Frequently Asked Question

 

What is AlphaFlo®?

AlphaFlo® is a liquid, acellular canine amniotic tissue allograft comprised of amnion, intended to supplement and protect canine tissues.

What are amniotic tissues?

Amniotic tissues are comprised of amnion and amniotic fluid surrounding the puppies during pregnancy. Amnion and amniotic fluid are rich sources of biologically active factors involved in tissue regeneration with reported anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic properties. Amniotic tissues contain key growth factors, cytokines, amino acids, exosomes, hyaluronic acid, and extracellular matrix proteins recognized as intrinsic to the complex tissue healing process¹. Published studies on the benefits and efficacy of amniotic tissue in wounds date back over 100 years².

What is an allograft?

A tissue graft from a donor of the same species as the recipient but not genetically identical.

Where do the tissues come from?

Tissues are recovered from healthy dogs during scheduled deliveries by Licensed Veterinarians using safe recovery techniques and sterile equipment without harm to the mother or puppies.

What are the potential advantages of using AlphaFlo®?

The use of canine amniotic tissue allografts to supplement and protect tissues in dogs may be minimally invasive, safe, and offer a morbidity profile comparable to or better than those of existing modalities, while offering potentially superior clinical results.

Ready availability of a convenient allograft potentiates clinical use without the time lapse for culturing cells or harvest techniques required for autologous therapies. Further, cytokine and growth factor profiles can vary dramatically between patients for a selected autologous product.

The reproducibility of each donor tissue also offers a more homogeneous protein concentration and product consistency in comparison to other regenerative modalities.

AlphaFlo®  is cryopreserved and maintained frozen before use, so as to preserve beneficial proteins and bioactive components that may be affected by lyophilization. Clinicians currently using PRP or autologous therapy should consider use of AlphaFlo® to achieve similar or improved clinical outcomes.

What are the product risks?

AlphaFlo® may not provide an improvement in the dog’s condition, and there is a possibility of an adverse reaction with the use of any allograft. This is not a complete list of risks. You should discuss the potential risks and benefits of product us for your particular case with your Veterinarian. See package insert for complete Instructions for Use.

Does AlphaFlo® have an FDA approval or a USDA license?

As an acellular, canine tissue allograft intended exclusively to supplement and protect tissues, AlphaFlo® does not meet the definition of a New Animal Drug subject to FDA regulation, or a biological product subject to USDA regulation. At present, there is no regulatory framework for animal tissue-based products that do not meet the definition of a New Animal Drug. In the absence of this regulation, AlphaFlo® is processed following current Good Tissue Practices (cGTP) from the human tissue standards.

Where can I buy AlphaFlo®?

AlphaFlo® is available for administration only by prescription by a licensed Veterinarian. Reference the location map or contact us for a provider in your specific area.