RCI-02

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RepliCel's regenerative technology could take the "Polar Silk Road" to China
New opportunities are arising at every turn for the regenerative medicine community. READ ARTICLE ...
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RepliCel CEO: Anticipating the Approval of Their Dermal Injector, its Impact in Europe and Beyond
Click here to read the full article and interview as it appears in Life Science:...
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RepliCel Showcases First Fully-Functional Prototypes of its Next-Generation Dermal Injector
Delivery of RepliCel’s patented prototypes kick-starts functional testing, matures licensing discussions, and confirms commercialization scheduleVANCOUVER,...
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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)....
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RepliCel Poised To Partner Up For Precision-Control Dermal Injector
To preview the interview with Tina Tan as it appears on Medtech.com, click here. (6/23/17)
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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....
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RepliCel CEO Provides Company Outlook
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United States Patent Issued to RepliCel for its Novel Dermal Injection Technologies
With exclusive U.S. rights to RCI-02 patents, RepliCel edges its nearest-term commercial asset closer to...
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To read the full interview as it appears on MedicalResearch.com, click here. (4/22/17)
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RepliCel Signs Two Key Service Partnerships for Final Prototype Manufacturing and Testing of its Dermal Injector
VANCOUVER, BC – February 28, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel”...
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RCI-02, RepliCel’s nearest-term commercial asset, enables game-changing reliability, reproducibility, and programmability of three-dimensional skin injections...
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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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New opportunities are arising at every turn for the regenerative medicine community.
READ ARTICLE


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Click here to read the full article and interview as it appears in Life Science: Investing News Network (11/22/17).

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Delivery of RepliCel’s patented prototypes kick-starts functional testing, matures licensing discussions, and confirms commercialization schedule

VANCOUVER, BC – Sept. 07, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce the timely arrival of its RCI-02 prototypes, which are now ready to be showcased to potential end users and licensing partners.

With functioning prototypes in-hand, RepliCel is now engaging with key opinion leaders and clinical dermatologists to solicit feedback critically important to aligning successful early adoption of the device, design clinical studies demonstrating its advantages in select applications, and position the Company for an anticipated successful launch of an approved next-generation dermal injector in the European market next year.

“As a practicing dermatologist and a co-founder of RepliCel, I am thrilled to see the functioning prototypes. We are excited to begin exploring the clinical applications of this device with our global network of dermatology experts,” stated RepliCel Chief Medical Officer, Dr. Rolf Hoffman, MD.

Data acquired from functional testing of the RCI-02 prototypes now underway will enable RepliCel to prepare an application for CE mark clearance to market the injector in Europe. The program now in place to collect user feedback, conduct functional testing, and prepare the CE mark application, are all contributing to mature partnership negotiations and align the device to be market-ready in 2018.

“Hitting this milestone confirms we are on track with this product’s commercialization schedule, which involves us getting the device market-ready and in the hands of a commercial partner,” states RepliCel President and CEO, R. Lee Buckler. “This is the landmark milestone we’ve been waiting for to mature ongoing partnership discussions into negotiations and deal execution.”

RepliCel’s business model is focused on leveraging its expertise in developing assets that can then be licensed to partners for co-development and commercialization. RepliCel is actively engaging licensing partners for various applications of its dermal injector device.

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

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

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

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

The near-term commercial opportunity for RCI-02 is to improve the injection of hyaluronic acid-based (“HA”) dermal fillers. RepliCel’s dermatologist advisors believe this device has the potential to significantly expand the number of HA dermal injection procedures currently performed. As an example, the HA market in the United States is currently growing at near double digits.1 These HA injections primarily address deep facial wrinkles and folds, but do not adequately address fine wrinkles. A device, such as RCI-02, which is capable of delivering a controlled injectable, utilizing a multi-head configuration, and eliminating the need for local anesthetic, has the potential to dramatically increase the HA market into new areas, including fine wrinkles of the face, the hands and the décolleté.

According to recent statistics released by the American Society for Plastic Surgery (April 2017), there were over 11 million minimally invasive cosmetic procedures performed nationally in 2016: over 80% were wrinkle treatments and hyaluronic acid filler injections, totalling an expenditure of over $3 billion.2 RCI-02 represents the nearest-term commercial opportunity for the Company, which it intends to have market-ready and in the hands of a co-development licensee and commercial partner in 2018.

