From a DES to a BMS* Biosensors Clinical Trial Program. Taking the LEAD in DES Clinical Excellence. From Single de Novo.
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1 Biosensors Clinical Trial Program Taking the LEAD in DES Clinical Excellence Our trials gather clinical data for this technology from a wide range of patients, including those with single de novo lesions, multiple vessel disease, acute coronary syndromes, bifurcations, left main, small vessels and extreme long lesions. Ordering Information Stent Length () Stent Diameter (). BMX- BMX- BMX- BMX- BMX- BMX-. BMX- BMX- BMX- BMX- BMX- BMX-.7 BMX-7 BMX-7 BMX-7 BMX-7 BMX-7 BMX-7 Trial n Planned FU Status Comparator STEALTH PK 7 yr Completed yrs yrs FU completed Gazelle (BMS) BEACON I yr Completed 77 yrs yrs FU completed Cypher (DES). BMX- BMX- BMX- BMX- BMX- BMX- BEACON II 7 yrs d FU available. BMX- BMX- BMX- BMX- BMX- BMX-. BMX- BMX- BMX- BMX- BMX- BMX- e- PMS PMR yrs PMS Enrollment Completed PMR Currently enrolling e- India PMD PMR yrs Currently enrolling Biosensors International Group, Ltd. licenses its proprietary BA drug and PLA technology to Terumo Corporation (Nobori ), Devax, Inc. (AXXESS ) and Xtent, Inc. (XTENT ). In vivo testing in porcine model demonstrates abluminal coating is absorbed after to months Data on file at Biosensors Intl n=7. Data on file at Biosensors Intl. Klauss, V.,, -year Clinical Follow-Up, oral presentation, TCT. Wykrzykowska, J., oral presentation, Late Breaking Trial Session, EuroPCR. Grube, E., Safety and Performance Evaluation of Biosensors Eluting Stent ( ) : a -year safety follow-up, e-poster, TCT The stent was used in the clinical trial. Di Mario, C., OCT: Differences between biodegradable and durable polymers Insights from the trial, oral presentation, TCT n=. Barlis, P. et al., An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a trial sub-study; European Heart Journal (), Hamilos, M. et al. on behalf of the Nobori Core investigators, Differential Effects of Drug-Eluting Stents on Local Endothelium-Dependent Coronary Vasomotion, J Am Coll Cardiol :- Randomized Multicenter Clinical Trial vs Gazelle (:) Primary Endpoint: In-Stent Late Loss at months Results:. vs. (p <.) BEACON I. Windecker, S. et al., Biolimus-eluting stent with biodegradable polymer versus -eluting stent with durable polymer for coronary revascularization (): a randomised non inferiority trial ; The Lancet ; 7 No. : -7. Windecker, S. et al., NEJM ; Morice, M.-C. et al., JAMA ; Serruys, P.W. et al., EuroIntervention ; Stone, G.W. et al., JAMA ; Costa, M. et al., Am J Card ; Chevalier, B. et al., EuroIntervention ; Ostojic, M. et al., EuroIntervention ; Stone, G.W. et al., NEJM ; Krukoff, M.W., JACC ; Verheye, S. et al., ACC/SCAI n= Cardiac Death, MI or TVR at months n=77 To Real World Randomized Multicenter All-Comers Clinical Trial vs Primary Endpoint: CV death, MI, clinically-indicated TVR at months Results: n=7. n= e- n=+ Drug Eluting Stent System is CE approved. p non-inferiority =. Multicenter Post Market Registry Primary Endpoint: MACE at months Ischemic Driven MI (Q-wave and NQ-wave) and Ischemic Driven TLR (PTCA and CABG) Multicenter Post Market Registry PMS: n= PMR: n= Primary Endpoint: MACE at months. n=7 CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. BEACON II. Compared to the stent platform Flexibility and trackability: n= in each group,. x stents Side branch access: n = in each group,. x /. x stents Bench test results may not necessarily be indicative of clinical outcomes Primary Endpoint Multicenter Registry Primary Endpoint: TVR at months Results:. Cumulative Incidence () From Single de Novo Registry, Pharmacokinetics Primary Endpoint: drug concentration at days and months e- India Months of Follow-Up 7 Flex,, Juno, Biolimus A and BA are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and other countries. All cited trademarks are the property of their respective owners. Not available for sale in the United States and certain other countries. Biosensors International Group, Ltd. All rights reserved. n= Multicenter Post Market Registry PMD: n= PMR: n= Primary Endpoint: MACE at months PMS = Post Market Surveillance PMR = Post Market Registry PMD = Post Market registry Diabetics - EN Rev. STEALTH PK From a DES to a BMS
