REVA Medical — Technical Presentation (September 2018)
17 slides from REVA Medical's technical presentation, Sep 24, 2018
Slide 1: On-going Activities with a Radiopaque Tyrosine-Carbonate-Based Polymeric BRS: Fantom
On-going Activities with a Radiopaque Tyrosine-Carbonate-Based Polymeric BRS: Fantom Ulf Landmesser, MD Charité – Universitatsmedizin Berlin, Berlin, Germany Exhibit 99.4
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest Speaker or Advisory Honoraria from Biotronik, Abbott, REVA.
Slide 3: Lessons Learned from 1st Generation BRS
Lessons Learned from 1st Generation BRS Importance of implant technique Selecting the right patients Accurate sizing Complete scaffold apposition Opportunities for design improvement Thinner struts Improved deliverability Increased strength and expansion capability
Slide 4: 2nd Generation Fantom BRS Improves Over 1st Generation Devices
2nd Generation Fantom BRS Improves Over 1st Generation Devices REVA’s Advanced Tyrocore Polymer Makes Fantom Unique Thin strut profile (125 µm) for deliverability and vessel healing X-ray visible for treatment accuracy Key ease-of-use features like single-step inflation and higher expansion range Bi
Slide 5: Fantom's Novel Tyrocore Polymer Designed Specifically for BRS
Fantom’s Novel Tyrocore Polymer Designed Specifically for BRS DES (CoCr) Absorb (PLLA) Fantom (Tyrocore) Radiopacity Tyrocore Characteristics: Biocompatible - derived from tyrosine amino acid Strong - phenyl ring structure Radiopaque - bound iodine Degradation Vessel uncaged in 1 year Complete resor
Slide 6: Fantom & Fantom Encore Global Clinical Trial Program
Fantom & Fantom Encore Global Clinical Trial Program FANTOM I First-in-human safety study (n=7) Year 4 FANTOM II Cohorts A&B (CE-mark Study) Multi-center safety and performance study (n=240) Year 2-3 FANTOM II Cohort C Long lesion and multiple vessel study (n=30-50) enrolling FANTOM STEMI Single cen
Slide 7: Key Study Overview: FANTOM II Primary Safety Study
Key Study Overview FANTOM II Primary Safety Study (CE-approval Study) 6 & 9 Month Follow-up Clinical & Imaging Cohort A: 6 months Cohort B: 9 months 12 Month Follow-up Clinical Angiographic (cohort A N=100) (cohort B N=105) OCT (cohort A N=73) (cohort B N= 80) IVUS (cohort A N=45) (cohort B N=27) 24
Slide 8: FANTOM II – Cohorts A & B Clinical Results (CEC-adjudicated)
FANTOM II – Cohorts A & B Clinical Results (CEC-adjudicated) As adjudicated by an independent Clinical Events Committee One patient died between 0-6 months. Exact cause of death not determined. Patient died at home 4 weeks after subsequent TAVI procedure. One death occurred between 6-12 months. Pati
Slide 9: FANTOM II – Cohorts A & B 24-Month Scaffold Thrombosis
FANTOM II – Cohorts A & B 24-Month Scaffold Thrombosis (CEC-adjudicated) As adjudicated by an independent Clinical Events Committee ** Maximum day=761 days Target lesion was not fully covered with scaffold. Significant untreated stenosis was present at index procedure. Patient returned 5 days post p
Slide 10: FANTOM II Angiographic Results (Core lab analysis)
FANTOM II Angiographic Results (Core lab analysis) Sustained Performance through 24 Months Baseline angiographic data was not available for two enrolled patients N = 156 patients available for recoil analysis Average follow up days=744 In-Scaffold Analysis Baseline (n=238)1 Cohort A – 6 Mo. (n=100)
Slide 11: FANTOM II – OCT Substudy Results
FANTOM II – OCT Substudy Results Evidence of Healing and Benign Scaffold Degradation through 24 Months (n=25) – OCT Core lab Excellent Strength No late recoil Stable lumen diameter between 6 and 24 months Complete coverage Early malaposition resolution Complete strut coverage at 24 months Mean Scaff
Slide 12: FANTOM II Long Term Follow-up Case Sample
FANTOM II Long Term Follow-up Case Sample Index – Post Implant Follow-up 6 Mo. Follow-up 24 Mo. Index - Pretreatment Index – Post Implant Follow-up 6 Mo. Follow-up 24 Mo.
Slide 13: Fantom & Fantom Encore Global Clinical Trial Program
Fantom & Fantom Encore Global Clinical Trial Program FANTOM I First-in-human safety study (n=7) Year 4 FANTOM II Cohorts A&B (CE-mark Study) Multi-center safety and performance study (n=240) Year 2-3 FANTOM II Cohort C Long lesion and multiple vessel study (n=30-50) enrolling FANTOM STEMI Single cen
Slide 14: Key Study Overview: Global Fantom Post Market Trial
Key Study Overview Global Fantom Post Market Trial Currently Enrolling in Europe Global Prospective Study Enrolling up to 1,500 patients in appr.100 clinical centers Primary endpoint: Target Lesion Failure at 12 months Clinical follow-up: 30 days and annual from 1-5 years (CEC adjudication of clinic
Slide 15: Global Fantom Post Market Trial Currently Enrolling
Global Fantom Post Market Trial Currently Enrolling Focused on Clinical Outcome R = Right Patient Selection Is the patient a good candidate for a scaffold? E = Excellent Vessel Preparation Can a stent like result be achieved in the preparation process? V = Vessel Sizing Is the vessel in the target t
Slide 16: Fantom Encore – CE Mark Approved 3rd Generation Bioresorbable Scaffold
Fantom Encore – CE Mark Approved 3rd Generation Bioresorbable Scaffold No changes to Tyrocore polymer composition or scaffold design Improved polymer processing and manufacturing techniques 1) Includes coating. Ormiston, J. New BRS Platforms. Presented EBC Rotterdam 2016.; Foin, N. Biomechanical Ass
Slide 17: Conclusions
Conclusions Fantom, a 2nd generation BRS Demonstrated device safety through 24 months 5.0% MACE @ 24 months; 0.4% VLST Fantom Encore, a 3rd generation BRS The thinnest struts of any clinically available BRS1 No compromise to radial strength or radiopacity Unique Tyrocore polymer Fantom clinical prog
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