With exclusive U.S. rights to RCI-02 patents,
RepliCel edges its nearest-term commercial asset closer to launch
in large aesthetic market
VANCOUVER, April 25, 2017 /CNW/ - 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 technologies 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 (4x4) 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 http://replicel.com/
for additional information.
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 * 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.
SOURCE RepliCel Life Sciences Inc.