Is Polyglycan a generic product?
No. Polyglycan® is patented 3-component formula which has demonstrated characteristics beyond any of these components used individually. Polyglycan is specifically formulated to have the same viscosity and lubricating properties as natural equine synovial fluid.
Is Polyglycan considered a medical device or a drug?
Polyglycan is a medical device – it achieves therapeutic effect by mimicking the physical properties of equine synovial fluid. The mechanical lubrication and cushioning provided by Polyglycan helps by protecting the joint in a non-chemical/non-metabolic manner.
Is Polyglycan manufactured in an FDA-registered facility?
Yes! The Polyglycan manufacturing facility achieved Current Good Manufacturing Practice (CGMP) status over 10 years ago, and is routinely inspected by FDA.
Are products similar to Polyglycan ever used in humans?
Yes! In fact, all hyaluronic acid products currently used in humans for intra-articular joint treatments are also medical devices.
What is a medical device?
FDA determines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
What are the label claims for the uses of Polyglycan?
Polyglycan is specifically formulated to mimic the physical properties of normal equine synovial fluid. The product’s intended use is in the synovial space (directly in the joint) in horses as a post-surgical lavage, a synovial fluid replacement, or as a viscosupplement.