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1 New Fantom Data Demonstrates Safety at 2 Years REVA Announces Next Generation Scaffold with 95 Micron Strut Thickness San Diego, California and Sydney, Australia (Wednesday, 1 November 2017, AEDT) The Fantom bioresorbable scaffold from REVA Medical, Inc. (ASX: RVA) shows continued positive clinical outcomes according to an interim data set from the FANTOM II clinical trial presented this week at the Transcatheter Therapeutics Conference ( TCT ) in Denver, Colorado. The Company also revealed plans for its next generation scaffold, named Fantom Encore, which will have a market-leading 95 micron strut thickness for the 2.5 mm diameter scaffold. Clinical outcomes were reported for an interim data set of 125 patients followed through 24 months. Findings included a low rate of Major Adverse Cardiac Events ( MACE ) of 5.6% and a single very late scaffold thrombosis event. REVA previously reported a MACE rate of 4.2% through 12 months for the complete 240-patient data set with a single scaffold thrombosis event in the sub-acute time frame. The 24-month outcomes demonstrate a sustained safety profile for Fantom. In addition to clinical follow up, a 25-patient subset in the trial underwent angiographic imaging to determine late lumen loss ( late loss ) at 24 months. Late loss is the difference between the diameter of a stented segment immediately after treatment compared with the follow-up angiogram. The clinical data showed a final in-scaffold late loss of 0.25 mm, which is in the desired range of 0.2 mm to 0.4 mm. This range historically corresponds with positive long-term outcomes for stents and scaffolds. The data were presented in a moderated poster session by trial investigator, Dr. Ricardo A. Costa, from Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, and in an oral presentation by Dr. James B. Hermiller Jr., from the Heart Center of Indiana in Indianapolis, Indiana. This preliminary data set from the FANTOM II trial provides physicians with an early look at two-year clinical results for the Fantom scaffold, said Dr. Costa. The low MACE rate and inscaffold late lumen loss measurement are encouraging as they demonstrate sustained safety and performance of Fantom out to 24 months in this group of patients. The FANTOM II trial is evaluating the safety and performance of the Fantom sirolimus-eluting bioresorbable coronary scaffold in 240 patients outside of the United States. Six-month data from the FANTOM II trial was used as the basis for European CE Marking for Fantom, which was granted in April of this year. REVA also announced plans for a 95 micron strut thickness scaffold. The new scaffold, named Fantom Encore, will utilize the same polymer as Fantom called Tyrocore, REVA s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Tyrocore is inherently radiopaque, making Fantom and Fantom Encore visible under fluoroscopy. Additionally, Tyrocore is strong, enabling thinner struts while retaining radial strength. Fantom HEAD OFFICE: 5751 Copley Drive, San Diego, CA (858) (858) (FAX) AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O Connell Street, Sydney NSW ARBN REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability
2 REVA Medical, Inc. ASX Announcement Page 2 Encore will be available in 2.5, 3.0 and 3.5 mm diameters. The 95 micron struts will be available on the 2.5 mm diameter scaffold. REVA s announcement of 95 micron strut thickness for Fantom Encore in the 2.5 mm diameter is a promising development for bioresorbable scaffold technology, stated Dr. Hermiller. Bioresorbable scaffolds have the potential to offer patients short term benefits of metallic stents without the long-term complications. Thinner struts have been associated with improved deliverability and vessel healing. The presentation materials delivered at the conference are attached hereto, and also available in the Investor Relations section of REVA s website at About Fantom Fantom is a sirolimus-eluting bioresorbable scaffold developed as an alternative to metallic stents for the treatment of coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, and then disappear (or resorb ) from the body over a period of time. This resorption is intended to allow the return of natural movement and function of the artery. Fantom is the only bioresorbable scaffold made from Tyrocore, REVA s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Tyrocore is inherently radiopaque, making Fantom the first and only bioresorbable scaffold that is visible under fluoroscopy. Fantom is designed with thin struts while maintaining strength and with distinct ease-of-use features such as expansion with one continuous inflation. About REVA Medical REVA Medical is a medical device company focused on the development and commercialization of bioresorobable polymer technologies for vascular applications. The Company s lead product, the Fantom bioresorbable scaffold, received European CE Mark on April 3, 2017 for the treatment of coronary artery