RenoVō® is a liquid, acellular, equine amniotic tissue allograft comprised of amnion and amniotic fluid, intended to supplement and protect tissues.
FREQUENTLY ASKED QUESTIONS
What is RenoVō®?
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 Board Certified 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 cover 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?
RenoVō® may not provide an improvement in the horse’s condition, and there is a possibility of an adverse reaction with use of any allograft. This is not a complete list of risks. You should discuss the potential risks and benefits of product use for your particular case with your Veterinarian. See package insert for complete Instructions for Use.
Have any clinical studies been performed with RenoVō®?
A first-of-its-kind, large prospective field study investigating the outcomes of ~170 horses with soft tissue and orthopedic injuries using RenoVō® was conducted in 2019. Criterion for inclusion in the study was lameness attributed to tendonitis/desmitis by diagnostic anesthesia and/or imaging, resulting in 100 subjects with 128 tendonitis/desmitis lesions meeting inclusion. The extended full manuscript is currently in preparation for select journal submission.
In 2019, the company also partnered with the Oklahoma State University College of Veterinary Medicine to conduct a randomized controlled evaluation of RenoVō® on equine limb wounds. The study, entitled “Efficacy and safety of an equine liquid amniotic tissue allograft on equine distal limb wound healing” is being conducted in conjunction with the university’s Equine Surgery and Sports Medicine faculty under the leadership of Dr. Schoonover.
A follow-on randomized controlled study of RenoVō® for both soft tissue and orthopedic joint use is scheduled for 2020 through the Oklahoma State University College of Veterinary Medicine.
Does RenoVō® have an FDA approval or a USDA license?
RenoVō® is an equine amniotic tissue allograft intended to cover and protect tissues. Although federal regulation of Veterinary Tissue and Tissue Based Products does not yet exist, Equus Innovations has proactively established a Quality Management System designed to meet the Standards set forth in 21 CFR §1271 Human Cells, Tissues, and Cellular and Tissue Based Products. Consistent with human tissue regulation, RenoVō® is processed following Current Good Tissue Practices (cGTP) and is subject to stringent USP testing prior to release.