Washington, D.C. 20549





Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934



Date of Report:  May 16, 2018

(Date of earliest event reported)



(Exact name of registrant as specified in its charter)






(State or other jurisdiction

of incorporation)


File Number)

(I.R.S. Employer

Identification No.)




5751 Copley Drive, San Diego, CA


(Address of principal executive offices)

(Zip Code)


(858) 966-3000

(Registrant’s telephone number, including area code)



(Former Name or Former Address, if changed since last report)




Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).


Emerging growth company


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  




Item 7.01   Regulation FD Disclosure


The information attached as Exhibit 99.1 to this report relating to REVA Medical, Inc. (“REVA” or the “Company”) will be presented at the Company’s Annual General Meeting on May 16, 2018 and from time to time by the Company at various other investor and analyst meetings.


Limitation of Incorporation by Reference


In accordance with General Instruction B.2 of Form 8-K, this information including the Exhibit is furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Current Report on Form 8-K will not be deemed an admission as to the materiality of any information that is required to be disclosed solely by Regulation FD.


Item 9.01  Financial Statements and Exhibits.










Presentation entitled “REVA Medical Corporate Presentation May 2018






Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.





REVA Medical, Inc.





Date:  May 16, 2018

/s/ Brandi L. Roberts


Brandi L. Roberts


Chief Financial Officer and Corporate Secretary




Slide 0

REVA Medical Corporate Presentation May 2018 ©2018 REVA Medical CC100021 Rev. F Exhibit 99.1

Slide 1

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 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 forward-looking 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 March 7, 2018, 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. Fantom, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc.

Slide 2

REVA Medical is a leader in bioresorbable polymer technologies for vascular applications Commercializing a proprietary product for Coronary Artery Disease and pursuing Peripheral Artery Disease therapies

Slide 3

REVA’s Disruptive Technology Tyrocore™ Proprietary bioresorbable polymer Uniquely designed for vascular scaffold applications Derived from naturally occurring tyrosine amino acid Covalently bound iodine for radiopacity Patent protection for 19 biomaterial polymer families Polymer properties are tailorable to meet a clinical application by modifying: Strength Flexibility Degradation time Drug delivery profile $4B Market $1.5B Market Potential $2.1B Market Potential Vascular Applications Coronary Artery Disease Peripheral Artery Disease, Above the Knee Peripheral Artery Disease, Below the Knee Sources: CAD Market: JP Morgan Equity Research Interventional Cardiology Market Model Dec. 2016; PAD Markets: BTK: Nehler M, et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. JVS 2014.; ATK: Murabito J, et al. Temporal trends in the incidence of intermittent claudication from 1950-99. AJE 2005.; Population data from United Nations online database.

Slide 4

The Problem: Coronary Artery Disease Cardiovascular Disease is the leading cause of death globally1 1. Source: World Health Organization Factsheet, May 2017. http://www.who.int/mediacentre/factsheets/fs317/en/ https://www.cdc.gov/heartdisease/facts.htm Coronary Artery Disease (CAD) is the most common type of heart disease CAD occurs when a build-up of plaque in a coronary artery blocks the flow of blood to the heart muscle Treatments for CAD aim to restore blood flow through the blocked artery

Slide 5

Evolution of Treatments for CAD Open Heart Surgery CABG 1960s Balloon Angioplasty 1970s Bare Stents 1990s 2002 Drug-Eluting Stents (DES) History of rapid innovation

Slide 6

Global Coronary Stent Market WW Market Share Abbott (Xience Sierra) 32% Boston Scientific (Synergy) 33% Medtronic (Resolute Oynx) 28% Other 7% Market data source: Year 2017, JP Morgan Equity Research Interventional Cardiology Market Model Feb. 2018. ~$4 BILLION US: $1.4B Japan: $440M Europe & Asia: $2.1B Large and Profitable “The good news about those [CRM and stent] businesses is, they are extremely profitable and they generate high cash flows.” Miles White, CEO Abbott, Q2 2017 Earnings Call

