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!!!!!!
PetVivo!Holdings,!Inc.!!OTCPINK:!PETV!
!
October!1,!2015!
!!FORWARDELOOKING!STATEMENTS!Statements!in!this!presentaNon!that!are!not!historical!facts!are!“forwardElooking!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! “forwardElooking! statements”.! Statements!regarding! future! plans! and! objecNves! are! forwardElooking!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)!
GelEDel!! PetVivo!• Royalty!Free!Mayo!Clinic!Technology!Transfer!• IniNal!Focus!–!Vet!Devices!Developed!for!Humans!• No!FDA!Approval!Required!for!Vet!Devices!!• Kush!Canine!ProducNon!&!Revenues!Q1!‘16!!• Cash!Flow!PosiNve!Within!12!Months!PostElaunch!• Validated!&!Scalable!Manufacturing!• Successful!Pivotal!FDA!Human!Trial!!• $13M+!Invested!Including!$7M!From!NIH!• Strong!IP!&!Extensive!Product!Pipeline!
!Our!Pet/Vet!Market!U.S.!Pet!Owners!Spend*!!
Source:!APPA;!USD!in!Billions!*!Agricultural!and!professional!equine!markets!not!included!!!
• Large!and!Growing!Market!o 2015E!U.S.!Pet!Spend!$60B!
• 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 FiveEyear!CAGR!of!6.4%!
• Pet!TherapeuNcs!Account!for!Just!3%!of!All!Pet!Expenditures!!
• Market!Ripe!for!Bener!and!More!EffecNve!TherapeuNcs!
$59!!$56!
$53!$51!
$48!$46!
$43!$41!
$39!$36!
$34!$32!
$30!$29!
$23!$21!
$17!
$0!!
$10!!
$20!!
$30!!
$40!!
$50!!
$60!!
Problem:!Canine!&!Equine!!Lameness!From!OsteoarthriNs!(OA)!• No!current!treatment!for!OA,!only!palliaNve!pain!therapy!
or!joint!replacement!• OA!is!a!condiNon!with!degeneraNng!carNlage,!creaNng!
joint!sNffness!from!mechanical!stress!resulNng!in!inflammaNon!&!pain!
• OA!lameness!worsens!with!Nme!from!ongoing!loss!of!protecNve!cushion!and!lubricity!(i.e.,!loss!of!slippery!padding)!
• NSAIDS!are!used!to!alleviate!the!pain!and!inflammaNon,!but!longEterm!cause!gastric!problems!
• NSAIDS&do¬&treat&the&car0lage°enera0on&issue&to&halt&or&slow&the&progression&of&the&OA&condi0on&&
Our!SoluNon:!Kush™!Joint!InjecNon!for!the!Treatment!of!OsteoarthriNs!
• Superior!treatment!to!safely!improve!joint!funcNon!• ReparaNve!Kush!parNcles!are!lubricious,!cushioning!&!longElasNng!• These!spongy!proteinEbased!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!
Pain& Inflamma0on&
Kush&Treated&Joint&
Kush&Par0cles&Cushioning&and&Protec0ng&Joint&
4&layers&of&car0lage&
Painful&Inflamed&Joint&
!!!!Kush!Canine!OA!Treatment!• Kush!Canine!ParNcles!Injected!!Into!Synovial!Space!!
• Standard!IntraEArNcular!Technique!!• No!Special!Training!• MulNple!Joints!Can!Be!Treated!Simultaneously!
• No!Recovery!Period!• Case!Studies!Show!That!Kush!Canine!Increases!WalkingERunning!AcNvity!&!Eliminates!Pain!MedicaNons!(e.g.,!NSAIDS)!
!!!Kush!Equine!Lameness!Treatment!• No!Current!ReparaNve!Treatment!for!Equine!Joint!Lameness!
• Kush!Equine!Injected!Into!Synovial!Joint!Space!Using!Standard!Technique!
• No!Special!Training!Required!• MulNple!Joints!Can!Be!Treated!• No!Special!PostETreatment!!• Case!Studies!Demonstrate!the!!Reduced!Appearance!of!Lameness!Beyond!Six!Months!