References: 1, 2 American Society of Plastic Surgeons (ASPS) Report of 2016 Surgeon/Physician Fees (April 2017) [Press release]. Retrieved from https://www.plasticsurgery.org/news/press-releases/more-than-16-billion-spent-on-cosmetic-plastic-surgery

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

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

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

Disclaimer for Forward-Looking Statements
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 anticipated successful launch of the RCI-02 dermal injector device in Europe next year; (ii) the Company’s plans to obtain CE mark clearance; (iii) the Company’s plans to mature ongoing partnership discussions into negotiations and deal execution; (iv) the expected benefits of the RCI-02 device; (v) the expected near-term commercial opportunities for the RCI-02 device; (vi) that the RCI-02 device has the potential to dramatically increase the HA market into new areas; and (vii) that the Company intends to have the RCI-02 device market ready and in the hands of a co-development licensee and commercial partner in 2018. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related to the Company bringing the RCI-02 device to market in the time expected; the risk that the RCI-02 may not perform as, or have the benefits, expected; the risk that the Company may be unable to find a licensee and/or commercial partner for the RCI-02 device; the risk that the Company will not obtain CE mark clearance; 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 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 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.

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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 preview the interview with Tina Tan as it appears on Medtech.com, click here. (6/23/17)

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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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With exclusive U.S. rights to RCI-02 patents, RepliCel edges its nearest-term commercial asset closer to launch in large aesthetic market

VANCOUVER, BC – April 25, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing cell therapies for aesthetic and orthopedic conditions, today announced the granting of a key patent in the United States (U.S. Patent No. 9,616,182) covering significant components of the Company’s novel, multi-needle dermal injection device.

In the development of propriety cell therapy products targeting pattern baldness (androgenetic alopecia) and aging or sun-damaged skin, RepliCel’s dermatology team identified a need for next-generation dermal injection techologies capable of bringing new levels of precision and control to any substances injected into the skin.

The patent issued by the U.S. Patent and Trademark Office (USPTO) relates to technologies designed to enable both unparalleled control and repeatable consistency of needle action and product deposition. The patent also relates to the element designed to numb the skin prior to injection with the intended effect of reducing, if not eliminating, the need for local anesthetic prior to aesthetic injection procedures.

The first device being developed under this patent, RCI-02, is designed for injecting soft tissue fillers such as hyaluronic acid (“HA”). According to recent statistics released by the American Society for Plastic Surgery (April 2017), there were over 11 million minimally invasive cosmetic procedures performed nationally in 2016: over 80% were wrinkle treatments and hyaluronic acid filler injections, totalling an expenditure of over $3 billion.1 RCI-02 represents the nearest-term commercial opportunity for the Company, which it intends to have market-ready and in the hands of a co-development licensee and commercial partner next year (2018).

The device is also being developed for the injection of RepliCel’s RCH-01 hair restoration and RCS-01 skin rejuvenation products. Future iterations of the device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.

The U.S. patent adds to the Company’s intellectual property portfolio, which includes two European patents for RCI-02, both granted February 9, 2017. RepliCel’s first European patent for its injection technologies (Patent No. 2623146) was validated in a total of fourteen countries, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Switzerland, Sweden and the United Kingdom. The second European Patent (No. 2809381) is now being validated in a number of European countries and is expected to be complete in the near future.

“We are confident RepliCel’s extensive patent estate for its cell therapy and injection devices will provide our products with long-term market exclusivity,” said Lee R. Buckler, CEO of RepliCel. “The granting of this U.S. patent is an important addition to RepliCel’s formidable intellectual property portfolio, which we believe will further build value for our investors.”

“Exclusive U.S. rights to the world’s largest aesthetic medical device market represents a significant opportunity for the Company as it addresses an unmet need in the cosmetic dermal injection market,” said Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, a practicing dermatologist and the primary inventor of the RCI-02 injector. “Single needle syringes available today do not have the ability to precisely deliver dermal fillers with predictable and consistent results,” he stated.

Dr. Hoffmann continued by saying, “RepliCel’s RCI-02 injector has been designed to provide unprecedented reliability, reproducibility, and programmability of three-dimensional skin injections, enabling clinicians better control and consistency, while also providing less-experienced injection specialists with the confidence to undertake these procedures with desired outcomes.”

“The Company is on track to have prototypes ready in Q3 2017 for initial functional and usability testing by engineers, as well as, user-groups,” continued Mr. Buckler. “This year is about building and testing commercial-grade prototypes. Next year, our goal is to get RCI-02 CE-marked, licensed to a commercial partner and generating revenue.”

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

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

By relying on electrical power (instead of thumb pressure) and digital controls, RCI-02 automates and simplifies the injection process. Equipped with a touch screen on its accompanying docking station, the device’s programmability allows for the delivery of precise quantities of material, at specific depths, through fine-gauge needles, on a single plain or trailing through multi-plains, as the needle retracts through the skin.
Overall benefits of this next-generation dermal injector technology are anticipated to include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow and evenly-dispersed injections.

