-01 injections, as compared to placebo injections. The study also measured the potential efficacy and impact injections had on tendon structure and function and the symptoms of Achilles tendinosis. The study was led by principal investigator Dr. Rob Lloyd-Smith, MDCM of the University of British Columbia (UBC) and was conducted at the UBC Sports Medicine Clinic in Vancouver, BC, Canada. Data from such a trial, not designed for statistical significance, often signals clinically significance, which is extremely informative for future product development and clinical trial design. The goal of the study was to establish sufficient evidence of safety to allow the Company to proceed with well-powered phase 2 studies investigating optimal dosing, treatment frequency, effect duration, etc.

As was expected with injecting 1.5mL into the Achilles tendon, all study participants who received injections (less one RCT-01-injected participant) reported at least one adverse event related to treatment regardless of treatment administered (RCT-01 or placebo). The adverse events were either soreness at the injection site or the observation of a partial thickness tear in the tendon post-injection. Most reports of soreness resolved shortly after receiving injections.

About Tendon Treatment Clinical Efficacy Measurements

VISA-A
The VISA-A scale aims to evaluate the clinical severity for patients with chronic Achilles tendinopathy. It is a questionnaire which evaluates symptoms and their effect on physical activity. It can be used to compare different populations with chronic Achilles tendinopathy and facilitate comparisons between studies. It can be used to determine the patient’s clinical severity. The VISA-A represents a clinically validated, reliable and disease-specific questionnaire to measure the condition of the Achilles tendon, but it is not a diagnostic tool. The final version of the questionnaire was named the Victorian Institute of Sport Assessment-Achilles Questionnaire.

VAS
A Visual Analogue Scale (VAS) is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. It is an instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient’s perspective, this spectrum appears on a continuum, in that their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised.

About Dr. Ross Davidson
Dr. Davidson is the former Director, Post Graduate Programmes in Sports Medicine at the University of Auckland, and a member of the New Zealand Orthopaedic Association and the Canadian Orthopaedic Association. He is the past president of the National Hockey League Physicians Society, past head physician and orthopaedic consultant for the Vancouver Canucks Hockey Club (NHL), past orthopaedic consultant to the Vancouver Grizzlies Basketball Team (NBA), past orthopaedic consultant to Allan McGavin Sports Medicine Centre, and past orthopaedic consultant to the Canadian Football League Players Association. Dr. Davidson held the position of clinical professor, department of orthopaedics at the University of British Columbia until 2000.

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 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 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 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
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) that RCT-01 has the ability to heal Achilles tendons, (ii) that RCT-01 will extend to numerous applications including repairing the patellar tendon of the knee (jumper’s knee), both tendons of elbow (tennis elbow, golfer’s elbow), and the rotator cuff, (ii) that the results of this clinical study will act as an opportunity to advance therapies for patients and incrementally add value for shareholders over the months ahead.

 

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. 

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View featured company Article on Advisor Access click here

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

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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.

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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.

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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.

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Click here to view the article on Cantech Letter

Vancouver-based RepliCel Life Sciences (TSXV:RP) concentrated on hair regeneration until 2011, participating in the $3 billion annual male pattern baldness industry. But when the far-reaching effects of its solution became apparent to its founders, RepliCel began expanding its offer to apply the technique of using cell therapy to encourage the healing of damaged or injured tissues to other body parts.

The company recently partnered with Tokyo-based cosmetic giant Shiseido, offering RepliCel access to the vast Asian market.

Cantech Letter talked to RepliCel as part of our “Five Questions” series. Our “Five Questions” Series runs all this week, posing the same five questions to up-and-coming Canadian innovation sector companies.

What does your company do?

RepliCel Life Sciences Inc. is a regenerative medicine company focused on developing autologous cell therapies for the treatment of musculoskeletal tissue injuries, aging and UV-damaged skin and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles.

RepliCel’s strategy is to license its assets to partners for late-stage development and commercialization. Shiseido, one of the world’s largest cosmetic companies, has an exclusive license for RepliCel’s pattern baldness product, RCH-01, in certain Asian countries including Japan, China and South Korea.

What problem are you trying to solve?

RepliCel is developing autologous cell therapies which address conditions caused by a deficit of the healthy, active cells required for normal healing and function.

RepliCel’s propriety injector device (RCI-02) is programmed to control depth, dose, and volume of the injection and allows for widespread injections across broad areas. In addition, RepliCel’s device has a built-in peltier element which numbs the skin just prior to injection eliminating the need for anesthetic. These features distinguish Replicel’s dermal injector from any others currently on the market.