Kush!!vs.!CompeNNon!Treatment( Rimadyl((NSAID) Hyaluronic(Acid(((((((((((((((((((((((((((((
Joint(InjectionsTotal(Joint(Replacement( Kush™(Canine(0(PetVivo
Pro Temporary(Pain(ReliefTemporary(Pain(Relief(((((((((((((((((Good(Safety(Profile (Joint(Replaced
Protects(Joint(0(Increases(
Activity(0(Reduces(Pain(0(
Excellent(Safety(Profile
Con
Potential(for(Gastric(Ulcers(and(Kidney(Problems(Does(
Not(Treat(Condition(
Effectiveness(Diminishes(Over(30(Days(J(
Minimally(Invasive(((((
Invasive(and(Expensive(Surgical(Procedure(
Requiring(RehabilitationMinimally(Invasive(((
Typical(((((
Owner(Cost*
$0.90(J($2.40(per(day(((((((Blood(Testing(Required((to(
Monitor(Toxicity$150(J($250(per(joint
$2,000(J($4,000((((((((((((((((per(joint $400(0($600(per(joint(
Annual(((((((
Owner(Cost($400(J($700 $1,800(J($3000 $2,000(J($4,000 $400(0($600(
Treatment(Once(or(Twice(Daily(((((((((((((((
by(OwnerMonthly((((((((((((((((((((((((((((
at(Vet((Clinic(Surgery(and(Rehab Typically(Once(per(Year(((((((((((((
at(Vet(Clinic
Vet(Revenue(
Opportunity
Vet(Revenue(Declining(Animal(Scripts(Can(Now(be(Filled(at(Most(Pharmacies
(Short(Duration(of(Effectiveness(Limits(Repeat(Business
Good(OneJTime(Revenue(Surgical(Expertise(Required(((((
Price(Resistance(
Repeat/Referral(Business(
Due(to(Kush's(Effectiveness/(
Duration/Value(Multiple(
Joints(Can(Be(Treated
*Costs(may(very(depending(on(animal(size,(dosing(and(treatment(location
IniNal!Kush!Markets!&!Comps!• Kush!Canine:!OsteoarthriNs!Market!EsNmate!!!
• 20,000,000!dogs!with!OsteoarthriNs!(USEEU)!• $2.6B&USIEU&Market&&
• Kush!Equine:!Lameness!Market!EsNmate!• 1,000,000!lame!horses!(USEEU)!• $600M&USIEU&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!to!5.0x!2014!sales.!!
Pet!Business!Model:!PetVivo,!Inc.!• US!DistribuNon!!
o Sales!through!exisNng!veterinary!distributors!!• MWI,!Panerson!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!E!costEeffecNve!social!media!!• Online!Media!E!consumer!educaNon!&!veterinary!professional!training!
• Canadian!DistribuNon!!o Establish!Canadian!distribuNon!&!technical!support!&!training!
• European!DistribuNon!o Establish!regional!EU!distribuNon!channels!!
!! !Pet&Therapeu0cs&& Species! Safety! Pilot!! Efficacy! Commercial!!VDE01! &Osteoarthri0s& !Canine!(Kush)! !! !! !! !! Q1&2016&&VDE02!!&Osteoarthri0s& !Equine!(Kush)! !! !! !! !! Q3&2016&VDE03!!&Digital&Cushion&Lameness& !Equine!&!Bovine! !! !! !! 2016&VDE04! &Urinary&Incon0nence&& !Canine! !! !! !! !! 2017&VDE06! &Osteoarthri0s& !Feline!(Kush)! !! !! !! !! 2017&
Pet!&!Human!Product!Pipeline!
Par0cle&Based&Devices&& Molded&Vascular&Devices&& Drug&Delivery&Devices&
!!!Human&Therapeu0cs& Biomaterial!
Safety!Proof!of!Concept!
Preclinical!Studies!
Pivotal!!Trial!!
FDA!Submission! Launch!