Slide 7

Large and Rapid Market Share Disruptions with New Technology Introductions Source: JP Morgan Equity Research Interventional Cardiology Market Model Dec. 2016. BMS 1st Gen BMS 2nd Gen DES 1st Gen DES 2nd Gen Innovation Matters: Current players not focused on R&D creating opening for companies with a disruptive innovation

Slide 8

Next Innovation: Bioresorbable Scaffolds 1. Gada H, et. Al. 5-year results of a randomized comparison of Xience V everolimus-eluting and Taxus paclitaxel-eluting stents. J Am Coll Cardiol Intv 2013;6:1263-6; Data from year 5 to 10 extrapolated from 5-year data TLF = cardiac death, target vessel MI, ischemic-driven TLR ~2% Increase in Target Lesion Failure Rates Every Year Following Treatment1 DES are associated with long term complications DES can limit future treatment options including coronary artery bypass, CT’s, and MRI’s Driven by limitations of current standard of care

Slide 9

Next Evolution in Treatment: BRS Open Heart Surgery CABG 1960s Bioresorbable Drug-Eluting Scaffolds 2013 and beyond Balloon Angioplasty 1970s Bare Stents 1990s 2002 Drug-Eluting Stents (DES)

Slide 10

What is a Bioresorbable Scaffold? Temporary implantable device restores blood flow to diseased arteries Provides radial support to artery during healing process Elutes drug to limit excess tissue formation Encapsulates within vessel wall Dissolves from the body over time and restores natural vessel motion Restores Blood Flow Supports Vessel Healing Dissolves and Restores Motion

Slide 11

The Appeal of a Bioresorbable Scaffold Value to Physician and Patient Preserves maximum flexibility for future treatment options (bypass grafting, MRI, CT) Allows artery to return to its natural state to restore freedom of movement May reduce the rate of future clinical events “The ideal of a stent that does its job and disappears is a valuable long-term goal, especially in young patients with long life-expectancy.” EuroPCR 2017 course director Dr. William Wijns “I think it’s not at all inconceivable to think that a better device… …will allow what will hopefully be shown to be long-term advantages of no longer having the permanent metal frame in the vessel…” Gregg Stone, MD, New-York Presbyterian/Columbia University quoted in tctmd.com1 1. Wood, S. New Absorb BVS meta-analysis begs the question: when to stop studying a first-gen device. tctmd.com July 2017.

Slide 12

First Generation BRS Associated with Scaffold Thrombosis Risk 2017 Abbott stops Absorb sales8 1) Calculated as Absorb Sales / DES Sales from JP Morgan Equity Research Interventional Cardiology Market Model Dec. 2016. 2) Abbott press release, Jan. 2011. 3) Abbott press release, Sept. 2012. 4) Jaguszewski M, et al. Acute thrombosis of bioabsorbable scaffold in a patient with acute coronary syndrome. EHJ 2013 doi:10.1093/eurheartj/eht060. 5) Capodanno D, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicenter GHOST-EU registry. EI 2015;10:1144-1153. 6) Ellis S, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. NEJM 2015;373:1905-15. 7) Serruys P, et al. ABSORB II: Three year clinical outcomes from a prospective, randomized trial of an everolimus-eluting bioresorbable vascular scaffold vs an everolimus-eluting metallic stent in patients with coronary artery disease. Presented TCT 2016. 8) Cox, C. No more Absorb BVS: Abbott puts a stop to sales. tctmd.com 2017. 2016 ABSORB II 3-year results reveal very late thrombosis events7 2015 ABSORB III 1-year results show trend towards higher scaffold thrombosis compared to DES6 2011 CE Mark2 2012 European commercial launch3 BRS European Market Share1 2013 Emerging reports of acute scaffold thrombosis in ACS4 2014 Higher than expected early/mid-term scaffold thrombosis in GHOST-EU study5

