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Please read before use or distribution. Exocellure products are supplied for professional and clinical use only, and this notice sets the boundaries of that use.
Exocellure Dermaceuticals products, including Exocellure UC-MSC Exosome Serums, the Profonde Collection home care line, and all related topical formulations, are intended exclusively for topical application by licensed healthcare professionals in a clinical or professional aesthetic setting.
These products are not intended for general consumer retail distribution unless specifically authorized by Exocellure Dermaceuticals Inc. in writing. No Exocellure product is intended to diagnose, cure, treat, or prevent any disease or medical condition.
All references to wound healing, tissue recovery, skin remodeling, collagen stimulation, anti-inflammatory activity, cellular regeneration, and similar outcomes reflect structure and function observations derived from preclinical research models, in vitro studies, in vivo animal studies, pilot clinical investigations, and systematic literature reviews pertaining to mesenchymal stem cell-derived exosomes (UC-MSC Exosomes) and related bioactive compounds.
These observations do not constitute FDA-approved, Health Canada-approved, or otherwise regulatory-sanctioned therapeutic claims. Preclinical and early-phase findings may not translate directly or predictably to human clinical outcomes.
No cited study or referenced research should be interpreted as establishing a confirmed, reproducible, or government-sanctioned therapeutic claim for any Exocellure product.
Exocellure Dermaceuticals topical exosome products have not received approval from the U.S. Food and Drug Administration (FDA) for any aesthetic, dermatologic, wound-healing, or therapeutic indication.
These products are formulated and positioned as professional-use cosmetic preparations and are not classified as drugs, biologics, or HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products) under 21 CFR Part 1271.
All practitioners, distributors, and clinic partners operating in the United States are solely responsible for ensuring that product acquisition, application, and communication comply with all applicable federal, state, and local regulations, including applicable FTC advertising guidelines.
Exocellure Dermaceuticals topical products are registered under Health Canada's Cosmetic Notification Form (CNF) pathway pursuant to the Cosmetic Regulations under the Food and Drugs Act. These products are classified as cosmetics and are not approved as drugs or natural health products under the Food and Drugs Act.
All Canadian practitioners, distributors, and clinic partners are responsible for compliance with applicable federal and provincial regulations governing the use, promotion, and sale of cosmetic products in their jurisdiction.
Exocellure products are manufactured using a patented liquid-stable exosome stabilization process. The underlying intellectual property, including granted and pending patents, is the exclusive property of the applicable patent holders and is licensed for use within Cellevion Group's commercial operations.
Unauthorized reproduction, reverse engineering, or misappropriation of Exocellure's proprietary formulations, technology, or trade secrets is strictly prohibited and may result in legal action.
Licensed practitioners and authorized clinic partners are solely responsible for:
Exocellure Dermaceuticals Inc. and Cellevion Group make no warranty, express or implied, regarding specific clinical outcomes, individual patient results, or performance characteristics beyond those described in product labeling and supporting technical documentation.
Individual results will vary based on patient skin condition, treatment protocols, practitioner technique, and other factors beyond Exocellure's control.
All Exocellure product documentation, training materials, white papers, clinical reference guides, and marketing assets are prepared exclusively for licensed medical professionals, authorized aesthetic practitioners, and authorized distribution partners. This content is not intended for direct consumer distribution.
Unauthorized reproduction or redistribution of Exocellure proprietary materials is prohibited.
For regulatory inquiries, contact info@exocellure.com.