enVVeno Medical Corporation · NASDAQ:NVNO
enVVeno Medical — VEITH Symposium 2024
65 slides from enVVeno Medical's conference presentation, November 2024
Slide 1: Setting New Standards for Venous Care
Setting New Standards for Venous Care VEITH SYMPOSIUM November 2024 Nasdaq: NVNO enVVeno.com
Slide 2: Agenda
Agenda 2 Welcome - Robert Berman, CEO Introduction - Dr. Marc Glickman, Senior Vice President and CMO Overview: One-Year Data from the SAVVE Pivotal Trial Dr. Matthew Smeds, St. Louis University VenoValve Results: CEAP Stratification Dr. Raghu Motaganahalli – Indiana University Patient Perspectives
Slide 3: One-Year Data of VenoValve Implantation in the SAVVE U.S. Pivotal Trial
November 20, 2024 One-Year Data of VenoValve Implantation in the SAVVE U.S. Pivotal Trial Presented by Dr. Matthew Smeds Professor of Surgery, Division of Vascular and Endovascular Surgery St. Louis University
Slide 4: Chronic Venous Insufficiency (CVI): Economic Impact
Chronic Venous Insufficiency (CVI): 4 Economic Impact ~2.5M ~$30k 20-40% Potential VV Spent on wound care per 1-year ulcer recipients patient per year2 recurrence1 the U.S. ~$3B ~40% Direct medical More workdays costs2 missed3 1. Yost, Mary, The Sage Group, Chronic Venous Disease, Epidemiology, Cost
Slide 5: CVI: Impact on Quality of Life
CVI: Impact on Quality of Life 5 Pain, Heaviness, Edema, Ulceration, Personal Care and Household Chores Sleep Deprivation and Social Isolation Reported Rates of Anxiety of up to 30%, Depression of up to 40%1 QoL Worse than Osteoarthritis, Angina, COPD2 1. Souza Nogueira G, Rodrigues Zanin C, Miyazak
Slide 6: Treatment of Deep CVI
Treatment of Deep CVI 6 Standard of Care = Compression Therapy Attaran RR & Ochoa Chaar CI, Phlebology . 2017 Mar;32(2):81-88 Maleti et al., J Vasc Surg Venous Lymphat Disord 2023;11:1265-75
Slide 7: VenoValve: Unique Bioprosthesis
VenoValve: Unique Bioprosthesis 7 Monocusp Valve FDA Breakthrough Device Designation Rigid stainless-steel frame FIH Pilot study demonstrated sustained benefit in patients up to 3 years Porcine aortic valve noncoronary leaflets Uloa & Glickman. Vascular and Endovascular Surgery 2022, Vol. 56(3) 277–
Slide 8: U.S Pivotal Trial
U.S Pivotal Trial 8 Inclusion Exclusion • Failure of at Least 3 Months • ABI >.61 • Hypercoagulable Condition • Iliac/IVC Obstruction or Poor Standard Care • BMI <40 • Acute Deep Venous Thrombosis Central Venous Flow • Axial Reflux > 1 Second or Pulmonary Embolism • Uncontrolled Diabetes • CEAP Scor
Slide 9: Valve Implant
Valve Implant • Proximal to Mid thigh Femoral vein • Mobilize the SFAfor adequate Femoral vein exposure
Slide 10: Valve Implant
§ Valve Implant en¥%eno
Slide 11: Patients Characteristics
Patients Characteristics 11 Demographics CEAP Classification • Age: 62.9 [38-83] • C4b: 5/73 (6.8%) • Male: 80.8% (N=59) • C4c: 5/73 (6.8%) • Race • C5: 21/73 (28.8%) • White: 86.3% (N=63) • C6: 42/73 (57.5%) • African American: 12.3% (N=9) • 73.8% (N=31/42) of patients • Other: 1.4% (N=1) with C6 d
Slide 12: Procedural Outcomes
§ Procedural Outcomes PROCEDURAL SUCCESS RATE 97.3” (N=73/75) INTRA-OPERATIVE DEVICE PATENCY 100” SAW/E DAYS TO DISCHARGE 1.2 day average hospital stay en¥%eno
Slide 13: Mechanical Aspiration Thrombectomy
Mechanical Aspiration Thrombectomy 13 • Endovascular salvage in 2 cases
Slide 14: 1 Year Results from SAVVE Trial
14 1 Year Results from SAVVE Trial enVVeno.com
Slide 15: Device Patency at 1 Year
Device Patency at 1 Year 15 *9 device occlusions. 8 recanalized.
Slide 16: Target Vein Patency Rate
Target Vein Patency Rate* 16 *Target Vein Patency Rate defined as absence of color flow in any of four locations of the target vein (femoral vein) where the VenoValve was implanted.
