rva-8k_20180922.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

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

 

 

Date of Report:  September 22, 2018

(Date of earliest event reported)

 

REVA MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

000-54192

33-0810505

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

 

 

 

5751 Copley Drive, San Diego, CA

92111

(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

 

On September 22, 2018, REVA Medical, Inc. (“REVA” or the “Company”) presented four key data sets demonstrating the capabilities of the Company’s Fantom® bioresorbable scaffold (“BRS”) at the Transcatheter Cardiovascular Therapeutics (“TCT”) conference being held September 21st through September 25th in San Diego, California, USA. The presentations included new procedural data from an indication expansion study in patients experiencing acute heart attacks as well as positive clinical and imaging results of the Fantom BRS through two years.

 

FANTOM STEMI Procedural Results

New data from the FANTOM STEMI pilot study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in a series of nine patients with acute heart attacks called ST-segment elevated myocardial infarction (“STEMI”). Patients experiencing a STEMI are a new patient population for Fantom. While these patients have a higher risk of complications than stable patients, the characteristics of their arterial blockages are typically well suited to BRS. The data were presented by Dr. Lukasz Koltowski from the Medical University of Warsaw in Warsaw, Poland.

 

FANTOM II Clinical Results

Two-year clinical results from the FANTOM II study were presented by Dr. Yuichi Saito from the Yale University School of Medicine in New Haven, Connecticut, USA. The data demonstrated safety and efficacy of Fantom at two years with the following outcomes:

 

 

Low 5.0% rate of Major Adverse Cardiac Events (“MACE”)  

 

A single very late scaffold thrombosis event for a rate of 0.4%

 

FANTOM II Imaging Results

Two-year optical coherence tomography (“OCT”) imaging results from the FANTOM II study were presented by Dr. Neils Holm from the Aarhus University Hospital in Aarhus, Denmark. The data showed an excellent healing profile for Fantom with sustained vessel lumen patency and no evidence of chronic scaffold recoil through two years.

 

FANTOM Clinical Review  

Dr. Ulf Landmesser, Professor of Cardiology at Charité Universitätsmedizin Berlin in Berlin, Germany delivered a comprehensive presentation of the Fantom BRS program. In addition to reviewing available clinical data, Dr. Landmesser provided an update on the Fantom Post Market Trial which is currently enrolling in Europe to evaluate the safety of Fantom in routine clinical practice.

 

The presentation materials delivered at the conference are attached hereto.  Copies of the presentations are also posted under the Investor Relations section of REVA’s website at www.revamedical.com.  

 

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.

(d)Exhibits.

 

Exhibit

Number

 

 

Description

99.1

 

Presentation entitled “Primary PCI in STEMI with sirolimus eluting FANTOM bioresorbable vascular scaffold first guided with optical coherence tomography – acute results from a FANTOM STEMI pilot study

99.2

 

Presentation entitled “FANTOM II Trial:  Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – 24-Month Follow-Up Clinical Outcomes Final Results”

99.3

 

Presentation entitled “Two-year healing patterns after implantation of the FANTOM bioresorbable scaffold”

99.4

 

Presentation entitled “On-going Activities with a Radiopaque Tyrosine-Carbonate-Based Polymeric BRS: Fantom”

 


 


 

SIGNATURES

 

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:  September 24, 2018

/s/ Brandi L. Roberts

 

Brandi L. Roberts

 

Chief Financial Officer and Corporate Secretary

 

 

rva-ex991_21.pptx.htm

Slide 1

Exhibit 99.1

rva-ex992_20.pptx.htm

Slide 1

Exhibit 99.2

rva-ex993_18.pptx.htm

Slide 1

Exhibit 99.3

rva-ex994_19.pptx.htm

Slide 0

On-going Activities with a Radiopaque Tyrosine-Carbonate-Based Polymeric BRS: Fantom Ulf Landmesser, MD Charité – Universitatsmedizin Berlin, Berlin, Germany Exhibit 99.4

Slide 1

Disclosure Statement of Financial Interest Speaker or Advisory Honoraria from Biotronik, Abbott, REVA.

