PetVivo Holdings Inc. (PETV) Corporate Presentation
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PetVivo Holdings Inc. (PETV) Corporate Presentation April 2016
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PetVivo Holdings Inc. (PETV) Corporate Presentation
- 2. !!!!!!FORWARD(LOOKING!STATEMENTS! This!presenta7on!and!the!accompanying!oral!commentary!contains!forwardClooking!statements!within!the!meaning! of!the!federal!securi7es!laws,!which!statements!are!subject!to!substan7al!risks!and!uncertain7es!that!could!cause! actual!results!to!differ!materially!from!those!an7cipated!or!projected!by!the!forwardClooking!statements.!ForwardC looking!statements!include!all!statements!that!are!not!statements!of!historical!facts!and!can!be!iden7fied!by!words! such! as! “an7cipates,”! “believes,”! “seeks,”! “es7mates,”! “expects,”! “intends,”! will,”! “would,”! “may,”! “plans,”! “poten7al,”!“predicts,!“projects,”!“should,”!“could,”!or!similar!expressions!and!the!nega7ves!of!those!expressions.!In! par7cular,!forwardClooking!statements!contained!in!this!presenta7on!and!the!accompanying!oral!commentary!relate! to,!among!other!things,!the!effec7veness!of!our!Kush™!therapeu7c!well!as!our!ability!to!develop!and!successfully! commercialize!other!companion!animal!or!human!therapeu7cs,!our!future!or!assumed!financial!condi7on,!results!of! opera7ons,!strategic!plans!and!objec7ves,!product!development!plans,!use!of!proceeds,!compe77ve!posi7on,!and! poten7al!opportuni7es.! ForwardClooking! statements! represent! our! management’s! current! beliefs! and! assump7ons! based! on! informa7on! currently!available.!Forward!looking!statements!involve!numerous!known!and!unknown!risks,!uncertain7es!and!other! factors!that!may!cause!our!actual!results,!performance!or!achievements!to!be!materially!different!from!any!future! results,!performance!or!achievements!expressed!or!implied!by!the!forwardClooking!statements.!We!discuss!these! risks,!uncertain7es!and!other!factors!in!the!sec7on!en7tled!“Risk!Factors”!in!our!Annual!Report!on!Form!10CK!that!we! filed!with!the!Securi7es!and!Exchange!Commission!(“SEC”)!on!March!23,!2016,!as!well!as!in!our!other!filings!with!the! SEC.!Except!as!required!by!law,!we!assume!no!obliga7on!to!update!any!forwardClooking!statements!publicly,!or!to! update!the!reasons!actual!results!could!differ!materially!from!those!an7cipated!in!these!forward!looking!statements,! even!if!new!informa7on!becomes!available!in!the!future.! Certain!of!the!informa7on!provided!in!this!presenta7on,!and!the!accompanying!oral!commentary,!has!been!obtained! from! independent! industry! sources,! publica7ons! or! research! reports.! This! informa7on! has! been! obtained! from! sources!we!believe!to!be!reliable.!However,!we!have!not!independently!verified!such!informa7on.!
- 3. Investment!Highlights!! • Commercial!stage!pet!therapeu7cs!company! • Ready!to!launch!commercializa7on!of!a!par7culate!device!for!the!$2B! osteoarthri7s!market!in!companion!animals!with!funding! • Kush™!product!offers!significant!benefits!for!the!management!of!pain!over! NSAIDs!which!are!the!exis7ng!standard!of!care!but!have!side!effects,!require! monitoring!and!are!o_en!not!well!tolerated! • Kush™!offers!significant!highCmargin,!revenue!opportuni7es!to!veterinarians! compared!to!other!scripts!providing!incen7ves!to!create!significant!demand! • InCclinic!treatments!grow!vet!prac7ce!revenues!and!accelerate!product! adop7on! • Expect!Kush™!Canine!produc7on!and!revenues!within!4C5!months!of!funding!! • Validated!and!scalable!manufacturing! • Extensive!pet!and!human!product!pipeline! • Experienced!management!! • Strong!intellectual!property!porbolio!