disease. REVA is located in San Diego, California, USA and employs over 50 people in the United States and Europe. Fantom, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc. Forward-Looking Statements This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions, and expectations and on information currently available to management. All statements that are not statements of historical fact, including those statements that address future operating plans or performance and events or developments that may occur in the future, are forwardlooking statements, such as those statements regarding the projections and timing surrounding commercial operations and sales, clinical trials, pipeline product development, and future financings. No undue reliance should be placed on forward-looking statements. Although management believes forward-looking statements are reasonable as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to vary materially from those expressed in forward-looking statements, including the risks and uncertainties that are described in the "Risk Factors" section of our Annual Report on Form 10-K filed with the US Securities and Exchange Commission (the SEC ) on February 28, 2017, and as updated in our periodic reports thereafter. Any forward-looking statements in this announcement speak only as of the date when made. REVA does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. HEAD OFFICE: 5751 Copley Drive, San Diego, CA (858) (858) (FAX) AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O Connell Street, Sydney NSW ARBN REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability
3 REVA Medical, Inc. ASX Announcement Page 3 United States Australia Australia Investor & Media Enquiries: Investor Enquiries: Media Enquiries: REVA Medical, Inc. Inteq Limited Buchan Consulting Brandi Roberts Kim Jacobs Rebecca Wilson Chief Financial Officer Andrew Cohen Cheryl Liberatore Director, Communications ir@revamedical.com HEAD OFFICE: 5751 Copley Drive, San Diego, CA (858) (858) (FAX) AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O Connell Street, Sydney NSW ARBN REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability
4 TCT 332: FANTOM II Trial: Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold First Report on Initial 24 Month Outcomes For personal use only Fantom II Clinical Trial Investigators
5 DIDACTIC SESSION: BIORESORBABLE VASCULAR SCAFFOLDS, PART 1 - DEVICES AND EMERGING DATA Session III. Next Generation Scaffolds Part 1: Design Iterations, Data, and Clinical Development Colorado Convention Center, Mile High Ballroom 4E-4F, Ballroom Level Tuesday, October 31, 4:43 PM - 4:53 PM Fantom: A Radio-Opaque Stent-Like BRS With Improved Expansion Characteristics James Hermiller, MD, FACC, MSCAI St Vincent Medical Group St Vincent Heart Center of Indiana Indianapolis, IN
6 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Company Edwards, Medtronic, Abbott, BSC Edwards, Medtronic, Abbott, BSC
7 Fantom Sirolimus Eluting Bioresorbable Coronary Scaffold 1 st and Only BRS Make with Tyrocore : Uniquely designed for vascular scaffolds Derived from naturally occurring tyrosine amino acid Bound iodine for radiopacity Proprietary, patent protected, and manufactured by REVA Medical RADIOPAQUE Procedural accuracy Accurate lesion coverage Precise Placement Full structural assessment STRONG Large expansion range 0.75mm for 3.0mm scaffold Maintains vessel patency Deliverable Thin 125µ struts Lower crossing profile Improved flexiblity Single step inflation Reduced procedure time BIOCOMPATIBLE Rapid vessel healing Vasomotion restoration
8 Fantom Ease of Use Features Makes the Implant Procedure Easier For personal use only Visibility Lower Crossing Profile Single Step Balloon Inflation 1 mm atm Fantom Absorb DESolve Absorb DESolve Nx Magmaris Fantom seconds Absorb Fantom DES Higher Expansion Tolerance 2 Limit of Expansion over Nominal, 3.0 mm Scaffolds Low Recoil % 6.8% % mm 0.4 4% 2.3% 2.0% 0.2 2% Fantom 0 Absorb DESolve Nx Magmaris Fantom 0% Absorb Magmaris Fantom Bench testing on 3.0 mm scaffolds in water at 37 C. 1. Product Instructions for Use. 2. Manufacturer reported data on file at Reva Medical. 3. Tests performed by and data on file at Reva Medical.
9 Fantom s Improved Healing Thin Struts and High Radial Strength Contribute to Excellent Healing Reduced Strut Thickness 1 Fantom Scaffold µm For personal use only Absorb DESolve Nx 166 Magmaris 125 Fantom Fantom Healing at 3 Months Mature, oriented cells; few platelets High Radial Strength 2 PLLA Scaffold N/mm Absorb Magmaris Fantom Bench testing on 3.0 mm scaffolds in water at 37 C. PLLA Scaffold Healing at 3 Months Mature & immature cells; persistent platelets 1) Values include coating. Absorb, DESolve, Magmaris source: Foin, N. Biomechanical Assessment of Bioresorbable Devices. CRT Fantom source: Holm, N. REVA Fantom II performance and healing patterns by OCT. REVA Symposium EuroPCR ) Radial strength measured at 15% compression. Tests performed by and data on file at Reva Medical.
