DESSOLVE I Trial Results The Micell Technology and Program Update DESSOLVE I Trial Results Mathias C. Vrolix, MD ZOL, Genk, Belgium

Disclosure Statement Nothing to Disclose CAUTION: The MiStent® Sirolimus DES is an investigational device that is not approved by the FDA for sale or use in the United States.

DES - Moving Away from Durable Polymers Durable polymers have been linked with very late (>1 yr) stent thrombosis events due to: Stimulus for chronic inflammation Local allergic reactions Incomplete re-endothelialization Positive remodeling Acquired incomplete stent apposition References: Cook S, et al. Correlation of Intravascular Ultrasound Findings With Histopathological Analysis of Thrombus Aspirates in Patients With Very Late Drug-Eluting Stent Thrombosis. Circulation. 2009;120:391-399 Joner M, et al. Pathology of Drug-Eluting Stents in Man: Delayed Healing and Late Thrombotic Risk. J Am Coll Cardiol. 2006;48:193–202 Cook S, et al. Incomplete Stent Apposition and Very Late Stent Thrombosis After Drug-Eluting Stent Implantation. Circulation. 2007;115:2426-2434

MiStent Bioabsorbable Coating Rapid elimination of polymer with controlled release of drug POLYMER – Absorbable Coating Known Polymer – PLGA Coating is cleared from stent in 45-60 days leaving a BMS Eliminated from tissue in 90 days DRUG Known Drug – SIROLIMUS Crystalline form (for modified release) contained within the polymer Formulation provides drug stability for sustained release with no burst Extensively tested proven drug, highly effective for suppression of neointimal hyperplasia STENT and DELIVERY SYSTEM Known Stent – GENIUS® Magic Stent and Rx Catheter CE Mark thin strut (64µm) cobalt chromium coronary stent Flexible and trackable with visibility and accuracy Illustrative SEM of MiStent DES Stent Platform

Safety & Efficacy in Porcine Model Significantly lower inflammation than BMS through 90 days in challenging overlap configuration. Significantly less NIH through 30 days. Lumen VER, 2x 30 day OLP MiStent DES *P < 0.05 Lumen VER, 2x 30 day OLP Vision BMS *P < 0.05

DESSOLVE I Clinical Study First-In-Human Trial Enrollment: 30 patients at 5 sites with de novo, type A/B1/B2 lesions MiStent DES: 2.5-3.5mm diameter x 19 or 23 mm length Evaluations: Primary: In-stent LLL in groups of 10 patients at 4, 6 and 8 months follow-up Safety: MACE - all death, MI (QW and NQW), and TVR Imaging: Angiography, IVUS and OCT evaluations at each time point Follow-up: Patients will be followed for 5 years 30 Pts Enrolled 10 Pts 4-Months Angio, IVUS, OCT 10 Pts 8-Months Angio, IVUS, OCT All patients evaluated for clinical events at 8 months 10 Pts 6-Months Angio, IVUS, OCT

Investigators and Sites Co-PRINCIPAL INVESTIGATORS William Wijns, MD Belgium John Ormiston, MD New Zealand Belgium William Wijns, MD, Cardiovascular Center, Aalst Mathias Vrolix, MD, ZOL, Genk New Zealand Jim Stewart, MD, Mercy Angiography Unit, Auckland Mark Webster, MD, Auckland City Hospital, Auckland Australia Robert Whitbourn, MD, St. Vincent’s Hospital, Melbourne

CROs and Core Labs DATA MANAGEMENT and SAFETY, CEC, DSMB Harvard Clinical Research Institute, Boston, MA CORE LABORATORIES Angiographic Core Laboratory @ Yale, New Haven, CT Alexandra Lansky, MD IVUS Core Laboratory @ Stanford, Stanford, CA Peter Fitzgerald, MD, PhD OCT Core Laboratory @ HVI, Cleveland, OH Hiram Bezzera, MD, PhD and Marco Costa, MD, PhD MONITORING GROUPS genae Associates, Inc. Pacific Clinical Research Group

Inclusion/Exclusion Criteria Key Criteria Patient: Stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia; No recent Q wave MI (<72 hrs) or no elevated cardiac biomarkers Target Lesion: Planned single, de novo, types A, B1 or B2 coronary lesions (according to the ACC/AHA classification) in the native coronary artery with >50% diameter stenosis; Vessel diameter 2.5 to 3.5 mm - maximum 23 mm long stent; Exclude if highly calcified, tortuous, thrombus present, proximal angulation; Exclude if located at side branch >2.5mm, ostial location, previously treated vessel Non-Target Lesion: May treat one critical non-target lesion in another vessel prior to target lesion

DAPT Pre-Procedure: Patient DAPT Compliance at 8-months: Recommendations: DAPT recommendations in accordance with ACC/AHA/SCAI PCI Practice Guidelines Aspirin indefinitely Plavix® (clopidogrel) for 12 months minimum of 6 months taking local country recommendations into consideration Pre-Procedure: 87% of patients were already on DAPT Patient DAPT Compliance at 8-months: Aspirin: 100% patients are continuing to take daily aspirin Plavix : 80% (24/30) remain on daily Plavix of 75 mg at 8 months 20% (6/30) discontinued at 6 months