How is your solution better than what is currently offered?

The regeneration of chronically injured tendon, the natural rejuvenation of the extra-cellular matrix under the dermis of those with aging or sun-damaged skin, and the regrowth of hair for those people suffering from pattern baldness attributed to androgenic alopecia are not conditions which can be resolved by currently available products or treatments.

How big is the market you are addressing?

The combined total addressable market size for pattern baldness, skin rejuvenation, tendon repair, and a next-generation dermal injector potentially valuable for any kind of dermal injection is understandably large – easily estimated at >$2 billion annually.

What will you be working to accomplish in the next year?

2015 is on track to be a transformative year for RepliCel as we move each of our assets into next-stage of clinical development. We anticipate accomplishing the following over the next 12 months:

-Clinical data from the RCT-01 (chronic Achilles tendinosis) trial in Canada and from
-Clinical data from the RCS-01 (aging and sun-damaged skin) trial in Germany
-Receipt of a CE mark clearing the RCI-02 dermal injector for sale in Europe
-Execution of a licensing partnership in Japan for RCT-01 or RCS-01
-Execution of a global licensing partnership for RCI-02 for select product(s)
-Launch of our phase 2 RCH-01 (pattern baldness) clinical trial in Germany
-Shiseido’s launch of its RCH-01 (pattern baldness) clinical trial in Japan
-Technology transfer complete to a contract manufacturing facility in North America

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ReaCT Trial at University of British Columbia Treating Patients with Autologous Cell
Therapy

VANCOUVER, BC – June 30, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that the first participant in its Phase 1/2 clinical trial of RCT-01, being tested for the treatment of chronic unilateral Achilles tendinosis, has been enrolled and their tissue biopsy sent for processing prior to intra-tendon ultrasound-guided injections. RCT-01 is comprised of non-bulbar dermal sheath (NBDS) cells isolated from hair follicles via a small biopsy taken from the back of the participant’s head. A total of 28 participants, male and female, will be included in this study, also known as the ‘ReaCT Trial’.

“The first participant enrollment and the subsequent booked patients are significant milestones in the development of RCT-01 and our NBDS fibroblast platform,” stated David Hall, CEO. “In parallel to the RCT-01 trial, we have a clinical trial application for a companion platform product, RCS-01, for aging and sun damaged skin currently under review by European regulators in Germany. Upon receiving approval to initiate the RCS-01 trial which is anticipated in the near future, we will have two active clinical trials based on our NBDS platform. Both of these clinical trials are designed to deliver safety, clinical, and biologic mechanistic data next year – approximately 6 months after participants receive their last injection.”

“Our RCT-01 treatment for chronic tendinosis represents a first step in developing a broad treatment platform for musculoskeletal injuries,” commented Lee Buckler, VP Business and Corporate Development. “We are looking to expand the application of our RCT-01 treatment into other indications and other markets, particularly in Japan, where we are actively seeking partners for RCT-01 to take advantage of the opportunity there for accelerated market access. RepliCel is committed to a business model of out-licensing and partnerships for the late-stage development and commercialization of all our products.”

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.

About the ReaCT Trial
The ReaCT trial is a randomized, double-blind, placebo-controlled, single-centre study being conducted at the University of British Columbia. The study will include 28 participants, male and female between 18 and 50 years, in good health with chronic Achilles tendinosis symptoms for 6 months or more and who have completed at least three months of physiotherapy with no improvement. Study participants will receive ultrasound-guided injections of either RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into areas of injury within the Achilles tendon. Participants’ overall health and tendinosis will be monitored over a six month period while they undergo post-treatment physiotherapy to help facilitate recovery from their Achilles tendinosis. To learn more about the trial and to determine if you qualify for participation please visit www.tendonstudy.com. More details on the trial design can be found on the www.clinicaltrials.gov website.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

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

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. Such forward-looking information can include without limitation statements 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: approval to conduct clinical trials; approval from the University of British Columbia’s Clinical Ethics Review Board; delays enrolling clinical trial participants; negative results from the Company’s clinical 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.