- 5. • GelCDel!Founded!in!1999!by!Dr.!David!Masters!and!headquartered!in!St.!Paul,!MN! • Completed!a!reverse!merger!on!3/11/14!with!Technologies!Scan!Corp!to!become! a!public!company!and!subsequently!renamed!PetVivo! • Technology!originally!developed!by!Dr.!Masters!at!Mayo!Clinic!and!then!licensed! on!a!royalty!free!technology!transfer! • Core!technology!for!thermoplas7c!proteinCbased!biomaterials!that!mimic!the! bodys!7ssue!to!allow!integra7on,!7ssue!repair!and!regenera7on!for!longCterm! implanta7on! • Pivoted!business!model!to!also!focus!on!$2B+!animal!therapeu7cs!market! • Lead!animal!product!is!VDC01!“(Kush™)!for!osteoarthri7s!indica7on!in!canines!! o No!FDA!Approval!Required!for!Vet!Devices!! • Lead!human!product!is!HDC05,!a!dermal!filler!for!wrinkles!the!cosme7c!market! o Successful!Pivotal!FDA!Human!Trial!! o PMA!Submission!deferred!un7l!a_er!Kush!commercializa7on!and!Company!completes! a!larger!capital!raise! • Over!$14M+!Invested!Including!$7M!From!NIH! • Strong!IP!&!Extensive!Product!Pipeline! PetVivo!Overview!!
- 6. !Companion!Animal!&!Veterinarian!Market!Overview! U.S.!Pet!Owners!Spend*!! Source:!APPA;!USD!in!Billions! *!Agricultural!and!professional!equine!markets!not!included! !! • Large!and!Growing!Market! o 2016E!U.S.!Pet!Spend!$63B! • Insensi7ve!to!Recent!Recession!! • 68%!of!U.S.!Households!!!! o 86M!Cats! o 78M!Dogs! o 8.3M!Horses! • Vet!Care!a!Leading!Growth!Driver! o $16B!in!U.S.!(2016E)! o 26%!of!Pet!Spend! • Pet!Therapeu7cs!Account!for!Just! 3%!of!All!Pet!Expenditures!! • Market!Ripe!for!Beher!and!More! Effec7ve!Therapeu7cs! $63! $60! $58! $56! $53! $51! $48! $46! $43! $41! $39! $36! $34! $32! $30!$29! $23! $21! $17! $0! $10! $20! $30! $40! $50! $60! $70!
- 7. Unmet!Medical!Need:!Canine!&!Equine!Lameness! From!OsteoarthriRs!(OA)! • OA!is!a!condi7on!with!degenera7ng!car7lage,!crea7ng! joint!s7ffness!from!mechanical!stress!resul7ng!in! inflamma7on!&!pain! • No!current!treatment!for!OA,!only!pallia7ve!pain!therapy! or!joint!replacement! • OA!lameness!worsens!with!7me!from!ongoing!loss!of! protec7ve!cushion!and!lubricity!(i.e.,!loss!of!slippery! padding)! • NSAIDS!are!used!to!alleviate!the!pain!and!inflamma7on,! but!longCterm!cause!gastric!problems! • NSAIDS!do!not!treat!the!carRlage!degeneraRon!issue!to! halt!or!slow!the!progression!of!the!OA!condiRon!!
- 8. Our!SoluRon:!Kush™!Joint!InjecRon!for!the!Treatment! of!OsteoarthriRs! • Superior!treatment!to!safely!improve!joint!func7on! • Repara7ve!Kush!par7cles!are!lubricious,!cushioning!&!longClas7ng! • These!spongy!proteinCbased!par7cles!mimic!the!composi7on!and! protec7ve!func7on!of!car7lage!(i.e.,!providing!both!a!slippery!cushion! and!healing!scaffolding)! • Kush!par7cles!protect!the!joint!as!an!ar7ficial!car7lage! Pain! InflammaRon! Kush!Treated!Joint! Kush!ParRcles!Cushioning!and! ProtecRng!Joint! 4!layers!of! carRlage! Painful!Inflamed!Joint!
