RepliCel Life Sciences Partners with European Firms to Develop Final Prototype of its Dermal Injector

Medical Device Investing

RepliCel Life Sciences (OTCQB:REPCF) announced it signed agreements with two companies in Europe in order to begin testing and manufacturing on its RCI-02 dermal injector prototype.

RepliCel Life Sciences (OTCQB:REPCF) announced it signed agreements with two companies in Europe in order to begin testing and manufacturing on its RCI-02 dermal injector prototype.
As quoted in the press release:

“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 (4×4) 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 https://replicel.com/ for additional information.

Click here for full press release.

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