Commercial-Grade Replicel Injectors RepliCel in Production
Commercial-Grade Replicel Injectors RepliCel in Production
Initial units will be dedicated to the functional and clinical testing needed to obtain market approval
VANCOUVER, BC, CANADA – 03 February 2020 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announces it has ordered the first production run of commercial-grade automated RepliCel dermal injectors and consumables (the “RepliCel Injector Product Line”). The RepliCel Injector Product Line is expected to market launch later this year.
"We are very excited to finally be at that point where we can announce that all the components for the commercial-grade injector and base unit have been ordered and are in production", stated R. Lee Buckler, RepliCel President and CEO. "Additionally the consumables including the needle-heads, syringes, and liners are also in production. As soon as the first units are assembled, this will trigger a series of meetings with potential distributors, investors, partners, key opinion leaders, and clinicians who have been waiting for commercial-grade units to further discussions. It is a very exciting time for RepliCel and its shareholders", Buckler concluded.
As previously outlined, once commercial-grade units are available, functional and clinical testing will be launched for the purpose of gathering all necessary data for submission to appropriate regulatory agencies for approval to market launch the injector and consumables. Plans are actively underway to pursue regulatory approvals for market launch in Europe, Hong Kong, the United States, and Japan.
RepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market applications for the device including the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, wounds, etc as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles. With commercial-grade units in-hand, RepliCel will work with its advisors, partners, and distributors to position the technology for an initially focused segment of applications.
About the RepliCel (RCI-02) Injector Product Line
RepliCel’s 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.
The RCI-02 Product Line is now in the final stages of development with final prototypes expected within the next few weeks after which the Company will transition to product manufacture, testing, and regulatory marketing approval. Upon successful delivery and assessment of the final device prototypes, a first production run of commercial-grade units of the RCI-02 injector and related consumables will be manufactured later this year to be used for both functional testing and clinical safety evaluation.
RCI-02 dermal injector 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) and subcutaneously (fat) via an array of multi-needle configurations. This needle head will 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 Company anticipates marketing approval to launch sales of the initial RCI-02 Product Line in 2020. Management is committed to being fully prepared for market launch in Europe and Hong Kong as it continues to plan for further product line innovation and pursue marketing approvals in the United States, Japan, China, and other key global markets.
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 people in industrialized nations, 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
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