- 9. !!!!Kush!Canine!OA!Treatment! • Kush!Canine!Par7cles!Injected!! Into!Synovial!Space!! • Standard!IntraCAr7cular!Technique!! • No!Special!Training! • Mul7ple!Joints!Can!Be!Treated! Simultaneously! • No!Recovery!Period! • Case!Studies!Show!That!Kush! Canine!Increases!WalkingCRunning! Ac7vity!&!Eliminates!Pain! Medica7ons!(e.g.,!NSAIDS)!
- 10. !!!Kush!Equine!Lameness!Treatment! • No!Current!Repara7ve!Treatment!for! Equine!Joint!Lameness! • Kush!Equine!Injected!Into!Synovial! Joint!Space!Using!Standard! Technique! • No!Special!Training!Required! • Mul7ple!Joints!Can!Be!Treated! • No!Special!PostCTreatment!! • Case!Studies!Demonstrate!the!! Reduced!Appearance!of!Lameness! Beyond!Six!Months!
- 11. IniRal!Kush!Markets!&!Comps! • Kush!Canine:!Osteoarthri7s!Market!Es7mate!!! • 20,000,000!dogs!with!Osteoarthri7s!(USCEU)! • $2.6B!US(EU!Market!! • Kush!Equine:!Lameness!Market!Es7mate! • 1,000,000!lame!horses!(USCEU)! • $600M!US(EU!Market! • Our!comp!group!consists!of!nine!animal!health!&! pet!therapeu7cs!companies.!This!group!includes! Abaxis,!Aratana!Therapeu7cs,!IDEXX!and!Zoe7s.! Companies!in!our!comp!group!currently!trade!at!an! average!of!7.5x!2016!revenues.!
- 12. Annual&Exams& 17% Diagnostics 17% Surgery& 17%Non9Invasive& Procedures 9% Pet&Food 4% Heartworm& Product&Sales 6% Flea9Tick&Sales 6% Vaccinations 15% Other&Pharma 9% • Declining!sales!of!high! margin!scripts!that!can!now! be!filled!at!pharmacies! • Vets!looking!for!addi7onal! ways!to!drive!revenue!and! traffic! • Kush!can!offer!significantly! higher!margin!opportunity!at! the!same!price!point!as! exis7ng!OA!medicines!while! providing!beher!outcomes! with!less!side!effects!for! animals! Source:(DVM(Newsmagazine’s(State(of(the(Profession(Report(for(2012( • According!to!DVM!Newsmagazine,!!veterinarians!es7mated!the!total!dollar! amount!at!which!most!of!their!clients!would!refuse!or!stop!treatment!for!their! pets!has!increased!from!$576!in!1997!to!$1,704!in!2012! !!!!Changing!Veterinarian!Business!Model!