2 Proven safety of a DES with an abluminal biodegradable polymer Significant Reduction in Cardiac Mortality in Complex Patients at Years Syntax Score High (>) With a reduction in MACE compared to the Cypher stent at years in From a DES to a BMS With no late or very late stent thrombosis in out to years year years HR. [. to.7] p =.7 HR. [. to.] p =. Cypher Cardiac Death Rate () Confirmed safety Cumulative Incidence () MACE (Cardiac Death, MI or TVR) at years p sup = n= n= post-hoc analysis The stent reduces the cardiac death rate by. compared to the Cypher stent at years = values for superiority Abluminal biodegradable coating No drug carrier or drug inside the stent: Early BMS-like endothelial. x x p=... n= n= (n strut=7) (n strut=) Endothelialization () in the mini swine model at days n= n= (n strut=7) (n strut=) The stent achieves. of near to complete strut Superior stent apposition More than times better stent apposition of the stent than the stent at months -.. BMS In the animal model, the stent achieves a similar level of re-endothelialization compared to its bare metal stent platform Distal vessel: change in diameter after pacing 7. p<. vs Baseline p<. vs Baseline. Proven efficacy of the drug Superior strut times better strut of the stent than the Cypher stent at months -.7 p=.. malapposed struts - Mortality benefit Months of follow-up p uncovered struts -. Abnormal vasomotion (vasoconstriction) was observed for the sirolimus eluting stent group after high pacing stimulation, while normal vasomotion (vasodilatation) was observed in the BA eluting stent group p=.. More targeted drug release. Reduced systemic exposure BA drug / Biodegradable PLA technology demonstrates preserved vasomotion 7. In-Stent Late Luminal Loss at months Low Late Loss. Lower level of late loss achieved in the trial with the stent at months compared to the stent. Highest pacing step Nitroglycerin eluting stent reference segment eluting stent stimulated segment eluting stent reference segment eluting stent stimulated segment.. Baseline. BA drug times more lipophilic than.... SPIRIT III.... SPIRIT II..7. GENESIS Pimecrolimus JUPITER Tacrolimus COSTAR II TAXUS IV Nobori Ph RESOLUTE REALITY Minimizes systemic exposure and reduces the drug circulating in the bloodstream.. Highest lipophilicity of the coon limus drugs. SIRTAX In stent late loss in =.. Due to high lipophilicity, the drug is rapidly absorbed by tissue For descriptive purposes only RCTs with different protocols should not be compared PLA biodegradation and BA drug elution from a DES Enhanced deliverability with advanced stent design Abluminal coating absorbed after - months to a BMS trackability flexibility trackability force (N) compressive force (N). - flexibility The curved connectors combined with the Quadrature Link design give the Juno stent platform improved flexibility, while preserving stent security and vessel scaffolding Deliverability defined as a combination of flexibility, trackability and pushability n = units for each group. x stents Less force needed to bend the stent for improved deliverability n = units for each group. x stents Less force needed with the stent to navigate through tortuous vessels for improved deliverability Larger side branch access initial cell opening to facilitate the side branch access
3 Proven safety of a DES with an abluminal biodegradable polymer Significant Reduction in Cardiac Mortality in Complex Patients at Years Syntax Score High (>) With a reduction in MACE compared to the Cypher stent at years in From a DES to a BMS With no late or very late stent thrombosis in out to years year years HR. [. to.7] p =.7 HR. [. to.] p =. Cypher Cardiac Death Rate () Confirmed safety Cumulative Incidence () MACE (Cardiac Death, MI or TVR) at years p sup = n= n= post-hoc analysis The stent reduces the cardiac death rate by. compared to the Cypher stent at years = values for superiority Abluminal biodegradable coating No drug carrier or drug inside the stent: Early BMS-like endothelial. x x p=... n= n= (n strut=7) (n strut=) Endothelialization () in the mini swine model at days n= n= (n strut=7) (n strut=) The stent achieves. of near to complete strut Superior stent apposition More than times better stent apposition of the stent than the stent at months -.. BMS In the animal model, the stent achieves a similar level of re-endothelialization compared to its bare metal stent platform Distal vessel: change in diameter after pacing 7. p<. vs Baseline p<. vs Baseline. Proven efficacy of the drug Superior strut times better strut of the stent than the Cypher stent at months -.7 p=.. malapposed struts - Mortality benefit Months of follow-up p uncovered struts -. Abnormal vasomotion (vasoconstriction) was observed for the sirolimus eluting stent group after high pacing stimulation, while normal vasomotion (vasodilatation) was observed in the BA eluting stent group