HDE05! &Dermal&Filler& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2017&HDE07! &Osteoarthri0s& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2017&HDE08! &Dermal&Filler&I&Lip& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018&HDE09! &Spinal&Disc&Repair& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018&HDE10! &Arteriovenous&(AV)&Shunt&& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018&HDE11! &Limb&Salvage&Shunt& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018&HDE12! &Female&Urinary&Incon0nence& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&HDE13! &Peripheral&Vascular&Gra^&& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&HDE14! &Coronary&Artery&Bypass&Gra^& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&HDE15! &Drug&Elu0ng&Stent&Coa0ng& !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&HDE16! &Mucoadhesive&Fentanyl&& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&HDE17! &Vasculitus&Wound&Closure& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&
&
9,107,937&–!Wound!Treatments!with!Crosslinked!Protein!Amorphous!Biomaterials!8,871,267&–!Protein!Matrix!Materials,!Devices!and!Methods!of!Making!and!Using!Thereof!!8,623,393&–!Biomatrix!Structural!Containment!and!FixaNon!Systems!and!Methods!of!Use!Thereof!!8,529,939&–!Mucoadhesive!Drug!Delivery!Devices!and!Methods!of!Making!and!Using!Thereof!!8,465,537!–!Encapsulated!or!Coated!Stent!Systems!8,153,591!–!Protein!Biomaterials!and!Biocoacervates!and!Methods!of!Making!and!Using!Thereof!7,662,409!–!Protein!Matrix!Materials,!Devices!and!Methods!of!Making!and!Using!Thereof!!6,342,250!–!Drug!Delivery!Devices!Comprising!BioEdegradable!Protein!for!the!Controlled!Release!of!Pharmacologically!AcNve!Agents!&!Method!of!Making!12&Foreign&Patents&Granted&&&Allowed&!16&Patent&Apps&Pending&(US&&&Foreign)!&&
Comprehensive!IP!Porvolio!!!!!!!!!!!!!!!Eight!Issued!US!Patents!
VerNcally!Integrated!IP!Porvolio!Raw!Materials!to!Finished!Products!• Eight!US!Patents!with!328!Claims!• Broad!Claim!Language!E!“Comprising”!TransiNons!• Our!Patents!&!Trade!Secrets!Protect:!
• Protein!&!Carbohydrate!Based!ThermoplasNcs!• Biomaterials!of!Many!ComposiNons!!• Medical,!Drug!Delivery!&!CombinaNon!Products!• Medical!&!PharmaceuNcal!ApplicaNons!• Validated!SelfEAssembly!ProducNon!Processes!
• Our!Intellectual!Property!is!Extensively!Cited!!• Over!150!Patent!Examiners!CitaNons!!• Over!250!Patent!Applicant!CitaNons!
• The!biomaterial!in!Kush!is!made!up!of!an!aggregated!assembly!of!nanoEsized!spheres!(i.e.!Proteoids)!
• Each!Proteoid!is!composed!of!proteins!and!carbohydrates,!the!building!blocks!of!mammalian!Nssue!
Proprietary!AggregaNon!/!SelfEAssembly!Manufacturing!Process!
Experienced!Proven!Leadership&
Randall&A.&Meyer&Chief!OperaNng!Officer!&!Director.!Mr.!Meyer!has!over!25!years!of!leadership!experience!in!medical!device!development!and!commercializaNon!including!experNse!in!successfully!growing!medical!device!companies!from!concept!to!profitability!as!a!Chief!ExecuNve!Officer,!Chief!OperaNng!Officer!and!Director.&!!!
John&Lai&CoEfounder,!CEO!&!Chairman.!Mr.!Lai!has!over!30!years!of!senior!operaNons!and!financial!experience!and!has!served!as!CEO,!President,!CFO,!and!Director!for!several!public!companies.!Mr.!Lai!has!extensive!experience!in!capital!structure,!financial!analysis,!business!formaNon,!mergers,!acquisiNons!and!driving!producNon!revenue!growth.!!
John&F.&Dolan&CoEfounder,!CFO,!General!Counsel!&!Director.!Mr.!Dolan!has!over!25!years!of!experience!as!a!legal!professional,!patent!anorney,!corporate!council!and!senior!execuNve!as!an!expert!in!the!uNlizaNon!of!IP!to!capitalize!and!commercialize!enNNes.!He!has!served!as!a!USPTO!patent!examiner!in!the!organic!chemistry!and!biotechnology!area.!!
David&B.&Masters,&Ph.D.&President,!CTO!&!Director.!Dr.!Masters!is!an!entrepreneur,!biochemist,!biomaterials!expert!and!inventor!with!credenENals!from!Rutgers,!Harvard,!U!of!MN!and!the!Mayo!Clinic.!Dr.!Masters!has!over!30!years!of!experience,!including!>50!publicaNons,!FDA!clinical!trial,!36!issued!or!pending!patents!and!>$7!million!in!NIH!grant!awards.!!