- 13. Kush!!vs.!CompeRRon! Treatment! Kush!Canine!(!PetVivo! Rimadyl!(NSAID)! Hyaluronic!Acid!Joint! InjecRons! Aratana! !Galliprant®!(AT(001)! Total!Joint!Replacement! !! !! !! !! !! !! !! !! !! !! !! !! !!Pro! !!Protects!Joint,!Increases! Ac7vity,!Reduces!Pain,! Excellent!Safety!Profile! !!Temporary!Pain!Relief! !!Temporary!Pain!Relief! Good!Safety!Profile! !!Temporary!Pain!Relief! with!claimed!reduced!risk! of!gastric!ulcers!and! kidney!problems!! !!Joint!Replaced! !! !! !! !! !! !! !! !! !! !! !! !! !!Con! !!Minimally!Invasive! !!Poten7al!for!gastric!ulcers! and!kidney!problems!does! not!treat!condi7on! !!Effec7veness!diminishes! over!30!days!C!Minimally! invasive! !!Only!trea7ng!OA!pain! without!trea7ng!OA! condi7on! !!Invasive!and!expensive! surgical!procedure! requiring!rehabilita7on! !! !! !! !! !! !! !! !! !! !! !! !! !!Dosing/Treatment! !!Typically!injected!once!per! year! !!Once!or!twice!daily!by! owner! !!Monthly!injec7on!at!vet! clinic! !!Daily!by!owner!! !!Surgery!and!Rehab! !! !! !! !! !! !! !! !! !! !! !! !! !!Typical!Owner!Cost*!!!$400C$600!per!joint! !!$0.90!C!$2.40!per!day! (toxicity!monitoring!extra)! !!$150!C!$250!per!joint! !!TBD! !!$2,000!C!$4,000!per!joint! !! !! !! !! !! !! !! !! !! !! !! !! !!Annual!Owner!Cost! !!$400!C!$600! !!$400!C!$700! !!$1,800!C!$3,000! !!TBD! !!$2,000!C!$4,000! !! !! !! !! !! !! !! !! !! !! !! !! !!Vet!Revenue! Opportunity! !!Significant!revenue!and! margin!opportunity,! Repeat/Referral!business! due!to!Kush's! effec7veness!and! dura7on,!mul7ple!joints! can!be!treated! !!Vet!revenue!declining!as! animal!scripts!can!now!be! filled!at!most!pharmacies! !!Short!dura7on!of! effec7veness!limits!repeat! business! !!At!this!7me!it!is!unclear! where!prescrip7ons!will! be!filled! !!Good!one!7me!revenue! Surgical!exper7se! required! Price!resistance! !! !! !! !! !! !! !! !! !! !! !! !! *Costs(vary(depending(on(animal(size,(dosing(and(treatment(locaFon(
- 14. Regulatory!Environment!&!Strategy!! • No!FDA!PMA!or!510(k)!approval!is!required!for!medical!devices!used!in!veterinary!medicine! • FDA!defines!a!medical!device!as!an!apparatus!or!other!item!that!does!not!achieve!its!intended! purpose!through!chemical!reac7on!in!the!body!and!is!not!dependent!on!being!metabolized!in!the! body! • Demonstrated!Human!Safety!&!Efficacy! C Classified!as!a!Medical!Device!by!the!FDA!–!no!chemical!reac7ons!with!Kush!par7cles!and! they!are!not!metabolized!in!the!body! C Pivotal!FDA!Human!Trial!Successfully!Completed!! C Ten!Years!of!Safety!&!Efficacy!in!Many!Species! • Commercial!Ready!in!Pet/Vet!Market! C Par7cles!Defined!as!a!Medical!Device!! C No!FDA!PMA!or!510(k)!Clearance!Required!for!Vet!Devices! C Significant!Margins!! • There!are!strong!precedents!of!comparable!medical!devices!marketed!under!this!exemp7on!in!the! veterinary!market:! C Polyglycan®!C!solu7on!used!to!supplement!and!replace!synovial!fluid!in!the!joints!of!animals! C Peridan™!C!a!sterile!veterinary!device!for!reduc7on!of!surgical!adhesions!in!horses!
- 15. CommercializaRon!Strategy!&!Sales!Channels! • US!Distribu7on!! o Sales!through!exis7ng!veterinary!distributors!which!account!for!75%!of! U.S.!distribu7on! • MWI,!Paherson!Veterinary,!Butler!Schein!Animal!Health!! o Regional!Business!Development!&!Training!Reps! • Educate!veterinarians!&!clinic!Staff! • Provide!distributor!rep!training! • Technical!support! o Marke7ng!&!Training! • Demand!side!pull!strategy!C!costCeffec7ve!social!media!! • Online!Media!C!consumer!educa7on!&!veterinary!professional! training! • Canadian!Distribu7on!! o Establish!Canadian!distribu7on!&!technical!support!&!training! • European!Distribu7on! o Establish!regional!EU!distribu7on!channels! !
