Tyrocore: a proprietary polymer uniquely designed for vascular scaffolds PD Dr. med Gregor Leibundgut Medizinische Universitätsklinik Kantonsspital Baselland Liestal, Switzerland Exhibit 99.2
Speaker's name : Gregor Leibundgut I have the following potential conflicts of interest to report: Receipt of honoraria or consultation fees: REVA Medical Potential conflicts of interest
Limited use of first generation BRS due to poor usability and clinical outcomes. The Tyrocore bioresorbable polymer is uniquely designed for vascular scaffold applications. Fantom, a second generation BRS made from Tyrocore, offers substantial improvements over first generation BRS. Novel Tyrocore Polymer Overcomes First Generation BRS Limitations
Tyrocore Composition Features Biocompatibility derived from tyrosine amino acid Strength polycarbonate phenyl ring structure (Iodinated diphenol) Radiopacity covalently bound iodine to polycarbonate backbone Ductility High molecular weight and composition provide ductility Flexibility Monomer molecules are linked with propane diol for flexibility Tyrocore Polymer Designed for Vascular Scaffolds Tyrocore Polymer Designed for Vascular Scaffolds Iodinated desamino-tyrosine polycarbonate Polylactic acid diol
Properties of Tyrocore versus PLLA Attribute Tyrocore PLLA1 Benefit Ultimate Tensile Strength 100-110 MPa 50-70 MPa Thinner strutsRadial strengthLongitudinal strength Elongation at Break (Ductility) 120-200% 2-10% Single-step inflationLarger expansion range X-Ray Visible Yes No Accurate placement Radiopacity 1) Poly(Lactic acid): Synthesis, Structure, Properties, and Applications. Edited by R.Auras, L-T.Lim, S.E.M.Selke, H.Tsuji. 2010 John Wiley & Sons, Inc.; p.141 Fantom Absorb DES A single Fantom scaffold contains < 1% of the iodine found in 1 ml of contrast media Tyrocore Offers Improved Properties Compared to PLLA 2× >50× ✔︎
1) Includes coating. Ormiston, J. New BRS Platforms. Presented EBC Rotterdam 2016.; Foin, N. Biomechanical Assessment of Bioresorbable Devices. Presented CRT 2017. 2) Bench testing on 3.0 mm scaffolds in water at 37°C. Radial strength measured at 15% compression. Tests performed by and data on file at REVA Medical. Tyrocore’s high tensile strength enables Fantom to have thinner struts while improving strength and reducing recoil Fantom Improved Performance -33% 1.5 × 1/3
Fantom Resists Longitudinal Compression Leibundgut G et al. - unpublished data A force of ~0.2 N was found during recrossing with a balloon catheter Longitudinal Stent Compression Absorb Magmaris Fantom
Degradation > 80% molecular weight loss Vessel uncaged in 1 year Resorption (mass loss) Results in reduced radiopacity over time Completed in ~ 4 years Radiolabel ADME study shows I2DAT is safely excreted I2DAT Water Carbon dioxide Tyrocore Degradation Hydrolysis Enzymes Cell metabolism Tyrocore Benign Degradation and Resorption desamino-tyrosine polycarbonate Polylactic acid diol Iodinated diphenol Polylactic acid diol &
0-3 months Structural support during critical vessel healing period Fantom Provides Support During Vessel Healing and Degrades in One Year Increase in strength due to hydration 0-1 month Degradation and vessel uncaged in one year 0-12 months Complete resorption within ~4 years
Fantom Absorb 3-month endothelialization in rabbit artery 6-month degradation in porcine artery 0-3 Months Fantom struts are covered with mature endothelium Substantially fewer adherent platelets than the Absorb control 4-12 Months Fantom shows no adverse reactions as vessel uncages No calcification at the interface between the tissue and the scaffold, which is observed with Absorb 12-42 Months Fantom final degradation and benign resorption Tyrocore Biocompatibility for Excellent Vessel Healing
0-12 Months - Degradation Absorb has an early peak of lactic acid associated with coating degradation Fantom has minimal lactic acid 12-42 Months - Resorption Absorb has a large lactic acid peak between 18 and 42 months associated with scaffold resorption Fantom lactic acid concentration is two orders of magnitude lower than Absorb during scaffold resorption Arterial Wall Lactic Acid Concentration during Scaffold Degradation Computational Model Tyrocore versus PLLA Degradation and Resorption Absorb Fantom Lactic acid concentration (mM) 1.2e-3 9.0e-4 6.0e-4 3.0e-4 0.0e+0
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 Assessment of Bioresorbable Devices. Presented CRT 2017. 2) Bench testing on 3.0 mm scaffolds in water at 37°C. Radial strength measured at 15% compression. Tests performed by and data on file at REVA Medical. Thinner Struts (again) without Compromising Radial Strength Fantom Encore - Third Generation Bioresorbable Scaffold Strut Thickness (µm) Absorb1 Magmaris1 Fantom Fantom Encore 2.5 mm 157 µm n/a 125 µm 95 µm 3.0 mm 157 µm 166 µm 125 µm 105 µm 3.5 mm 157 µm 166 µm 125 µm 115 µm Radial Strength2 N/mm Higher is better
Tyrocore is a new and differentiated polymer for vascular scaffolds. Fantom offers substantial improvements over first generation BRS: Reduced strut thickness Increased radial strength Larger expansion range Radiopacity Improved vessel healing Fantom Encore has the thinnest struts of any bioresorbable scaffold1 without compromising radial strength or radiopacity. Tyrocore’s strength, biocompatibility, and safety profile has been demonstrated in pre-clinical and clinical studies. 1) 95 µm strut thickness in the 2.5 mm diameter size Conclusions