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Conference program to include presentations on the clinical development of RepliCel’s skin rejuvenation, hair regeneration, and tendon repair technologies

VANCOUVER, BC – June 5, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that RepliCel’s technology founders and management will be attending the 23rd World Congress of Dermatology (“WCD”) 2015 held in Vancouver, British Columbia, Canada. This year’s congress will take place from June 8 – 13, 2015 at the Vancouver Trade and Convention Centre. The RepliCel team will be involved in multiple sessions spanning the length of this conference. Chief Scientific Officer, Dr. Kevin McElwee will be chairing a session entitled: “Hair Biology and its exploitation in health and disease” on Tuesday, June 9th from 8 – 10 AM PST in West 2015-107. Dr. McElwee will also be giving a poster presentation entitled: “Hair-follicle derived mesenchymal cells in cell therapy: multiple therapeutic applications” on Thursday, June 11th from 9 AM – 1PM PST. Chief Medical Officer, Dr. Rolf Hoffmann, will be coming from Germany to co-chair a session entitled: “Alopecia Areata” on Thursday June 11th from 2:30 – 4:30 PM PST in West 223-224. Also present at this conference will be RepliCel’s CEO David Hall, VP Business and Corporate Development Lee Buckler, and Director of Research and Development Dr. Hisae Nakamura.

“We are pleased Vancouver is host to this year’s World Congress of Dermatology and excited to be participating among the world’s leading experts advancing science and technology in dermatology. We congratulate the event organizers, and in particular Drs. Jerry Shapiro, Harvey Lui and David McLean, who were amongst the visionary founding group of our company, on putting together what promises to be an outstanding program and world-class event,” stated David Hall, CEO of RepliCel. “We look forward to the contributions of our Chief Scientific Officer, Dr. Kevin McElwee, and Chief Medical Officer, Dr. Rolf Hoffmann, the scientific co-discoverers of RepliCel’s technology, in the conference at sessions highlighting various aspects of RepliCel’s hair follicle-derived technologies.”

About World Congress of Dermatology
WCD is the world’s oldest and longest-running international dermatology meeting, with the first Congress in 1889. It is presented by the International League of Dermatological Societies and will feature over 200 scientific sessions featuring experts and companies in the medical, surgical and cosmetic dermatological fields. The WCD’s focus is to bring the interests and priorities of the dermatology industries to an international, professional focus. For more information about the congress, visit The World Congress of Dermatology website.

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China, and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a proprietary injection device optimized for the administration of its products and licensable for use with other dermatology applications. The Company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

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

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

This press release contains forward-looking information. 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: approval to conduct clinical trials; negative results from the Company’s clinical 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.

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Clinical trial at the University of British Columbia now recruiting patients

VANCOUVER, BC – May 21, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today an upcoming poster presentation at the International Society for Cellular Therapy (ISCT) on RepliCel’s autologous cell treatment for chronic Achilles tendinosis currently in a Phase 1/2 clinical trial. The presentation, taking place on May 29th from 5:30 PM to 7:00 PM local time, will review RepliCel’s RCT-01 product isolated from specific cells located in the outer sheath of the hair follicle which are highly expressive of type 1 collagen, critical to the regeneration of tendon tissue. Pre-clinical work showed a similar protein expression profile between non-bulbar dermal sheath (NBDS) cells which constitute RCT-01 and both tendon derived cells and dermal fibroblasts in terms of their ability to produce tendon-related proteins under ex vivo mechanical force (stretching). Other data to be presented includes safety data from animal studies demonstrating NBDS cells were well-tolerated, did not form tumors or migrate to secondary sites.

“Based on our animal studies and predicate clinical trials done by collaborators using dermal fibroblasts for tendinosis,” stated RepliCel’s Director of Research and Development and poster co-author, Dr. Hisae Nakamura, “we believe delivering collagen producing cells directly to the site of injury will address the underlying cause of tendinosis which will be superior to currently available treatments.”

RepliCel is now actively recruiting patients for this trial, to learn more visit www.tendonstudy.com.

Tendinosis is the most prevalent form of overuse tendon injuries, impairing 30 to 50 million people worldwide. Tendinosis results from degeneration of tendon cells and collagen fibres caused by repetitive tendon usage and aging. Currently available treatments for tendinosis are directed mainly towards pain management and facilitation of the healing process. They do not often mediate complete recovery and leave individuals immobilized for several months. Therefore, improved therapeutic strategies are needed.

The four day conference will take place May 27 – 30, at Caesars Palace in Las Vegas, Nevada. The ISCT is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective treatments to improve patients’ lives. RepliCel supports the advancement of cell therapy not only through its breakthrough technologies, but also through active participation in industry organizations like ISCT that play a key role in shaping the future of the industry.

About ISCT
ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. ISCT is the only group focused on pre-clinical and translational aspects of developing cell therapy products. As such, ISCT helps academic, government and biotech/pharma sectors transform research into practice and product. For further information visit ISCT 2015 website.

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The Company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

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

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

This press release contains forward-looking information. 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: approval to conduct clinical trials; negative results from the Company’s clinical 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.

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

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