The near-term commercial opportunity for RCI-02 is to improve the injection of hyaluronic acid-based dermal fillers. RepliCel’s dermatologist advisors believe this device has the potential to significantly expand the number of HA dermal injection procedures currently performed. As an example, the HA market in the United States is currently valued at over US$1 billion per year and is growing at near double digits.2 These HA injections primarily address deep facial wrinkles and folds, but do not adequately address fine wrinkles. A device, such as RCI-02, which is capable of delivering a controlled injectable, utilizing a multi-head configuration, and eliminating the need for local anesthetic, has the potential to dramatically increase the HA market into new areas including fine wrinkles of the face, the hands and the décolleté.

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

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

References:
1, 2 American Society of Plastic Surgeons (ASPS) Report of 2016 Surgeon/Physician Fees (April 2017) [Press release]. Retrieved from https://www.plasticsurgery.org/news/press-releases/more-than-16-billion-spent-on-cosmetic-plastic-surgery

Forward-Looking Statements
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 the dermal injector device will be market ready in the near term and in the hands of a co-development licensee and commercial partner next year (2018); (ii) that the second European Patent (No. 2809381) will be validated in a number of European countries in the near future; (iii) that the Company’s extensive patent estate for its cell therapy and injection devices will provide its products with long-term market exclusivity; (iv) that the Company’s intellectual property portfolio will continue to build value for its investors; (v) that the Company will have prototypes ready in Q3 2017 which will be used for initial functional and usability testing by engineers and user-groups; (vi) the Company’s goal is to get the injector device CE-marked and licensed to a commercial partner next year in order to generate revenue; (vii) that the dermal injector technology will improve handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections; (viii) that the device has the potential to significantly expand the number of HA dermal injection procedures currently performed including into new areas like the fine wrinkles of the face, the hands and the décolleté; (ix) that the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes; and (x) that future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc. 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 there will be delays enrolling clinical trial participants; the risk that the Company’s patents will not be granted or validated in one or more countries; 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 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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VANCOUVER, BC – February 28, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced it has recently signed agreements with two European firms both of whom have committed to work with RepliCel to get the Company’s commercial-grade RCI-02 dermal injector prototypes manufactured and tested.

“The execution of these agreements covers what we believe to be the final stages needed to prepare RCI-02 for a market authorization application in the form of a CE mark in Europe,” stated RepliCel President and CEO, R. Lee Buckler. “With our first functional protoypes scheduled for this summer, we continue to work toward having this device ready for a CE mark application and in the hands of a licensing and commercial partner next year,” stated Buckler. “Meanwhile,” he concluded, “while we had originally hoped to receive some of our clincal data in February, we remain confident all three clinical data sets will be received and announced very shortly and all still before the end of the Quarter.”

AMI is an Austrian manufacturer of medical technology based near the shores of Lake Constance, within easy reach of Germany and Switzerland. AMI develops, manufactures and distributes their medical products throughout the world. All of them are made according to the highest quality standards and enable doctors to take even better care of their patients.

“We are proud of our unique working relationship with AMI given that they typically only work on their own products,” stated RepliCel’s Co-Founder and Chief Medical Officer who is also a practicing dermatologist in Germany. “Their commitment to working with us on our device is a testament to their belief in the product’s value and its ultimate potential to be widely adopted by the aesthetics industry.”

Art of Technology (“AoT”), based in Zurich Switzerland is an independent contract developer specializing in the design, development and miniaturization of complex customer specific electronic devices and embedded systems for use in industrial, medical and space applications. Certified in accordance with ISO9001 and ISO13485, the firm emphasizes consistent quality documentation throughout the duration of a project including risk analysis, management and technical documentation to support CE approval.

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

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

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 two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for 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. 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 Statements
This and related press release contain forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) that the dermal injector device will result in a near term commercial opportunity for revenue generation; (ii) that the dermal injector will improve the injection of hyaluronic acid-based dermal fillers; (iii) that the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes; (iv) that the dermal injector will be RepliCel’s next licensing deal; (v) that the dermal injector, once developed, will represent game-changing reliability, reproducibility, and programmability of three dimensional skin injections; (vi) that future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.; (vii) that the device will be ready for a CE-mark application and potential market launch in 2018; (viii) that the overall benefits of dermal injector technology include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections; (ix) that the device will have a profound impact on all dermal injections; and (x) the dermal injector device will be able to be used for fine wrinkles across broad areas, like fine wrinkles in the face, hands and décolleté. 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 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 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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RCI-02, RepliCel’s nearest-term commercial asset, enables game-changing reliability, reproducibility, and programmability of three-dimensional skin injections

VANCOUVER, BC – February 9, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced the granting of two patents in Europe related to its multi-needle dermal injection technologies.

