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1 REVA Announces Positive 12-Month Clinical Results 4.2% rate of MACE equivalent to best-in-class drug-eluting stents San Diego, California and Sydney, Australia (Wednesday, 17 May 2017, AEST) At the Paris Course on Revascularization ( EuroPCR ) being held this week in Paris, France, REVA Medical, Inc. (ASX: RVA) ( REVA or the Company ) announced sustained positive clinical results from the FANTOM II clinical trial. The trial is evaluating the safety and performance of the Company s Fantom sirolimus-eluting bioresorbable coronary scaffold in 240 patients outside the United States. Six-month data from the trial was used as the basis for European CE Marking for Fantom, which was granted last month. The current data release showcases safety data through 12 months in all patients, as well as imaging data on subsets of patients from the trial. Clinical follow-up on the 240 patients showed a very low 4.2% rate of Major Adverse Cardiac Events ( MACE ) through 12 months. MACE is a composite of cardiac death, myocardial infarction ( heart attack ), and clinically-driven revascularization. The 12-month MACE rate demonstrates a strong safety profile for Fantom over a sustained timeframe. In addition to the low MACE rate, there have been no reported cases of late or very late scaffold thrombosis to date. Subsets of patients in the trial underwent angiographic imaging to determine late lumen loss ( late loss ) at six and nine 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-segment late loss of 0.17 mm (±0.34 mm) at six months, and 0.29 mm (±0.41 mm) at nine months, which is in the desired range of 0.20 mm to 0.40 mm. This range historically corresponds with positive long-term outcomes for stents and scaffolds. REVA also released nine-month Optical Coherence Tomography ( OCT ) results on a subset of patients from the trial. The OCT imaging results demonstrated continued vessel patency and sustained healing with greater than 99% strut coverage at nine months. Data from the FANTOM II clinical trial through 12 months continues to demonstrate a postive safety profile for Fantom, stated Dr. Alexandre Abizaid, co-principal investigator for the trial and Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. These results, sustained through an extended timeframe, provide additional confidence about the future outlook for this next-generation bioresorbable scaffold. The presentation materials delivered at the conference are attached hereto, and are available in the Investor Relations section of REVA s website at 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 About REVA REVA is a medical device company located in San Diego, California, USA, that has developed a proprietary bioresorbable scaffold, as an alternative to metal stents, to treat coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, then disappear (or resorb ) from the body over a period of time. This resorption allows the return of natural movement and function of the artery, a result not attainable with permanent metal stents. The Company s Fantom scaffold has been designed to offer an ideal balance of thinness and strength, with distinct ease-of-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations. 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 performance and events or developments that we expect or anticipate will occur in the future, are forward-looking statements, such as those statements regarding the projections and timing surrounding our plans to commence commercial operations and sell products, conduct clinical trials, develop pipeline products, incur losses from operations, list our securities for sale on a U.S. stock exchange, and assess and obtain future financings for operating and capital requirements. Readers should not place undue reliance on forward-looking statements. Although management believes forwardlooking 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 may be updated in our periodic reports thereafter. Any forwardlooking 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. United States Australia Australia Investor & Media Enquiries: Investor Enquiries: Media Enquiries: REVA Medical, Inc. Inteq Limited Buchan Consulting Cheryl Liberatore Kim Jacobs Rebecca Wilson Director, Communications Andrew Cohen 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 The FANTOM II Study First Report for the 12-month clinical outcomes of the Fantom sirolimus-eluting bioresorbable scaffold Dr. Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil

4 Potential conflicts of interest Speaker's name: Dr. Alexandre Abizaid I have the following potential conflicts of interest to report: Consultant to REVA Medical, Inc. 1

5 Fantom Bioresorbable Scaffold Fantom (REVA Medical) Sirolimus Eluting Bioresorbable Scaffold Desaminotyrosine Polycarbonate Key Scaffold Features Complete scaffold visibility under x ray Single step continuous inflation Clinically significant expansion range Optimal radial strength at 125 µm thickness Vasomotion restoration ~1 year No special storage or handling Visibility Deliverability Vessel Patency 2

