Company Update. 28 May REVA Medical, Inc.

Transcription

1 Company Update 28 May

2 Recent Milestones Q2 through Q 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 7

3 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 8

4 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 9

5 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,

6 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 11

7 Coronary Stent Market 2014 Market Projected 2025 Market 2014 revenues $4.2b worldwide * 80% BRS Usage BRS has the potential to dominate the future coronary stent market *JP Morgan Interventional Cardiology Market Model March 2015 Includes: US, Europe, Japan and other Asian Countries 12

8 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 13

9 Fantom Delivering the Next Advancement in Bioresorbable Scaffolds Visible Deliverable Drug Eluting Disappears to restore FANTOM natural vasomotion Thin Struts Strong Easy to Use 14

10 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 Absorb Fantom Xience Fantom Fantom is the only completely visible bioresorbable scaffold 15

11 Fantom is Designed with Thinner Struts Without Sacrificing Scaffold Strength Strut Thickness Comparison Absorb (ABT) Cypher* (JNJ) TAXUS* (BSC) FANTOM (REVA) Integrity* (MDT) Xience* (ABT) Fantom Absorb Reduced strut thickness minimizes material in the vessel * Metal Drug-Eluting Stent 16

12 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 Metal Metal Fantom 3.0mm Nominal Device Polymer enables broad expansion range without fracture 17

13 Fantom Preclinical Results Confirm Performance Visibility Deliverability Vessel Patency 18

14 Clinical Program FANTOM I pilot trial initiated December 2014 FANTOM II CE Trial initiated March 2015; includes up to 30 sites in 8 countries 19

15 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 20

16 FANTOM I Example Case 4-month Angiographic Follow-up Contrast Pre-Treatment Post-Treatment 4-Month Follow-up 21

17 FANTOM I Clinical Trial Acute Results 100% acute procedural success 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. No Major Adverse Cardiac Events reported to date 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,

18 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 23

19 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 24

20 FANTOM II Example Case Baseline Result Index Angiogram Post-Deployment 25

21 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 26

22 Fantom Manufacturing Process Scalable to High Volume Production Fantom Process Polymer Tube Lasing Fantom Complete cgmp polymer manufacturing capability in-house 27

23 Protecting the Fantom Scaffold REVA Filings and Exclusively Licensed Patents Core Technology Protected through REVA s 300+ IP portfolio allows for pipeline technology 28

24 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 29