Veterinarians

What is BIO-PLY™?

BIO-PLY™ is an “off-the-shelf” allogenic orthobiologic derived from platelets that has powerful anti-inflammatory and regenerative and antimicrobial properties.

How does BIO-PLY™ work?

The platelet-derived factors in BIO-PLY™ dampen inflammation by decreasing the release of pro-inflammatory cytokines such as IL-1β. These factors also balance a healthy immune response by quieting inflammatory pathways in neutrophils and macrophages. Importantly, these factors increase hyaluronic acid production and collagen synthesis in the joint capsule and cartilage cells. When taken together, these multimodal activities restore homeostasis in injured tissue and promote regeneration.

How do we create BIO-PLY™?

Qentoros has a herd of healthy equine donors who donate blood once a month. These donors undergo strict screening to ensure they do not transmit infectious diseases during donation as per the FDA-CVM’s requirements for donor eligibility. They are also screened for highly active platelets. We harvest these platelets from the donated blood and, using our patent pending processing method, we extract, isolate, and highly concentrate the platelet-derived factors that have anti-inflammatory and regenerative activities. This processing method also remove inactive factors and factors that would cause an immunogenic response such as antibodies. BIO-PLY manufacturing is conducted using Good Manufacturing Practices (GMP) per the FDA-CVM’s guidelines to produce ACTPs.

Why is BIO-PLY different?

BIO-PLY™ cuts out the need for complicated kits and bulky equipment as it is provided as a convenient vial kept on the back of your truck or on the shelf of your pharmacy. The “off-the-shelf” nature of BIO-PLY is not only convenient but also provides a consistent product due to the quality control measures that Qentoros builds into our manufacturing. These checkpoints are built strategically into several key steps in the manufacturing process to ensure a highly active and pathogen free product that will not cause an immunogenic reaction. Our research found that pooling the product of multiple horses increases the efficacy of the product; this is especially advantageous when treating older horses that may have a diminished healing capacity. The bioactive factors in BIO-PLY are stable in a cooler or refrigerator for up to 7 days and up to 6 months in a freezer. In addition, BIO-PLY can be used alongside other systemic and local pharmaceuticals such as NSAIDs, sedatives and antibiotics.

Where can I purchase BIO-PLY?

At present, BIO-PLY is undergoing the rigorous FDA approval process. We have several Investigational New Animal Drug files and a Veterinary Master File open with the FDA’s Center for Veterinary Medicine. BIO-PLY™ is also within the FDA-CVM’s Veterinary Innovation Program that fast-tracks highly innovative products.

If you are interested in using BIO-PLY at your clinic prior to FDA approval, please contact Qentoros to become a host site for clinical trials.