Two European firms team up to lead RepliCel's
next-generation dermal injector (RCI-02) to market-ready
status
VANCOUVER, Feb. 28, 2017 /CNW/ - 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 (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.
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.
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.
SOURCE RepliCel Life Sciences Inc.