10 FANTOM II Trial Safety & Performance Study for the Fantom Sirolimus- Eluting Bioresorbable Coronary Scaffold
11 FANTOM II Study Investigators Australia Dr. Muller, Dr. Jepson, Dr. Walters Belgium Dr. De Bruyne Brazil Dr. Abizaid, Dr. Costa, Dr. Chamie, Dr. Perin Denmark Dr. Christiansen, Dr. Lassen, Dr. Okkels-Jensen France Dr. Carrié, Dr. Chevalier, Dr. Fajadet, Dr. Collet Germany Dr. Weber-Albers, Dr. Naber, Dr. Achenbach, Dr. Frey, Dr. Lutz, Dr. Kische, Dr. Ince, Dr. Brachmann Netherlands Dr. Amoroso, Dr. Wykrzykowska, Dr. Daemen Poland Dr. Dudek, Dr. Kochman, Dr. Koltowski, Dr. Lesiak, Dr. Wojdyla
12 FANTOM II Study Design and Endpoints Study Design - Safety and Performance Trial patients in 2 cohorts - 2.5mm to 3.5mm vessels - Lesion length 20mm - Angiographic follow-up Cohort A: 6 months 117 Pts. Cohort B: 9 months 123 Pts. - Serial imaging sub-studies Study Population N= 240 Patients 28 Clinical Centers Participating Cohort A (117 Patients) 6 Mo Clinical Follow-up (MACE) 6 Mo Angiographic Follow-up (LLL) Includes OCT & IVUS 24 months Annual Clinical Follow-up (5 yrs) Cohort B (123 Patients) 6 Mo Clinical Follow-up (MACE) 9 Mo Angiographic Follow-up (LLL) Includes OCT & IVUS 48 months Annual Clinical Follow-up (5 yrs) Cohort A: 24 months (25 Patients) Cohort B: 48 months (25 Patients)
13 FANTOM II Cohorts A & B Study Overview and Baseline Characteristics Study Population N= 240 Patients 28 Clinical Centers Patient Characteristics (N=240) Patient Age (average years) 62.7 ± & 9 Month Followup Clinical & Imaging 12 Month Follow-up Clinical Annual Follow-up Through 5 years Angiographic (cohort A N=100) (cohort B N=105) OCT (cohort A N=73) (cohort B N= xx) IVUS (cohort A N=45) (cohort B N = 27) 24 Month Follow-up Clinical Imaging Sub-set Male 70.4% Diabetes 23.8% Current/Former Smoker 59.6% Hypertension 73.8% Hyperlipidemia 70.8% Prior PCI 43.8% Prior CABG 2.9% Prior MI 26.3% Recent LVEF <40% 0.0% (N=231)
14 FANTOM II Cohorts A & B Lesion Characteristics and Procedural Outcomes Lesion Characteristics Target Lesion Location (n=238) 1 LAD 48.7% (116) LCX 31.3% (74) RCA 20.2% (48) ACC/AHA Lesion Class (n=238) 1 Type A 18.5% (44) Type B1 49.6% (118) Type B2 29.4% (70) Type C 2.5% (6) Initial Outcomes Acute Procedural Outcomes Acute Technical Success (1) 95.8% Acute Procedural Success (2) 99.1% Clinical Procedural Success (3) 99.6% (1) Defined as successful delivery and deployment of the intended scaffold in the intended lesion without device related complications. (2) Defined as acute technical success (see definition above), resulting in a residual stenosis of 50 percent with no immediate (in-hospital) MACE. (3) Defined as acute procedural success (see definition above), with no MACE thirty days post-intervention and with a final diameter stenosis 50 percent. (1) Two pre-procedure angiograms were not available
15 FANTOM II Cohort A & B Safety Results Preliminary Interim Data set Components of 6-Month Primary Endpoint (modified ITT): non-hierarchical 6 Month (n = 240) 12 Months (n = 240) 24 Month Ongoing (N = 125) MACE 2.1% (5) 4.2% (10) 5.6% (7) Cardiac Death 0.4% (1) 1 0.8% (2) 1,2 0.8 (1) 2 MI 1.3% (3) 1.3% (3) 2.4 (3) Clinically Driven TLR 0.8% (2) 2.5% (6) 3.2 (4) * As adjudicated by an independent Clinical Events Committee (1) One patient died between 0-6 months. Exact cause of death not determined. Patient died at home 4 weeks after subsequent TAVI procedure. (2) One death occurred between 6-12 months. Patient was reported to have died of COPD by treating physician but cardiac relation could not be excluded.
