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Brian T. Barnett, DVM, MBA

Initial Results & Observations: Kush Canine for Treatment of Canine Osteoarthritis.

Randolph Animal Hospital 1435 Zoo Parkway Asheboro, NC 27205 2-18-2016

There is an unmet need to treat canine osteoarthritis (OA) that is safe, affordable, easily administered, efficacious, and without adverse side effects. At Randolph Animal Hospital we see arthritic dogs daily. The canine patient population represents eighty percent of our revenues. Our current treatment for canine OA relies on constant NSAID medication, Opiods (like Tramadol), Gabapentin, anabolic steroids, and Adequan to reduce pain and inflammation. This pharmaceutical therapy has several problems, including limited effect, difficulty in providing consistent compliance (the client must be able to give a pill or injection), and a high likelihood of gastric tract complications.

The Kush Canine particles for intra-articular injection is a medical device designed to prevent the occurrence and reoccurrence of joint pain from loss of cartilage or tissuebone mechanical malfunction caused by joint dysfunction not associated with infection (e.g., lameness, osteoarthritis). The injected Kush particles are micro-sized lubricious cushions that provide an artificial cartilage effect to protect the joint's natural tissue during joint articulation.

The following case study was conducted at Randolph Animal Hospital using client owned dogs treated with Kush Canine:

Case Study #1 “Shep" Davis Breed: Australian Shepherd Age: 13 years Weight: 66 lbs. Condition: Hip Dysplasia (Coxofemoral Degenerative Joint Disease) bilateral Treatment: Kush Canine I.A. bilateral injections Nov 16, 2015 "Shep" was anesthetized employing Propofol for induction and isoflurane (gas anesthesia) for maintenance. The dermis over both coxofemoral joints was shaved and a surgical prep was applied. Both joints were tapped employing a 20 gauge IV catheter. 0.2 cc of joint fluid was extracted from the right joint and 0.3 cc from the left joint. Both joints were infused with 0.25 cc Triamcinalone and 2.4 cc Kush Canine particles. Shep recovered uneventfully and was released to his owner the same day. Degree/Grade of Lameness pre & post treatment (scale 0 - 4) "Shep" has been on chronic Novox (carprofen) administration (50 mg BID) since July 2013 for difficulty rising and limping.

Even with Carprofen treatment he had a grade 2 lameness. Radiographs of the severe joint changes are enclosed. If he were younger he would be a candidate for total hip replacement. Post Kush Canine injections "Shep" is no longer receiving Carprofen or any other NSAID. His owner claims that he is now back to chasing her pair of young dogs around in the yard. She also claims that he is back to taking long walks on their farm when he had previously stayed close to the house. His activity level is especially encouraging as he lives outdoors and he have had a cold winter. His owner reported that as of Feb. 11, 2016 he has still not taken any NSAIDS (or other pain medications) and is getting around well.

The Kush canine treatment device is delivered via intraarticular injection. The particles inject easily and smoothly into the synovial space using either a 20 or 22 gauge needle. This is a straightforward in-clinic procedure to preform. We are seeing excellent early results treating knee, hip & elbow joints. Improvement was seen by the next day. The results may have been visible more quickly but the patients all had post op opiod injectable medications. We are seeing increased range of motion. Owners are reporting visibly better ambulation and more ease in raising. Two of the dogs were able to stop NSAIDS completely.

The proposed pricing structure for the product builds a strong business case for our animal hospital and for our clients. The Kush procedure revenues are generated at time of treatment, in the clinic. This is important because veterinary clinics/hospitals are seeing margin and profit eroded, as more and more pharmaceutical prescriptions are being fulfilled outside the clinic rather than at the veterinary clinics/hospitals.

While my experience and observations of the Kush product are limited in duration I believe this product has demonstrated to be effective in treating canine OA joints. This product shows much potential in serving the very large arthritic canine population and growth within my practice.

2014-2016 Brian T. Barnett, DVM, MBA Dr. Barnett has been the owner and chief of staff at Randolph Animal Hospital in Asheboro, NC since May of 2002. Dr. Barnett earned his Bachelors of Science in Zoology from Auburn University and then his Doctorate in Veterinary Medicine from Auburn University's College of Veterinary Medicine. In addition to his science and veterinary degrees, Dr. Barnett holds an MBA from Wake Forest's Babcock School of Management.

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