After signing a new deal with two new key partners RepliCel Life Sciences is getting ready to launch its RCI-02 dermal injector next year.
RepliCel Life Sciences (TSXV:RP,OTCQB:REPCF) signed an agreement with two European companies in order to get its RCI-02 dermal injector prototypes into manufacturing and testing. The injector is projected to be ready for launch in 2018.
According to Kerastem, the hair loss treatment is a $7 billion industry and IBISWorld claims there are no companies with a dominant market share of the industry.
The injector is a motorized injection device, capable of being programmed depending on the task needed. According to RepliCel, the injector was made to improve how injectables are used and to remove the “risks and uncertainties of injection outcomes” from syringes used manually.
RepliCel works in the hair restoration market, with a cell therapy called RCH-01. It is currently under clinical investigation at the Toho University Medical Center Ohashi Hospital. An upcoming trial will test 160 male subjects.
According to the recent press release, the two companies that have joined RepliCel’s project are AMI (Agency for Medical Innovation), a manufacturer of medical technology in Germany, and Art of Technology, a swiss developer specialized in design, development, and miniaturization of complex customer specific electronic devices and embedded systems for use in industrial, medical and space applications.
“With our first functional prototypes 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,” said RepliCel President and CEO R. Lee Buckler in a statement.
A CE mark means a product has been evaluated and meets the EU’s standards regarding safety, health, and environmental protection.
“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,” said Dr. Rolf Hoffmann in the statement.
A company looking into regeneration treatment
RepliCel also has a stake in skin regeneration. The company started a trial to treat patients suffering from an aged and UV-damaged skin in August 2015, with approval from German Competent Authority, the Paul-Ehrlich-Institut (PEI), using injections of RCS-01 fibroblasts. The trial is still ongoing.
RepliCel is also testing a treatment for tendon repair with injections to tests subjects who suffer from chronic Achilles tendinosis.
In an emailed note, Buckler said, ”Today’s news should provide shareholders and prospective investors with confidence that we are on track with the projections I laid out in the Letter to Shareholders at the beginning of the year. We are focused on getting the commercial-grade prototypes of our device manufactured and tested this year to position it for a CE-mark application and licensing deal next year. This is our nearest-term commercial asset and we expect will drive our transition from a pre-revenue to a revenue-generating company within the next 18 months.”
Opinions from the experts
Before the announcement, Dr. George S. Mack, an analyst with BioDecade, said RepliCel represents an undiscovered opportunity, but its low market cap precludes mutual funds and pensions from owning it.
James E. Brumley from Small Cap Network said this news is a sign of progress for investors but also signals that “the company is moving more rapidly than perhaps most [RepliCel] shareholders have expected.”
Over a one-year period, RepilCel’s share price has gone up by 295 percent.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.