GI Dynamics, Inc. - ASX Announcement
Data Presented at ADA Show the Effects of GI Dynamics' EndoBarrier® Therapy on Glycemic Control and Reducing Diabetes Medication in Patients with Type 2 Diabetes and ObesityData Presented at the Scientific Sessions of the American Diabetes Association Demonstrate Increased Bile Acids Levels Following EndoBarrier Therapy; Further Establishes Potential Mechanism of Action
SAN FRANCISCO, United States and SYDNEY, Australia - 16 June 2014 - GDI ynamicsI,nc. (ASX: GID)ma, edicadlevicceompandevelopininnovati vtereatmentfsotrypd2eiabeteasnd
obesityt,odaaynnouncedatfainding
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dremonstrattehaecuteffects
oEf ndoBarrier
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gnlycemicontroli,tasbility troeducreeliancoedniabetems edications,
includininsulina,ws elalfsi ndingtshahtelexpl aiintpsotentiaml ech anismoafctionT. hese findingws erperesentedinthr epeosteprresentationastth7e4 tSh cientifiScessionostfhAe merican DiabeteAs ssociatioiSnaFrancisco.
"ThdeatparesenteaAt DAexpanupoalreades tablishedevidencperesentedrecentlyaotther
medicaml eetingasndfurthevralidatheowthEe
ndoBarriedrevicwe orktsoaffecatndimprove
glycemicontrol,s"aiDaviMaggsM, .Dc.,hief medicaolfficerG,DI ynamicsI,nc".Thfeindings fromthessetudieasnanalysesshowthaEt ndo BarrieprositivelimpactHs bA1acnweighitn patientws ittypd2eiabeteasnobesityI.mporta ntlyt,hfeindingaslso showthaEt ndoBarrier Therapcareducreeliancoedniabetes medicationsf,romoraalgents tionsulitnherapyT. hiisasn importanctonsiderationfoprhysicianastsheyco ntemplattereatmenrtegimenfsotrheipratients."
Acute Effects on Glucose; Impact on Satiety and Insulin Requirements Findingfsromthsetudy",ThAe cutEe ffecotf EndoBarrieTr reatmenotn GlucosHe omeostasiisn ObesUe ncontrolleDiabetiScubjects,e"valuate dtheffectostfhEe ndoBarriedrevicoenglucose homeostasisH, bA1cw, eighltossi,nsulirequire mentasndappetitien33patientsG. lucoswe as monitorecdontinuouslfyoorne weebkeginnintgwdoaybsefore placemenottfhdeevice.
UsoetfhEe ndoBarriedrevicreesulteianancute droianveragdeailglucosbe2y9%withidays positmplantationd,espitraeeduction o5f0%iinsulidosdeurinth itsimeA. esarlya1s2weeks afteEr ndoBarrieirnsertions,ubjec tdsemonstratesadignificanrteduc tioinbnotwh eigh(t-8.k9ga)nd HbA1lcevel(s-1.4%l)eadingtoa decreasieinnsulin requirementsI.nterestinglyw, eighltosws as accompaniedbdyaecreasienappetitdeem onstratebdtyhveisuaalnalosgcale.
"ThaebilitotfhEe ndoBarrietraocutelaffect glucosheomeostasisb,efore significanwt eighltoss hahsacdahancteoccuirfsascin atingandresemblerseportosnbari atriscurgery,s"tatedGabriella LiebermanM, .D.I,nstitutoeEf ndocrinologyS,hebMa edi caCl enterT, eAl vivI,s rael".Thfeactthat thdeeviciempactaslwl eightg,lucosaendappetite makeiastttractivfeotrhtereatmenotdfiabesity
www.gidynamics.com
US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA 02421 T +1 (781) 357-3300 F +1 (781) 357-3301
EUROPEAN OFFICE: De Tweeling 20-22 's-Hertogenbosch 5215 MC, THE NETHERLANDS T: + 31 13 547 9300
AUSTRALIAN OFFICE: Level 8, 17-19 Bridge Street, Sydney, NSW 2000 T +61 2 9325 9046
GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN 151 239 388
GI Dynamics, Inc. - ASX Announcement Page 2
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Improvements in HbA1c, Weight Loss and Reduction of Oral Diabetes Medications
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devictelooweHr bA1ca,cceleratwe eighltosas
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analysisp,resenteitnhpeoste"rEndoscopic, Duodenal-JejunaBl ypasLs ineEr xertRs obust ImprovemenitnGlycemiandBodyWeighitnObese Patientws itTh ypD2e i abetes,e"valuate71 patientws hocompleted12months oEf ndoBarrieTr herapy.
ThuesoetfhEe ndoBarriedrevi creesulteid1an.4%mediadn
ecreasieHn bA1(cfrom8.2%at
baselinte6o.8)o;tfhes5e7%achievethre
AssociationP.atientesxperienced
ecommended7%HbA1octfhAe mericanDiabetes raobusetffecottnotablodweight losws ithEndoBarrieTr herapy,
resultinig1an0.4%reductio(nf rom106.abtaselinte9o3.kg)N. otablyp,atientws eraeblteo reducuesoebfackgroundiabetems edications.
Increased Levels of Bile Acids Following Treatment with EndoBarrier Researchaisndicatetdhabtile acidlsevelms aybe tiettoheffectiv enesosgfastribcypass surgerys,ucaRs oux-en-Ygastribcypas(sRYGB )T. hperesentation",Duodenal-JejunaBl ypass LineIrncreaseBs ilAe cidLs evelisPnatientws ith SeverOe besitanTypD2e iabeteMs ellitus" investigatetdhuesoef thEe ndoBarriedrevicaend itesffectosbnilaecids toexplorietpsotential mechanismoafction.
