PetVivo Holdings, Inc. OTCPINK: PETV Lameness Repair Company “Running is the Life” FORWARD-­‐LOOKING STATEMENTS Statements in this presentaNon that are not historical facts are “forward-­‐looking statements”. Viewers are cauNoned that any such statements are not guarantees of future performance and that actual developments or results may vary materially from those in these “forward-­‐looking statements”. Statements regarding future plans and objecNves are forward-­‐looking statements that involve various risks and uncertainNes. Much of the informaNon, analysis, plans and conclusions contained herein were assembled or derived by company management and there can be no assurance that they will prove accurate. No securiNes regulator or stock exchange has reviewed or accepted responsibility for the adequacy or accuracy of this presentaNon. PetVivo Holdings (PETV) Gel-­‐Del •
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PetVivo Gel-­‐Del Founded 1999, St. Paul, Minnesota Royalty Free Tech Transfer from Mayo Clinic $13M+ Invested Including $7M From NIH Manufacturing FDA Validated For Human Trial Pivotal FDA Human Trial Successfully Completed Strong Human & Veterinary Pipelines Extensive Patent Por\olio Revenues Q4 2015 Cash Flow PosiNve Within 12 Months Experienced Leadership John Lai CEO & Chairman David B. Masters President, CTO & Director John F. Dolan CFO, General Counsel & Director Randall A. Meyer Chief OperaNng Officer Director Patented BioCoacervaNon ProducNon Process PrecipitaNon CoacervaNon Coacervate PrecipitaNon of Extracellular Matrix Components (Collagen, ElasNn, Heparin) into a Coacervate that is heat processed into ThermoplasNc Extracellular Matrix (ECM) Biomaterial Cost-­‐Efficient Scalable Manufacturing
•  Manufacturing Process FDA Validated for Human Clinical Trial ProducNon •  Manufacturing Scaled from 0.01 Kilograms to Several Kilograms in Practice -­‐ Thousands of Syringes •  Very Consistent Lot to Lot ProducNon •  Single-­‐Use Sterile Bag Processing Eliminates Cleaning Steps, Reduces Infrastructure and Increases Capacity ThermoplasNc ProperNes: Simplified Manufacturing; Many ApplicaNons
Figure 1A
Coated Catheter Molded Grai Melted MasterGel Bejer Implant Material: Why? •  Isolated Purified Components o  Source Tissues Purified to Soluble Component Form o  Memory of Source Tissue Type Removed •  Precludes Wrong Tissue Response e.g., Cadaveric Tissue o  No Inflammatory or Foreign Body Response •  Comprised of Collagen, ElasNn & Heparin o  Same Components As Natural Extracellular Matrix •  Components Self-­‐Assemble = BiocoacervaNon o
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Forms Insoluble Matrix – Slippery, Wet, Permeable, Durable & Resilient Mimics Natural Precursor Scaffold in ComposiNon, Structure & HydraNon Promotes NeovascularizaNon & is Non-­‐Cloqng Facilitates Cellular IntegraNon & RegeneraNon of FuncNonal Tissue •  Flexible & Adjustable Biomaterial Pla\orm o  Modifying ComposiNon & Components Adjusts Material CharacterisNcs Biomaterial Has Nano-­‐Structure (SEM) •  The MasterGel biomaterial is made up of an aggregated assembly of nano-­‐sized spherical complexes we refer to as “Proteoids” •  Each Proteoid is composed of proteins and carbohydrates, the building blocks of mammalian Nssue Matches Natural Precursor Extracellular Matrix Osmium Tetroxide Stained Samples Show Very Similar TEM Micrographs Gel-­‐Del ThermoplasNc Biomaterial (TEM) Natural Precursor ECM Formed in Coronary Artery During Stent Restenosis (TEM)* ElasNn Glycosaminoglycans *Enhanced Extracellular Matrix Accumulation in Restenosis of Coronary Arteries After Stent Deployment, I-­‐M Chung, H. K. Gold, S. M. Schwartz, Y. Ikari, M. A. Reidy, T. N. Wight Journal of the American College of Cardiology Vol 40, No 12, 2002 Broad IP Por\olio Eight Issued or Allowed US Patents 6,342,250 – Drug Delivery Devices Comprising Biodegradable Protein for the Controlled Release of Pharmacologically AcNve Agents and Method of Making the Drug Delivery Devices 7,662,409 – Protein Matrix Materials, Devices and Methods of Making and Using Thereof 8,153,591 – Protein Biomaterials and Biocoacervates and Methods of Making and Using Thereof 8,465,537 – Encapsulated or Coated Stent Systems 8,529,939 – Mucoadhesive Drug Delivery Devices and Methods of Making and Using Thereof 8,623,393 – Biomatrix Structural Containment and FixaNon Systems and Methods of Use Thereof 8,871,267 – Protein Matrix Materials, Devices and Methods of Making and Using Thereof 12 Foreign Patents Granted & Allowed 16 Patent Apps Pending (US & Foreign) Extensive Product Pipeline Pet TherapeuQcs VD-­‐01 OsteoarthriQs VD-­‐02 OsteoarthriQs VD-­‐03 Digital Cushion Lameness VD-­‐04 Urinary InconQnence VD-­‐06 OsteoarthriQs Species Safety Canine (Kush) Equine (Kush) Equine & Bovine Canine Feline (Kush) Biomaterial Safety Pilot Proof of Concept Efficacy Commercial Q4 2015 Q2 2016 2016 2017 2017 HD-­‐05 Dermal Filler FDA Launch Submission 2017 HD-­‐07 OsteoarthriQs HD-­‐08 Dermal Filler -­‐ Lip HD-­‐09 Spinal Disc Repair HD-­‐10 Arteriovenous (AV) Shunt HD-­‐11 Limb Salvage Shunt HD-­‐16 Mucoadhesive Fentanyl HD-­‐17 Vasculitus Wound Closure Human TherapeuQcs HD-­‐12 Female Urinary InconQnence HD-­‐13 Peripheral Vascular Gra[ HD-­‐14 Coronary Artery Bypass Gra[ HD-­‐15 Drug EluQng Stent CoaQng ParQcle Based Devices Preclinical Studies Molded Vascular Devices Pivotal Trial Drug Delivery Devices 2017 2018 2018 2018 2018 2019 2019 2019 2019 2019 2019 ParNcle Devices: Proven Products; Many ApplicaNons ParNcles •  Demonstrated Safety & Efficacy o  Classified as a Medical Device by the FDA o  Pivotal FDA Human Trial Successfully Completed o  Ten Years of Safety & Efficacy in Many Animal Species •  Validated ParNcle Manufacturing CapabiliNes o  Manufacturing FDA Validated For Human Trial Close-­‐up of syringe needle point •  Minor VariaNons Allow DifferenNated Devices o  ParNcle Devices OpNmized for Each IndicaNon & Species o  ConcentraNon, Density, Syringe/Needle Type & Volume •  Ready for Commercial Sale in Pet/Vet Market o  ParNcles Defined as a Medical Device o  No FDA Clearance Required for Veterinary Devices Our Pet/Vet Market •  Large and Growing Market U.S. Pet Owners Spend* $60 $50 $40 $29 $30 $30 $21 $20 $32 $34 $36 $39 $41 $43 $46 $48 $51 $53 $56 $23 $17 $10 $0 Source: APPA; USD in Billions * Agricultural and professional equine markets not included $59 o  2014 U.S. Pet spend $58.4B •  InsensiNve to Recent Recession •  68% of U.S. Households o  96M Cats o  83M Dogs o  8.3M Horses •  Vet care a leading growth driver o  $15B in U.S. (2014) o  26% of Pet Spend o  Five-­‐year CAGR of 6.4% •  Pet TherapeuNcs Account for Just 3% of All Pet Expenditures •  Market Ripe for Bejer and More EffecNve TherapeuNcs Problem: Lameness From OsteoarthriNs (OA) •  OA is a condiNon with degeneraNng carNlage, creaNng joint sNffness from mechanical stress resulNng in inflammaNon and pain •  OA joint sNffness and lameness worsens with Nme from gradual carNlage degeneraNon and an ongoing loss of protecNve cushion and lubricity (i.e., loss of slippery padding) •  Non-­‐steroidal anN-­‐inflammatory drugs (NSAIDS) are used to alleviate the pain and inflammaNon caused by OA, but long-­‐term NSAIDS cause gastric problems •  Moreover, NSAIDS do not treat the carQlage degeneraQon issue to halt or slow progression of the OA condiQon The PetVivo SoluNon: Kush™ Joint InjecNon For OsteoarthriNs •  Superior treatment to safely improve joint funcNon •  ReparaNve Kush parNcles are lubricious, cushioning & long-­‐lasNng •  These spongy protein-­‐based parNcles mimic the composiNon and protecNve funcNon of carNlage (i.e., providing both a slippery cushion and healing scaffolding) •  Kush parNcles protect the joint as an arNficial carNlage Painful Inflamed Joint Kush Treated Joint 4 layers of carNlage Pain InflammaQon Kush ParQcles Cushioning and ProtecQng Joint Kush Canine OA Treatment •  No Current Treatment o Only PalliaNve Pain Therapy -­‐ Joint Replacement •  Affects 20M Owned Dogs (US-­‐EU) •  $2.6B US-­‐EU Market •  Kush Canine Injected Into Synovial Space Using Standard Technique •  No Recovery Period •  MulNple Joints Can Be Treated Simultaneously •  Case Studies