kiomedine unique soft implant - kiomed pharma
TRANSCRIPT
FOR SUSTAINABLE OSTEOARTHRITIS PAIN RELIEF AND OUTSTANDING RESPONSE RATE
Uniquesoft implant
KioMedinevsone composition
• Primary component: 20mg/ml animal-free KiOmedine® CM Chitosan• Other ingredients: 35mg/ml sorbitol, phosphate-buffered water for injection• Pack contents: pre-filled 3ml sterile glass syringe in blister pack• Indication: one single-shot intraarticular injection for the symptomatic treatment of knee osteoarthritis (OA)
Performance and duration of effect-ClinicaldatafromarandomizedcontrolledtrialinpatientswithOAofthekneehaveshownthatasingleintraarticularinjectionofKioMedinevsone providedsignificantimprovementinpain,stiffnessandfunctionalityupto6months.
- In clinical investigation, the safety profile of a repeated injection of KioMedinevsoneintothekneewasnotalteredafteranintervalof3months.
Dosage and administration-RemovesynovialfluidbeforeinjectingKioMedinevsone.-Strictasepticinjectiontechniqueshouldbeemployedduringtheadmin-istrationofKioMedinevsone.
-DonotusedisinfectantscontainingquaternaryammoniumsaltsforskinpreparationasKioMedinevsonemayprecipitateintheirpresence.
- Use a luer needle of appropriate size, i.e. 20G to 23G, and suitablelengthforinjectingKioMedinevsone.
ContraindicationsForintraarticularuseonly.DonotinjectKioMedinevsoneinpatientswhohave:-aknownallergyorhypersensitivitytoanyoftheproductcomponentsespeciallyediblemushrooms.
- infectionsorskindiseaseatoraroundtheinjectionsite.-severeinflammation,synovitisorinflammatoryarthritisofthekneejoint.-ahistoryofautoimmuneandcrystaldiseases,evidenceoflymphaticorvenousstasisorseriousblooddisorders.
Precaution-TodatenodataisavailableonpotentialinteractionsofKioMedinevsone injectedconcomitantlywithotherintraarticulartreatments.
-KioMedinevsoneshouldnotbeusedinpresenceofsuspiciousinflam-matoryfluid.
Adverse events-Potentialadverseeventsmayoccurafterintraarticularinjections.Injec-tionofKioMedinevsonecancause temporary jointpain, jointeffusion,jointswelling,jointstiffness,jointwarmth,injectionsitepainorsynovitisofthetreatedjoint.Rarecasesofacutesynovialinflammationcharacter-izedbypainfuleffusionoftheknee,andpossiblylow-gradefever,havebeen reported following an intraarticular injection of KioMedinevsone.Analysisofsynovial fluid revealsaseptic fluidwithnocrystals.Theselocal reactions respondwell to rest, cold application, oral painkillers, non-steroidalanti-inflammatorydrugs(NSAIDs)and/orarthrocentesis,andmaynotaffecttheclinicalbenefitofthetreatment.
- IntraarticularinfectionsdidnotoccurintheclinicaltrialofKioMedinevsone.
Information for patientsBefore injecting KioMedinevsone, please inform your patient about itscomposition,performance,contraindicationsandadverseevents:-Asaprecautionarymeasure,thepatientshouldavoidanyintensephys-icalorexcessiveweight-bearingactivitiesfor48hoursaftertheinjec-tionofKioMedinevsone.Thepatientshouldbeadvisedtoprogressivelyusethetreatedkneeandperformregularphysicalexercise.
-Transientlocalreactions,suchasjointpain,effusion,swellingorstiff-ness, have been reported following the injection of KioMedinevsone.Thesesymptomsarecommonpost-injectioncomplicationsofintraar-ticularinjectionsinthetargetpopulationandcanbemanagedwithrest,coldapplicationor/andpressurebandageandmaynotaffecttheclini-calbenefitofthetreatment.
-Whentransientlocalreactionsoccur,thepatientshouldbeadvisedtotakeoralpainkillers(paracetamol)orNSAIDwithoutdelay.
1.Worldwideexclusivelicensetoproducechitosanfrommushrooms,forapplicationsinmedicine/pharmaceuticals:patentfamilyWO03/068824.
2.PatentclaimingKiOmedine®chitosanderivativesandproductsforvariousclinicalindications,filedbyKiOmed:WO2019/105719.
3.DouetteP,ChaussonM,ThéatreE,HermitteL.BiologicalevaluationofKIO014forviscosupplementation-E-DND-KIO014-TD017,Sept2019.
4.RocasalbasG,ChaussonM,HermitteL.IntendedactionassessmentofKIO014-Verificationofnon-clinicalperformance-E-DND-KIO014-TD013,April2020.
5.ABTSassay:MillerNJ,Rice-EvansC,DaviesMJAnewmethodformeasuringantioxidantactivity.BiochemSocTrans1May1993;21(2):95S.PMID:8359548.
6.BentinJ,EmansP,SkaliczkiG,HaverkampD,Asingleinjectionofanimal-freeCA-Chitosanprovideslong-lastingreductionofosteoarthriticsymptoms-TheAPROOVEclinicalstudy.PosterWCO-ESCEO2020.
Wecannotguaranteethatalloftheinformationprovidedisaccurateorcomplete,norcanweguaranteethatitwillbesuitableforauser’sindividualcircumstances.Thisbrochureisthereforeprovidedforinformationpurposesonly.
