REVA Medical Announces Interim Clinical Results at EuroPCR ... · REVA Medical, Inc. – ASX Announcement Page 3 HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-

HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777

REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.

REVA Medical Announces

Interim Clinical Results at EuroPCR No Major Adverse Coronary Events from RESTORE trial

San Diego, California and Sydney, Australia (Thursday 17 May 2012 AEST) – REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”) announced at the European Course on Revascularization, the largest European stent meeting held this week in Paris, France, that there were no reported Major Adverse Coronary Events (MACE) on 16 patients who were enrolled in the Company’s RESTORE trial, with no incidences of ischemic target lesion revascularization (TLR), myocardial infarction (heart attack) or stent thrombosis. The first enrolled case is approaching 5 months and all patients enrolled in the study continue to do well.

Reporting on the results of the RESTORE clinical trial was Principal Investigator, Alexandre Abizaid, MD from Sao Paulo’s Dante Pazzanese Institute de Cardiologie, who implanted the first ReZolve scaffold in December 2011. “I am pleased to inform the cardiology community at EuroPCR of the early success and clinical experience with REVA’s ReZolve scaffold. In this preliminary analysis, the device has demonstrated its ability to maintain lumen patency during the critical early healing period, and this experience was noted across several sites and investigators.” In addition, Dr. Abizaid announced that REVA would be moving to an approximately 20% lower profile sheathless delivery system (6Fr guide compatible), called ReZolve2, for the upcoming CE Mark Trial. The Company adopted a pilot trial strategy with very tight patient inclusion criteria to ensure patient safety, yet provide enough enrolled patients to demonstrate sufficient product performance. After carefully reviewing patient data generated to date, the Company has concluded that the current patient cohort reported upon has met the objectives of the pilot trial; the Company will continue to enroll more patients in the pilot trial through the second quarter of 2012, but will conclude enrollment in the pilot trial no later than 30 June 2012. “We are very pleased with the results to date in the RESTORE pilot study,” commented REVA’s CEO, Bob Stockman. “The scaffold is performing well and physicians commented that they appreciated ReZolve’s visibility under x-ray as well as the scaffold’s sizing range, two very distinctive features of ReZolve’s fully bioresorbable polymer scaffold. ReZolze2 is a thinner more easily deliverable device because it does not require a protective sheath. We believe that by improving deliverability we will significantly speed up the rate of patient enrollment in our upcoming CE trial. ReZolve2 will be the product we commercialize.”

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The next important milestone for REVA will be the 6-month clinical evaluation on the first cohort of patients, which will be reported at October’s Transcatheter Therapeutics Technology Conference (“TCT”). The presentation given by Dr. Alexandre Abizaid at the EuroPCR conference on Thursday, 17 May 2012, is included in its entirety with this announcement. The presentation is also available on the Company’s website at www.revamedical.com.

About REVA

REVA is a development stage medical device company incorporated in Delaware, USA that is focused on the development and eventual commercialization of its proprietary, bioresorbable stent products. REVA’s principal product, the ReZolve scaffold, combines REVA’s proprietary stent design with a proprietary polymer that is metabolized and cleared from the body. The ReZolve scaffold is designed to offer full x-ray visibility, clinically relevant sizing and a controlled and safe resorption rate. In addition, by early encapsulation of the stent in the artery tissue coupled with the loss of scaffold structure over time, the ReZolve scaffold may reduce the incidence of late forming blood clots, or thrombosis, a rare but serious problem associated with drug-eluting metal stents currently on the market. REVA will require clinical results and regulatory approval before it can begin selling the ReZolve scaffold.

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 historical, 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. You should not place undue reliance on these forward-looking statements. Although management believes these 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 the forward-looking statements, including our ability to obtain the regulatory approvals required to market our ReZolve scaffold, our ability to timely and successfully complete our clinical trials, our ability to protect our intellectual property position, our ability to commercialize our products if and when approved, our ability to develop and commercialize new products, and our estimates regarding our capital requirements and financial performance, including profitability. Other risks and uncertainties that may cause our actual results to vary materially from any forward-looking statements 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 29 February 2012, as updated in our Quarterly Report on Form 10-Q filed with the SEC for the period ended 31 March 2012. We may update our risk factors from time to time in our periodic reports or other current reports filed with the SEC. 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. F

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United States

Investor and Media Enquiries: Cheryl Liberatore Director, Investor Relations and Marketing REVA Medical, Inc. +1 858 966-3045

Australia

Investor Enquiries: David Allen or Alan Taylor Inteq Limited +61 2 9231 3322 Media Enquiries: Katie Mackenzie or Rebecca Wilson Buchan Consulting +61 3 9866 4722

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2012 REVA Medical, Inc. 0 0

ReZolve A Polymer Scaffold to Restore the Vessel

Dr. Alexandre Abizaid

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Disclosure Statement of Financial Interest

• Consulting Fees

• REVA Medical, Inc.

Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

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RESTORE Clinical Trial ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold

Initiated December 2011

• Up to 50 patients – Sites in Brazil & Europe

• Primary Endpoint(s): – Freedom from ischemic-driven target lesion

revascularization at 6 months – Quantitative measurements at 12 months

(QCA/IVUS)

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RESTORE Clinical Trial – Device ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold

Drug-eluting (Sirolimus)

Radiopaque Strong and Resilient

Polymer

Unique Slide & Lock Design

Tyrosine-derived polycarbonate material that is radiopaque

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ReZolve Device Specifications

• 3.0 mm x 18 mm • Treatment range: 2.9 mm to 3.4 mm • Post-dilation up to 3.7 mm • 7 French today (6 Fr. planned)

• 80µg Sirolimus • Fully radiopaque • Sheathed rapid exchange delivery system (sheathless planned)

• Balloon expandable • No special storage or handling F

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ReZolve Proprietary Technology

• ‘Slide & Lock’ design – Ratchet design – Strong – Minimal recoil

• Tyrosine-derived polycarbonate – Tunable – Visible – Biocompatible – Drug compounded into tyrosine base

material

Our Ratchet Concept

Metal

ReZolve

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RESTORE Clinical Trial Investigators

• Germany – Prof. Dr. med. Björn Andrew Remppis,

Bad Bevensen – Prof. Dr. med. Johannes Brachmann, Coburg – Prof. Dr. med. Volker Schächinger, Fulda – PD Dr. med. Stephan Fichtlscherer, Frankfurt – Professor Dr. med. Axel Schmermund,

Frankfurt – Prof. Dr. med. Norbert Frey, Kiel – Prof. Dr. med. Nikos Werner, Bonn

• Brazil – Dr. Alexandre Abizaid, Sao Paulo Principal Investigator

• Austria – Dr. med. Matthias Heigert , Salzburg

• Poland – Dariusz Dudek, MD PhD, Krakow

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RESTORE Clinical Trial Inclusion/Exclusion Criteria

• Primary Inclusion Criteria – Clinical evidence of myocardial ischemia or positive function test – Visually estimated stenosis >50% and <100% – Reference vessel diameter 2.9 mm – 3.3 mm (confirmed by IVUS)

– Lesion length ≤ 12mm

• Primary Exclusion Criteria – Myocardial infarctions within 24 hours of the procedure – Ejection fraction <25% – Target vessel is totally occluded (TIMI 0 or 1) – Significant stenosis (>50%) proximal or distal to target lesion – Highly calcified lesion F

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RESTORE Clinical Trial Progress Update

• 16 patients enrolled as of May 14, 2012

• Enrollment distribution – 4 patients in Brazil – 6 patients in Austria – 6 patients in Germany

No reported MACE to date

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Clinical Case Examples

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CASE 01 First ReZolve Implant – Baseline and Procedure Details • Baseline

– 56 year old caucasian female – CV risk factors: Hypertension, prior MI, smoker – LAD lesion >90% stenosis – Estimated reference vessel size 3.1 mm – Estimated lesion length 12 mm

• Procedure – Intervention of LAD with ReZolve on December 21, 2011 – Predilation with 30 mm x 12 mm non-compliant balloon – 3.0 mm x 18 mm ReZolve scaffold implant, 12 atm – Patient now past 4 month time point ; asymptomatic

Procedure performed by Dr. Alexandre Abizaid, Sao Paulo, Brazil

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Case 01 First ReZolve Implant – Pre-implant

90% Stenosis

Procedure performed by Dr. Alexandre Abizaid, Sao Paulo, Brazil

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Case 01 First ReZolve Implant – Final ReZolve Implant Result

Post ReZolve Implant

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Case 01 First ReZolve Implant – Final ReZolve Implant Result

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Case 01 First ReZolve Implant – IVUS Imaging

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Case 01 First ReZolve Implant – OCT Imaging

Backbone

Sliding Slot

Rail – “U”

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CASE 02 Baseline and Procedure Details • Baseline

– 74 year old male – CV risk factors: Hypertension, Hypercholesterolemia – LAD lesion >95% Stenosis – Estimated reference vessel size 3.0 mm – Estimated lesion length 9 mm

• Procedure – Intervention of LAD with ReZolve on March 21, 2012 – Predilation with 3.0 mm x 12 mm non-compliant balloon (13atm ,30 sec)

– 3.0 mm x 18 mm ReZolve scaffold implanted (12 atm, 20 sec)

– Post-dilation with 3.25 mm x 20 mm non-compliant balloon (12 atm, 32 sec)

– Patient now past 1 month time point in FU-visit; asymptomatic

Procedure performed by Dr. med Matthias Heigert, II.Medizin, University Clinic, Salzburg, Austria

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Case 02 Pre-implant

90% Occlusion

95+% Stenosis For

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Case 02 Delivery to Lesion Site

90% Occlusion 95+% Occlusion

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Case 02 Final ReZolve Implant Result

Post-Implant Pre-Implant

ReZolve Implant

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Case 02 OCT Imaging

Distal Scaffold Mid Scaffold Proximal Scaffold

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RESTORE Clinical Trial Observations

• Acute Result: All patients have patent arteries

• Scaffold is fully visible during procedure

• ReZolve deployed with continuous inflation pressure

• All enrolled patients remain asymptomatic (1-5 months post-implant)

Two stents could not reach lesion site due to current pilot device profile and vessel tortuosity

Sheathed system limits deliverability to small and tortuous arteries Therefore…

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ReZolve2 Addresses Deliverability Needs

• Lower Profile (6 Fr.)

• No sheath

– Improved retention • Increased radial strength

Will be used in upcoming CE Trial

ReZolve (1.83 mm profile)

ReZolve2 (1.47 mm profile)

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Pivotal CE Trial • Multi-Center Global Trial

– Up to 30 sites in Brazil, Europe, Australia and New Zealand

• First enrollment planned for Q4 2012

• ReZolve2 system is 6 Fr. and sheathless

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REVA Medical Announces Interim Clinical Results at EuroPCR ... · REVA Medical, Inc. – ASX Announcement Page 3 HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-

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