The first patent, European Patent No. 2623146, has been validated in a total of fourteen national countries, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Switzerland, Sweden and the United Kingdom. The second patent, European Patent No. 2809381, will also be validated in a number of European countries in the near future.

The first device being developed under these patents, RCI-02, is designed for injecting hyaluronic acid (“HA”) and other products as dermal fillers. The device is also being developed for the injection of RepliCel’s RCH-01 hair restoration and RCS-01 skin rejuvenation products. Future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.

“These patents are an important milestone for the Company as it underpins the near-term commercial value of RCI-02 for the delivery of other injectables beyond our own products. RCI-02 coupled for the injection of dermal fillers and other aesthetic treatments represents an early opportunity for licensing and revenue,” stated RepliCel CEO Lee Buckler. “This year we will build and test commercial-grade functioning prototypes with the goal of having it ready for a CE-mark application and potential market launch in 2018. Ongoing discussions with several multinational companies about potential commercial partnerships for the device give us confidence this represents one of RepliCel’s next licensing deals. ”

Overall benefits of this next-generation dermal injector technology are anticipated to include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections. Additionally, the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes.

“RCI-02 was originally conceived to deliver our cellular products; however, we believe this device will have a profound impact on all dermal injections – particularly in the cosmetic dermal injection market. For the first time, the dermatology sector will be given a device, RCI-02, which enables clinicians unprecedented reliability, reproducibility, and programmability of three dimensional skin injections,” commented Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, who is a practicing dermatologist and is the visionary for the RCI-02 injector. “Dermatologists have been hindered for years by a single needle syringes’ inability to precisely deliver approved dermal fillers into fine wrinkles of the face, décolleté, and hands. RCI-02 is designed to address these unserved markets while also improving on current markets by enabling precise and repeatable delivery of injectable substances. RCI-02 will enable clinicians to better control injection consistency while also enabling less skilled clinicians to undertake these procedures with the desired results.”

“In addition to the near-term commercial opportunity RCI-02 represents for revenue generation, we believe ensuring the optimal and controlled delivery of our cell-based products will be an important component to the commercial value we are creating around the development of our products for both aging or sun damaged skin and pattern baldness,” commented Lee Buckler, CEO.

About RCI-02

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

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

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

The near-term commercial opportunity for RCI-02 is to improve the injection of is hyaluronic acid-based dermal fillers. RepliCel’s dermatologist advisors believe this device has the potential to significantly expand the number of HA dermal injection procedures currently performed. As an example, the HA market in the United States is currently valued at over US$1 billion per year and is growing at near double digits. These HA injections primarily address deep facial wrinkles and folds, but do not adequately address fine wrinkles. A device, such as RCI-02, which is capable of delivering a controlled injectable, utilizing a multi-head configuration, and eliminating the need for local anesthetic, has the potential to dramatically increase the HA market into new areas including the fine wrinkles of the face, the hands and the décolleté.

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 two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for 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. 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 Statements

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 the dermal injector device will result in a near term commercial opportunity for revenue generation; (ii) that the dermal injector will improve the injection of hyaluronic acid-based dermal fillers; (iii) that the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes; (iv) that the dermal injector will be RepliCel’s next licensing deal; (v) that the dermal injector, once developed, will represent game-changing reliability, reproducibility, and programmability of three dimensional skin injections; (vi) that future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.; (vii) that the device will be ready for a CE-mark application and potential market launch in 2018; (viii) that the overall benefits of dermal injector technology include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections; (ix) that the device will have a profound impact on all dermal injections; and (x) the dermal injector device will be able to be used for fine wrinkles across broad areas, like fine wrinkles in the face, hands and décolleté. 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 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 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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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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RCI-02 injector device promises the potential for unparalleled injection precision, the use of less anesthetic per procedure, and the enhanced treatment of fine wrinkles of the face, décolleté and hands

VANCOUVER, BC – January 11, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced that it has been granted a patent (EP2623146) by the European Patent Office for its injection device technologies. The first device being developed under this patent, RCI-02, is designed for injecting hyaluronic acid as a dermal filler. The device is also being developed for the injection of RepliCel’s RCH-01 hair restoration and RCS-01 skin rejuvenation products. Future iterations of the technology and device will be optimized for other injectables such as drugs, vaccines, fat grafts, etc.

“This patent grant is an important milestone for the company as it underpins the commercial value of RCI-02 for the delivery of other injectables beyond our own products. RCI-02 coupled with an application in the area of hyaluronic acid (HA) represents an early opportunity for licensing and revenue,” stated RepliCel CEO Lee Buckler.

