Microneedling, also known as percutaneous collagen induction therapy is a breakthrough treatment option in dermatology that has been shown to provide measurable clinical results with little to no recovery. Microneedling is a safe, effective, and minimally invasive aesthetic treatment for numerous dermatologic conditions including acne scars, rhytides, and striae (1). This treatment was first documented in 1994 when Orentreich and Orentreich began exploring a skin needling procedure using a technique called "subcision" to release fibrous strands that were responsible for depressed cutaneous scars and rhytides (5). Three years later Camarand and Doucet expanded on this through the development of what is called needle dermabrasion, a similar process that used a tattoo gun without ink. In the early 2000's the first microneedling stamping device was developed specifically to treat facial rhytides and skin laxity (2).
PROCELL™ MULTI-TOOL MD
MICRODERMABRASION / MICROCHANNEL STAMPER
Proprietary and Revolutionary
CytoVive™ is proud to offer ProCell™ Therapies industry leading microchanneling /microdermabrasion tools.
Combines microneedling with microdermabrasion
Larger needling tips for faster treatment times
No backflow of tissue fluids
Designed for an ideal tapping technique
Needles are not dragged across the skin
Perpendicular design to prevent clinician fatigue
Swiss-made Maxon motor
The goal of microneedling is to create numerous, evenly distributed microchannels in the superficial layers of the dermis that penetrate just beyond the epidermal-dermal junction. This controlled skin injury (often observed as pinpoint bleeding) stimulates a wound healing cascade that takes place with minimal damage to the epidermis. This leads to the release of Platelet Derived Growth Factor (PDGF), Fibroblast Growth Factors (FGF), Transforming Growth Factor Alpha and Beta (TGF-α and TGF-β), Vascular Epithelial Growth Factor (VEGF), and Epidermal Growth Factor (EGF) (2). Fibroblasts and platelets are then signaled to migrate toward these microchannels where they stimulate neovascularization and neocollagenesis. Fibroblasts also secrete fibronectin, an extracellular glycoprotein that provides a three dimensional matrix for collagen deposition within the skin (2). Microneedling treatments have been shown to provide a measurable difference in skin laxity and a visible reduction in fine lines and wrinkles (4).
ProCell™ Stamping vs. Dragging Device vs. Rolling Device
As said above, the goal of microneedling is to take advantage of the wound healing cascade that results from creating numerous microchannels in the skin while causing only minimal damage to the epidermis. Ideal clinical outcomes are best achieved without inducing a lot of epidermal trauma. When a device causes too much damage the resulting wound healing cascade that follows serves to do just that, heal the wounds. In order to take full advantage of this wound healing cascade, the wounds must be minimal. This allows for the growth factors that are released at the site of injury to manifest their healing potential towards building cumulative regenerative effects, instead of that energy being consumed to heal the wounds of an overly aggressive treatment.
ProCell™ Therapies Livra™ MD System
Livra™ MicroChannel Delivery Serum contains cytokines and growth factors derived from bone marrow mesenchymal stem cell cultures as well as supplemental TGF beta-3 and IGF-1 from recombinant technology. Nanotechnology delivery mechanisms enhance the penetration of these potent pro-healing and anti-inflammatory biosignals. When applied immediately after MicroNeedling, this solution penetrates the micro-channels and delivers high concentrations of exogenous growth factors that may enhance production of healthy new skin (6).
#1 Cellular Renewal Serum supports cellular renewal and has potent regenerating properties which may improve skin firmness, elasticity, and tone. Fine lines and wrinkles may diminish over time, and skin may look and feel brighter, more luminous, and healthy (6).
#2 Healing Accelerator Serum contains powerful moisturizers, revitalizing actives and stem cytokines. It also provides a lipophilic barrier to seal in hydrophilic serum ingredients, further enhancing their pro-healing anti-inflammatory effect (6).
ProCell™ Microneedling in Combination with Livra™
After 1 Treatment
After 2 Treatments
After 3 Treatments
The FDA's Stance on Microneedling Devices
Under section 201(h) of the FD&C Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including and component, part, or accessory which is:
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or
Intended to affect the structure or any function of the body of man,
and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes (9).
The important factor in determining if a microneedling tool is considered to be "a device" under the FD&C Act is the depth of needle penetration. The stratum corneum is the superficial layer of dead skin cells that will slough off naturally during the desquamation process (3). Therefore, aesthetic tools like those used to perform microdermabrasion are not be considered "devices" because they do not penetrate the living layers of the skin, and subsequently they are not considered by the FDA as "an intent to affect the structure or function of the body of man". Microneedling devices that do penetrate beyond the stratum corneum into living layers of skin are considered by the FDA as "an intent to affect the structure or function of the body of man" (9).
As of now, microneedling devices do not fall within any classification regulation, and there is no legally marketed predicate device upon which to base a determination of substantial equivalence. The FDA believes that these devices may in the future be suitable for classification under the De Novo classification process (Section 513(f)(2) of the FD&C Act). Right now, ProCell™ is one of several microneedling device manufacturers seeking 510(k) status. If the FDA grants a De Novo request for a microneedling device, the specific device and device type would then be classified in class I or II, and may be marketed as such immediately and serve as a predicate for future devices (9). Clinicians that are actively practicing microneedling should be mindful of the FDA classifications pertaining to microneedling devices and continue to stay informed.