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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 Number #3 "Doc" Bisher Breed: Australian Cattle Dog Age: 11 yrs Weight: 58.3 lbs Condition: Degenerative Joint Disease in bilateral elbows and stifles

Overview of initial results and observations: "Doc" had left patella luxation repair o 527-2008 at the local referral clinic. He then tore his ACL and had extracapsular repair performed Dec. 2008. May 2009 he sustained a right ACL rupture and concomitant patella luxation. The right leg was repaired via TPLO with trochoplasty and tubilial tuberosity transposition. He started Carprofen for stifle arthritis 11-25-2009 and has been on Rimadyl, Previcox or Deramaxx most of the time since 11-2009. He also receives 8 Adequan injections two to three times per year. Oct. 16, 2015 he received Propofol as an induction agent and anesthesia was maintained employing isoflurane and oxygen Radiographs revealed moderate bilateral hip dysplasia.

Severe DJD in both stifles and elbow. Left Stifle-extracted 0.25 cc of joint fluid employing a 20 gauge 1 /2 inch needle. Infused 0.5 cc Triamcinolone followed by 1.6 cc Kush Canine. Left elbow-extracted 0.2 cc of joint fluid employing a 20 gauge 1 /2 inch needle. Infused 0.5 cc triamcinolone followed by 0.8 cc Kush Canine. Right stifle- employing a 20 gauge 1 1/2 inch needle extracted 0.1 cc of synovial fluid. Infused 0.5 cc triamcinolone followed by 1.6 cc Kush Canine. Right elbow-employing a 20 gauge 1 /2 inch needle extracted 0.15 cc joint fluid. Infused 0.5 cc triamcinolone followed by 0.8 cc Kush Canine. Doc despite his extensive DJD has required little adjunctive NSAID therapy. His owner reports that he can now keep up with the younger dogs at the home. As of Feb. 2016 Mr. Bisher is still reporting outstanding results and says he has not given any Adequan since infusion and Previcox infrequently.

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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