Overall benefits of this next-generation dermal injector technology include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, an expectation of more consistent clinical results because of the injector’s controls, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections. Additionally, it is expected that a whole new class of injection specialists may be enabled to perform certain dermal injection procedures due to the device’s simplicity and programmability.

“RCI-02 was originally conceived to deliver our cellular products; however, we believe this device will have a profound impact on all dermal injections – particularly in the cosmetic dermal injection market,” commented Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, who is a practicing dermatologist and remains the visionary for the RCI-02 injector. “Dermatologists have been hindered for years by a single needle syringes’ inability to precisely deliver approved dermal fillers into fine wrinkles of the face, décolleté, and hands. RCI-02 is designed to address these unserved markets while also improving on current markets by enabling precise and repeatable delivery of injectable substances. RCI-02 will enable clinicians to better control injection consistency while also enabling less skilled clinicians to undertake these procedures with the desired results.”

“Overall, we expect RCI-02 will increase the market for existing cosmetic injectables by expanding their use into applications not previously addressable, shortening procedure times, and improving both patients’ experience and cosmetic results. We believe ensuring the optimal and controlled delivery of our cell-based products is an important component to the commercial value we are creating around the development of our products for both aging or sun damaged skin and pattern baldness,” commented Lee Buckler, CEO. “However, the nearer-term commercial opportunity for RepliCel is in bringing RCI-02 to the cosmetic injectable market where our first target is hyaluronic acid. We believe this device has the potential to significantly expand the number of HA dermal injection procedures currently performed. As an example, the HA market in the United States is currently valued at over US$1 billion per year and is growing at near double digits. These HA injections primarily address deep facial wrinkles and folds but do not adequately address fine wrinkles. A device, such as RCI-02, which is capable of delivering a controlled injectable, utilizing a multi-head configuration, and eliminating the need for local anesthetic, has the potential to dramatically increase the HA market into new areas including the fine wrinkles of the face, the hands and the décolleté,” concluded Lee Buckler.

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

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

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

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 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 propriety injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Visit http://www.replicel.com for additional information.

For more information, please contact:

CORPORATE:
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 area of hyaluronic acid (HA) represents an early opportunity for licensing and revenue; (ii) it is expected that a whole new class of injection specialists may be enabled to perform certain dermal injection procedures due to the device’s simplicity and programmability; (iii) the company’s belief that this device will have a profound impact on all dermal injections; (iv) RCI-02 is anticipated to enable clinicians to better control injection consistency while also enabling less skilled clinicians to undertake these procedures with the desired results; (v) the Company’s belief that this device has the potential to significantly expand the number of HA dermal injection procedures currently performed; (vi) RCI-02’s unparalleled injection precision; (vii) the use of less anesthetic per procedure; (viii) RCI-02’s ability to remove the risks and uncertainties of injection outcomes resulting from manual syringes; and (ix) the expected benefits of the RCI-02. 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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Canadian companies driving global breakthroughs in regenerative medicine

By Kathryn Boothby

To read this article on the Financial Post website, click here.
CCRM – helping position Canadian companies at the centre of regenerative medicine around the world

Rapid advances in regenerative medicine are bringing the promise of curative solutions for chronic conditions closer to reality. Canadian companies are at the forefront of this revolution, paving the way for this country to be a standard-bearer of breakthrough treatments for patients around the globe.

Therapies using cells are potentially improving outcomes and reducing or eliminating side effects for such devastating diseases as diabetes, hemophilia, and critical limb ischemia, as well as conditions such as chronic tendinosis, damaged skin, and pattern baldness. New tools and technologies are also helping to put an end to bulky, obtrusive mechanisms to deliver life-saving treatments.

“We are at a powerful leading edge for medicine,” says Michael May, president and chief executive officer of the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto. “The ability to regenerate tissue will transform the treatment of diseases, quality of life, and the economics of health care.”

“Billions are being spent globally in the field of regenerative medicine on investment, research, development and sales,” says May. “Now, with clinical efficacy being demonstrated, we’re seeing more regulatory approvals and resulting mega-deals between small companies and large corporations.”

But where does Canada fit in the global picture? The discovery of stem cells in Canada in the 1960s sparked the worldwide use of bone marrow transplants for patients with leukemia and aplastic anemia. “This spawned an incredible research machine that made some important discoveries over the ensuing years. We are at a similar junction today,” he says. “We’re leading the science and have begun to leverage commercialization around the globe. The system is primed; we now need to fuel it with private investment to ensure Canada is at the centre of this emerging industry.”

