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1 AGM Presentation Sydney, Australia and San Diego, California (Thursday, 26 May 2016 AEST) REVA Medical, Inc. (ASX: RVA) ( REVA or the Company ) is pleased to provide the attached presentation that will be made at the Company s 2016 Annual General Meeting of Stockholders (the AGM ). The presentation will be available on our website shortly before the meeting. The AGM is being held today, Thursday, 26 May 2016 at 10:30 a.m. AEST (which is 5:30 p.m. on Wednesday, May 25, 2016 U.S. PDT) at the AGL Theatre in the Museum of Sydney at the corner of Phillip and Bridge Streets in Sydney, Australia. The AGM will be audiocast and may be accessed within Australia by dialing five minutes prior to the scheduled start time. Callers in the United States and Canada may access the call by dialing If you are asked to provide an access code, please spell out the word REVA to the operator and you will be connected promptly. If you reside outside of Australia, the United States, or Canada, or if you prefer to access the audiocast through our website, please visit Events & Presentations under the Investors section of our website at and click on the listen to webcast link. A replay of the audiocast will be available on our website after the call. About REVA REVA is a clinical stage medical device company located in San Diego, California, USA, that is working to commercialize its proprietary bioresorbable stents, which are called scaffolds. The Company s scaffolds have been developed as an alternative to metal stents, which are small tube-like devices permanently implanted into an artery 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 initial product, the Fantom scaffold, has been designed to offer an ideal balance of thinness and strength and distinct easeof-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations. REVA will require successful clinical trial results and regulatory approval before it can commercialize Fantom or any other product. 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 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 will occur in the future, are forward-looking statements, such as those statements regarding our ability to obtain regulatory approvals, timely and successfully complete our clinical trials, protect our intellectual property position, commercialize our products if and when approved, develop and commercialize new products, recruit and retain our key personnel, and estimates regarding our capital requirements and financial performance. You should not place undue reliance 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 our 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 March 10, 2016, and as may be 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. 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 2016 Annual General Meeting 10:30 a.m., 26 May 2016 Sydney, Australia 1

4 Important Notice Not an Offer for Securities This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in the Company nor does it constitute financial product advice nor take into account your investment objectives, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of the Company and conduct its own investigations and analysis. Information is a Synopsis Only This presentation only contains a synopsis of information on the Company and, accordingly, no reliance may be placed for any purpose whatsoever on the sufficiency or completeness of such information. Information presented in this presentation is subject to change without notice and REVA does not have any responsibility or obligation to inform you of any matter arising or coming to their notice after the date of this presentation, which may affect any matter in the presentation. Forward-Looking Statements This presentation 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 our ability to obtain regulatory approvals, timely and successfully complete our clinical trials, protect our intellectual property position, commercialize our products if and when approved, develop and commercialize new products, recruit and retain our key personnel, and estimates regarding our capital requirements and financial performance, including profitability. You should not place undue reliance on these forward-looking statements. Although management believes these forwardlooking statements are reasonable as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to vary materially from those expressed in the 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 United States Securities and Exchange Commission (the SEC ) on March 10, 2016, and as may be updated in our periodic reports thereafter. Any forward-looking statements in this presentation 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. Disclaimer This presentation and any supplemental materials have been prepared by the Company based on available information. The information contained in this presentation is an overview and does not contain all information necessary to make an investment decision. Although reasonable care has been taken to ensure the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness, or correctness of such information and opinions and no reliance should be placed on such information or opinions. To the maximum extent permitted by law, none of the Company, or any of its members, directors, officers, employees, or agents or advisers, nor any other person accepts any liability whatsoever for any loss, however arising, from the use of the presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability arising from fault or negligence on the part of the Company or any of its directors, officers, employees, or agents. 2

5 Establish Quorum Call to Order 3

6 Proxy Proposals 1. Elect Class III directors Dr. Ross Breckenridge and Robert Stockman 2. Ratify appointment of independent registered public accounting firm 3. Approve issuance of equity securities up to 10% of the issued capital of Company 4. Approve, on an advisory basis, executive compensation 5. Approve increase in non-executive directors fee pool to US$450, Approve grants of 11,800 options to each of 7 non-executive directors 13. Approve award of 6,300 RSUs to Dr. Ross Breckenridge 14. Approve award of 10,000 RSUs to Brian Dovey Approve awards of 6,300 RSUs to each of 5 other non-executive directors 4