Slide 17: Major Adverse Events (MAEs) at 1 year
Major Adverse Events (MAEs) at 1 year 17 17 out of 18 subjects with MAEs through 30 days not impacted and achieved clinical meaningful benefit at 1 year
Slide 18: rVCSS: Clinically Meaningful Benefit
rVCSS: Clinically Meaningful Benefit 18
Slide 19: rVCSS: Point Improvement Clinically Meaningful Benefit
rVCSS: Point Improvement 19 Clinically Meaningful Benefit
Slide 20: Patients < 3 Point rVCSS
Patients < 3 Point rVCSS 20 15%
Slide 21: C6 Patients: Active Ulcers
C6 Patients: Active Ulcers HealX marker – Standard unit of measurement Ulcer 1 Area: 60.83 cm² Length: 14.24 cm Width: 5.61 cm Ulcer 2 Area: 9.99 cm² Length: 5.06 cm Width 2.78 cm Outcomes up to one year: • Total area of ulceration after surgery compared to baseline • Ulcer healing and improvement
Slide 22: Average Ulcer Area Reduced To – C6 Patient
Average Ulcer Area Reduced To 22 – C6 Patient
Slide 23: Ulcer C6 Patient: Severity of the Disease
Ulcer C6 Patient: Severity of the Disease 23 Nasdaq: NVNO | enVVeno.com
Slide 24: Percent Avg Ulcer Area Reduction
Percent Avg Ulcer Area Reduction 24
Slide 25: Impact of VenoValve Implantation
Impact of VenoValve Implantation 25 Nasdaq: NVNO | enVVeno.com
Slide 26: Ulcer Healing Summary
§ Ulcer Healing Summary SAYZE | « Ulcer Healing or Improvement at 12 Months Following VenoValve Implant Procedure 80” of Ulcers Reduced in Size from baseline (n=40/50) ULCER DURATION ULCER DURATION <1 YEAR >1YEAR 100% 78% Improved Improved n=12/12 n=28/36 92% 31% Fully Healed Fully Healed nad n=11/3
Slide 27: VAS Leg Pain Score
Be VAS Leg Pain Score SAWZE | » Percentage Improvement in Median VAS Scores at 12 Months 90% 9 % 20% 1 75” 70% | 60% 75% Improvement 50% in Median VAS at 12 Months 40% N=54 30% 20% 10% 0% i it i Baseline 3 months 6 months 12 months enwyeno MEDICAL
Slide 28: Quality Of Life Indicators
Quality Of Life Indicators 28
Slide 29: VEINES SYMs Score
BE VEINES SYMs Score SAWZE |» 70 65 2 8 60 OG n iS L BS 6 D S50 z S45 40 35 i a i Baseline 3 months 6 months 1 Year Visit en¥%eno
Slide 30: VEINES QoL
B VEINES QoL SAVE | VEINES QoL Baseline 3 months 6 months 1 Year Visit en¥%eno
Slide 31: EQ-5D-5L Index Score Through 12 months
EQ-5D-5L Index Score 31 Through 12 months
Slide 32: Use of Compression Therapy
Use of Compression Therapy 32
Slide 33: Conclusion
Conclusion 33 The VenoValve is a safe and effective treatment for patients for the treatment of chronic venous insufficiency (CVI) due to deep valvular incompetency.
Slide 34: Q&A Thank You!
Q&A 34 Thank You! Nasdaq: NVNO | enVVeno.com
Slide 35: Impact Of Placement Of The VenoValve On CEAP Score In Patient's Treated In SAVVE Trial
November 20, 2024 Impact Of Placement Of The VenoValve On CEAP Score In Patient’s Treated In SAVVE Trial Presented by Dr. Raghu Motaganahalli Professor of Surgery, Division Chief and Program Director Division of Vascular Surgery Indiana University Methodist Hospital
Slide 36: How Does VenoValve Affect Advanced Chronic Venous Disease (C4–C6)?
How Does VenoValve Affect Advanced Chronic Venous Disease (C4–C6)?
