PREVEIL DCB Feasibility Study A Prospective, Multi-Center, Single-Arm Trial to Assess the Safety and Feasibility of the Surmodics SurVeil Drug-Coated Balloon in the Treatment of Subjects with De Novo Lesions of the Femoropopliteal Artery Wellmont CVA Heart Institute Kingsport, Tennessee D. Christopher Metzger, MD

PREVEIL DCB Feasibility Study Study design Prospective, U.S., multi-center, single-arm, safety and feasibility Objective To assess the safety and functionality of the Surmodics SurVeil drug coated balloon in the treatment of symptomatic PAD due to de novo stenoses of the femoral and popliteal arteries. Patients / sites 13 subjects at 3 clinical sites Dr. Gary Ansel; OhioHealth (OH)Dr. Ravish Sachar; Rex Hospital (NC)Dr. D. Christopher Metzger; Wellmont CVA Heart Institute (TN) Primary endpoint Peak paclitaxel plasma concentrations through 30 days post-index DCB procedure Key secondary performance endpoints Primary patency and late lumen loss at 6 months Key secondary safety endpoints Freedom from evidence of paclitaxel toxicity, major vascular complications, or thrombolysis in Myocardial Infarction (TIMI)-defined major and minor bleeding Follow-up Immediate, 1, 2, 4, 12 hours post-procedure; 1, 6, 12, 24, 36 month visitsFollow up included angiogram at 6 months and duplex ultrasound (DUS) at 1, 6, 12, 24, 36 month visits Status First subject: April 5, 2016Enrollment completion: December 9, 2016

Comparison to Benchmark DCBs Balloons dry expanded to nominal pressure DCB #1 DCB #2 SurmodicsSurVeil® DCB DCB #3

DCB Comparison: SEM 50X SurmodicsSurVeil® DCB DCB #2 DCB #1 DCB #3

Key Inclusion CriteriaPREVEIL DCB Feasibility Study Clinical ≥18 years oldRutherford-Becker class 2-4 Angiographic De novo target lesion in femoral and popliteal arteriesTarget lesion ≥ 50% stenosisTarget lesion length ≤ 90 mmTarget vessel RVD 4-6 mmAfter pre-dilation, target lesion ≤ 70% residual stenosisPatent inflow artery free from significant stenosisAt least one patent native outflow artery to ankle or foot, free from significant stenosis

Key Exclusion CriteriaPREVEIL DCB Feasibility Study Clinical Acute limb ischemia Previous lower-extremity PTA with DCB within 3 monthsPrior vascular intervention within 2 weeks or planned vascular intervention within 30 days post-procedure Angiographic Previous intervention at lesion sitePrevious treatment of target vessel Severe concentric calcification of target lesionTarget lesion involved or adjacent to aneurysm

DemographicsPREVEIL DCB Feasibility Study (n=13) Mean age 67.8 Male (%) 69.2% Current smoking (%) 53.9% Diabetes mellitus (%) 46.2% Hypertension (%) 84.6% Hypercholesterolemia (%) 100% Family history of PAD (%) 0% Family history of CAD (%) 81.8% Ischemic heart disease (%) 23.1%

Lesion CharacteristicsPREVEIL DCB Feasibility Study (n=13) Mean Lesion Length (mm) 56.4 Mean Treatment Area (mm) 81.5 Mean Pre-Procedure Diameter Stenosis (%) 87.2 Mean RVD (mm) 5.0 Mean Post-Procedure Diameter Stenosis (%) 14.2

Secondary Safety EndpointsPREVEIL DCB Feasibility Study Discharge (n=13) 30 Days(n=13) 6 Months(n=13) 12 Months (n = 13) Evidence of Paclitaxel Toxicity 0% 0% 0% 0% Major Vascular Complications 0% 0% 0% 0% TIMI-Defined Bleeding 0% 0% 0% 0% 30 Days (n=13) 6 Months(n=13) 12 Months (n = 13) Target Lesion Revascularization 0% 0% 0% Target Vessel Revascularization 0% 0% 0% Arterial Thrombosis 0% 0% 0% Embolic Events 0% 0% 0%

Primary EndpointPREVEIL DCB Feasibility Study Peak Paclitaxel Plasma Concentration Cmax(ng/mL)(N=13) Mean ± SD (N)Median (25%tile, 75%tile)Range (min, max) 2.25 ± 2.5 (10)1.22 (0.472, 3.10)(0.235, 8.24) Group Mean Plasma Paclitaxel Concentration (ng/mL) Versus Nominal Time Baseline Post Procedure 1 Hour 2 Hours 4 Hours 12 Hours/(Or Upon Discharge) 30 Days Mean 0.00 1.92 0.348 0.301 0.326 0.255 BLQ Min 0.00 0.175 BLQ BLQ BLQ BLQ BLQ Median 0.00 1.07 0.249 0.235 0.231 0.222 BLQ Max 0.00 8.24 0.962 0.736 0.986 0.723 BLQ

