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Why Next-gen EV Products?
Next-gen EV products means ensured quality, safety and effectiveness, which means more value for people who care about their skin!
Proprietary Stem Cell Technology Brings Next-gen EVs with Advanced Skin Benefits
We've applied our proprietary stem cell technologies to formulate DERMA-activEXO and DERMA-fresEXO and develop the Étrive Platinum and Gold Aesthetic Solutions.
Étrive platinum
Lyophilized Aesthetic Solution
For INTENSE skin or hair care with aesthetic professionals
Étrive Gold
Lyophilized Aesthetic Solution
For REGULAR skin care with aesthetic professionals or at home
Frequently Asked Questions (FAQ)
EV Questions and Answer For Clients and Consumers
EV Questions and Answer For Skincare Professionals and Medical Spa Providers/Practitioners
Other Common Questions in Categories
EVs
Extracellular vesicles are membrane-bound vesicles with various sizes and are produced from almost all cell types. They contain various biological molecules that play a crucial role in cell-to-cell communication through the transfer of these molecules to their neighboring cells.
The bioactive components of EV include signaling proteins, such as growth factors and cytokines, as well as microRNAs, which play key regulatory roles in various cellular functions.
Exosomes can be derived from various sources, including plants, animals (such as cow’s milk), and most commonly, humans—particularly from stem cells, which support self-renewal and regeneration, or from platelet-rich serum.
EVs for skin care
EVs have only emerged in the fields of skin and hair care in recent years. As skincare ingredients, EV-based products deliver a wide range of bioactive molecules—including growth factors, cytokines, and microRNAs. These molecules may play roles in skincare by supporting younger appearance.
The primary role of EV in skincare is support of skin rejuvenation. By delivering components to the skin, EVs can offer the following benefits:
- Supports skin’s natural renewal processes
- Visibly improves elasticity and firmness over time
- Helps reduce the appearance of fine lines and uneven skin tone
- Enhances the look of smoothness and radiance
There are two common types of EV-based skincare products: purified EVs and conditioned media with enriched EVs. Purified EV products feature a high purity of EVs, which may offer enhanced skin rejuvenation effects. In contrast, EV-enriched conditioned media contains the nutrient-rich culture medium used to grow stem cells, which can provide variety of nutrients that may benefit the skin renewal.
Exosomes can effectively penetrate the outermost layer of the skin—the stratum corneum—and reach the deeper dermal layers. Once there, they release bioactive molecules that stimulate the production of collagen and elastin. As natural carriers, exosomes are highly efficient at delivering these regenerative compounds deep into the skin, promoting enhanced skin rejuvenation and accelerating wound healing.
The most common methods for applying exosome products are topical application either directly or after certain skincare procedures, the latter of which allows for deeper delivery into the skin dermis layer for enhanced absorption and effectiveness of rejuvenation.
Many exosome products are formulated to be suitable for all skin types, offering targeted benefits based on individual skin needs. In general:
Platelet-rich plasma (PRP) is a popular skincare practice for skin rejuvenation. However, EVs from stem cells offers advantages in (1) More variety of growth factors and other bioactive materials to enhance even more for skin rejuvenation; (2) EVs application is less non-invasive and does not need blood draw. (3). PRP effects also depends on the individual's age and condition, but EVs, especially the EVs from umbilical cord tissue-derived stem cells, provides better rejuvenation capability than PRP.
Manufacture of EVs
Etrive Platinum and Gold Aesthetic Solutions are made from a single sourced human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSCs)
Ethical and non-invasive hUC-MSC cell source is screened for the absence of 9 common human viruses including HIV, HBV, and HCV and met all other release criteria including retroviral activity, in vitro and in vivo adventitious agent testing. The tissue donor met all eligibility and testing requirements for birth tissue per FDA 21CFR Part 1271. GMP Raw materials can be traced in FDA master File #30241 and GMP Expansion media in Master File #17799.
End-to-end GMP-like manufacturing process, starting from hUC-MSC proliferation and expansion, followed by EV purification (only for Platinum Aesthetic Solution) through multi-step procedures to remove non-EV contaminants, and completed with lyophilization and final packaging through the DERMA-activEXO (Platinum) or DERMA-fresEXO (Gold) formulation technologies.
First of the all, the source of the stem cells have been screened for the absence of nine common human viruses. The final product has been tested for the level of endotoxin, absence of mycoplasma, absence of virus, bacterial, and fungal pathogens.
Regulations on EVs for cosmetic use
FDA does not require pre-market approval of EV products used in cosmetics. However, EVs used for disease treatment (drugs or biological products) require FDA's approval. Although there is no requirement for a proof for product efficacy for a condition in cosmetics, manufactures should adhere to the laws and regulations regarding product manufacturing, safety, and labeling.
Yes, EVs from human sources are allowed to be sold and used in the US.
While cosmetic applications of EV products do not require FDA approval, it is important for both manufacturers and consumers to understand that these products are intended to improve the appearance of skin and hair, not to diagnose, treat, or cure any medical conditions. Any claims related to disease treatment must be reviewed and approved by the FDA. Currently, no EV-based products have received FDA approval as drugs for therapeutic use.
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