Slide 2

Lessons Learned from 1st Generation BRS Importance of implant technique Selecting the right patients Accurate sizing Complete scaffold apposition Opportunities for design improvement Thinner struts Improved deliverability Increased strength and expansion capability

Slide 3

2nd Generation Fantom BRS Improves Over 1st Generation Devices REVA’s Advanced Tyrocore Polymer Makes Fantom Unique Thin strut profile (125 µm) for deliverability and vessel healing X-ray visible for treatment accuracy Key ease-of-use features like single-step inflation and higher expansion range Biocompatible for safety Stable for room temperature shipping and storage

Slide 4

Fantom’s Novel Tyrocore Polymer Designed Specifically for BRS DES (CoCr) Absorb (PLLA) Fantom (Tyrocore) Radiopacity Tyrocore Characteristics: Biocompatible - derived from tyrosine amino acid Strong - phenyl ring structure Radiopaque - bound iodine Degradation Vessel uncaged in 1 year Complete resorption in ~ 4 years Iodinated desamino-tyrosine

Slide 5

Fantom & Fantom Encore Global Clinical Trial Program FANTOM I First-in-human safety study (n=7) Year 4 FANTOM II Cohorts A&B (CE-mark Study) Multi-center safety and performance study (n=240) Year 2-3 FANTOM II Cohort C Long lesion and multiple vessel study (n=30-50) enrolling FANTOM STEMI Single center pilot study in STEMI (n=10-20) enrolling FANTOM Post Market Trial Global Post-market Trial (n=1,500) enrolling FANTOM III (Pivotal trial for US approval) 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 6

Key Study Overview FANTOM II Primary Safety Study (CE-approval Study) 6 & 9 Month Follow-up Clinical & Imaging Cohort A: 6 months Cohort B: 9 months 12 Month Follow-up Clinical Angiographic (cohort A N=100) (cohort B N=105) OCT (cohort A N=73) (cohort B N= 80) IVUS (cohort A N=45) (cohort B N=27) 24 Month Follow-up & Clinical Imaging Sub-set Complete Annual Follow-up Through 5 years Study Population N= 240 Patients 28 Clinical Centers Patient Characteristics (N=240) Patient Age (average years) 62.7 ± 10.1 Male 70.4% Diabetes 23.8% Current/Former Smoker 59.6% Hypertension 73.8% Hyperlipidemia 70.8% Prior PCI 43.8% Prior CABG 2.9% Prior MI 26.3% Recent LVEF <40% 0.0% (N=231)

Slide 7

FANTOM II – Cohorts A & B Clinical Results (CEC-adjudicated) As adjudicated by an independent Clinical Events Committee One patient died between 0-6 months. Exact cause of death not determined. Patient died at home 4 weeks after subsequent TAVI procedure. One death occurred between 6-12 months. Patient was reported to have died of COPD by treating physician but cardiac relation could not be excluded. Three target vessel related MI and one non-target vessel related MI. Components of 6-Month Primary Endpoint (modified ITT): non-Hierarchical 6 Month (n = 240) 12 Months (n = 240) 24 Months (n=240) MACE 2.1% (5) 4.2% (10) 5.0% (12) Cardiac Death 0.4% (1)1 0.8% (2)1,2 0.8 % (2) MI 1.3% (3) 1.3% (3) 1.7% (4)3 Clinically Driven TLR 0.8% (2) 2.5% (6) 2.9% (7)

Slide 8

FANTOM II – Cohorts A & B 24-Month Scaffold Thrombosis (CEC-adjudicated) As adjudicated by an independent Clinical Events Committee ** Maximum day=761 days Target lesion was not fully covered with scaffold. Significant untreated stenosis was present at index procedure. Patient returned 5 days post procedure with a scaffold thrombosis Distal segment of scaffold was in a 2.0mm vessel and the scaffold had significant malaposition that was not corrected (Below the protocol limit of 2.4 mm) Definite or Probable Scaffold Thrombosis (N = 240 Patients) Acute (0 – 1 day) 0.0% (0) Sub-acute (2 – 30 days) 0.4% (1)1 Late (31 – 365 days) 0.0% (0) Very Late (>365 days)** 0.4% (1)2

Slide 9

FANTOM II Angiographic Results (Core lab analysis) Sustained Performance through 24 Months Baseline angiographic data was not available for two enrolled patients N = 156 patients available for recoil analysis Average follow up days=744 In-Scaffold Analysis Baseline (n=238)1 Cohort A – 6 Mo. (n=100) Cohort A – 24 Mo.3 (Subset n=36) RVD (mm) 2.71 ± 0.37 2.70 ± 0.36 2.67 ± 0.33 MLD (mm) 0.82 ± 0.31 2.23 ± 0.41 2.18 ± 0.48 Diameter Stenosis (%) 69.5 ± 11.0 15.3 ± 15.2 15.1 ± 17.9 Acute Gain (mm) 1.68 ± 0.41 Acute Recoil (%) 4.0 ± 8.32 Mean LLL (mm) 0.25 ± 0.40 0.23 ± 0.49 In-Segment Analysis Mean LLL (mm) 0.17 ± 0.34 0.21 ± 0.49