CCRM is actively working to achieve that goal by coordinating access to bundles of technologies from around the globe; creating and supporting companies to further develop and commercialize those discoveries; and establishing relevant industry networks and accessible infrastructure. CCRM currently works with a 50-member industry consortium that includes therapeutic innovation companies, multinational pharmaceutical organizations such as Pfizer and Amgen, and infrastructure and tool companies such as GE Healthcare and Stemcell Technologies.

“Access to strong academic and industry networks enables us to now build a third key stakeholder group —an investor network,” says May.

That strategy is beginning to pay off for some of Canada’s cell therapy companies, including RepliCel Life Sciences Inc., Hemostemix Inc., and Sernova Corp.

RepliCel (TSX.V: RP) is driving multiple products in the regenerative medicine arena with three cell therapy products in clinical development, and a dermal injection device that promises to change the way any product is delivered in or under the skin, including the over $2-billion worth of dermal fillers injected annually.

“2015 is a pivotal year for the company,” says Lee Buckler, RepliCel’s vice-president, business and corporate development. “This is the year we moved all our cell therapy assets forward in clinical development, which sets us up for transformative catalysts over the next 18 months.” Earlier this year, RepliCel launched a Canadian trial for chronic tendinosis and just recently announced the launch of a dermatology trial in Germany. Topping off the trio is a trial for pattern baldness with commercialization partner Shiseido Company, which is expected to launch in Japan shortly.

RepliCel is one of a handful of foreign cell therapy companies with an active partnership in Japan. “Having Shiseido, one of the world’s largest cosmetic firms, as RepliCel’s partner for its pattern baldness product, has given us notable credibility in that market,” says Buckler, “and we are now engaging other companies in Japan about partnerships for our other products.”

“Partnering in Japan is at the top of our list because the government has expedited the process of developing cell-based therapies, making it possible to bring cell therapies to market faster there than any other regulated market in the world,” says Buckler.

Hemostemix (TSX.V: HEM) is currently undertaking an international phase-two, double-blind, randomized, placebo-controlled clinical trial to test the efficacy of a cell therapy to treat critical limb ischemia (CLI). CLI is characterized by insufficient blood flow to the lower limbs caused by blockages in small blood vessels. In North America alone, some four million people have the disease, and 25% will die from it. Currently, the only treatment is amputation.

The process involves collecting cells from a patient’s blood that are then manufactured into a cell therapy and delivered back to the patient. The company believes that the reintroduced cells create new blood vessels that restore blood flow and save the limb from amputation.

“CLI is a severe disease, threatening millions of people’s lives worldwide. We are running our clinical trials in leading international centers, including Canada, the U.S., South Africa, and soon in Taiwan,” says Dr. Elmar Burchardt, Hemostemix’ president and chief executive officer and former vice-president of regenerative medicine at Pfizer.

Sernova (TSX.V: SVA), a clinical stage company, is treating chronic, debilitating diseases such as insulin-dependent diabetes, hemophilia A and thyroid disease using a regenerative medicine approach through the placement of immune-protected therapeutic cells into an implanted pre-vascularized medical device. The company believes that the Cell Pouch System, about the size of a business card, creates a natural organ-like environment when placed under the skin and the cells release required proteins or hormones such as insulin, or Factor VIII potentially eliminating the need for chronic injections or infusions.

For diabetes, Sernova’s product — the device and cells implanted in humans — is being designed to mimic the pancreas where cells (islets) read blood sugar levels then release both insulin and other hormones into the bloodstream. The company has recently become a fully integrated pharmaceutical company as it has gained worldwide exclusive rights to a glucose responsive insulin-producing stem cell technology from University Health Network (UHN). The company has received grants from the National Research Council, Juvenile Diabetes Association and support from both the Canadian and Ontario governments to assist with its activities.

“If Sernova’s treatment leads to patients no longer having to take injections or deal with a cumbersome device, this could improve the quality of life for millions of people, reduce the debilitating side-effects of the disease, and cut health care system costs significantly,” says Dr. Philip Toleikis, Sernova’s president and chief executive officer.

“Canada imports close to 100% of our medical treatments,” notes May. “It would be much more exciting to be exporting our treatments and using our health care system to develop and deliver those products to patients around the world, all while improving the health of Canadians here at home.”

Canadian companies working in regenerative cell therapy have globally competitive technologies and great science. RepliCel, Hemostemix, and Sernova are all moving products through clinical trials at a time when big industry players are making investments in manufacturing, therapeutics and tools to facilitate the production of cells.

“While every company’s corporate strategy is different,” concludes RepliCel’s Buckler, “it is our corporate intention to build sufficient value in our assets, licenses, and royalty streams so that the company becomes a home-grown acquisition target thus contributing valuable assets to the growing appetites for regenerative medicine among the global multinational players.”

