02/05/13. VRM 104A copyright Vet-Stem, Inc. Why Offer Regenerative Medicine. Small Animal Clinician s Approach - Outline

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1 Small Animal Clinician s Approach Vet-Stem Credentialing Course Veterinary Regenerative Medicine 104A Slide 1 Small Animal Clinician s Approach - Outline Patient Selection Owner Discussion Adipose Collection The Lab Process Behind Closed Doors Joint Injection Rehabilitation Outcome Expectations Retreatment / Banking / Cell Culture Stem Insure Preventative Banking Pricing Guidelines / Insurance Coverage Slide 2 Why Offer Regenerative Medicine Owner demand Ability to treat chronic diseases v Ability to treat chronic pain v Even expanding uses of this new tool v Suppor<ng peer- reviewed data v Professional growth and pride cu@ng edge v Good training and easy to start v New profit center never at Walmart or Internet! v v Slide 3 104A copyright Vet-Stem, Inc. 1

2 Case Selection v History v Physical Exam v Diagnos<cs v Concurrent Medica<ons v The Ideal Case v Owner Expecta<ons/Compliance Slide 4 Case Selection CONCURRENT MEDICATIONS Compa<ble v NSAIDS v An<bio<cs (not in same syringe) v Hyaluronic acid Less Compa<ble v Immunosuppressive drugs v Cyclosporine v Cor<costeroids v An<bio<cs in same syringe Slide 5 Case Selection IDEAL CASE v Clearly defined disease Clinical Symptoms OA v Non- surgical candidate v With surgery in case where surgery alone prognosis guarded v No major systemic diseases v No major spinal disease (disc, spondylosis) v NSAID non- responsive or lack of tolerance v Owner has ra<onal expecta<ons Slide 6 104A copyright Vet-Stem, Inc. 2

3 Case Selection LESS THAN IDEAL v Poorly defined disease v Spondylosis v Loose car<lage fragments v Spontaneous luxa<on (major instability) v Systemic illness (Cushing s) v Expecta<ons too high Slide 7 Contraindications Patients with Active Cancer: No data suggesting adult stem cells become cancer except in extreme in-vitro laboratory conditions. Mixed data if patient has active cancer: - some studies show MSCs can help - some studies show MSCs might accelerate Vet-Stem takes the conservative role and recommends not treating patients with active cancer. Attending veterinarian and owner can over-ride and treat anyway with waiver if they believe benefit outweighs the potential risk. Slide 8 It s your pet s very own stem cells, just concentrated Collection is as simple and quick as a spay Cells ready to inject in less than 48 hours The cells help reduce pain, repair the damage in the joint, prevent further decline, and improve quality of life May help reduce need for pain meds Lasts about 1-4 years Extra cells banked for life! Very safe How to Explain to Owners Slide A copyright Vet-Stem, Inc. 3

4 Adipose Collection Sites Pro Easy anatomy Easier than OHE Even skinny dogs have fat in this site Pro Easy access Skinny dogs have fat Falciform Ligament Site Thoracic Wall Site Con In abdomen Con Possible seroma Cosmetics Slide 10 Adipose Collection What fat do we not want? NO LIPOMAS Slide 11 Tube with Fat Ready to Pack Slide A copyright Vet-Stem, Inc. 4

5 Cell Count and Viability Assessment Nucleocounter New Brunswick Slide 13 Dosing Summary Accurate cell count Needed for mul<ple doses Assess viability assure quality/safety Adjust volume - Aliquot into doses needed Sterile fill syringes azach appropriate filters Cryopreserve/bank excess for future Asep<c injec<on Slide 14 Stem Cell Banking v Excess cells can be banked v Storage is in liquid nitrogen v Cell viability +14 years* * Spurr et al, Cryobiology, 2002 (human stem cells) Mar<nello et al. Vet Science 2010 (canine adipose stem cells) Slide A copyright Vet-Stem, Inc. 5

