Initial units delivered and first phase of functional testing nearly complete
VANCOUVER, BC, CANADA - 25 May 2021 - RepliCel Life Sciences Inc. (TSX.V:RP) (OTCPK:REPCF) (FRA:P6P2) ('RepliCel' or the 'Company'), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that it has received the first units of its dermal injector and is nearing completion of the preliminary phase of functional testing required to launch executing on the larger-scale production and testing plan.
'In our February update, we announced that manufacturing of RepliCel's initial batch of commercial-grade dermal injectors and related consumables was resuming and that, upon delivery of the first units, we would commence functional testing. I am pleased to report we have now entered this phase,' stated RepliCel President and CEO, R. Lee Buckler.
Having received the first few units of the dermal injector earlier this month, a team of assigned engineers and technicians initiated a battery of functional testing to stress the units and ensure compliance with strict functional specifications set by the RepliCel team. This testing phase has resulted in a small number of component upgrades and software modifications which, when data shows full specification compliance, will signal the end of this initial phase of testing.
A comprehensive testing plan including a wide range of required functional and safety tests has been put in place to which over forty units will be subjected to produce the data needed for the submission to regulators seeking marketing approval later this year. All this is being done in collaboration with and under the supervision of the regulatory team at MainPointe Pharmaceuticals which is RepliCel's partner for the products' commercialization in the United States.
'While we execute on the dermal injector product line pre-submission testing, we are also engaged with Japanese authorities on procuring permission to use the dermal injector and consumables in RepliCel's clinical study of its RCS-01 cell-based skin rejuvenation product in Japan for which planning and preparations have now commenced,' stated Buckler.