KiOmed Pharma S.A.4,rueHauteClaire4040Herstal-Belgiumcontact@kiomedpharma.comwww.kiomedpharma.com
References
V02-2021/02
About KiOmed PharmaCapitalizingonahistoryofinnovationandexpertiseinexclusivenaturalchitosanchemistry,KiOmedPharmadevelopsaunique pipeline of medical devicesthataddressesunmetmedicalneedsinhigh-impactpathologiesandmajorsocialburdenssuchasinvalidating osteoarthritis, skin aging and ophthalmology.
For safety concerns and incident reports please contact our medical device vigilance department immediately (e-mail: [email protected]).
Productcode:UDI-DI:05404023514004
For more information, please refer to the instructions for use provided with the package unit and on our website: www.kiomedine-one.com
KioMedinevsoneisthenewgenerationsingleshot injectionintendedforthesymptomatictreatment ofkneeosteoarthritisbasedonworld-firstexclusive animal-freeKiOmedine® CM Chitosan.
KiOmedine® CM Chitosan isapatentedtechnology1,2 madeinBelgium,resultingfromyearsofresearchandinnovation.Thankstoaunique structurethatdiffersfromhyaluronicacidandnaturalchitosan,KioMedinevsonehas anexclusivedualmechanismofactiontotackleOApain andothersymptoms.
ENHANCEMENTOF LUBRICATION
PROTECTION
Effective up to
6 monthsTreatment response up to
76%Sustainable
OA pain reliefOutstanding
response rate
Inarandomizedsingle-blindAPROOVEclinicaltrial,thesafetyandefficacyofasingleshotofKioMedinevsonehavebeenprovenafterinjectionin70patients6.
Noseriousorunexpectedadverseeventsorpatientwithdrawalsrelatedtothesafetyofthetreatmentwerereported.TreatmentRelatedAdverseEvents(TRAEs)weretransientpost-injectionlocaleffectsthatarecommonlyobservedafterIAinjectionofsingleshotproductsandwereconsistentinnature(e.g.pain,swelling),intensityandincidencewitheffectsreportedafterinjectionofcrosslinkedHA-basedproductsO.
Reference APROOVE - stage 2 (63patients)
Arthralgia 25.4%(16)
Joint effusion 6.3% (4)
Joint swelling 6.3% (4)
Musculoskeletal stiffness /
Synovitis/Arthritis 4.8% (3)
capacitythatisroughlyfive times higher(in vitro)thanthatofexistingHAtechnologies.ThisispotentiallylinkedtospecificinteractionsandtheattractionbetweenCM-chitosanmoleculesandReactiveOxygenSpecies(ROS).
Furthermore,KiOmedine® CM Chitosanhasenabledthedevelopmentofaresorbableimplantwithuniquedegradation resistance and up to 1-monthjointresidencetimewithno need for crosslinking3,5.
Scientificevidenceforimprovedlubrication andhighfreeradicalscavenging
ProvensafetyandeffectivenessinOAkneepain reductionafterasingleinjectionofKioMedinevsone
Lubricationcapacitydemonstratedbyalowcoefficientoffriction(COF)andkneemobilityrecoveryafteralesionassessedusingbothin vitroandex vivomodels.
Thankstoitslubricationproperties,KioMedinevsoneoffersimprovedjointfrictionreductionandprovidesbetterkneemobilitywithlong-lastingrelief6.
Enhancement of lubrication and mobility4
Asanaturalfreeradicalscavenger,KioMedinevsoneshowsanunprecedentedfreeradicalscavengingcapacity,whichprotectstheendogenoushyaluronicacidinsynovialfluid.Thisprotectioncanslowdowntheirreversibledegradationcausedbyoxidativestress,whichoccursnaturallyduringthedevelopmentofOA.
KioMedinevsonecontributessignificantlytotheprotectionofendogenoussynovialcomponentsandhasascavenging
Scavenging property5
0 20 40 60 80 100 120 140 160 180 200
FREE RADICAL SCAVENGING CAPACITY(IN EQUIVALENT OF TROLOX)
* Phosphate buffer + 3.5% sorbitol
BUFFER*KioMedinevsone
HA BENCHMARK(NASHA TECHNOLOGY)
HA BENCHMARK(HYLAN GF-20)
KioMedinevsone
***
***
HYALURONAN
95
90
85
80
75
70
65HYALURONAN/CM-CHITOSAN
(RATIO: 1/0,7)
% REMAINING MOLECULAR WEIGHT OF HYALURONAN PLACED 24H IN AN OXIDATIVE ENVIRONMENT
***
0 10
2
10
8
14
12
6
4
2 3 4 5 6 7
EVOLUTION OF WOMAC PAIN SCORE (stage 2, PP cohort, ANOVA for repeated measures, *p<0,0001)
TIME (MONTH)
WOMA
C PAIN
SCOR
E (0/2
0)
KioMedinevsone
OFor more information about adverse events and contraindications, please refer to the instructions for use provided with the package unit and available on our website
OASF*
250
200
*
150
100
50
0MIX KioMedinevsone / OASF*
RATIO 50/50 (V/V)* Synovial Fluid from OsteoArthritis patient
COEFFICIENT OF FRICTIONKioMedinevsone VS OASF
KioMedinevsone HA BENCHMARK(HYLAN GF-20)
HA BENCHMARK(NASHA TECHNOLOGY)
60
50
40
30
20
10
0
COEFFICIENT OF FRICTIONKioMedinevsone VS COMPETITION
HA BENCHMARK(HYLAN GF-20)
100
90
80
70
60
50
40
30
20
10
0KioMedinevsone
% KNEE MOBILITY RECOVERY OFINJURED KNEE IN THE SHEEP MODEL
*
66%reduction in
WOMAC PAIN
86%of patient satisfied
90% of physicians
satisfied