This story was produced by Postmedia Works on behalf of Market One Media Group for commercial purposes. Postmedia’s editorial departments had no involvement in the creation of this content.

To read this article on the Financial Post website, click here.

FINANCIAL POST ARTICLE – SPONSORED BY REPLICEL LIFE SCIENCES

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Novel features of next-generation design promise to serve and expand the dermal injectable market

VANCOUVER, BC – July 29, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company, is pleased to announce that the final design specifications of its next-generation dermal injector (RCI-02) have been locked. Prototypes for industrial and regulatory testing will now be built to prepare for an application for CE mark clearance to market the injector in Europe in 2016.

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


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

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

Overall benefits of this next-generation dermal injector include improved handling, reduction or elimination of the need for local anesthetics, quicker procedure times, an expectation of enhanced intra- and inter-patient clinical results because of injection controls (e.g., the injection specialist is allowed to focus on filler product placement vs injection technique), and a significant expansion of the areas that can be injected due to the ability to conduct broad, shallow, and evenly-dispersed injections. Additionally, it is expected that a whole new class of injection specialists will be enabled to perform certain injection procedures due to the device’s simplicity and programmability.

“While RCI-02 was originally conceived to deliver our cellular products, we believe this device will have a profound impact on all dermal injections – particularly the cosmetic dermal injection market,” commented Dr. Rolf Hoffmann, Chief Medical Officer and visionary for the RCI-02 injector. “Dermatologists have been frustrated for years by the lack of a precise injector to deliver currently approved dermal fillers into the broad potential markets for fine wrinkles of the face, décolleté, and hands. RCI-02 is designed to address these unserved markets while also improving on current markets by enabling precise and repeatable delivery of injectable substances. RCI-02 will enable clinicians to better control injection consistency while also enabling less skilled clinicians to undertake these procedures with the desired results.”

“The optimal delivery of our cell-based products is ultimately expected to be an important part of the success of our treatments for both aging and sun damaged skin and pattern baldness,” commented David Hall, RepliCel CEO. “In addition, we believe this device has the potential to significantly expand the number of dermal injection procedures currently performed – in particular, cosmetic injectables. As an example, the US Hyaluronic Acid (HA) market is currently valued at over US$1 billion per year and growing in excess of 10% per year. This market primarily serves dermal areas that address deep facial wrinkles and folds but does not adequately address fine wrinkles. A device capable of delivering a controlled injectable, utilizing a multi-head configuration, that eliminates the need for local anesthetic, has the potential to dramatically increase the HA market into areas including the fine wrinkles of the face, the hands and the décolleté. Overall we expect RCI-02 will expand the market for existing cosmetic injectables by expanding their use into applications not previously addressable, shortening procedure times, and improving both patients’ experience and cosmetic results.”

“The final lock down of specifications for the RCI-02 dermal injector allows us to significantly expand our business development activities,” stated Lee Buckler, VP Business & Corporate Development. “We are now on-track to apply and receive CE mark clearance to sell this device in Europe next year,” continued Buckler, “and that is beginning to garner the attention of those companies with dermal injectables already on the market. In addition to opening up entire new applications for the cosmetic dermal injection business, RCI-02’s programmable delivery options should have a receptive audience in the areas such as but not limited to intra-lesional therapy, glutathione/ascorbic acid skin whitening, Mesotherapy, platelet rich plasma (PRP), collagenase injections for burns and keloid scars, and corticoid steroids for inflammatory skin diseases. We believe this product, in the hands of the appropriate commercial licensees, is capable of generating material revenue for the company in the near-term and of becoming a substantial asset for RepliCel Life Sciences. ”

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 has also developed a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. 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 statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) the expected timing of CE mark clearance and European marketing of the RCI-02 injector (the “RCI-02”); (ii) the RCI-02’s ability to remove the risks and uncertainties of injection outcomes resulting from manual syringes; (iii) the expected benefits of the RCI-02; (iv) the ability of a new class of injection specialists to perform certain injection procedures and achieve desired results using the RCI-02; (v) the expected impact of the RCI-02 on various dermal injection markets, particularly the cosmetic injectables market; (vi) our expected expansion of business development activities; and (vii) our ability to generate material revenue from the RCI-02 in the near-term. 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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To read the article on Stockhouse click here

Until 2011, RepliCel Life Sciences (TSX: V.RP, Stock Forum) was engaged in the business of hair regeneration, developing treatment solutions for those suffering from pattern baldness. Compared to other entities within the space, RepliCel was pursuing a minimally invasive treatment with potentially permanent results. This innovative process involved growing cells extracted from the patient’s healthy hair follicles to stimulate growth in areas experiencing hair loss due to androgenic alopecia.