Slide 13

History Repeats: Late Stent Thrombosis Nearly Stops 1st Generation DES Without Continued Innovation, We Might Not Have Achieved 2nd Generation DES 1) BA & BMS TLR: Kiemeneji F, et al. Continued Benefit of Coronary Stenting Versus Balloon Angioplasty: Five-Year Clinical Follow-Up of Benestent-I Trial. JACC 2001;37:1598-603. 2) BMS ST: Ellis S, et al. Long-term safety and efficacy with paclitaxel-eluting stents. JACC 2009;2:1248–59. 3) DES: Jensen LO, et al. Safety and efficacy of everolimus versus sirolimus eluting stents 5 year results from SORT-OUT IV. JACC 2016;67:751-62. 4) Wells Fargo Securities Yearly Drug-Eluting Stent Sales Estimates: 2010A to 2018E, Feb 2018. DES designed to reduce restenosis (TLR) rates But, stent thrombosis emerged as a large concern FDA Advisory Panel convened 12/2006 to evaluate DES and stent thrombosis risks DES lost nearly 30% market share to BMS as physicians returned to using BMS over these safety concerns4 2nd generation DES technical advancements resulted in improved outcomes and are now the standard of care 5-Year Event Rates1,2,3 TLR ST

Slide 14

Fantom Bioresorbable Scaffold Tyrocore™ Sirolimus Scaffold Design Delivery System Radiopaque Provides strength during critical vessel healing period Restores natural vessel motion in one year Complete resorption with benign degradants Proprietary to REVA Balloon expandable ring-and-link structure Unique design for each diameter (2.5, 3.0, and 3.5 mm) Large expansion range Semi-compliant nylon balloon High 18 atm rated burst pressure Rapid exchange First anti-proliferative agent used in drug eluting stents Highly lipophilic with broad therapeutic window Demonstrated across multiple clinical studies and drug eluting stents (c) molekuul www.fotosearch.com Combines Novel Polymer with Established Drug and Design

Slide 15

Fantom Offers Substantial Improvement Over 1st Generation BRS Competitors have struggled to show improved long term safety Physicians are seeking improvements in 2nd generation devices Thinner, more deliverable, easier to use; no compromise on strength Improved safety Fantom Absorb Material Tyrocore™ PLLA Strut thickness1 125 µm 157 µm Strength2 0.22 N/mm 0.14 N/mm Radiopacity Yes No 1) Includes coating. 1st Gen source: Foin, N. Biomechanical Assessment of Bioresorbable Devices. CRT 2017. Fantom source: Holm, N. REVA Fantom II performance and healing patterns by OCT. REVA Symposium EuroPCR 2017. 2) Strength at 15% compression. Tests performed by and data on file at Reva Medical. DES Absorb Fantom

Slide 16

Fantom Clinical Performance 12 Months 24 Months FANTOM (n=240) FANTOM II1 Major Adverse Cardiac Events/”MACE" 4.2% 5.6% (preliminary results for 125 patients) ABSORB (n=1,322) ABSORB III Target Lesion Failure/”TLF” 7.8%2 11.0%3 XIENCE (n=686) ABSORB III Target Lesion Failure/”TLF” 6.1%2 7.9%3 1) Hermiller, J. Fantom: A Radio-Opaque “Stent-Like” BRS with Improved Expansion Characteristics. Presented TCT 2017. 2) Ellis S, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. NEJM 2015;373:1905-15. 3) Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. Presented ACC 2017. Excellent Clinical Performance through 24 Months

Slide 17

Demonstrated Low Scaffold Thrombosis Fantom (n=240) Absorb (n=1,322) Xience DES (n=686) Study FANTOM II1 ABSORB III ABSORB III Scaffold Thrombosis Acute (0 to 1 day) 0% 0.15%2 0.58%2 Subacute (2 to 30 days) 0.4% 0.91%2 0.15%2 Late (31 to 365 days) 0% 0.46%2 0%2 Very Late ( >365 days) 1 event (preliminary results for 125 patients) 0.3%3 0%3 1) Hermiller, J. Fantom: A Radio-Opaque “Stent-Like” BRS with Improved Expansion Characteristics. Presented TCT 2017. 2) Ellis S, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. NEJM 2015;373:1905-15. 3) Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. Presented ACC 2017. All 240 patients beyond 18 months - 125 patients beyond 24 months of follow-up Strong Performance through 24 Months