16 FANTOM II Cohort A & B Safety Results Definite or Probable Scaffold Thrombosis Acute (0 1 day) 0.0% (0) Sub-acute (2 30 days) 0.4% (1) Late ( days) 0.0% (0) Very Late (>365 days) - Interim data set 1 event All 240 patients beyond 18 months patients beyond 24 months of follow-up * As adjudicated by an independent Clinical Events Committee
17 FANTOM II Angiographic QCA Results Preliminary Interim Data Set In-Scaffold Analysis Baseline (n=238) 1 Cohort A 6 Mo. (n=100) Cohort A 24 Mo. (Subset n=25) RVD (mm) 2.71 ± ± 0.36 MLD (mm) 0.82 ± ± 0.41 Diameter Stenosis (%) 69.5 ± ± ± ± ± 20.3 Acute Gain (mm) 1.68 ± 0.41 Acute Recoil (%) 4.0 ± Mean LLL (mm) 0.25 ± ± 0.56 In-Segment Analysis Mean LLL (mm) 0.17 ± ± 0.52 (1) Baseline angiographic data was not available for two enrolled patients (2) N = 156 patients available for recoil analysis
18 FANTOM II Long Term Follow-up Case Sample Female, 63 years old No angina, 50% LVEF, no family history of CAD Hypertension, Hyperlipidemia, non-smoker Prior PCI/DES May 14, 2015 in prox CX (MI May 10, 2015) 80% stenosis of the mid-lad Treated with a 3.0 x 18mm Fantom scaffold Enrollment and Follow-up History Treated with a 3.0 x 18mm Fantom scaffold : July 28, M Follow-up with Imaging: March 1, M Follow-up (clinical only): July 28, M Follow-up with Imaging: August
19 FANTOM II Long Term Follow-up Case Sample Index - Pretreatment Index Post Implant Follow-up 6 Mo. Follow-up 24 Mo. Procedure Details Pre-dilation performed BSC Maverick 2.5 x 15mm balloon Fantom Scaffold implant 3.0 x 18mm Fantom deployed at 14atm Post Dilation Performed 3.25 x 6mm NC Sprinter to 16atm
20 FANTOM II Long Term Follow-up Case Sample Index Post Implant Follow-up 6 Mo. Follow-up 24 Mo.
21 FANTOM Program Clinical Summary Fantom offers new and clinically important features Ease-of-use Radiopacity with complete scaffold visibility Low crossing profile with high flexibility Single-step inflation, no special handling requirements Favorable expansion profile Thin struts and radial strength to facilitate vessel healing Data demonstrates continued safety through 24 mo. Low MACE Rate (5.6%) Imaging sub-study shows sustained results No change in average late lumen loss from 6 to 24 months No evidence of late or chronic scaffold recoil
22 Fantom Global Clinical Program Enrollment Complete In Follow Up FANTOM I First-in-human safety study (n=7) Year 3 FANTOM II Cohorts A&B Multi-center safety and performance study (n=240) Year 2 Enrolling FANTOM II Cohort C Long lesion and multiple vessel, multi-center study (n=50) enrolling FANTOM STEMI Single center pilot study in STEMI (n=20) enrolling Planning FANTOM Registry European post-market multi-center registry (n=125+) planning FANTOM III (US pivotal trial) Multi-center RCT vs. metallic DES (n=1,800-2,200) planning FANTOM Japan (pivotal trial) Multi-center RCT vs. metallic DES (n= ) planning
23 Fantom Product Evolution Next Generation: Fantom Encore Thinner struts without compromising radial strength 95 micron on 2.5 mm diameter No changes to Tyrocore TM polymer composition or scaffold design Improved polymer processing and manufacturing technique European approval and launch anticipated in 2018 Diameter Fantom Fantom Encore 2.5 mm 125 µm 95 µm 3.0 mm 125 µm to be announced 3.5 mm 125 µm to be announced
24 Thank you! 19
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