6 Fantom Radiographic Visibility Fantom Fantom s (x ray) visibility (Covalently bound Iodine to polymer) Allows for: Precise scaffold placement Accurate lesion coverage Full structural assessment after deployment Less reliance on invasive imaging compared to other BRS (IVUS/OCT) Absorb Xience Fantom 3

7 Fantom Enhanced Deliverability Thin 125µm strut design enables: Reduced scaffold crossing profile Greater device flexibility Increased access to a greater number of lesions Full blood flow restoration Lesion Fantom Courtesy of A. Abizaid, Dante Pazzanese, Sao Paulo, Brazil 4

8 Fantom Single Step Inflation Inflation process: Continuous inflation to intended diameter Reduces arterial occlusion time for the patient Increases speed for scaffold delivery for the physician Eliminates the need to recall multiple inflation schemes [VIDEO] REVA s advanced polymer enables single step inflation 5

9 Fantom Bioresorbable Scaffold Features Post dilation without compromise Substantial expansion safety margin 0.75 to 1.0 mm depending upon device size Able to adjust for vessel taper 3.0mm Nominal Device Polymer enables expansion to 3.75 mm without fracture Restoration of vasomotion Maintains radial strength during healing Restoration of vasomotion approx. 1 yr. Eliminates undesirable shear stress induced by a permanent implant 6

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. Brachman Netherlands Dr. Amoroso, Dr. Wykrzykowska, Dr. Daemen Poland Dr. Dudek, Dr. Kochman, Dr. Koltowski, Dr. Lesiak, Dr. Wojdyla 8

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 A (117 Patients) 6 Mo Clinical Follow up (MACE) 6 Mo Angiographic Follow up (LLL) Includes OCT & IVUS Sub 24 months Study Population N= 240 Patients 28 Clinical Centers Participating Cohort B (123 Patients) 6 Mo Clinical Follow up (MACE) 9 Mo Angiographic Follow up (LLL) Includes OCT & IVUS Sub 48 months Cohort B: 9 months 123 Pts. - Serial imaging sub studies Cohort A: 24 months (25 Patients) Cohort B: 48 months (25 Patients) Annual Clinical Follow up (5 yrs) Annual Clinical Follow up (5 yrs) 9

13 FANTOM II Cohort A & B Study Overview and Baseline Characteristics Study Population N= 240 Patients 28 Clinical Centers Patient Characteristics (N=240) 6 & 9 Month Follow up Clinical & Imaging 6 & 12 Month Follow up Clinical Long Term Follow up Clinical (annual through 5 years) 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) Patient Age (average years) 62.7 ± 10.1 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) 10

14 FANTOM II Cohort A 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 Initial Outcomes Acute Procedural Outcomes Acute Technical Success (1) 95.8% Acute Procedural Success (2) 99.1% Clinical Procedural Success (3) 99.6% Type A 18.5% (44) Type B1 49.6% (118) Type B2 29.4% (70) Type C 2.5%(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 11

15 FANTOM II Cohort A & B Safety Results Components of 6 Month Primary Endpoint (modified ITT): non Hierarchical N=240 (%), (N) MACE 2.1% (5) Cardiac Death 0.4% (1) 1 Target vessel MI 1.3% (3) Clinically Driven TLR 0.8% (2) Components of 12 Month Secondary Endpoint (modified ITT): non Hierarchical N=240 N, (%) MACE 4.2% (10) Cardiac Death 0.8% (2) 1,2 Target vessel MI 1.3% (3) Clinically Driven TLR 2.5% (6) (1) One patient died between 0 6 months. Exact cause of death not determined. Patient died at home 4 weeks after subsequent TAVI procedure. * As adjudicated by an independent Clinical Events Committee Note: Excludes 3 Non Clinically Driven TLRs (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. 12