- 16. !! !Pet!TherapeuRcs!! Species! Safety! Pilot!! Efficacy! Commercial!! VDC01! !OsteoarthriRs! !Canine!(Kush)! !! !! !! !! Q3!2016!! VDC02!!!OsteoarthriRs! !Equine!(Kush)! !! !! !! !! Q4!2016! VDC03!!!Digital!Cushion!Lameness! !Equine!&!Bovine! !! !! !! 2017! VDC04! !Urinary!InconRnence!! !Canine! !! !! !! !! 2018! VDC06! !OsteoarthriRs! !Feline!(Kush)! !! !! !! !! 2017! !Pet!&!Human!Product!Pipeline! ParRcle!Based!Devices!! Molded!Vascular!Devices!! Drug!Delivery!Devices! !! !Human!TherapeuRcs! Biomaterial! Safety! Proof!of! Concept! Preclinical! Studies! Pivotal! !Trial!! FDA! Submission! Launch! HDC05! !Dermal!Filler! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2017! HDC07! !OsteoarthriRs! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018! HDC08! !Dermal!Filler!(!Lip! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019! HDC09! !Spinal!Disc!Repair! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019! HDC10! !Arteriovenous!(AV)!Shunt!! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019! HDC11! !Limb!Salvage!Shunt! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019! HDC12! !Female!Urinary!InconRnence! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019! HDC13! !Peripheral!Vascular!Grag!! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2020! HDC14! !Coronary!Artery!Bypass!Grag! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2020! HDC15! !Drug!EluRng!Stent!CoaRng! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2020! HDC16! !Mucoadhesive!Fentanyl!! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2020! HDC17! !Vasculitus!Wound!Closure! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2020!
- 17. Cost(Efficient!Scalable!Manufacturing • Validated!Manufacturing!Process! o Manufacturing!FDA!Validated!For!Human!Clinical!Trial! Produc7on!! o SingleCUse!Inline!MFG!Processes! o Very!Scalable!Manufacturing!! o Very!consistent!lotCtoClot!produc7on! o SingleCuse!sterile!nag!processing!eliminate!cleaning! steps,!reduces!infrastructure!and!increases!capacity! o Low!CAPEX!Infrastructure!! o Product!is!Room!Temp!Stable!Beyond!24!Months! • Base!par7cle!materials!manufactured!internally!then! asep7cally!placed!into!syringes!and!packaged!for! distribu7on! ! • Company!has!already!scaled!manufacturing!to!produce!batches!of!two!Kilograms!of!base! par7cles!which!equates!to!approximately!5,000!2mL!syringes!or!roughly!$650,000!of!sales! based!on!distributor!prices! • Company!will!retain!manufacturing!of!base!material!in!house!to!protect!IP!but!will!look!to! outsource!syringe!filling!and!packaging!once!they!reach!appropriate!scale!
- 18. Comprehensive!IP!Poriolio!(!Eight!Issued!US!Patents! • Eight!US!Patents!with!328!Claims! • Broad!Claim!Language!C!“Comprising”!Transi7ons! • Our!Patents!&!Trade!Secrets!Protect:! • Protein!&!Carbohydrate!Based!Thermoplas7cs! • Biomaterials!of!Many!Composi7ons!! • Medical,!Drug!Delivery!&!Combina7on! Products! • Medical!&!Pharmaceu7cal!Applica7ons! • Validated!SelfCAssembly!Produc7on!Processes! • Our!Intellectual!Property!is!Extensively!Cited!! • Over!150!Patent!Examiners!Cita7ons!! • Over!250!Patent!Applicant!Cita7ons!
- 19. Investment!Highlights! • Commercial!stage!pet!therapeu7cs!company! • Ready!to!launch!commercializa7on!of!a!par7culate!device!for!the!$2B! osteoarthri7s!market!in!companion!animals!with!funding! • Kush™!product!offers!significant!benefits!for!the!management!of!pain!over! NSAIDs!which!are!the!exis7ng!standard!of!care!but!have!side!effects,!require! monitoring!and!are!o_en!not!well!tolerated! • Kush™!offers!significant!highCmargin,!revenue!opportuni7es!to!veterinarians! compared!to!other!scripts!providing!incen7ves!to!create!significant!demand! • InCclinic!treatments!grow!vet!prac7ce!revenues!and!accelerate!product! adop7on! • Expect!Kush!Canine!produc7on!and!revenues!within!4C5!months!of!funding!! • Validated!and!scalable!manufacturing! • Extensive!pet!and!human!product!pipeline! • Experienced!management!! • Strong!intellectual!property!porbolio!
