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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 #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.

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