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4 Studies - 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 studies were 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.

Case Study #2 “Suzie” Phillips Breed: Golden Retriever Age: 11 years Weight: 60 lbs Condition: Congenital Hip Dysplasia (diagnosed at less than one year of age via radiographs after the puppy presented "bunny hopping")

Treatment: Suzie presented grade 2/3 lameness. She was very reluctant to get up from a lying position and walks "post legged" in her hind quarters. She refuses to jump on the sofa or into a car. She will walk stairs reluctantly. She has used NSAIDS as needed since 2005 but consistently since Nov. 2013.

Radiographs changes show advanced severe degenerative joint changes in both coxofemoral joints and flattening of both femoral heads. Nov. 25, 2015, Suzie was anesthetized employing propofol as an induction agent and maintained on isoflurane and oxygen. The right coxofemoral joint was tapped employing a 20 gauge 2 inch IV cath. 1 cc of joint fluid was withdrawn and 0.5 cc of Vetalog (Triamcinolone) infused followed by 1.2 cc Kush Canine. 0.15 cc of joint fluid were withdrawn from the left coxofemoral joint. 0.5 cc of Triamcinolone followed by 1.2 cc of Kush Canine were infused. Suzie had improvement in her gait and had minimal NSAIDS given until 1-18-2016 at which point she developed a swelling on the right caudal portion of her skull which was diagnosed as Osteosarcoma (this cancer was not associated with Kush Canine. Golden Retrievers have a very high cancer rate genetically) via biopsy. Due to the pain associated with this disease she has been on Deramaxx and Tramadol since.

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.

Case Study #4 "Greta" Falkowski Breed: German Shepherd Age: 14 yrs. Body Weight: 83 lbs. Condition: Bilateral Severe DJD stifles, Discospondylosis

Overview of initial results and observations: Greta has had bilateral ACL repair via

TPLO in 2007 and 2008. She required NSAID therapy for difficulty rising starting in May 2012. She could not tolerate Previcox or Deramaxx (GI symptoms) and eventually was able to tolerate moderate doses of Metacam. She had 8 Adequan injections July 2014. Her rear leg musculature continued to atrophy and she started to drag her hind legs and wear down her nails until they bled.

We added an anabolic steroid (Nandrolone Decanoate) to her multimodal therapy Oct. 2015. Oct. 26, 2015 she was induced with Propofol and anesthesia was maintained with isoflurane and oxygen. Radiographs are included. Left Stifle- employing a 20 gauge 1 %2 inch needle with the stifle in a flexed position extracted 0.15 cc synovial fluid. Infused with 0.5 cc Kenalog-10 (Triamcinolone acetonide 10mg/ml) followed by 2.4 cc Kush Canine. Right Stifle-employing a 20 gauge 1 12 inch needle with the stifle in a flexed position extracted 0.05 cc synovial fluid. Infused with 0.5 cc Kenalog-10 (Triamcinolone acetonide 10mg/ml) followed by 2.4 cc Kush Canine.

She was sent home the same day as her procedure and rechecked the following day. She was no longer dragging her toes. She has continued not to drag her toes but still requires some Metacam due to the arthritis in her spinal column that cannot be treated with Kush Canine. Due to her age Greta has multiple problems but the clients have stated that they do feel the Kush Canine has made an impact on her ability to walk.

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.