FAQs

• ariessence pure PDGF+®, is a cosmetic product consisting of proprietary, pure, recombinant, sterile platelet-derived growth factor (PDGF) and a proprietary blend of sterile hyaluronic acid (HA) for topical use designed to improve the appearance of skin. ariessence is not intended to treat, diagnosis or prevent any disease, or affect the structure or function of the human body.
• Accordingly, ariessence is listed with FDA as a cosmetic product (Cosmetic Product Listing Number – 53​-171423-311193). As with all cosmetic products, FDA pre-approval is not required.

The following 4 products are different formulations containing rhPDGF-BB. Each has received the highest level of FDA approval, which requires the most stringent FDA review and approval processes; these processes require pre-clinical and clinical trials providing proof of the safety and effectiveness of each product for its approved use(s)*.

• Augment® Bone Graft
• Augment® Injectable
• GEM 21S®
• Regranex® (becaplermin) gel

FDA approval is required for products that contain PDGF-BB when they are intended for therapeutic or medical purposes — for example, to diagnose, treat, or prevent disease, or to affect the structure or function of the body. ariessence pure PDGF+ is a topical cosmetic product, not a therapeutic drug, and therefore does not require FDA pre-market approval.

Over 5.5 million people have been treated with FDA approved products containing PDGF over the past 28 years.*

A kit of ariessence includes 5 syringes of pure PDGF-BB (ingredients: Water, Sodium Acetate, sh-Polypeptide-59 Dimer, aka rhPDGF-BB) and one vial of sterile, uncrosslinked, high- and low-molecular weight HA (ingredients: Water, Sodium Acetate, Hyaluronic Acid).

ariessence pure PDGF+ is recommended for use within six months of manufacture, based on available stability data.

Yes. PDGF is the most studied tissue growth factor in regenerative medicine. There are literally thousands of peer-reviewed published studies on PDGF including over 100 clinical trials involving the use of PDGF.

No. The rhPDGF-BB in ariessence is made via cutting edge recombinant technology, a highly regulated sterile manufacturing process resulting in pharmaceutical grade rhPDGF-BB with no human components. It is not derived from any human tissue or cells.