Proven!Products!E!Validated!Mfg.!!Pet!Market!Launch!Ready!
• Demonstrated!Human!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!Species!
• Validated!Manufacturing!!o Manufacturing!FDA!Validated!For!Human!Trial!!o SingleEUse!Inline!MFG!Processes!o Very!Scalable!Manufacturing!!o Low!CAPEX!Infrastructure!!o Room!Temp!Stable!Beyond!24!Months!
• Commercial!Ready!in!Pet/Vet!Market!o ParNcles!Defined!as!a!Medical!Device!!o No!FDA!Clearance!Required!for!Vet!Devices!o Significant!Margins!!!!!
!
!!
CloseEup!of!syringe!needle!
point!
ParNcles!
PetVivo!Investment!Highlights!• IniNal!Kush!product!producNon!&!revenues!Q1!2016!• Cash!flow!posiNve!within!12!months!of!commercial!launch!• Risk!much!lower!by!iniNally!focusing!on!veterinary!devices!
that!are!in!lateEstage!development!• Business!and!manufacturing!processes!easily!scalable!!!!!• Products!proven!in!both!pets!&!humans!• Extensive!pet!and!human!product!pipeline!• InEclinic!treatments!grow!vet!pracNce!revenues!and!
accelerate!product!adopNon!• Experienced!management!!• Strong!intellectual!property!porvolio!
PetVivo™!Holdings,!Inc.!!OTCPINK:!PETV!
“Running!is!the!Life”!
12100!Singletree!Lane,!Suite!186!Eden!Prairie,!Minnesota!
Ph:[email protected]!www.petvivo.com!
Appendix!A!!
Technology!!&!!
Manufacturing!!
Patented!BioCoacervaNon!!ProducNon!Process!
PrecipitaNon!of!Extracellular!Matrix!Components!(Collagen,!!!!!!ElasNn,!Heparin)!into!a!Coacervate!that!is!heat!processed!into!ThermoplasNc!Extracellular!Matrix!(ECM)!Biomaterial!
PrecipitaNon! CoacervaNon! Coacervate!
MasterGel!!Biomaterial!
*Enhanced!Extracellular!Matrix!Accumulation!in!Restenosis!of!Coronary!Arteries!After!Stent!Deployment,!IEM!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!!
ElasNn!
Glycosaminoglycans!
Natural!Precursor!ECM!!Formed!in!Coronary!Artery!!During!Stent!Restenosis*!
Matches!Natural!Precursor!Extracellular!Matrix!!! Osmium!Tetroxide!Stained!Samples!Show!Very!Similar!TEM!Micrographs!
!
CostEEfficient!Scalable!Manufacturing
• Manufacturing!Process!FDA!Validated!for!Human!Clinical!Trial!ProducNon!
• Manufacturing!Scaled!from!0.01!Kilograms!to!Several!Kilograms!in!Practice!E!Thousands!of!Syringes!
• Very!Consistent!Lot!to!Lot!ProducNon!• SingleEUse!Sterile!Bag!Processing!
Eliminates!Cleaning!Steps,!Reduces!Infrastructure!and!Increases!Capacity!
ThermoplasNc!ProperNes:!Simplified!Manufacturing;!Many!ApplicaNons Figure 1A
Coated!Catheter!
Molded!Gra{!
Melted!MasterGel!
Bener!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!SelfEAssemble!=!BiocoacervaNon!o Forms!Insoluble!Matrix!–!Slippery,!Wet,!Permeable,!Durable!&!Resilient!o Mimics!Natural!Precursor!Scaffold!in!ComposiNon,!Structure!&!HydraNon!o Promotes!NeovascularizaNon!&!is!NonEClo~ng!o Facilitates!Cellular!IntegraNon!&!RegeneraNon!of!FuncNonal!Tissue!
• Flexible!&!Adjustable!Biomaterial!Plavorm!!o Modifying!ComposiNon!&!Components!Adjusts!Material!CharacterisNcs!!
Appendix!B!!
Human!TherapeuNcs!
!Leading!Human!Devices!
!!!SynovoLife™!
ORTHOPEDIC!JOINT!TREATMENTS!
!!!!SPINAL!DISC!TREATMENT&!!!!DiskLife™!! CARDIOVASCULAR!DISEASE!TREATMENTS!