Show That Kush Increases Walking-­‐Running AcNvity & Eliminates Pain MedicaNons (e.g., NSAIDS) Kush Equine Lameness Treatment •  No Current ReparaNve Treatment for Equine Joint Lameness •  Annually Affects 1M Horses (US-­‐EU) •  $600M US-­‐EU Market •  Kush Equine Injected Into Synovial Joint Space Using Standard Technique •  No Special Training Required •  MulNple Joints Can Be Treated •  No Special Post-­‐Treatment •  Case Studies Demonstrate the Reduced Appearance of Lameness Beyond Six Months Leveraging Market Shiis: Improving Bojom Line -­‐ AcceleraNng AdopNon •  Historically, drug sales represent up to 30% of revenues at a typical veterinary pracNce (Veterinary PracNce News) •  Revenues and margins at veterinary pracNces are being eroded by online, big box and tradiNonal pharmacies •  PracNces are looking for ways to replace lost drug revenues •  PetVivo is focused on expanding pracNce revenues by providing products that require in-­‐clinic experNse •  Kush treatments at veterinary clinics will grow pracNce revenues and improve margins •  Improving pet health and the bojom line will accelerate Kush adopNon by both pet owners and veterinary pracNces Pet Business Model: PetVivo, Inc. •  US DistribuNon o  Sales through exisNng distributors •  MWI, Pajerson Veterinary, Butler Schein Animal Health o  Regional Business Development & Training Reps •  Educate veterinarians & clinic Staff •  Provide distributor rep training •  Technical support o  MarkeNng & Training •  Demand side pull strategy -­‐ cost-­‐effecNve social media •  Online Media -­‐ consumer educaNon & veterinary professional training •  Canadian DistribuNon o  Establish Canadian distribuNon & technical support & training •  European DistribuNon o  Establish regional EU distribuNon channels Leading Human Devices S
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ynovoLife™ iskLife™ ORTHOPEDIC JOINT TREATMENTS SPINAL DISC TREATMENT CARDIOVASCULAR DISEASE TREATMENTS UroLife™ TREATMENT FOR STRESS URINARY INCONTINENCE CosmetaLife® (Injected Dermal Filler) •  $1.3B WW Dermal Filler Market •  Growing Market 10-­‐15% CAGR ParQcles in Saline Inverted Microscope 100 um
•  Successful 150 PaNent Pivotal Clinical Trial o  Met FDA Primary Efficacy Goal o  No Different Than Restylane o  Split-­‐Face Nasolabial Fold CorrecNon o  Next Step: PMA Submission Pivotal Clinical Trial Results: PaNents Preferred CosmetaLife™
CosmetaLife dermal filler 100 injected into one side and Restylane (Control) injected into other side of 80 each face. Blinded Subjects scored each naso-­‐labial 60 fold using the Global AestheNc Improvement 40 Scale and preferred Gel-­‐
Del’s product at all Nme points. 20 CosmetaLIfe Restylane 0 3-­‐Mos 6-­‐Mos 9-­‐Mos 12-­‐mos Global AestheQc Improvement Scale – Subject Scored Details found at: www.clinicaltrials.gov NCT00414544 CosmetaLife
IniNal 10 subjects per site excluded. Approximately 80 Subjects AddiNonal Human ParNcle Devices & Markets •  SynovoLife – Synovial Joint InjecNon for OsteoarthriNs •  6M (7%) in US SymptomaNc Knee OsteoarthriNs between age 50 to 84 years(1) •  No EffecNve ReparaNve Treatment; Symptom Treatment or Joint Replacement •  CosmetaLife – Lip Dermal Filler •  Extension of Dermal Filler With An IndicaNon Specifically For Lip Plumping •  Current Lip Treatments Either Cause Scarring or Dissipate •  DiscLife – Spinal Disc Repair •  More Than 10% of US Adults Have Chronic Low Back Pain(2) •  InjecNon of ParNcles Into Spinal Disc To Expand/Repair Disc & Relieve Pain •  UroLife – Female Urinary InconNnence •  ParNcles Injected Into The Bladder Wall Around the Urinary Sphincter to Provide RegeneraNve Tissue Bulking to Stop Urinary Leakage •  Current Therapies of Limited EffecNveness, Oien Require Daily MedicaNons •  18.7% of Adult Women Affected by Urinary InconNnence(3) (1) Losina E, Walensky RP, Reichmann WM, Holt HL, Gerlovin H, Solomon DH, et al. Impact of Obesity and Knee OsteoarthriNs on 1Morbidity and Mortality in Older Americans. Ann Intern Med. 2011;154:217-­‐226. (2) Freburger, Janet K., et al. "The rising prevalence of chronic low back pain." Archives of Internal Medicine 169.3 (2009): 251-­‐258. (3) Ebbesen, Marit H., et al. "Prevalence, incidence and remission of urinary inconNnence in women: longitudinal data from the 1Norwegian HUNT study (EPINCONT)." BMC urology 13.1 (2013): 27. Cardiovascular Disease Treatments Ovine TesNng (n=12) Toxicology Comparison Study to ePTFE VasoShunt – Arteriovenous (AV) Shunt VasoGrai & VasoShunt – Biomaterial Conduit Non-­‐Cloqng ArNficial Blood Vessel