Slide 37: Patients Characteristics
Patients Characteristics 37 Demographics CEAP Classification • Age: 62.9 [38-83] • C4b: 5/73 (6.8%) • Male: 80.8% (N=59) • C4c: 5/73 (6.8%) • Race • C5: 21/73 (28.8%) • White: 86.3% (N=63) • C6: 42/73 (57.5%) • African American: 12.3% (N=9) • 73.8% (N=31/42) of patients • Other: 1.4% (N=1) with C6 d
Slide 38: Patients Characteristics per CEAP Classification
Patients Characteristics per 38 CEAP Classification No statistical differences across the 3 CEAP cohorts, Age comparison: P-value= 0. 2635
Slide 39: Change in rVCSS and Systemic Reflux Data
Change in 39 rVCSS and Systemic Reflux Data SYSTEMIC DERIVED REFLUX Average of reflux values 2cm, 5cm, 10cm below the valve compared to caudal/popliteal reflux average at baseline The Pearson correlation coefficient was 0.16, indicating a positive correlation between the two outcomes; as the change
Slide 40: Change in rVCSS and Systemic Reflux Data – C6 Subjects
Change in rVCSS and Systemic Reflux Data – C6 Subjects
Slide 41: Change in rVCSS and Systemic Reflux Data - C5 Subjects
Change in rVCSS and Systemic Reflux Data - C5 Subjects
Slide 42: Average rVCSS score change for patients with ≥3 points at 12 Months
Average rVCSS score change for 42 patients with ≥3 points at 12 Months
Slide 43: Average rVCSS score change for patients with ≥3 points at 12 Months - per CEAP class
Average rVCSS score change for patients with 43 ≥3 points at 12 Months - per CEAP class
Slide 44: Average VAS (Pain) Score Changed from Baseline
Average VAS (Pain) Score Changed from Baseline 44
Slide 45: Average VAS (Pain) Score Improvement at 12 Months - per CEAP Class
Average VAS (Pain) Score Improvement 45 at 12 Months - per CEAP Class 53% 46% 35%
Slide 46: VEINES SYMS Score
§ VEINES SYMS Score SAME «: 70 65 2 8 60. OG n < i BS 6 D S50 z S45 40 35 a ci Baseline 3 months 6 months 1 Year Visit enwyeno MEDICAL
Slide 47: Avg VEINS SYM Score Improvement at 12 Months - per CEAP Class
Avg VEINS SYM Score Improvement at 12 Months 47 - per CEAP Class 28% 39% 40%
Slide 48: VEINES QoL
§ VEINES QoL SAYZE | as VEINES QoL Baseline 3 months 6 months 1 Year Visit envweno MEDICAL
Slide 49: Avg VEINS QOL score Improvement at 12 Months - per CEAP Class
Avg VEINS QOL score Improvement at 12 Months 49 - per CEAP Class 43% 36% 34%
Slide 50: Average Ulcer Area Reduced To – C6 Patient
Average Ulcer Area Reduced To 50 – C6 Patient
Slide 51: Percent Avg Ulcer Area Reduction
Percent Avg Ulcer Area Reduction 51
Slide 52: Use of Compression Therapy
Use of Compression Therapy 52
Slide 53: Conclusion
Conclusion 53 • This data suggests that not only is the VenoValve safe and effective, but is effective for all patients from C4b - C6. • Perhaps implanting patients early with the VenoValve would results in less severity of disease and symptoms for patients • VenoValve offers a novel treatment optio
Slide 54: Q&A Thank You!
B Q&A Thank You! 54 IEDICAL
Slide 55: Setting New Standards for Venous Care
Setting New Standards for Venous Care
Slide 56: Patient Case Study: Patient 023-001
56 Patient Case Study # 1 Presented by: Dr. Raghu Motaganahalli Patient 023-001 enVVeno.com
Slide 57: Patient 023-001
Patient 023-001 57 Baseline Patient Past Medical Demographics History Age 41 Hodgkins Lymphoma / 1991 Race Caucasian Thyroid CA / 2014 Sex Female DVT CEAP Class C5 Hyperlipidemia Height 165cm Weight 84.2kg BMI 30.9
Slide 58: 023-001 - Implant Date: 08/08/23
023-001 - Implant Date: 08/08/23 58 SURGICAL PROCEDURE On 08/08/2023 patient underwent placement of a 9mm VenoValve into the right femoral vein, primary closure POST-OP NOTES FOLLOW-UP NOTES • 7 day follow up it was reported that there was thrombus noted in FV • No initial complications and through
Slide 59: Patient 023-001
Patient 023-001 59 BASELINE 30 DAYS 3PROGRESSION MONTHS 6 MONTHS
Slide 60: Patient Case Study: Patient 020-002
60 Patient Case Study # 2 Presented by: Dr. Marc Glickman Patient 020-002 enVVeno.com
Slide 61: Patient 020-002
Patient 020-002 61 Baseline Patient Past Medical Demographics History Age 50 DVT Race Caucasian Diabetes Sex Female Patient has healed her wound CEAP Class C6 only 2 times in the last 20 years History of venous stasis ulcer ulcer for 20 years History of multiple superficial venous procedures Used co
Slide 62: 020-002: Implant Date 8/18/22
020-002: Implant Date 8/18/22 62 SURGICAL PROCEDURE On 8/18/22 patient underwent placement of a 9 mm VenoValve into the right femoral vein, mid- thigh region, bovine patch used POST-OP FOLLOW-UP NOTES NOTES • Patient was discharged the next day and Improvement in RVCSS from baseline 14 pt: treated w
Slide 63: Patient 023-001
Patient 023-001 63 BASELINE PROGRESSION
Slide 64: Patient Perspectives
64 Patient Perspectives enVVeno.com
Slide 65: Setting New Standards for Venous Care
Setting New Standards for Venous Care