Frequently Asked Questions
What is RenoVō®?
RenoVō® is a liquid, acellular, equine amniotic tissue allograft comprised of amnion and amniotic fluid, intended to supplement and protect tissues.
What are amniotic tissues?
Amniotic tissues are comprised of amnion and amniotic fluid surrounding the foal 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, 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 mares during live birth by Licensed Veterinarians using safe recovery techniques and sterile equipment without harm to the mare or foal.
What are the potential advantages of using RenoVō®?
The use of equine amniotic tissue allografts to supplement and protect tissues in horses may be minimally invasive, safe, and offer a morbidity profile comparable to or better than those of existing modalities, including autologous stem cell or interleukin-1 receptor antagonist platforms (e.g., IRAP II™ System), 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. RenoVō® is cryopreserved and maintained frozen before use, so as to preserve beneficial proteins that may not survive lyophilization. Clinicians currently using autologous stem cell or IRAP II™ System therapy should consider use of RenoVō® to achieve similar or improved clinical outcomes.
What are the product risks?
Does RenoVō® have an FDA approval or a USDA license?
As an acellular, equine tissue allograft intended exclusively to supplement and protect tissues, RenoVō® 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, RenoVō® is processed following current Good Tissue Practices (cGTP) from the human tissue standards.