agm presentation for personal use onlymay 28, 2015 · the agm is being held hursday, t28 may 2015...

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HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O’Connell Street, Sydney NSW 2000 • +61 2 9237 2800

ARBN 146 505 777 • REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability

AGM Presentation

Sydney, Australia and San Diego, California (Thursday, 28 May 2015 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 2015 Annual General Meeting of Stockholders (the “AGM”). The presentation will be available on our website shortly before the meeting.

The AGM is being held Thursday, 28 May 2015 at 10:30 a.m. AEST (which is 5:30 p.m. on Wednesday, May 27, 2015 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 (02) 8223 9773 five minutes prior to the scheduled start time. Callers in the United States and Canada may access the call by dialing 1-877-312-5413. 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 www.revamedical.com, 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 development stage medical device company located in San Diego, California, USA, that is focused on the development, testing, and eventual commercialization of its proprietary bioresorbable stents, which are called “scaffolds” because of their temporary nature. The Company’s scaffolds are currently in clinical studies and 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 intended commercial product, the FantomTM scaffold, has been designed to offer an ideal balance of thinness and strength, and distinct ease-of-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 products. 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,

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REVA Medical, Inc. – ASX Announcement

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HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O’Connell Street, Sydney NSW 2000 • +61 2 9237 2800

ARBN 146 505 777 • REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability

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 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 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 30, 2015, 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 +61 2 9229 2700 +61 3 9866 4722 +1 858-966-3045 Annabel Murphy +61 2 9237 2800

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2015 REVA Medical, Inc. 6

28 May 2015

Company Update

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Recent Milestones

• Q2 through Q4 2014 – Developed Fantom™ (to offer the desired advancements for a second generation product)

• November 2014 – Completed $25 million financing (warrants issued with financing could provide up to ~$23 million follow-on funding)

• December 2014 – Initiated first human implants of Fantom

• March 2015 – Initiated FANTOM II CE Mark clinical trial

• January and March 2015 – Appointed two new directors

• May 2015 – Announced CEO search as next step for commercialization

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2015 Goals

• Enroll 110 patients in FANTOM II trial (to provide CE data set)

• Perform 6-month follow-up on a majority of the CE patients (primary data set for CE mark application)

• Initiate enrollment of additional patients (Cohort B, 110 patients)

• Evaluate IP portfolio for additional pipeline products

• Begin implementation of corporate, manufacturing and marketing/sales initiatives to support commercialization

• Engage new Chief Executive Officer

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CEO Search

• Announced in May 2015

• Process anticipated to take 3 to 6 months

• Primary qualifications

– Bringing medical devices to market, including both CE Mark and FDA

– Leading a US publicly traded company

• Bob Stockman to continue as Chairman

– Continues as CEO through transition

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Bioresorbable Scaffolds Today’s Snapshot

• Clinical data continues to demonstrate safety and additional potential BRS benefits – Comparable MACE to DES (7.3% vs. 9.1%)* and low stent thrombosis (0.6%)*

– Restoration of natural vasomotion

– Signal for reduced angina (recurrent chest pain) in BRS patients

• BRS being used in complex cases (CTOs, bifurcations, left main)

• Physicians seeking improvements in 2nd generation devices – Thinner, more deliverable, easier to use; no compromise on strength

* Absorb II Study of 500+ patients, Absorb vs. Xience DES, one-year data published by Abbott Vascular September 14, 2014

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“Bioresorbable scaffolds have the potential to transform the way coronary artery disease is treated. With further advancements bioresorbable scaffold usage may be as

high as 80% within the next ten years.“

Dean Kereiakes, M.D., FACC, FSCAI

Principal Investigator, Absorb III and IV US Clinical Trials Medical Director, The Christ Hospital Heart & Vascular Center

and the Lindner Research Center in Cincinnati, OH Professor of clinical medicine at Ohio State University F

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Coronary Stent Market

2014 Market Projected 2025 Market

*JP Morgan Interventional Cardiology Market Model March 2015 Includes: US, Europe, Japan and other Asian Countries

2014 revenues $4.2b worldwide*

80% BRS Usage

BRS has the potential to dominate the future coronary stent market

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Fantom™ Sirolimus-Eluting Bioresorbable Scaffold

Designed to allow the restoration of blood flow

in patients being treated for coronary artery disease then disappear completely from the body over time

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Disappears to restore

natural vasomotion

Fantom Delivering the Next Advancement in Bioresorbable Scaffolds

FANTOM

Visible

Deliverable Thin Struts

Drug Eluting

Easy to Use

Strong

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Fantom is Completely Visible Under X-Ray A Unique Feature Among Bioresorbable Scaffolds