Baseline Patient Characteristics Demographics (N=30 patients) Age Mean ± SD (N) 62.57 ±9.95 (30) Range (Min, Max) (44.00,86.00) Gender Male 73.3% (22/30) Female 26.6% (8/30) Risk Factors (N=30 patients) MI 16.7% (5/30) PCI of Non-TV 30.0% (9/30) Previous PCI of TV 10.0% (3/30) Diabetes Mellitus 23.3% (7/30) Hypertension 76.7% (23/30) Hypercholesterolemia 86.7% (26/30)

Baseline Lesion Characteristics (N=30 patients) Vessel Location LAD 36.7% (11/30) LCX 23.3% (7/30) RCA 40.0% (12/30) Length, mm 1<=Length<10 mm 26.7% (8/30) 10<=Length<20 mm 70.0% (21/30) Length>=20 mm 3.3% (1/30) Calcification, (Moderate/Severe) Moderate Severe Lesion Classification A 20.0% (6/30) B1 43.3% (13/30) B2 C 13.3% (4/30)

Procedural Characteristics Measure (N=30 patients) RVD (mean ±SD) 2.9 ±0.3 Lesion Length (mean ±SD) 13.2 ±3.8 Mean %DS Pre Procedure (±SD) 69.3 ±7.7 Max Stent Deployment Pressure (atm) 13.9 ±2.7 Number of non-TV lesion treated 26.7 (8/30)

Procedural Outcomes Measure Device Success 96.6% (29/30)* (N=30 patients) Device Success 96.6% (29/30)* Lesion Success 100% Procedural Success *MiStent DES was unable to cross the lesion due to calcification in the artery. A subsequent MiStent was implanted.

Angiographic Parameter Procedural Outcomes Angiographic Parameter Mean (±SD) (n=30 pts) Range (min-max) In-Stent %DS 2.26% (±7.44) -12.43% - 14.72% In-Lesion %DS 13.37% (± 7.39) -2.53% - 29.36% In-Stent MLD (mm) 2.83 (±0.30) 2.05 - 3.46 In-Lesion MLD (mm) 2.51 (±0.28) 1.69 - 3.01

Safety Events MiStent Total MACE 3.33% (1)** TLF 0% TVF as adjudicated by CEC MiStent (N=30 pts) Total MACE 3.33% (1)** TLF 0% TVF Peri-procedural MI 6.7% (2)*** Stent Thrombosis * MACE defined as death, MI (QWMI and NQWMI) and TVR ** non TV, NQWMI: increased troponin following diagnostic angiogram at 44 days post-index procedure *** ppmi: CK-MB elevation only post-procedure

Primary Endpoint – In-Stent Late Lumen Loss Angiographic Results Primary Endpoint – In-Stent Late Lumen Loss In- Stent LLL (mm) 4-Month Group (n=10) 6-Month Group 8-Month Group Mean (± SD) 0.01 (± 0.12) 0.21* (± 0.36) 0.09 (± 0.10) Median Range 0.03 -0.22 to 0.21 0.10 -0.03 to 1.20 0.08 -0.01 to 0.28 Includes outlier with lesion outside proximal end to stent that grew into the stent. Excluding outlier the mean 6-mo LLL was 0.1mm

Angiographic Results Patient Level In-stent LLL (QCA) by Follow-Up Group No Binary Restenosis Linear Regression indicates minimal change in Late Lumen Loss between 4 and 8 Months In-stent LLL (mm)

IVUS Results Demonstrate Low Neointimal Hyperplasia consistent with the low in-stent late loss seen angiographically Parameter* 4-Month Group Mean (SD) (n=9) 6-Month Group (n=7) 8-Month Group (n=8) Neointimal Obstruction (%) 5.2 (±3.2) 8.0 (±3.1) 10.9 (±4.6) Neointimal Volume Index (mm3/mm) 0.3 (±0.2) 0.7 (±0.4) 0.8 (±0.5) *1 case (4 month), 3 cases (6 months) and 2 cases (8 month) were not interpretable

IVUS at 8M Follow-up Proximal Distal Proximal Distal %NIH: 4.3%, maxCSN 16.6% 002_001: 3.0x23mm for LCX

Thin homogeneous tissue coverage OCT Results High rate of stent strut coverage at all time points Stent Strut Coverage Mean 4-Month 84.7% 6-Month 93.4% 8-Month 96.5% Thin homogeneous tissue coverage

Conclusions MiStent DES: Designed for the coating to be cleared off the stent in 45-60 days leaving a BMS with sustained drug release Efficacy Angiography & IVUS evaluations indicate good inhibition of neointimal hyperplasia In-stent LLL at 8 months was 0.09 mm Percent neointimal obstruction at 8 months was 10.9% No binary restenosis or revascularizations Essentially no change in extent of NIH from 6 to 8 months follow up Safety OCT demonstrates good strut coverage 96.5% at 8 months MACE events: 1 non-TV, NQWMI at 44 days post-procedure No stent thrombosis

DESSOLVE II Design Primary Endpoints Sub-Study Evaluations Prospective, unbalanced (2:1) randomized, superiority trial 183 patients enrolled at 26 sites Primary Endpoints Efficacy: In-stent LLL at 9 months Safety: MACE at 9 months Sub-Study Evaluations OCT in 30 patients Endothelial Function Testing in 42 patients Ability of target vessel to heal with return of endothelial function after stent deployment Status Enrollment Complete – Results Q3-2012 183 Enrolled 2:1 Randomization MiStent DES 122 pts Endeavor® Sprint 61 pts

The Micell Technology and Program Update DESSOLVE I Trial Results END