16 FANTOM II Cohort A & B Safety Results Scaffold Thrombosis Assessment 12 Months Event Rate N=240 (%), (N) Scaffold Thrombosis Per Protocol Definitions 0.4% (1) 1 Scaffold Thrombosis Per ACR Definition Definite 0.4% (1) Probable 0.0% (0) Only 1 case of scaffold thrombosis reported to date Current Long Term Follow up Patients through 12 month follow up 240 Patients through 18 month follow up Approx.: 140 Patients through 24 month follow up Approx.: 10 * As adjudicated by an independent Clinical Events Committee Note: Excludes 3 Non Clinically Driven TLRs (1) Target lesion was not fully covered with scaffold. Significant untreated stenosis was present at index procedure. Patient returned 5 days post procedure with a scaffold thrombosis 13

17 FANTOM II Cohort A & B Angiographic QCA Results In Scaffold Analysis Baseline (n=238) 1 Cohort A 6 Mo. (n=100) Cohort B 9Mo. (n=105) RVD (mm) 2.71 ± ± ± 0.37 MLD (mm) 0.82 ± ± ± 0.43 Diameter Stenosis (%) 69.5 ± ± ± 14.3 Acute Gain (mm) 1.68 ± 0.41 Acute Recoil (%) 4.0 ± Mean LLL (mm) 0.25 ± ± 0.36 In Segment Analysis Mean LLL (mm) 0.17 ± ± 0.41 (1) Baseline angiographic data was not available for two enrolled patients (2) N = 156 patients available for recoil analysis 14

18 Fantom Scaffold OCT Mean Lumen Area Analysis 6 Month Assessment PCI Research Aarhus University Hospital Baseline Follow up Difference p value Mean lumen area (mm 2 ) 6.8 (1.7) 5.7 (1.4) 1.1 ( 1.3; 0.9) < Minimal lumen area (mm 2 ) 5.3 (1.4) 4.4 (1.4) 1.0 ( 1.3; 0.7) < Month Assessment Baseline Follow up Difference p value Mean lumen area (mm 2 ) 7.1 (1.6) 5.6 (1.5) 1.6 ( 1.7; 1.4) < Minimal lumen area (mm 2 ) 5.7 (1.4) 4.0 (1.4) 1.7 ( 1.9; 1.4) < Mean(SD) Reference: As presented by Jo Simonsen TCT

19 Fantom Scaffold OCT Stent Area Analysis 6 Month Assessment PCI Research Aarhus University Hospital Baseline Follow up Difference p value Mean stent area (mm 2 ) 7.1 (1.5) 7.2 (1.4) 0.1 ( 0.02;0.24) 0.12 Minimal stent area (mm 2 ) 5.9 (1.3) 6.0 (1.3) 0.1 ( 0.02;0.25) Month Assessment Baseline Follow up Difference p value Mean stent area (mm 2 ) 7.4 (1.6) 7.3 (1.5) 0.1 ( 0.2;0.0) 0.16 Minimal stent area (mm 2 ) 6.1 (1.4) 6.0 (1.3) 0.1 ( 0.2;0.1) 0.43 Mean(SD) 16

20 Fantom Scaffold OCT Strut Coverage PCI Research Aarhus University Hospital 6 Month Assessment Follow up Covered struts 98.1% (95.9;99.4) 9Month Assessment Median(IQR) Follow up Covered struts 99.0% (98.3;100.0) 17

21 Case Sample Baseline assessment and Pre dilatation 68 yo. Female History of Hypertension No prior PCI Non smoker No Diabetes LVEF = 66% Baseline Assessment Mid LAD Lesion Est. Stenosis = 80% Est. RVD = 2.79mm Lesion Length = 14 mm [VIDEO] 18

22 Case Sample Index Procedure Actual Deployment Data Scaffold: 3.00 x mm Actual Deployment Pressure = 12 atm Diameter stenosis result = 10% Post dilatation: 3.25 x 15 mm, 16 atm, 15 sec [VIDEO] Post Implant [VIDEO] 19

23 Case Sample 6 Month Follow up Procedure [VIDEO] [VIDEO] Vessel remains widely patent at 6 months 20

24 FANTOM Program Clinical Summary Fantom offers new and clinically important features Radiopacity Deliverability Single step inflation No special handling requirements Initial clinical data demonstrates Good acute performance Enhanced device deliverability Minimal residual stenosis and acute recoil (4%) Sustained performance and safety through 12 months Low MACE Rate (4.2%) No evidence of late scaffold thrombosis 21

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