- 25. Beher!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,!Elas7n!&!Heparin! o Same!Components!As!Natural!Extracellular!Matrix! • Components!SelfCAssemble!=!Biocoacerva7on! o Forms!Insoluble!Matrix!–!Slippery,!Wet,!Permeable,!Durable!&!Resilient! o Mimics!Natural!Precursor!Scaffold!in!Composi7on,!Structure!&!Hydra7on! o Promotes!Neovasculariza7on!&!is!NonCClong! o Facilitates!Cellular!Integra7on!&!Regenera7on!of!Func7onal!Tissue! • Flexible!&!Adjustable!Biomaterial!Plaborm!! o Modifying!Composi7on!&!Components!Adjusts!Material!Characteris7cs! !
- 28. CosmetaLife®!(Injected!Dermal!Filler)! 100 um ParRcles!in!Saline! Inverted!Microscope! • $1.3B!WW!Dermal!Filler!Market! • Growing!Market!10C15%!CAGR! • Successful!150!Pa7ent!Pivotal! Clinical!Trial! o Met!FDA!Primary!Efficacy!Goal!! o No!Different!Than!Restylane!! o SplitCFace!Nasolabial!Fold! Correc7on! o Next!Step:!PMA!Submission!
- 29. Pivotal!Clinical!Trial!Results:!! Pa7ents!Preferred!CosmetaLife™ CosmetaLife!dermal!filler! injected!into!one!side!and! Restylane!(Control)! injected!into!other!side!of! each!face.!Blinded!Subjects! scored!each!nasoClabial! fold!using!the!Global! Aesthe7c!Improvement! Scale!and!preferred!GelC Del’s!product!at!all!7me! points.! Details!found!at:! www.clinicaltrials.gov! NCT00414544!CosmetaLife 0! 20! 40! 60! 80! 100! 3CMos! 6CMos! 9CMos! 12Cmos! CosmetaLIfe! Restylane! Global!AestheRc!Improvement!Scale!–!Subject!Scored! Ini7al!10!subjects!per!site!excluded.!Approximately!80!Subjects! ! !
- 30. Dermal!Filler!Market!&!Comps! • $1.3B!WW!Dermal!Filler!Market1! • 10C15%!CAGR! • Our!comp!group!consists!of!other!dermal!filler! manufactures!and!distributors! o Valeant/Nestle!May!2014!transac7on!($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)! !
- 31. Addi7onal!Human!Par7cle!Devices!&!Markets! • SynovoLife!–!Synovial!Joint!Injec7on!for!Osteoarthri7s!!! • 6M!(7%)!in!US!Symptoma7c!Knee!Osteoarthri7s!between!age!50!to!84!years(1)! • No!Effec7ve!Repara7ve!Treatment;!Symptom!Treatment!or!Joint!Replacement! • CosmetaLife!–!Lip!Dermal!Filler! • Extension!of!Dermal!Filler!With!An!Indica7on!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)! • Injec7on!of!Par7cles!Into!Spinal!Disc!To!Expand/Repair!Disc!&!Relieve!Pain!! • UroLife!–!Female!Urinary!Incon7nence!! • Par7cles!Injected!Into!The!Bladder!Wall!Around!the!Urinary!Sphincter!to!Provide! Regenera7ve!Tissue!Bulking!to!Stop!Urinary!Leakage! • Current!Therapies!of!Limited!Effec7veness,!O_en!ReC1uire!Daily!Medica7ons! • 18.7%!of!Adult!Women!Affected!by!Urinary!Incon7nence(3)! ! (1)!Losina!E,!Walensky!RP,!Reichmann!WM,!Holt!HL,!Gerlovin!H,!Solomon!DH,!et!al.!Impact!of!Obesity!and!Knee!Osteoarthri7s!on! 1Morbidity!!!and!Mortality!in!Older!Americans.!Ann!Intern!Med.!2011;154:217C226.!! (2)!Freburger,!Janet!K.,!et!al.!"The!rising!prevalence!of!chronic!low!back!pain."!Archives!of!Internal!Medicine!169.3!(2009):!251C258.! (3)!Ebbesen,!Marit!H.,!et!al.!"Prevalence,!incidence!and!remission!of!urinary!incon7nence!in!women:!longitudinal!data!from!the! 1Norwegian!HUNT!study!(EPINCONT)."!BMC!urology!13.1!(2013):!27.!