p=.. More targeted drug release. Reduced systemic exposure BA drug / Biodegradable PLA technology demonstrates preserved vasomotion 7. In-Stent Late Luminal Loss at months Low Late Loss. Lower level of late loss achieved in the trial with the stent at months compared to the stent. Highest pacing step Nitroglycerin eluting stent reference segment eluting stent stimulated segment eluting stent reference segment eluting stent stimulated segment.. Baseline. BA drug times more lipophilic than.... SPIRIT III.... SPIRIT II..7. GENESIS Pimecrolimus JUPITER Tacrolimus COSTAR II TAXUS IV Nobori Ph RESOLUTE REALITY Minimizes systemic exposure and reduces the drug circulating in the bloodstream.. Highest lipophilicity of the coon limus drugs. SIRTAX In stent late loss in =.. Due to high lipophilicity, the drug is rapidly absorbed by tissue For descriptive purposes only RCTs with different protocols should not be compared PLA biodegradation and BA drug elution from a DES Enhanced deliverability with advanced stent design Abluminal coating absorbed after - months to a BMS trackability flexibility trackability force (N) compressive force (N). - flexibility The curved connectors combined with the Quadrature Link design give the Juno stent platform improved flexibility, while preserving stent security and vessel scaffolding Deliverability defined as a combination of flexibility, trackability and pushability n = units for each group. x stents Less force needed to bend the stent for improved deliverability n = units for each group. x stents Less force needed with the stent to navigate through tortuous vessels for improved deliverability Larger side branch access initial cell opening to facilitate the side branch access
4 Proven safety of a DES with an abluminal biodegradable polymer Significant Reduction in Cardiac Mortality in Complex Patients at Years Syntax Score High (>) With a reduction in MACE compared to the Cypher stent at years in From a DES to a BMS With no late or very late stent thrombosis in out to years year years HR. [. to.7] p =.7 HR. [. to.] p =. Cypher Cardiac Death Rate () Confirmed safety Cumulative Incidence () MACE (Cardiac Death, MI or TVR) at years p sup = n= n= post-hoc analysis The stent reduces the cardiac death rate by. compared to the Cypher stent at years = values for superiority Abluminal biodegradable coating No drug carrier or drug inside the stent: Early BMS-like endothelial. x x p=... n= n= (n strut=7) (n strut=) Endothelialization () in the mini swine model at days n= n= (n strut=7) (n strut=) The stent achieves. of near to complete strut Superior stent apposition More than times better stent apposition of the stent than the stent at months -.. BMS In the animal model, the stent achieves a similar level of re-endothelialization compared to its bare metal stent platform Distal vessel: change in diameter after pacing 7. p<. vs Baseline p<. vs Baseline. Proven efficacy of the drug Superior strut times better strut of the stent than the Cypher stent at months -.7 p=.. malapposed struts - Mortality benefit Months of follow-up p uncovered struts -. Abnormal vasomotion (vasoconstriction) was observed for the sirolimus eluting stent group after high pacing stimulation, while normal vasomotion (vasodilatation) was observed in the BA eluting stent group p=.. More targeted drug release. Reduced systemic exposure BA drug / Biodegradable PLA technology demonstrates preserved vasomotion 7. In-Stent Late Luminal Loss at months Low Late Loss. Lower level of late loss achieved in the trial with the stent at months compared to the stent. Highest pacing step Nitroglycerin eluting stent reference segment eluting stent stimulated segment eluting stent reference segment eluting stent stimulated segment.. Baseline. BA drug times more lipophilic than.... SPIRIT III.... SPIRIT II..7. GENESIS Pimecrolimus JUPITER Tacrolimus COSTAR II TAXUS IV Nobori Ph RESOLUTE REALITY Minimizes systemic exposure and reduces the drug circulating in the bloodstream.. Highest lipophilicity of the coon limus drugs. SIRTAX In stent late loss in =.. Due to high lipophilicity, the drug is rapidly absorbed by tissue For descriptive purposes only RCTs with different protocols should not be compared PLA biodegradation and BA drug elution from a DES Enhanced deliverability with advanced stent design Abluminal coating absorbed after - months to a BMS trackability flexibility trackability force (N) compressive force (N). - flexibility The curved connectors combined with the Quadrature Link design give the Juno stent platform improved flexibility, while preserving stent security and vessel scaffolding Deliverability defined as a combination of flexibility, trackability and pushability n = units for each group. x stents Less force needed to bend the stent for improved deliverability n = units for each group. x stents Less force needed with the stent to navigate through tortuous vessels for improved deliverability Larger side branch access initial cell opening to facilitate the side branch access