The hair loss treatment space, like the progressive condition at its base, is monumentally huge. With 40% of American males experiencing pattern baldness by the age of 30, it is of little surprise that the hair loss treatment market, according to a 2013 study conducted by the International Society of Hair Restoration, rakes in $3.0 billion annually.

RepliCel was unique in its offering as other treatments for hair loss such as hair transplants, covers like weaves and toupees, and medicated topical creams like Rogaine were respectively limited, noticeable and temporary. Stem cells have also been touted as a remedy for hair loss, but the research is far from complete and this division of scientific study is heavily regulated, creating a bottleneck between tech development and the shelf.

The ability to safely extract healthy cells from the dermal sheath cup of the hair follicle and grow those same cells in a lab environment, gave RepliCel a virtually limitless method to regenerate someone’s head of hair using their own cells with a science that would take years instead of decades to bring to commercialization.

Soon after David Hall joined the company as CEO, they embarked on an expansion of applications of this amazing family of cells. By utilizing a different cell population from the hair follicle – the non-bulbar dermal sheath fibroblast cell group – the company also found opportunity treat other conditions such as tendinosis, a chronic degeneration of the tendon due to aging and injuries, by the injection of these active fibroblasts.

Another condition treatable by the aforementioned cell group is skin damage caused by aging, UV exposure and lifestyle choices which results in wrinkles and sagging as the dermal layer loses its elasticity. Injection of the active collagen-expressing fibroblasts is designed to reverse this degenerative process.

This addition in corporate direction enhanced the company’s potential long-term profitability but also diversified its attentions and capacity. While the company dealt with growth media issues it had to resolve on the manufacturing of the pattern baldness product, Replicel’s market momentum began to tread water as investors lost interest in what was otherwise a promising venture. The company has worked hard to bring this multi-pronged beast under control and in the last 18 months has enacted initiatives which have brought schedules back online, powering a cycle of trials that will see major advances in commercialization of all three of its proposed treatments.

On top of the bio-med side, the company has also developed a patent-pending state-of-the-art delivery system for the above treatments which in and of itself bears tremendous potential for another lucrative avenue of revenue generation. This dermal injector allows for programmable depth and dose with built-in freezing replacing the need for anaesthetic. Its leading-edge design is expected to disrupt the dermal filler market which in 2013, according to the American Society of Plastic Surgeons, consisted of almost 6.0 million injected procedures and over $3.0 billion in revenue. Good news considering that RepliCel expects the approval for this device in 2016.

For those interested, below is a graphed timeline of testing and development for the company’s current pipeline:


That’s a healthy plate of activity and one might surmise RepliCel could topple under the weight of its multi-faceted offerings, but management has been keen to design a corporate philosophy that focuses on value creation and IP rather than the mechanics of mass manufacture and commercial product launches. This will allow the company to license out its technology to multiple partners for a global reach not easily attained by vertically modeled bio-tech firms and to continue its R&D efforts enhancing current offerings as well as developing new marketable technologies.

Partnerships are another strong point for RepliCel as the company has teamed with 140 yr-old cosmetic giant Shiseido Company based in Tokyo. Shiseido, the third largest cosmetics company on the planet, has signed an agreement with RepliCel, giving Shiseido exclusive geographic licensing for RCH-01 (treatment of pattern baldness) in certain Asian countries such as Japan, China and South Korea. As a result of the agreement, both companies will share their respective improvements to the technology while individually carrying out of human clinical trials. Due to the recently enabled legislation in Japan which offers potential early access to the market, RepliCel has embarked on a focused Japanese licensing program for its fibroblast based treatments for tendinosis and ageing and UV damaged skin.

The company has also partnered with the University of British Columbia, Department of Dermatology and Skin Science to conduct research on the biomechanical and functional characteristics of hair follicles. This association with reputable academia provides a boatload of credence for RepliCel’s innovative tech and gives hope for future potentially commercial discoveries.

Meanwhile, as the trial results continue to come in, RepliCel is building a solid foundation for taking the company to the next level and its family of investors may see the lucrative fruition of its efforts as early as 2016. As of yet, the company’s story is relatively unknown, but as it continues to progress through these trials and development phases, it is becoming increasingly apparent that it is wildly undervalued. The challenge will be if management can continue to keep control of its corporate ship, meet those necessary milestones and initiate growth to capture a long-term slice of an already lucrative sector. In the end, 2015 will be the proving ground for RepliCel’s long-term success. I will be watching them closely over the next 12 months.

Read more at Stockhouse

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