!UroLife™!
TREATMENT!FOR!STRESS!URINARY!INCONTINENCE!
CosmetaLife®!(Injected!Dermal!Filler)!
100 um
Par0cles&in&Saline&Inverted&Microscope!
• $1.3B!WW!Dermal!Filler!Market!
• Growing!Market!10E15%!CAGR!
• Successful!150!PaNent!Pivotal!Clinical!Trial!o Met!FDA!Primary!Efficacy!Goal!!o No!Different!Than!Restylane!!o SplitEFace!Nasolabial!Fold!
CorrecNon!o Next!Step:!PMA!Submission!
Pivotal!Clinical!Trial!Results:!!PaNents!Preferred!CosmetaLife™
CosmetaLife!dermal!filler!injected!into!one!side!and!Restylane!(Control)!injected!into!other!side!of!each!face.!Blinded!Subjects!scored!each!nasoElabial!fold!using!the!Global!AestheNc!Improvement!Scale!and!preferred!GelEDel’s!product!at!all!Nme!points.!
Details!found!at:!www.clinicaltrials.gov!NCT00414544!CosmetaLife
0!
20!
40!
60!
80!
100!
3EMos! 6EMos! 9EMos! 12Emos!
CosmetaLIfe!
Restylane!
Global&Aesthe0c&Improvement&Scale&–&Subject&Scored&IniNal!10!subjects!per!site!excluded.!Approximately!80!Subjects!
!!
Dermal!Filler!Market!&!Comps!• $1.3B!WW!Dermal!Filler!Market1!
• 10E15%!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)!!
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,!O{en!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;154:217E226.!!(2)!Freburger,!Janet!K.,!et!al.!"The!rising!prevalence!of!chronic!low!back!pain."!Archives!of!Internal!Medicine!169.3!(2009):!251E258.!(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.!
Ovine!TesNng!(n=12)!Toxicology!Comparison!Study!to!ePTFE!
Cardiovascular!Disease!Treatments!
VasoShunt!–!Arteriovenous!(AV)!Shunt!!!
!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!Se~ngs!o No!Current!Temporary!Shunts!Have!NonEClo~ng!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!NonEclo~ng!Features!of!VasoGra{!Available!!
• Coronary!Artery!Bypass!Gra{!o 400,000!CABG!Procedures!Annually!In!US!(American!Heart!AssociaNon)!o No!OffETheEShelf!Small!Diameter!Gra{s!Currently!Available!!
(1)Akoh!JA.!ProstheNc!AV!!Gra{s!for!!Hemodialysis.!J!Vasc!Access.!2009!JulESep;10(3):137E47.!Review.!PubMed!PMID:!19670164.!
VasoGra{!&!VasoShunt!–!Biomaterial!Conduit!!!!NonEClo~ng!ArNficial!Blood!Vessel
• $5.7!M!in!NIH!Grant!Funding!• Successful!180EDay!Swine!Studies!• Successful!Pilot!ProducNon!• Any!Type!of!Vascular!Gra{!or!Shunt!!• Bener!Than!Gold!Standard!ePTFE!Gra{s!• NonEClo~ng!ProperNes!
o Devices!&!Device!CoaNngs!o Improve!Any!Blood!ContacNng!Device!o Stents,!Gra{s,!Catheters,!etc.!o Allows!Small!Diameter!Gra{s!
• Inherent!Drug!Delivery!Capability!!
CaroNd!artery! VasoShunt!
2!wk!implantaNon!(ovine)!
VasoShunt!
End!to!side!anastomosis!with!12!cm!long!VasoE!!!Gra{!shunNng!caroNd!to!jugular!in!sheep!(n=6)!
!Shunt!–!tube!of!biomaterial VasoShunt:!U.S.!Dept.!of!Defense!Porcine!Clo~ng!Study!• Length!was!5!mm!i.d.!and!5E6!cm!long!(wall!thickness!matches!natural!
blood!vessel)!• Able!to!shunt!severed!iliac!artery!for!4–5!hours!without!clo~ng!
(hemocompaNble)!!• 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!reconnecNon!of!severed!vessels!in!military!trauma!applicaNons!
Biomaterial!is!hemocompatable!and!structurally!sound!!
VasoShunt!
NaNve!Artery!
iliac artery shunt!