CaroNd artery VasoShunt •
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o  Devices & Device CoaNngs 2 wk implantaNon (ovine) VasoShunt o  Improve Any Blood ContacNng Device o  Stents, Grais, Catheters, etc. o  Allows Small Diameter Grais •  Inherent Drug Delivery Capability End to side anastomosis with 12 cm long Vaso-­‐ Grai shunNng caroNd to jugular in sheep (n=6) $5.7 M in NIH Grant Funding Successful 180-­‐Day Swine Studies Successful Pilot ProducNon Any Type of Vascular Grai or Shunt Bejer Than Gold Standard ePTFE Grais Non-­‐Cloqng ProperNes Shunt – tube of biomaterial
VasoShunt: DOD Porcine Cloqng Study •  Length was 5 mm i.d. and 5-­‐6 cm long (wall thickness matches natural blood vessel) •  Able to shunt severed iliac artery for 4–5 hours without cloqng (hemocompaNble) •  No cloqng inside the grai iliac artery shunt VasoShunt NaNve Artery Biomaterial is hemocompatable and structurally sound Conclusion: VasoShunt shows great promise for short term circulatory reconnecNon of severed vessels in military trauma applicaNons Cardiovascular Devices & Markets •  VasoShunt – Arteriovenous (AV) Shunt o  Annually ≈250,000 US Dialysis PaNents Require Vascular Access (US Renal Data System) o  Over 50% of NaNve & ePTFE Shunts Fail Within 1 year(1) •  VasoShunt – Temporary Vascular Shunt for Limb Salvage o  Treatment of Vascular Injuries in Military Theatre & Trauma Seqngs o  No Current Temporary Shunts Have Non-­‐Cloqng Feature of VasoShunt •  Peripheral Vascular Grai o  WW Market Growing From $6.6B in 2014 to $8.4B in 2018 – CAGR of 6.3% (BCC Research) o  No Peripheral Vascular Grais with Non-­‐cloqng Features of VasoGrai Available •  Coronary Artery Bypass Grai o  400,000 CABG Procedures Annually In US (American Heart AssociaNon) o  No Off-­‐The-­‐Shelf Small Diameter Grais Currently Available (1)Akoh JA. ProstheNc AV Grais for Hemodialysis. J Vasc Access. 2009 Jul-­‐Sep;10(3):137-­‐47. Review. PubMed PMID: 19670164.
Kush Markets & Comps •  Veterinary Care: A Leading Growth Driver o  $15B U.S. Veterinary Care Market (2014) o  Five-­‐year CAGR of 6.4% •  Canine OsteoarthriNs Market esNmate: o  20,000,000 dogs with OsteoarthriNs (US-­‐EU) o  $2.6B US-­‐EU Market •  Equine Lameness Market EsNmate o  1,000,000 lame horses (US-­‐EU) o  $600M US-­‐EU Market •  Our comp group consists of companion animal diagnosNc/pharm companies Abaxis, Aratana TherapeuNcs, IDEXX and ZoeNs. Abaxis, IDEXX and ZoeNs currently trade at 4.0x 2015E sales. Dermal Filler Market & Comps
•  $1.3B WW Dermal Filler Market1 •  10-­‐15% CAGR •  Our comp group consists of other dermal filler manufactures and distributors o  Valeant/Nestle May 2014 transacNon ($1.4B, or more than 5.0x sales) o  Allergan trades at over 7.0x 2014 E sales 1WW Dermal Filler Market is an average of the following: Allergan: 2013 WW Filler Market $1.3B, CAGR 10% (5/12/2014) Market Research Reports: 2013 WW Filler Market $1.0B, CAGR 15% (6/17/14) PetVivo Investment Highlights •  IniNal Kush product producNon & revenues Q4 2015 •  Cash flow posiNve within 12 months of commercial launch •  Risk much lower by iniNally focusing on veterinary devices that are in late-­‐stage development •  Business and manufacturing processes easily scalable •  Products proven in both pets & humans •  Extensive pet and human product pipeline •  In-­‐clinic treatments grow vet pracNce revenues and accelerate product adopNon •  Experienced management •  Strong intellectual property por\olio PetVivo Holdings, Inc. OTCPINK: PETV Lameness Repair Company “Running is the Life” 12100 Singletree Lane, Suite 186 Eden Prairie, Minnesota Ph: 612-­‐296-­‐7305 jlai@petvivo.com www.petvivo.com