Primary EndpointPREVEIL DCB Feasibility Study 1Three subjects had insufficient data to complete the analysis and are excluded from descriptive statistics2Levant 2 Subset (serum); data from PMA P130024 SSED3IN.PACT SFA Trial Sub-Study (plasma); data from PMA P140010 SSED Peak Plasma Paclitaxel Concentrations Comparison Device Patients Paclitaxel Dose (mg) Tmax Cmax (ng/mL) AUC0-last (hr*ng/mL) Surmodics SurVeil DCB EFS1 13 1.3 – 3.8 Immediately post-procedure 2.25 ± 2.5 3.74 ± 3.2 Bard Lutonix2 22 1.3 – 5.0 Immediately post-procedure 5.10±3.21 8.39±4.00 Medtronic IN.PACT Admiral3 24 2.8 – 16.8 0.17 hr 7.9±7.70 29.4±22.06

Secondary Performance EndpointsPREVEIL DCB Feasibility Study Patency at 6 Months N=13 95% CI Primary Patency No restenosis* at 6 monthsFreedom from TLR at 6 monthsLate Lumen Loss (mm) Mean±SD (N) Median (Q1, Q3)Range (min,max) 100% (13/13)100% (13/13)100% (13/13)0.27±0.54 (13)0.19 (0.04,0.62)(-0.91,1.05) [75.3%,100.0%][75.3%,100.0%][75.3%,100.0%][-0.06,0.59] *Primary patency, freedom from binary restenosis by US or TLR

Secondary Performance EndpointsPREVEIL DCB Feasibility Study Rutherford-Becker Classification Clinical Improvement Compared With Baseline 30 Days (n=13) 6 Months(n=13) 12 Months (n=13) Grade + 3 Markedly Improved 46.2% 69.2% 61.5% Grade + 2 Moderately Improved 23.1% 30.8% 23.1% Grade +1 Mildly Improved 7.7% 0.0% 7.7% Grade 0 No Change 23.1% 0.0% 7.7% Grade -1 Mildly Worsening 0.0% 0.0% 0.0% Grade -2 Moderately Worsening 0.0% 0.0% 0.0% Grade -3 Markedly Worsening 0.0% 0.0% 0.0%

Secondary Performance EndpointsPREVEIL DCB Feasibility Study Ankle Brachial Index/Toe Brachial Index (ABI/TBI) Measurements Difference30 Days-Baseline Difference6 Months-Baseline Difference12 Months-Baseline Resting ABI Mean±SD (N) Median (Q1, Q3)P Value from Signed Rank Test 0.29±0.26 (13)0.25 (0.17, 0.49)0.001 0.28±0.24 (11)0.16 (0.12, 0.48)˂0.001 0.19±0.31 (13)0.13 (0.07, 0.34)0.046 6-Minute Walk Test 6-Minute Walk Test Difference30 Days-Baseline Difference6 Months-Baseline Difference12 Months-Baseline Change from Baseline (m) Mean±SD (N) Median (Q1, Q3)P Value from Signed Rank Test 62.02±74.65 (11)30.76 (10.00, 129.62)0.014 90.37±119.87 (11)115.00 (10.00,178.70)0.032 75.97 ± 113.10 (11)30.76 (-26.00, 198.12)0.102

Secondary Performance EndpointsPREVEIL DCB Feasibility Study Walking Impairment Questionnaire (WIQ) WIQ Measurements Difference30 Days-Baseline Difference6 Months-Baseline Difference12 Months-Baseline Walking Distance Score Mean±SD (N) Median (Q1, Q3)P Value1Walking Speed Score Mean±SD (N) Median (Q1, Q3)P Value1Stair Climbing Score Mean±SD (N) Median (Q1, Q3)P Value1 31.70±44.73 (13)37.57 (-0.14, 65.48)0.04019.48±35.82 (13)20.65 (-4.35, 42.39)0.08138.78±41.99 (13)54.17 (0.00, 66.67)0.007 41.77±33.15 (13)53.27 (24.86, 68.68)0.00323.24±42.10 (13)21.74 (4.35, 43.48)0.08927.56±39.25 (13)25.00 (8.33, 50.00)0.032 50.72±45.57 (13)65.48 (21.02, 89.99)0.00328.09±43.52 (13)32.61 (1.09, 64.13)0.04536.22±41.02 (13)50.00 (12.50, 62.50)0.008 1P Value from Signed Rank Test

SummaryPREVEIL DCB Feasibility Study Device met secondary performance criteriaTechnical, device, and procedure success criteria achieved30 day results demonstrated:Systemic paclitaxel levels were low and cleared rapidlyAcute success achieved in 100% of subjects6 month results demonstrated:Primary patency rate of 100%Late lumen loss data encouraging12 month results demonstrated:Improvement in Rutherford classification (92.3%)Statistically significant improvements in ABI, walking distance, walking speed and stair-climbing100% freedom from TLR through 12 months