BASELINE CHARACTERISTICS. Patients (n) 62. Age (years) 77.6 ± 7.4. Male gender (%) 59.7% Weight (kg) 81.7 ± 17.4

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1 FRONTIER III Results of a study to assess a New Fully Absorbable Patch Based Large Hole Vascular Closure Device Michael Laule, MD 1, Arne Schwindt, MD 2, Peter Crean, MD 3, Matthew Thompson, MD 4, Andrej Schmidt, MD 5 1. Charité University Hospital, Berlin, Germany 2. St. Franziskus Hospital - Münster, Germany 3. St. James s Hospital, Dublin, Ireland 4. St. George s Hospital, Blackshaw Road, London, UK. 5. Leipzig University Hospital, Leipzig Germany. Aim Results Assess the safety and clinical performance of a new fully percutaneous patch based synthetic absorbable Large Hole BASELINE CHARACTERISTICS CLOSURE PROCEDURES Follow-up Patients Closure Device (18-24F). Methods 50+ patients undergoing large bore femoral percutaneous access for TAVI, EVAR and TEVAR, prospective, nonrandomized in 6 European centres Patients (n) 62 Age (years) 77.6 ± 7.4 Male gender (%) 59.7% Weight (kg) 81.7 ± 17.4 Hypertension (%) 82.3% Patients (n / %) 62 TAVR 42 (68) EVAR 16 (26) TEVAR 4 (6) Site Closures (n/ %) 70 Discharge 62 3 Month Month Subjects (70 closures) completed Assessment of puncture site with DUS/CT at discharge, 30 days, 90 days and 1 year Primary endpoint: Incidence and severity of major complication Diabetes mellitus (%) 30.6% Peripheral vascular surgery (%) 6.5% TAVR 42 (60) EVAR 24 (34) TEVAR 4 (6) across 6 European centers No device related major vascular complications (VARC-2) rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation (as defined by VARC-2 Claudication 1.6% Closure sheath size No late minor or major device related PerQseal Technology Previous arterial access procedure in CFA 8.1% 18F 89% > 18F 11% vascular complications 97% Technical success 3 minor device related complications (haematoma, asymptomatic stenosis, and pseudoaneurysm) No clinically significant changes on ultrasound or CT-angiogram CE Mark approved Conclusion Implant Encapsulated Implant absorbing and extra-arterial Implant Absorbed Clinical demonstration of safety with excellent outcomes from discharge through 1, 3 and 12 month follow-up The device performed reliably with a low learning curve 32 days 91 days 180 days Provides a real option for fully percutaneous closure with reduced hospital costs and procedure times.

2 Aim and Methods Aim of the Study Assess the safety and clinical performance of a new fully percutaneous patch based synthetic absorbable Large Hole Closure Device (18-24F) Methods 50+ patients undergoing large bore femoral percutaneous access for TAVI, EVAR and TEVAR, prospective, non-randomized in 6 European centres Assessment of puncture site with DUS/CT at discharge, 30 days, 90 days and 1 year Primary endpoint: Incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation (as defined by VARC-2 1 ) is no worse than those associated with cut-down or suture based closure devices of 14.7% 1. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. European Journal of Cardio-Thoracic Surgery 42 (2012) S45 S60.

3 PerQseal Technology Fully absorbable patch based Synthetic absorbable low-profile implant Designed for large arteriotomies (up to 24F) Seals from inside Simple operation (OTW) Controls of bleeding throughout delivery/deployment No suture, collagen or metal components Day 1 Day 180 Absorbed fully within 180 days (animal model) Used at conclusion of primary procedure

4 Pre-clinical Histopathology: days post implantation the Implant Encapsulated Implant absorbing and extra-arterial Implant Absorbed 32 days 91 days 180 days Porcine abdominal aorta luminal surface 22F Day 1 Implantation site Complete Day 162 Implantation site undifferentiated from native arterial wall No granuloma/scaring No perivascular fibrosis Longitudinal 162 days

5 Procedural Information BASELINE CHARACTERISTICS Patients (n) 62 Age (years) 77.6 ± 7.4 Male gender (%) 59.7% Weight (kg) 81.7 ± 17.4 Hypertension (%) 82.3% Diabetes mellitus (%) 30.6% Peripheral vascular surgery (%) 6.5% Claudication 1.6% Previous arterial access procedure in CFA 8.1%

6 Procedural Information CLOSURE PROCEDURES INDEX PROCEDURES Patients (n / %) 62 TAVR 42 (68) Index Procedure Device Index Procedure Sheath Hole OD for closing (n=70) EVAR 16 (26) TEVAR 4 (6) Site Closures (n/ %) 70 Sapien III 14F e-sheath 23F 8 Sapien III 16F e-sheath ~ 24F 13 Evolut R (w St Jude 18F) 14F 21F 15 Lotus 18F 22F 5 TAVR 42 (60) SJM Portico 19F 22F 1 EVAR 24 (34) Nellix (w/ Cook 18F) 14F 22F 2 TEVAR 4 (6) Nellix (w/ St Jude 18F) 14F 21F 3 Closure sheath size Endurant II 20F 20 F 13 Zenith TX2 22F ~ 24F 2 18F 89% > 18F 11% Zenith TX2 20F 22F 3 In-Craft (w St Jude 18F) 14F 21F 5

7 Study Results 62 Patients (with 70 closures) completed across 6 European centers Follow-up Patients Procedures No. Discharge 62 TAVR 42 3 Month 59 EVAR Month 51 TEVAR 4 No device related major vascular complications (VARC-2) 97% Technical success 3 minor device related complications (haematoma, asymptomatic stenosis, and pseudoaneurysm) No late minor or major device related vascular complications No clinically significant changes on ultrasound or CT-angiogram CE Mark approved

8 Conclusion PerQseal Technology Easy to use device Patch based, fully absorbable implant Requires no pre-procedure steps Has clinically demonstrated its safety with excellent outcomes from discharge through 1, 3 and 12 month follow-up The device has performed reliably with a low learning curve (3 simple steps for deployment) Provides a real option for fully percutaneous closure with reduced hospital costs and procedure times

9 FRONTIER III Results of a study to assess a New Fully Absorbable Patch Based Large Hole Vascular Closure Device TCT 2017 Presented by Priv-Doz Dr med Michael Laule Financial Disclosure Statement: The below table of contributing Investigators have or will: 1. Not receive any compensation from any source whereby the value of the compensation paid could be influenced by the outcome of the study. 2. Not have any equity interest in the Investigational Device or Sponsoring Company. 3. Not have any proprietary or other financial interest in the Investigational Device or related technology. 4. Receive Institutional grant/research support not exceeding 25,000, other than the costs of conducting this study. Study Sponsor: Vivasure Medical Ltd Investigational Device: Vivasure Closure Device Sites and Contributing Investigators St. James s Hospital, Department of Cardiology, Dublin, Ireland Blackrock Clinic, Dublin, Ireland Dr. Peter Crean, Cardiologist St. Franziskus-Hospital Munster - Germany Prof. Dr. Giovanni Torsello and Dr Arne Schwindt, Vascular Surgeons Universitätsklinikum Leipzig AöR, Department Interventional Angiology - Germany Prof. Dr. Dierk Scheinert and Dr Andrej Schmidt, Cardiologists, Angiologists Charité-Universitätsmedizin Berlin - Germany Priv. Doz. Dr. med. Michael Laule, Cardiologist, Angiologist St George s Hospital London - UK Prof. Matthew Thompson and Prof. Ian Loftus, Vascular Surgeons