FAQs
How do I mix ariessence pure PDGF+ with ariessence pure HA?
Below are some common questions about ariessence pure PDGF+
ariessence pure PDGF+ FAQs:
Is ariessence pure PDGF+ approved by the FDA?
- 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, while ariessence is listed with FDA as cosmetic product (Cosmetic Product Listing Number – 53-171423-311193), like most other cosmetic products, the specific ariessence product has not received, nor does it require, premarket approval by FDA.
- While ariessence is not FDA approved, the pure PDGF component of ariessence is also present in four (4) medical therapeutic products that are FDA approved. The pure PDGF in ariessence is exactly the same, and from the same manufacturing line and meets the same exacting standards, as the pure PDGF in the 4 FDA approved products.
What are the intended use of the 4 FDA approved products that contain pure PDGF?
- Augment® is FDA approved for regeneration of orthopedic-related tissues in foot & ankle arthrodesis,
- Augment® Injectable is also approved for regeneration of orthopedic-related tissues in foot & ankle arthrodesis,
- GEM 21S® is FDA approved for regeneration of oral and periodontal tissues including gingiva, mucosa and bone, and
- Regranex® Gel is FDA approved for stimulating the healing of skin wounds in diabetic patients.
- Augment®, Augment® Injectable and GEM 21S® are each implanted or injected into the body during surgery. Regranex® Gel is intended for topical application onto open skin wounds. These 4 products have each 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 the product.
Do products containing pure PDGF generally require FDA approval?
- Not necessarily. Although there are certain FDA-approved products that contain PDGF (see above), these are drug-device combination products and/or are intended for use in the treatment, cure, mitigation, or prevention of disease or intended to affect the structure or functions of the body.
How widespread is the use of pure PDGF?
- Over 5 million people are believed to have been treated with PDGF over the past 15 years.
What are the ingredients in ariessence pure PDGF+?
- A kit of ariessence includes 5 syringes of PDGF-BB (ingredients: Water, Sodium Acetate, sh-Polypeptide-59 Dimer aka PDGF-BB) and one vial of sterile, uncrosslinked, high- and low-molecular weight HA (ingredients: Water, Sodium Acetate, Hyaluronic Acid.
Is PDGF well studied?
- Yes. PDGF is the most well studied tissue growth factor in regenerative medicine. There are literally thousands of peer-reviewed published studies on PDGF encompassing over 100 clinical trials involving the use of pure PDGF.
Are there any human components in ariessence pure PDGF+?
- No. The pure PDGF in ariessence is made via cutting edge recombinant technology, a highly regulated sterile manufacturing process resulting in pharmaceutical grade PDGF with no human components. It is not derived from any human tissue or cells. Every lot of PDGF meets exacting standards established during the FDA approval process for purity, potency and sterility. This process is similar to how many FDA approved biologic drugs are made today.