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.