6 Injection Recommendations v Inject all joints intra-articular if they have significant pain or arthritis v Inject IV to assist in treatment of those areas of inflammation that might not have been observed (homing) v Module 105A will review injection techniques in detail Slide 16 Concurrent Modalities Compatible v Oral supplements v Cryotherapy (GameReady) v Low energy therapy (laser, ultrasound) v Acupuncture / chiropractic Not Compatible v High energy therapy (shockwave) Slide 17 Rehabilitation Guidelines v Download website recommenda<ons v Quiet for 30 days with controlled exercise daily v Water therapy op<onal aaer surgical site completed closed and no risk of infec<on v Follow up exams and evalua<on forms v Diet and weight management Slide A copyright Vet-Stem, Inc. 6

7 Outcome Expectations þ 75% of dogs will have a positive outcome that the owner can observe by 60 days. þ 80% of owners report improvement in Quality of Life by 90 days þ Set expectations so Owners do not believe they are going to get a puppy back unless they own a puppy! þ 2/3 of dogs go past one year without retreatment Slide 19 Retrospective Canine OA Cases Veterinary Score Average Veterinary Scores of Dogs in Regards to Pain, Lameness, and Range of Motion 2008 Commercial Clinical Data* Veterinary Scale: 5=Extreme (considering euthanasia) 4=Severe 3=Moderate 2=Mild 1=Normal Day Day Day Pain Lameness (N=141, pre-tx) (N=146, pre-tx) Slide Range Of Motion (N=141, pre-tx) *Voluntary responses from commercial cases. Slide A copyright Vet-Stem, Inc. 7

8 Slide 22 Price $1350 includes: processing of 2 tubes, doses for 1 st tx, and 1 st year of storage $950 if animal owned by a veterinarian/tech $120 shipping/handling applies to processing ($60 each way) $100 /tube beyond 2 tubes *** Insurance Coverage*** Slide 23 Price $350 recovered banked dose (addigonal doses $100 ea) $60 shipping/handling applies to recovery $150/yr/animal for storage (1 st year free) *** Insurance Coverage*** Slide A copyright Vet-Stem, Inc. 8

9 Insurance Coverage When veterinarians started recommending Vet- Stem therapy to our policyholders, as an insurance company, we were excited to be able to offer coverage for a new treatment modality for serious orthopedic condi<ons. - Dr. Jules Benson, BVSc MRCVS, VP Veterinary Services ( Slide 25 StemInsure Providing dogs with a lifetime of stem cells StemInsure Description: ü Collect fat at time of another procedure/surgery ü Only 5 to 15 grams of fat is needed (size of 1 to 3 grapes) ü Fat is shipped overnight to Vet-Stem ü A small number of cells is stored for future culturing Slide 26 StemInsure Providing dogs with a lifetime of stem cells Summary: ü Collect when young and avoid future surgery ü Lower cost overall for owners ü Use in OA and soft tissue injuries ü Future value for new uses ü Owner Peace of Mind Slide A copyright Vet-Stem, Inc. 9

10 Compassionate Use Thorough work up Appropriate specialist involved Case by case approval Pa<ent follow- up See op<onal module on compassionate use Canine liver, atopy, IBD Feline renal Other autoimmune condi<ons Slide 28 Keys to Success ü Careful patient selection ü Careful owner education - expectations ü Proper Collection close dead space ü Proper Injection Technique Timing, location and mixing of cells ü Follow up and Rehab Program Slide 29 Getting Started ü Complete the short exam questions on the website or print and in your answers. ü A Vet-Stem representative will then call you to assist with getting your supplies for your first case. ü Elective Courses: ü Business Module how to integrate ü Collection and Injection Videos Slide A copyright Vet-Stem, Inc. 10

11 Conclusion ü Easy to start ü No capital investment ü Complete technical assistance from vets ü Build your Center of Excellence in Regenerative Veterinary Medicine 10 Years 10,000 Patients The Gold Standard in Veterinary Regenerative Medicine Slide 31 Veterinary Referral Center Slide 32 Regenerative Medicine - Center of Excellence ü Advanced Training ü Compassionate Use ü Clinical Trial Participation ü Opinion Leader ThinkTank ü Co-op Marketing ads, web, referrals Slide A copyright Vet-Stem, Inc. 11

12 Lex and the Purple Heart Slide A copyright Vet-Stem, Inc. 12