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Assisi Animal Health announces the completion of its first clinical trial

Feb 01, 2018

Assisi Animal Health wants to share with the veterinary community important news in the management of pain and inflammation in animals. This just-completed study of our flagship product, the Assisi Loop®, has successfully demonstrated the clinical efficacy of our NPAID (Non-Pharmaceutical Anti-Inflammatory Device) in the practice of veterinary medicine. This university-conducted study of our FDA-cleared anti-inflammatory device demonstrates that its benefits for pain relief, formally found in humans, also extend to animalhealthcare.
 
The Assisi Loop is a patented, portable,  pulsed electromagnetic field (PEMF) medical device, originally cleared for treatment of post-operative pain and edema in humans.

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Its targeted signal enhances the production of nitric oxide and promotes vasodilation and oxygenation in damaged human and animal tissues. The Loop is sold only to veterinary professionals or to pet owners with a prescription from a veterinary professional. Many veterinary clinicians have adopted the Loop for post-acute and recuperative surgical patients, wound healing, and for animals with long-term chronic inflammatory and degenerative disorders suchs as IVDD, OA, Wobblers disease, cystitis and pancreatitis, among other conditions.
 
The Assisi Loop is considered both an in-clinic therapy, but importantly, a take-home (or barn) treatment that is easy for a pet owner to handle, that avoids pilling and some of the difficulties encountered with the use of pharmaceutical agents. A Clinical Use Guide containing over 40 treatment protocols covering the Loop's use for almost 300 clinical situations will soon be available to veterinarians.
 
Since 2014, Assisi Animal Health has studied the efficacy of our proprietary PEMF technology on animals. We believe that the proven science that works on humans should also benefit other species in the control of pain and inflammation.  
 
As you may know, FDA clearance is not required for medical devices in the veterinary world.  To fill the research gap, for the benefit of clinicians Assisi Animal Health has sponsored our own clinical research at leading veterinary institutions to demonstrate proof of efficacy of our technology in dogs and cats, the most-treated species in clinics.
 
This two-year clinical trial was conducted at North Carolina State University's College of Veterinary Medicine. The study was conducted under the direction of Dr. Natasha Olby, VetMB, PhD, MRCVS, DACVIM, a specialist in Neurology.   
 
The study employed the Assisi Loop as part of a pre-to-postoperative treatment regimen to reduce pain and hasten recovery.
 
The Assisi Loop PEMF device has been cleared by the FDA for prescription use in humans. To our knowledge, this clinical study is the first published double blind, placebo-controlled, randomized study of such a device to demonstrate clinical efficacy in the practice of veterinary medicine. This tightly controlled study demonstrates that the Loop's healing and pain relief benefits found in humans also extends to animal healthcare. The complete article on the study and its results will be published in the Journal of Neurotrauma; the abstract of the trial report may be found here.

Dr. Deirdre Chiaramonte DVM ACVIM CCRT CERP CVA, Assisi's Manager of Clinical Studies, commented: "This is the first university study to demonstrate a positive clinical benefit of an NPAID in the treatment of postoperative Grade V IVDD. The results of this study show undeniably the Loop's ability not only to reduce pain in a severe population, but also to help target neural tissue to recover faster.  This speeds the patient's ability to return to more normal function more quickly, and suggests that using the Loop should be considered as 'best practice' in surgery and rehab cases, both in hospital and as a take-home therapy."
 
A basic summary of main conclusions from the Loop IVDD Study is as follows:
 
-There was a statistically significant difference in the incisional pain level between Loop-treated and placebo patient groups. This pain benefit in the Loop-treated group got larger (more significant) the longer time went on.
 
-The Loop-treated group had lower levels of the biomarker GFAP when compared to the placebo group. GFAP is a structural protein that is released from astrocytes when neurological injury occurs. The fact that the Loop-treated patients had lower levels of GFAP could mean that the Loop has a neuroprotective effect.
 
-The Loop-treated group had a statistically greater degree of recovery of proprioception compared to the control group.  This may be evidence of the neuroprotective effects of the Loop.

Assisi Animal Health is dedicated to making an animal's journey as pain free as possible.   A second trial using the Loop is completed and in peer review. We currently have four studies underway encompassing canines and felines. We will keep you informed as results become available.
 
Assisi Animal Health will be at VMX (formerly the NAVC Conference) in Orlando, at booth #2639, from Feb. 3-7, 2018. Come by and see us. We will have printed study report abstracts in the booth and demonstration units of our new therapeutic beds, powered by Assisi Loop PEMF technology.


Category: News

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