UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2017
Commission File Number 000-50112
RepliCel Life Sciences Inc.
(Translation of registrant’s name
into English)
Suite 900 - 570 Granville Street,
Vancouver, British Columbia V6C 3P1
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F ☒ Form
40-F ☐
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Note: Regulation S-T Rule
101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security
holders.
SUBMITTED HEREWITH
99.1 News Release dated
September 7, 2017 - RepliCel Showcases First Fully-Functional Prototypes of its Next-Generation Dermal Injector
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
RepliCel Life Sciences Inc.
/s/ Lee Buckler
Lee Buckler, President
Date: September 7, 2017
3
Exhibit 99.1
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 schedule
VANCOUVER, Sept. 7, 2017 /CNW/ - 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.
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.
SOURCE RepliCel Life Sciences Inc.
View original content with multimedia: http://www.newswire.ca/en/releases/archive/September2017/07/c1089.html
%CIK: 0001205059
For further information: Lee Buckler, CEO and President, 604-248-8693,
info@replicel.com
CO: RepliCel Life Sciences Inc.
CNW 06:00e 07-SEP-17
This regulatory filing also includes additional resources:
ex991.pdf
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