Slide 18

Pipeline Development: Fantom Global Clinical Program FANTOM I First-in-human safety study (n=7) Year 3 FANTOM II Cohorts A&B Multi-center safety and performance study (n=240) Year 2 FANTOM II Cohort C Long lesion and multiple vessel study (n=30-50) enrolling FANTOM STEMI Single center pilot study in STEMI (n=20) enrolling FANTOM Post Market Trial European post-market trial (n=1,500) enrolling FANTOM III (US pivotal trial) Multi-center RCT vs. metallic DES (n=1,800-2,200) planning FANTOM Asia Multi-center RCT vs. metallic DES (n=350-400) planning Enrollment Complete – In Follow Up Enrolling Planning

Slide 19

Targeted Launch Underway in Europe PHASE 1 Stents available: 700k Established markets: Germany, Switzerland, Austria, Benelux, Denmark Favorable BRS reimbursement Demonstrated interest in new technologies 150 TARGET ACCOUNTS Stents available: 180k Large hospitals ~1,000 procedures annually Prior experience with BRS European stent market data source: DRG MedTech 360 Market Report IC Devices Europe, June 2015. EUROPEAN MARKET Stents available: 2.2M 2.2 MILLION 700 THOUSAND 180 THOUSAND

Slide 20

Making Commercial Progress Despite Headwinds Q3 2017 Q4 2017 Q1 2018 Q2 2018 Sales & Distributors Sales VP 2 Sales Managers 3 Sales Managers Turkish Distributor Customers 125% increase 78% increase tba 1st Commercial Implants Germany Switzerland Fantom Encore Turkey Revenue $17,000 $28,000 65% growth $53,000 89% growth tba Shipments $105,000 $98,000 $128,000 tba Milestones 1st Commercial Shipments FANTOM II interim 2-year clinical data release Fantom Encore 2.5 mm CE Mark BTK CE Mark Submission FANTOM II 2-year clinical & OCT imaging results release

Slide 21

Attractive Market Opportunity with Manageable Investment PHASE 1 $36 million revenue potential with 20% share Direct sales with 6 reps PHASE 2 Potential to double Phase 1 gross revenue Areas of interest: Turkey, Italy, Spain, Brazil, Middle East, Eastern Europe Sales through distributors 1) Calculations based on estimated annual procedures at targeted hospitals and an illustrative ASP of $1,000 SHARE GROWTH DRIVERS Clinical experience New product launch Indication expansion: long lesion, multi-vessel, AMI 150 Target Accounts

Slide 22

Fantom® Encore 2.5 mm Thinner strut profiles are associated with improved ease-of-use and vessel healing Thinner strut profiles achieved without compromising other performance features such as strength and x-ray visibility REVA Recently Secured CE Mark for the Thinnest Strut Profile Bioresorbable Scaffold on the Market Currently launching in select accounts while we pursue CE Mark of additional diameter sizes Plan to launch full product line later this year Absorb1 DESolve Nx1 Magmaris2 Fantom3 Fantom Encore 2.5 mm not available 157 µm 156 µm n/a 125 µm 95 µm Strut Profiles of 2.5 mm BRS with CE Mark 1. Values include coating. Absorb and DESolve source: Foin, N. Biomechanical Assessment of Bioresorbable Devices. CRT 2017. 2. www.magmaris.com. 3. Fantom source: Holm, N. REVA Fantom II performance and healing patterns by OCT. REVA Symposium EuroPCR 2017.