Slide 10

FANTOM II – OCT Substudy Results Evidence of Healing and Benign Scaffold Degradation through 24 Months (n=25) – OCT Core lab Excellent Strength No late recoil Stable lumen diameter between 6 and 24 months Complete coverage Early malaposition resolution Complete strut coverage at 24 months Mean Scaffold Area Scaffold Strut Coverage Mean Lumen Area Scaffold Strut Apposition

Slide 11

FANTOM II Long Term Follow-up Case Sample Index – Post Implant Follow-up 6 Mo. Follow-up 24 Mo. Index - Pretreatment Index – Post Implant Follow-up 6 Mo. Follow-up 24 Mo.

Slide 12

Fantom & Fantom Encore Global Clinical Trial Program FANTOM I First-in-human safety study (n=7) Year 4 FANTOM II Cohorts A&B (CE-mark Study) Multi-center safety and performance study (n=240) Year 2-3 FANTOM II Cohort C Long lesion and multiple vessel study (n=30-50) enrolling FANTOM STEMI Single center pilot study in STEMI (n=10-20) enrolling FANTOM Post Market Trial Global Post-market Trial (n=1,500) enrolling FANTOM III (Pivotal trial for US approval) 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 13

Key Study Overview Global Fantom Post Market Trial Currently Enrolling in Europe Global Prospective Study Enrolling up to 1,500 patients in appr.100 clinical centers Primary endpoint: Target Lesion Failure at 12 months Clinical follow-up: 30 days and annual from 1-5 years (CEC adjudication of clinical events) Independent DSMB to monitor safety and adverse events

Slide 14

Global Fantom Post Market Trial Currently Enrolling Focused on Clinical Outcome R = Right Patient Selection Is the patient a good candidate for a scaffold? E = Excellent Vessel Preparation Can a stent like result be achieved in the preparation process? V = Vessel Sizing Is the vessel in the target treatment range ? A = Apposition Key Protocol Requirement Lesion Selection: Visually estimated RVD ≥ 2.5 to ≤ 3.75 mm No vessel segment < 2.4 mm or > 3.75 mm Lesion Preparation: Mandatory pre-dilatation NC balloon sized 1:1 to distal RVD and uniformly expanded to its intended diameter Post Dilatation: Mandatory post-dilatation NC balloon sized 0 – max. 0.50 mm larger than distal RVD inflated to ≥ 16 atm Goals >90 % Scaffold expansion after post-dilatation Full scaffold apposition to arterial wall

Slide 15

Fantom Encore – CE Mark Approved 3rd Generation Bioresorbable Scaffold No changes to Tyrocore polymer composition or scaffold design Improved polymer processing and manufacturing techniques 1) Includes coating. Ormiston, J. New BRS Platforms. Presented EBC Rotterdam 2016.; Foin, N. Biomechanical Assessment of Bioresorbable Devices. Presented CRT 2017. 2) Bench testing on 3.0 mm scaffolds in water at 37°C. Radial strength measured at 15% compression. Tests performed by and data on file at REVA Medical. Thinner Struts (again) without Compromising Radial Strength Strut Thickness (µm) Absorb1 Magmaris1 Fantom Fantom Encore 2.5 mm 157 µm n/a 125 µm 95 µm 3.0 mm 157 µm 166 µm 125 µm 105 µm 3.5 mm 157 µm 166 µm 125 µm 115 µm Radial Strength2 N/mm Higher is better

Slide 16

Conclusions Fantom, a 2nd generation BRS Demonstrated device safety through 24 months 5.0% MACE @ 24 months; 0.4% VLST Fantom Encore, a 3rd generation BRS The thinnest struts of any clinically available BRS1 No compromise to radial strength or radiopacity Unique Tyrocore polymer Fantom clinical program expanding Global Fantom Post Market Trial - enrolling 1500 patients across 100 to 150 clinical centers Indication expansion studies in long lesions and STEMI 1) 95 µm strut thickness in the 2.5 mm diameter size