Primaransecondarbilaecidlsevelws erme easur eidsnevepnatientws
itthypd2eiabeteasnd
obesitypriotroplacemenottfhEe ndoBarriedrevi caendfollowingremovaal5t2weekostfreatment. Aftetrreatmentf,asti ntgotablilaecidlseve lisncreasetd4o.3±0.8 μmol/L(from0.7±0.3 μmol/L baselinep;<0.05)A. lsof,asting primary(from0.04±0.01to2.1±0.4 μmol/La)ndsecondary(from
0.07±0.0t1o.5±0.4 μmol/Lb)ilaecidlsevelisn creasefrombaselin(ep<0.0vsb.aselinfeobroth). Thesfeindingosffefrurtheirnsighitntthme ech anismtshautnderlitehe therapeutiecffecotf EndoBarrieTr herapy.
EndoBarrieTr herapdoensowt orfoerveryonea;
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studiest,hme osctommocnomplica tionws erneauseav,omitinganduppearbdominaplaiOnt.her uncommorniskisncludienfectiont,r aumad,evicme igratioanbleedi nga,nyowf hichmayresulitn endoscopiocsrurgicarlemoval.
ThEe ndoBarriedreviciecsurrentlyundeirnvestigati oninthUe .Sim.na ulti centerp,ivotacllinical trial (ThEe NDOTrial) fotrhtereatmenotpfatientws hohave uncontrolletypd2eiabeteasnare obeseE. ndoBarrieTr herapyhabseenapprovedinse lecctountrieisnterna tionallsyinc2e01a0nids availablieCn hileA, ustralia ansdelecctountrieisEn ur opaentdhMe iddlEe ast.
www.gidynamics.com
US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA 02421 T +1 (781) 357-3300 F +1 (781) 357-3301
EUROPEAN OFFICE: De Tweeling 20-22 's-Hertogenbosch 5215 MC, THE NETHERLANDS T: + 31 13 547 9300
AUSTRALIAN OFFICE: Level 8, 17-19 Bridge Street, Sydney, NSW 2000 T +61 2 9325 9046
GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN 151 239 388
GI Dynamics, Inc. - ASX Announcement Page 3
About GI DynamicsGDI ynamicsI,nc(.ASXG: IDi)tshdeevelopeorEf ndoBarrier ®t,hfeirsetndoscopicall y-deliveredevicteh erapyapprovedfotrhe
treatmenotfyp2deiabeteasnd/oorbesityE. ndoBarrieiars
pprovedancdommerciallayvailabliemn ultiplceountrieosutsidte
hUe .S.
EndoBarrieinrsoatpprovedfosralietnh
Ue .Sa.ndilsimitebdyfederallawto investigationaulsoenlyinthUe nitedStates
G. I
Dynamiciscsonductinpagivotal clinicatlriaolEf ndoBarrier itnhUe .Sf.otrhtereatmenotpfati entws hohavuencontrolletdyp2e diabeteasnadroebeseF.oundedin2003G, I DynamicishseadquartereidLn exingtonM, a ssachusettsF.omr orienformationp,lease visit www.gidynamics.com.
Forward-Looking StatementsThiasnnouncemenctontainfsorward-lookingst atementcsoncerningo:udrevelopmenatn
cdommercializationpl anso;uprotential
revenuesc,ostsp,rofitabilityanfdinanciaplerformanceo;uarbil itytobtairneimbursemenftooruprroductso;ucrlinicatlr ialsa,nd associatedregulatorysubmissionasnd approvalst;hneumbearnldocationocfo mmerciaclentreosfferintghEe ndoBarrier ®a;ndour intellectuaplropertypositioTnh. esfeorw ard-lookingstatementasrbeasedotnhceurrenetstimateasnedxpectationosffuture eventbsy thme anagemenotGf DI ynamicsI,nca.ostfhdeatoetfhis announcemenatnadrseubjecttnaoumbeorrfiskasnudncertainties that
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amounotoftheerxpensese;xecutionrisksc;ompetitionr;iskrsela tedtmo arkeatcceptancoepfroductsi;ntellectuaplropertyr isksa;nd assumptionrsegardintghseizoetfhaevai lablme arketb,enefitosofuprroducts, producptricingt,imingopfroducltaunches, future financiarlesultasndothefract oGrsi.vetnhesuencertaintiesy,oushouldnot placuendureeliancoenthesfeorward-lookings tatements.
Wdeonoatssumaenyobligationtopubliclyupdatoerevisaeny forward-lookinsgtatementsw, hethe futureventosortherwis eu,nlesrsequirebdylaw.
arrasesulotnfewinforma tion,
Investor Enquiries: Media Enquiries:
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RoberCt raneC, hieFfinanciaOl fficer
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www.gidynamics.com
US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA 02421 T +1 (781) 357-3300 F +1 (781) 357-3301
EUROPEAN OFFICE: De Tweeling 20-22 's-Hertogenbosch 5215 MC, THE NETHERLANDS T: + 31 13 547 9300
AUSTRALIAN OFFICE: Level 8, 17-19 Bridge Street, Sydney, NSW 2000 T +61 2 9325 9046
GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN 151 239 388
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