• Increases confidence during the procedure – Precise scaffold placement

– Accurate lesion coverage

– Confirmation of apposition to vessel wall

– Reduces need for IVUS catheter use (saving $)

– No permanent metal markers left behind

Fantom is the only completely visible bioresorbable scaffold

Absorb Fantom Xience Fantom

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Fantom is Designed with Thinner Struts Without Sacrificing Scaffold Strength

Strut Thickness Comparison

* Metal Drug-Eluting Stent

Absorb(ABT)

Cypher*(JNJ)

TAXUS*(BSC)

FANTOM(REVA)

Integrity*(MDT)

Xience*(ABT)

Reduced strut thickness minimizes material in the vessel

Fantom Absorb

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Fantom Offers Distinct Ease-of-Use Features Overcomes Limitations of Competitive Bioresorbable Scaffolds

• Complete visibility under x-ray

• Single-step inflation to intended diameter – No need for intermediate inflation steps

• No procedural time limitations

• Post-dilation without compromise – Broad expansion range without fracture

• No special storage or handling

3.0mm Nominal Device

Polymer enables broad expansion range without fracture

Fantom

Metal

Metal

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Fantom Preclinical Results Confirm Performance

Deliverability Vessel Patency Visibility

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Clinical Program • FANTOM I pilot trial initiated December 2014 • FANTOM II CE Trial initiated March 2015; includes up to 30 sites in 8 countries

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FANTOM I Pilot Trial

• Initiated December 2014

• Trial Goal

– Verification of acute performance

• Current Status – Enrollment complete

– 7 patients enrolled at 2 clinical sites

– Acute performance demonstrated

– Follow-up ongoing

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FANTOM I – Example Case 4-month Angiographic Follow-up

Contrast Pre-Treatment Post-Treatment 4-Month Follow-up

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FANTOM I Clinical Trial Acute Results • 100% acute procedural success

• No Major Adverse Cardiac Events reported to date

Acute Procedural Outcomes Technical Success (1) 100% n=7

Acute Procedural Success (2) 100% n=7

Clinical Procedural Success (3) 100% n=7

(1) Defined as successful delivery and deployment of the device. (2) Defined as technical success with residual stenosis <50% with no immediate (in-hospital) MACE. (3) Defined as acute procedure success without the occurrence of MACE through 30 days.

Preliminary Reported MACE Results through 4-Month Follow-up In-Hospital 0 MACE Events n=7

30-Day Results 0 MACE Events n=7

4-Month Angiographic Follow up Results 0 TLR Events n=4 (1)

(1) Four patients have completed 4-month angiographic follow-up as of May 11, 2015 For

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FANTOM II CE Trial

• Initiated Enrollment March 2015

• Safety and Performance Evaluation

• Two Cohorts – 110 Patients with 6-month angiographic follow-up

• primary data set for CE Mark application

– 110 Patients with 9-month angiographic follow-up

• Evaluates performance after significant degradation

• Recruitment Ongoing

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CE Marking Clinical Requirements

• Demonstrate device safety for use in the intended indication

• Minimum trial requirements – Baseline, interim, and six-month assessments of patient safety

– Minimum of 100 patients

• Demonstration of safety – Major Adverse Cardiac Event (MACE) rate at six months post-implant

– Late lumen loss at six months

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FANTOM II – Example Case Baseline Result

Index Angiogram Post-Deployment

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Commercialization

• CE Mark application anticipated mid-2016

• Actively planning early commercialization efforts

– First launch to target EU

– Follow-on launch planning underway

– Direct sales force or distribution partnership with Boston Scientific

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Fantom Manufacturing Process Scalable to High Volume Production

Fantom Process

Fantom

Lasing

Polymer Tube

Complete cGMP polymer manufacturing capability in-house For

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Protecting the Fantom Scaffold

REVA Filings and Exclusively Licensed Patents Core Technology

Protected through 2030 - 2034

2014 2018 2022 2026 2030 2034

REVA’s 300+ IP portfolio allows for pipeline technology For

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Summary

• In clinical trials with competitive and differentiated bioresorbable scaffold

• Implementing corporate, manufacturing, and marketing/ sales initiatives to support commercialization

• CEO search underway

• Market potential for bioresorbable scaffolds is substantial and will be fueled by advancements in technology

• Extensive IP portfolio provides for pipeline product opportunities

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agm presentation for personal use onlymay 28, 2015 · the agm is being held hursday, t28 may 2015...

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