7 Results of Voting Collection of ballots/voting Inspector report on voting Other business Adjournment 5

8 Company Update Approaching CE Mark 6

9 Agenda The market opportunity Fantom advantages and performance Commercial preparations Financial position Key milestones 7

10 Mission and Focus To restore patient health for life through the application of biomaterials in the development and sale of implantable medical devices Focused on commercialization of an advanced drug-eluting bioresorbable scaffold for the treatment of cardiovascular disease Fantom 8

11 Large Coronary Stent Market ~$4b market historically dominated by metal stents Bioresorbable EU/Asia 2015 Geographic Market Japan U.S Market Share Medtronic Other Boston Scientific Europe / Asia Abbott - Metal Abbott BRS ~5 million stents annually; growing 3% per year 9 SOURCE: JP Morgan Interventional Cardiology Market Model Nov Includes: US, Europe, Japan and other Asian Countries

12 Metal Stents Present an Ongoing Risk Metal remains in the body forever ~2% increase in Target Lesion Failure rates per year TLF = cardiac death, target vessel MI, ischemic-driven TLR (revascularization) 10 SOURCE: Gada H et. Al. J Am Coll Cardiol Intv 2013;6: Data from year 5 to 10 extrapolated from 5-year data

13 Why BRS are a Better Solution 1. Safety: May reduce long-term TLF rates 2. Treatment flexibility: Preserves future options 3. Vasomotion: Returns vessel to its natural state 4. Anti-coagulation: Long-term need eliminated Patient demand Intuitive and compelling value proposition 11

14 1 st Generation BRS Have Struggled Both products made of PLLA Absorb (Abbott Vascular) First to market Launched OUS late ,000 patients in >100 countries FDA panel approval March 2016 Mixed reaction to clinical results Developing sub-100 µm scaffold; year end? DESolve (Elixir Medical) Launched OUS early 2014 Limited commercial uptake ~2% BRS share in top 5 EU markets* 100 µm not yet commercially viable Developing 120 µm scaffold (date TBD) PLLA, >150 µm strut, drug-eluting PLLA, >150 µm strut, drug-eluting 12 * DRG Interventional Cardiology Devices Europe 2016

15 BRS: Timing to Cross the Chasm Bioresorbable European adoption <2 years 7 years? BRS penetrated Innovator phase quickly BRS penetration has slowed in Early Adopter phase Analyst estimates - crossing the chasm in Europe in E SOURCES: Everett Rogers diffusion of innovations theory JP Morgan Interventional Cardiology Market Model Nov

16 BRS: Accelerating Crossing the Chasm 3-4 Adoption accelerators: Next-gen devices Absorb US/Japan launches <2 years 7 years ? SOURCES: Everett Rogers diffusion of innovations theory JP Morgan Interventional Cardiology Market Model Nov

17 Why Fantom? Visible Precision placement Confidence in optimal deployment Thin Highly deliverable Increased accessibility / tortuous vessels Low profile = less vessel obstruction Faster healing Easy to Use Straightforward procedure / metal-like implant Higher expansion tolerance Intra-procedural flexibility Simple single-step deployment Absorb (BRS) Fantom Xience (Metal) Key advantages driven by REVA s proprietary polymer 15

18 Healing Profile Example of Good Healing Fantom Healing at 3 Months Mature, oriented cells Few platelets Example of Poor Healing Mature, oriented cells Few platelets PLLA Scaffold Healing at 3 Months Area of Interest Immature cells Persistent platelets Mature & Immature cells Persistent platelets SOURCE: Internal Preclinical Testing 16

19 Our Top Three Priorities 1. Obtaining CE Mark 2. Preparing for Commercial Launch 3. Optimizing Financial Strength 17

20 Clinical Enrollment and Follow-up Success FANTOM I (7 patients, 2 sites, Brazil/Poland) Trial initiated December 2014 Enrollment completed March 2015 Patient follow-up completed through 12 months FANTOM II (240 patients, 28 enrolling sites, 8 countries) Trial initiated March 2015 Enrollment completed March 2016 Cohort A 117 patients for CE Mark application data set Cohort B 123 patients for additional data Cohort A 6-month follow-up completed Early Cohort A patients past 14 months 18

21 FANTOM II Safety Results Low Major Adverse Cardiac Events (MACE) 6-Month MACE Results (Cohort A) Timeframe Event In-Hospital 1 (Post Procedure MI) 30-Day Follow-up 1 (MI/TLR/SAT) 90-Day Follow-up 0 6-Month Follow-up 0 Components of the Primary Endpoint (ITT): Hierarchical N=117 MACE % Cardiac Death 0.0 % MI 1.71% 19 Clinically Driven TLR 0.00% (1) As adjudicated by an independent Clinical Events Committee One event pending final adjudication review