5 Biosensors Clinical Trial Program Taking the LEAD in DES Clinical Excellence Our trials gather clinical data for this technology from a wide range of patients, including those with single de novo lesions, multiple vessel disease, acute coronary syndromes, bifurcations, left main, small vessels and extreme long lesions. Trial n Planned FU Status Comparator STEALTH PK 7 yr Completed yrs yrs FU completed Gazelle (BMS) BEACON I yr Completed 77 yrs yrs FU completed Cypher (DES) BEACON II 7 yrs d FU available e- PMS PMS Enrollment Completed yrs PMR PMR Currently enrolling e- PMD India PMR yrs Currently enrolling From Single de Novo To Real World STEALTH PK n=7 Registry, Pharmacokinetics Primary Endpoint: drug concentration at days and months n= Randomized Multicenter Clinical Trial vs Gazelle (:) Primary Endpoint: In-Stent Late Loss at months Results:. vs. (p <.) BEACON I n= Multicenter Registry Primary Endpoint: TVR at months Results:. n=77 Randomized Multicenter All-Comers Clinical Trial vs Cypher Primary Endpoint: CV death, MI, clinically-indicated TVR at months Results: BEACON II n=7 Multicenter Post Market Registry Primary Endpoint: MACE at months Ischemic Driven MI (Q-wave and NQ-wave) and Ischemic Driven TLR (PTCA and CABG) Cumulative Incidence () Primary Endpoint Cardiac Death, MI or TVR at months Cypher. n=. n=7 p non-inferiority =. 7 Months of Follow-Up e- n=+ Multicenter Post Market Registry PMS: n= PMR: n= Primary Endpoint: MACE at months e- India n= Multicenter Post Market Registry PMD: n= PMR: n= Primary Endpoint: MACE at months PMS = Post Market Surveillance PMR = Post Market Registry PMD = Post Market registry Diabetics
6 Ordering Information Stent Length () Stent Diameter (). BMX- BMX- BMX- BMX- BMX- BMX-. BMX- BMX- BMX- BMX- BMX- BMX-.7 BMX-7 BMX-7 BMX-7 BMX-7 BMX-7 BMX-7. BMX- BMX- BMX- BMX- BMX- BMX-. BMX- BMX- BMX- BMX- BMX- BMX-. BMX- BMX- BMX- BMX- BMX- BMX- Biosensors International Group, Ltd. licenses its proprietary BA drug and PLA technology to Terumo Corporation (Nobori ), Devax, Inc. (AXXESS ) and Xtent, Inc. (XTENT ). In vivo testing in porcine model demonstrates abluminal coating is absorbed after to months Data on file at Biosensors Intl. Data on file at Biosensors Intl. Klauss, V.,, -year Clinical Follow-Up, oral presentation, TCT. Wykrzykowska, J., oral presentation, Late Breaking Trial Session, EuroPCR. Grube, E., Safety and Performance Evaluation of Biosensors Eluting Stent ( ) : a -year safety follow-up, e-poster, TCT The stent was used in the clinical trial. Di Mario, C., OCT: Differences between biodegradable and durable polymers Insights from the trial, oral presentation, TCT. Barlis, P. et al., An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a trial sub-study; European Heart Journal (), Hamilos, M. et al. on behalf of the Nobori Core investigators, Differential Effects of Drug-Eluting Stents on Local Endothelium-Dependent Coronary Vasomotion, J Am Coll Cardiol :-. Windecker, S. et al., Biolimus-eluting stent with biodegradable polymer versus -eluting stent with durable polymer for coronary revascularization (): a randomised non inferiority trial; The Lancet ; 7 No. : -7. Windecker, S. et al., NEJM ; Morice, M.-C. et al., JAMA ; Serruys, P.W. et al., EuroIntervention ; Stone, G.W. et al., JAMA ; Costa, M. et al., Am J Card ; Chevalier, B. et al., EuroIntervention ; Ostojic, M. et al., EuroIntervention ; Stone, G.W. et al., NEJM ; Krukoff, M.W., JACC ; Verheye, S. et al., ACC/SCAI. Compared to the stent platform Flexibility and trackability: n= in each group,.x stents Side branch access: n= in each group,.x /.x stents Bench test results may not necessarily be indicative of clinical outcomes Drug Eluting Stent System is CE approved. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Flex,, Juno, Biolimus A and BA are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and other countries. All cited trademarks are the property of their respective owners. Not available for sale in the United States and certain other countries. Biosensors International Group, Ltd. All rights reserved. - EN Rev.
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