- 33. !Cardiovascular!Devices!&!Markets! • VasoShunt!–!Arteriovenous!(AV)!Shunt! o Annually!≈250,000!US!Dialysis!Pa7ents!Require!Vascular!Access!(US!Renal!Data!System)! o Over!50%!of!Na7ve!&!ePTFE!Shunts!Fail!Within!1!year(1)! • VasoShunt!–!Temporary!Vascular!Shunt!for!Limb!Salvage! o Treatment!of!Vascular!Injuries!in!Military!Theatre!&!Trauma!Sengs! o No!Current!Temporary!Shunts!Have!NonCClong!Feature!of!VasoShunt! • Peripheral!Vascular!Gra_!! o WW!Market!Growing!From!$6.6B!in!2014!to!$8.4B!in!2018!–!CAGR!of!6.3%!(BCC!Research)! o No!Peripheral!Vascular!Gra_s!with!NonCclong!Features!of!VasoGra_!Available!! • Coronary!Artery!Bypass!Gra_! o 400,000!CABG!Procedures!Annually!In!US!(American!Heart!Associa7on)! o No!OffCTheCShelf!Small!Diameter!Gra_s!Currently!Available! ! (1)Akoh!JA.!Prosthe7c!AV!!Gra_s!for!!Hemodialysis.!J!Vasc!Access.!2009!JulCSep;10(3):137C47.!Review.!PubMed!PMID:!19670164.!
- 34. VasoGra_!&!VasoShunt!–!Biomaterial!Conduit!!!! NonCClong!Ar7ficial!Blood!Vessel • $5.7!M!in!NIH!Grant!Funding! • Successful!180CDay!Swine!Studies! • Successful!Pilot!Produc7on! • Any!Type!of!Vascular!Gra_!or!Shunt!! • Beher!Than!Gold!Standard!ePTFE!Gra_s! • NonCClong!Proper7es! o Devices!&!Device!Coa7ngs! o Improve!Any!Blood!Contac7ng!Device! o Stents,!Gra_s,!Catheters,!etc.! o Allows!Small!Diameter!Gra_s! • Inherent!Drug!Delivery!Capability! ! Caro7d! artery! VasoShunt! 2!wk!implanta7on!(ovine)! VasoShunt! End!to!side!anastomosis!with!12!cm!long!VasoC!!! Gra_!shun7ng!caro7d!to!jugular!in!sheep!(n=6)!
- 35. !Shunt!–!tube!of!biomaterial VasoShunt:!U.S.!Dept.!of!Defense!Porcine!Clong!Study! • Length!was!5!mm!i.d.!and!5C6!cm!long!(wall!thickness!matches!natural! blood!vessel)! • Able!to!shunt!severed!iliac!artery!for!4–5!hours!without!clong! (hemocompa7ble)!! • 3.8!mm!ID!small!diameter!gra_s!patent!for!over!6!months!in!porcine! femoral!artery! Conclusion:!VasoShunt!shows! great!promise!for!short!term! circulatory!reconnec7on!of! severed!vessels!in!military! trauma!applica7ons! Biomaterial!is!hemocompatable!and! structurally!sound!! VasoShunt! Na7ve! Artery! iliac artery shunt!