RepliCel Life Sciences Inc., a clinical stage regenerative medicine company, announced the granting of two patents in Europe related to its multi-needle dermal injection technologies.
The first patent, European Patent No. 2623146, has been validated in a total of fourteen national countries, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Switzerland, Sweden and the United Kingdom. The second patent, European Patent No. 2809381, will also be validated in a number of European countries in the near future.
The first device being developed under these patents, RCI-02, is designed for injecting hyaluronic acid (“HA”) and other products as dermal fillers. The device is also being developed for the injection of RepliCel’s RCH-01 hair restoration and RCS-01 skin rejuvenation products. Future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.
“These patents are an important milestone for the company as it underpins the near-term commercial value of RCI-02 for the delivery of other injectables beyond our own products. RCI-02 coupled for the injection of dermal fillers and other aesthetic treatments represents an early opportunity for licensing and revenue,” stated RepliCel CEO Lee Buckler. “This year we will build and test commercial-grade functioning prototypes with the goal of having it ready for a CE-mark application and potential market launch in 2018. Ongoing discussions with several multinational companies about potential commercial partnerships for the device give us confidence this represents one of RepliCel’s next licensing deals. ”
Overall benefits of this next-generation dermal injector technology are anticipated to include improved handling, reduction or elimination of the need for 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. Additionally, the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes.
“RCI-02 was originally conceived to deliver our cellular products; however, we believe this device will have a profound impact on all dermal injections – particularly in the cosmetic dermal injection market. For the first time, the dermatology sector will be given a device, RCI-02, which enables clinicians unprecedented reliability, reproducibility, and programmability of three dimensional skin injections,” commented Dr. Rolf Hoffmann, RepliCel’s chief medical officer, who is a practicing dermatologist and is the visionary for the RCI-02 injector. “Dermatologists have been hindered for years by a single needle syringes’ inability to precisely deliver approved dermal fillers into fine wrinkles of the face, décolleté, and hands. RCI-02 is designed to address these unserved markets while also improving on current markets by enabling precise and repeatable delivery of injectable substances. RCI-02 will enable clinicians to better control injection consistency while also enabling less skilled clinicians to undertake these procedures with the desired results.”
“In addition to the near-term commercial opportunity RCI-02 represents for revenue generation, we believe ensuring the optimal and controlled delivery of our cell-based products will be an important component to the commercial value we are creating around the development of our products for both aging or sun damaged skin and pattern baldness,” commented Lee Buckler, CEO.
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.
By relying on electrical power (instead of thumb pressure) and digital controls, 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.
The near-term commercial opportunity for RCI-02 is to improve the injection of is hyaluronic acid-based dermal fillers. RepliCel’s dermatologist advisors believe this device has the potential to significantly expand the number of HA dermal injection procedures currently performed. As an example, the HA market in the United States is currently valued at over US$1 billion per year and is growing at near double digits. These HA injections primarily address deep facial wrinkles and folds, but do not adequately address fine wrinkles. A device, such as RCI-02, which is capable of delivering a controlled injectable, utilizing a multi-head configuration, and eliminating the need for local anesthetic, has the potential to dramatically increase the HA market into new areas including the fine wrinkles of the face, the hands and the décolleté.
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.