Slide 23

Long Term Growth Strategy WIN IN CORONARY INVEST IN PERIPHERAL Geographic Growth European countries Countries that accept CE Mark New approvals, e.g. Brazil, Japan, US Product Improvements Fantom Encore: next generation with thinner struts New sizes including longer lengths and larger diameters Indication Expansion Long lesions Multi-vessel disease Acute myocardial infarction Clinical Evaluation Pursue below the knee CE Mark with current platform Assess product performance Polymer R&D Invest in development of novel polymers specifically designed for peripheral artery applications Develop New Products Introduce unique scaffolds for below the knee and above the knee revascularization

Slide 24

Innovating to Build a $1+ Billion Company Sources: Coronary Market Potential estimate calculations: DRG MedTech 360 Market Report IC Devices Europe, June 2015; Peripheral Market Opportunity estimate calculations: BTK: Nehler M, et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. JVS 2014.; ATK: Murabito J, et al. Temporal trends in the incidence of intermittent claudication from 1950-99. AJE 2005.; Population data from United Nations online database. Coronary Revenue Potential Peripheral Market Opportunity $1.5+ BILLION Europe: 33% Japan: 18% U.S.: 49% BELOW THE KNEE $2.1+ BILLION Europe: 40% Japan: 16% U.S.: 44% ABOVE THE KNEE Phase 1 Target Accounts Phase 1 Market Phase 2 Market CE Mark Market Japan US Revenue calculation assumes 20% market share and $1,000 ASP Cumulative revenue potential with new market entry:

Slide 25

Experienced Management Team Reggie Groves Chief Executive Officer Brandi Roberts Chief Financial Officer Jeffrey Anderson SVP, Clinical and Regulatory Affairs Richard Kimes SVP, Operations Carmelo Mastrandrea VP, Europe Joann Yao Sr. Dir., Global Marketing

Slide 26

Board of Directors Ray Larkin, Chairman (2017--) Eunoe Inc, Bentley Labs, Nellcor Puritan Bennett Reggie Groves, CEO (2017--) Medtronic, McKinsey Bob Stockman, Co-Founder (1999 – ) Ioptex, “A” Company, Critikon Brian Dovey (2001 – ) Domain Associates, Rorer Group Robert Thomas (2010 – ) Citigroup Australia, multiple boards Ross Breckenridge, MA FRCP PhD (2015--) Silver Creek Pharmaceuticals, University College London Hospital Steve Oesterle (2018--) Medtronic, NEA, Temasek, Harvard & Stanford

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Corporate Priorities & Milestones CORPORATE PRIORITIES Ensuring Fantom’s commercial success Expanding our business Managing our cash position UPCOMING MILESTONES FANTOM II 24-month data release, May 2018 Launch Fantom Encore broader matrix, 2018 Geographic expansion to Brazil and additional European countries, 2018 CE Mark for Fantom in below-the-knee application, 2018 US conditional IDE study protocol approval, anticipated 2018

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REVA Investment Highlights LARGE, PROFITABLE MARKET DISRUPTIVE TECHNOLOGY Commercializing FANTOM® INNOVATIVE PIPELINE FIRST & ONLY proprietary polymer bioresorbable scaffold for coronary artery disease: Fantom® made with Tyrocore™ ~$4 billion coronary stent market ripe for innovation Proprietary bioresorbable polymer technologies for vascular applications Strong IP Patent protection extending 2029-2034 European launch Q3 2017 Phase 1: Germany, Switzerland, Austria, Benelux, Denmark Phase 2: Geographic expansion anticipated early 2018 CE Mark Fantom Encore anticipated 2018 Multiple opportunities for growth: Product line expansion, geographic growth, and extended indications Peripheral product development below and above the knee SOLID FINANCIAL POSItion Listed on Australian stock exchange in 2010 (ASX: RVA.AX) Cash: $14.9 million1 Mkt Cap: $90 million2 Potential US stock market listing 2018; SEC registered Includes cash, cash equivalents, and investment securities as of March 31, 2018. US dollars as of close May 14, 2018.

Slide 29

o Fantom has CE Mark only. Fantom is available in select countries that accept CE Mark. Fantom is not available in the U.S. or countries that do not accept CE Mark.