Product and Medical Disclaimer

ReGenEDGE Medical LLC is an independent distributor of regenerative medicine and related products. We do not manufacture, physically handle, package, label, or ship products. Products are supplied, fulfilled, and shipped by third-party vendors, manufacturers, suppliers, or other third parties. Ordering and payment for products are handled by vendors; ReGenEDGE Medical LLC does not collect payments, issue invoices, accept purchase requests, or process orders through this website.

Products marketed or referenced on this website may include human cells, tissues, and cellular and tissue-based products (HCT/Ps), exosome-related products, biologics, medical devices, dietary supplements, injectables, platelet-rich-plasma-related products, and similar product categories. Different products are subject to different regulatory pathways, including but not limited to Section 361 or Section 351 of the Public Health Service Act, drug regulation, biologic regulation, medical device regulation, and dietary supplement regulation. Regulatory status may change over time.

References to any product on this website do not represent that the product is FDA-approved, FDA-cleared, or approved or cleared for any particular indication unless that statement is expressly made and supported by approved labeling. Some products may be marketed without FDA premarket approval or clearance, and the U.S. Food and Drug Administration has issued public warnings regarding certain regenerative medicine products, including stem cell and exosome products that have not been demonstrated to be safe or effective.

Product information may be provided by third-party vendors, manufacturers, suppliers, publications, or other sources. ReGenEDGE Medical LLC does not independently verify, warrant, or guarantee the regulatory status, safety, efficacy, labeling, indications, clinical performance, suitability, or availability of third-party products. Vendors generally provide approved marketing copy, labels, instructions for use (IFUs), and approved claims. ReGenEDGE may also create or adapt educational and marketing content. ReGenEDGE may use AI-assisted compliance screening to support content review, but AI-assisted screening is supplemental and does not replace vendor-approved claims, label review, regulatory review, or qualified healthcare or regulatory counsel where appropriate.

Healthcare professionals are responsible for independently reviewing product labeling, instructions for use, regulatory status, clinical evidence, patient suitability, contraindications, risks, informed consent requirements, adverse event reporting requirements, and all applicable laws and professional standards before using or recommending any product.

No statement on this website should be interpreted as a claim that any product diagnoses, treats, cures, mitigates, or prevents any disease or condition unless expressly permitted by applicable law and approved labeling. Individual outcomes may vary. ReGenEDGE Medical LLC does not guarantee clinical, business, reimbursement, or patient outcomes.

For adverse event and product complaint reporting, see our Adverse Event and Product Complaint Reporting page. Healthcare professionals may also have direct reporting obligations to manufacturers and to the U.S. Food and Drug Administration.