RepliCel announces the update of the dermal injector
The tests move on to the next phase; the results lead to some component upgrades to ensure optimum performance, quality compliance and commercial scale production capabilities
VANCOUVER, BC / ACCESSWIRE / October 27, 2021 / RepliCel Life Sciences Inc. (OTC PINK: REPCF) (TSXV: RP) (FRA: P6P2) (“RepliCel” or the “Company”), a company developing new generation technologies in aesthetics and orthopedics, provided an update on its injector program dermal.
Initial test results have proven that the injector meets all primary product and functionality specifications while revealing some technical issues that have now been resolved regarding the transfer of technologies from pilot scale to full scale production. commercial. Based on feedback from testing, some production components, software, and changes have been made and others are pending delivery. These were necessary to ensure seamless compliance with RepliCel’s product specifications and multinational regulatory quality guidelines. The first series of unit production will be completed after successfully passing the first series of tests currently underway, which involves approval of all components and production on a commercial scale.
“That’s why we’re testing,” added RepliCel CEO R. Lee Buckler. “Rigorous testing produces a high-quality product that meets specifications and meets all relevant safety standards in various markets around the world. weeks, we have continued to make significant progress and meet deadlines in other areas such as the assembly line for the production of components and the launch of one of the next phases of testing that we call testing. a “clinical simulation” to be conducted at a third-party facility using donated post-surgical human tissue. “
The company looks forward to bringing the pre-commercial device to market and submitting our marketing request to regulators in the coming weeks.
About the RepliCel Skin Injector Product Line
The RepliCel skin injector product line consists of a desktop touch screen control unit wired to a portable electronic injector with a push button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation before injection. Exclusive consumables include two different multi-needle heads, syringe cartridges and liners.
RepliCel management and advisors have engaged key clinical opinion leaders in identifying high value added market applications for the device, including the injection of various substances into the skin and subcutaneous layers. These substances include toxins, skin fillers, drugs, biologics, PRP, fats, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, aging / skin damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation. , aesthetic sculpting and reduction of fine wrinkles.
Clinical grade consumables and injector business units are currently in production and testing with the goal of collecting all the data needed to complete submission to regulatory agencies seeking market authorization. Plans are actively underway to obtain regulatory approvals for market launch initially in the United States, Europe, Hong Kong and Japan, before being followed by other markets around the world.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for cosmetic and orthopedic conditions affecting what the company estimates to be approximately one in three people in industrialized countries, including aging / sun damaged skin, baldness and chronic degeneration of the tendons. These conditions, often associated with aging, are caused by a deficit of healthy cells necessary for normal tissue healing and function. These cell therapy product candidates are based on the innovative RepliCel technology, using cell populations isolated from a patient’s healthy hair follicles.
The Company’s product portfolio includes RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia from Shiseido Company Limited. RepliCel retains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel retains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, the RCI-02, and associated consumables, which should improve the delivery of its cell therapy products and certain other injectable products. YOFOTO has exclusively licensed the commercial rights to the RCI-02 device and consumables in Greater China for dermatological applications and is expected to first launch the product in Hong Kong upon approval for market launch in the United States or in Europe. Please visit www.replicel.com for more information.
- RepliCel’s three cell therapy products have now been tested in more than 100 patients in four countries on three continents.
- RepliCel now has key strategic partners in the United States, China and Japan, each of which is now investing heavily in further clinical trials and the development of RepliCel’s products for their markets. Data from each of the clinical programs will strengthen product development initiatives for RepliCel and its other partners around the world.
For more information please contact:
Lee Buckler, CEO and Chairman
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THE SOURCE: RepliCel Life Sciences, Inc.
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