22 FANTOM II Efficacy Results Minimal Late Lumen Loss In-Scaffold Analysis Baseline (n=115) Post Procedure (n=112) 6 Months (n=100) RVD (mm) 2.68 ± ± ± 0.35 (n=101) MLD (mm) 0.79 ± ± ± 0.39 Diameter Stenosis (%) 70.3 ± ± ± 11.5 (n=99) Acute Recoil (%) 2.9 ± 8.8 Acute Gain (mm) 1.67 ± 0.41 Mean LLL (mm) (in-scaffold) 0.29 ± 0.38 Mean LLL (mm) (in-segment) 0.21 ± 0.32 Preliminary Results: Analyzed by an independent QCA core lab 20

23 BRS Clinical Data Current Status At 6-month time point Abbott ABSORB Series Elixir Medical DESolve Biotronik Dreams Fantom MACE 5.0% -7.0% 3.25%* 3.3% 1.7% Stent Thrombosis 0 1.5% 0%** 0% 0.9% Late Lumen Loss In-Stent In-Segment Strut Thickness 157µm 150µm 120µm - 2.5mm 150µm Ease of Use Crossing Profile Visibility Deployment Expansion 1.43mm Not visible Multi-Step 0.5mm 1.44mm Not visible Multi-Step 0.5mm 1.75mm Not visible Single Step unknown µm 1.35mm Visible Singe Step mm Notes:. 21 * Increased to 5.9% at 12 months **Only showed definite and not probable SOURCE: CV Pipeline, Market Monitors, Inc, Physician reports.

24 FANTOM II Patient Case Angiographic Assessment Pre-Implant Post-Implant 6-Month Follow-up > 95% occlusion Full vessel revascularization Vessel remains widely patent 22

25 FANTOM II Patient Case OCT Assessment Post-Implant 6-Month Follow-up Full lesion expansion with complete vessel apposition Fully patent lumen with complete strut coverage 23

26 Our Top Three Priorities 1. Obtaining CE Mark 2. Preparing for Commercial Launch 3. Optimizing Financial Strength 24

27 Commercialization Priorities Clarify Boston Scientific distribution option Build sales/clinical team in Europe Ramp-up full operational capabilities Talent Systems Manufacturing scale Supply-chain alignment Timing CE Mark submission completed Q3 16 CE Mark approval targeted Q4 16 Commercialization anticipated H

28 Manufacturing Timeline Product Total of 4 sizes Validated Total of 6 sizes Validated Total of 9 sizes Validated Infrastructure Manufacturing and Distribution System Implemented Facility Upgrade and Validation Complete Launch Commercial Capacity Available 5,000/yr ,000/yr ,000/yr Launch Quantity Available Q1/

29 Manufacturing Readiness ~20,000 sq. ft. available for manufacturing State-of-the-art equipment ISO 13485:2012 certified cgmp Polymer Manufacturing Tube Fabrication Scaffold Assembly 27

30 Our Top Three Priorities 1. Obtaining CE Mark 2. Preparing for Commercial Launch 3. Optimizing Financial Strength 28

31 Financial Strength and Flexibility Cash position allows achievement of near-term milestones $22.1 million in cash at March 31, 2016 $11.4 million cash proceeds from exercise of warrants in February 2016 Comfortably meets near-term operating and capital needs Facilitates commercial preparations Commercially capable out of current facility 29

32 Key Milestones CE Mark CE Mark Submission CE Mark Approval Coordinate BSC Distribution Option First sales NASDAQ Listing Secure Market Makers & Bankers Effect/Complete Listing Capital Raise Amount / Timing: Dependent on BSC Distribution Option 30

33 Summary Next Milestone: CE Mark Excellent market opportunity: REVA s proprietary product, Fantom, represents an important innovation in the ~$4 billion global coronary stent market Regulatory approvals underway: CE Mark application to be completed in Q3 16; CE Mark approval expected in Q4 16 Commercial launch: Initial launch expected in select markets in H1 17 Value proposition: Fantom offers compelling differentiated advantages for physicians and intuitive value for patients adoption will be aided by patient demand Demonstrated clinical success: Excellent acute procedural success, rapid healing response, strong safety profile with low major adverse cardiac events Commercially capable: REVA expects to be able to meet commercial manufacturing needs from its 37,500 square foot state-of-the-art facility in San Diego, California 2016 is a pivotal year for REVA We ve come a long way 31