Setting New
Standards for
Venous Care

Setting New
Standards for
Venous Care

What is Chronic Venous Insufficiency (CVI)?

Insufficient blood is returned to the heart and lungs due to damaged valves in the veins of the leg.

First-in-class surgical replacement venous valve for treatment of Chronic Venous Insufficiency (CVI) in the deep veins of the leg.

Patient Experience From Pivotal SAVVE® Trial

Initial Positive Efficacy Data From SAVVE Trial

11-Month Topline Revised Venous Clinical Severity Score (rVCSS) Improvement*

Overall 8.46 Average Revised Venous Clinical Severity Score (rVCSS) Improvement Per Patient for Patients Showing Clinical Meaningful Benefit (rVCSS Improvement ≥ 3 Points) including:

9.29 Points for Patients at the Two-Year Milestone

8.08 Points for Patients at the One-Year Milestone

8.71 Points for Patients at the Six-Month Milestone

72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery

94% of VenoValve Study Patients Showing Clinical Improvement at a Weighted Average of Eleven Months Post Surgery (rVCSS Improvement ≥ 1 point)

* Data compared to baseline

12 Month Ulcer Healing Data Showing Significant Improvement

91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved

100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed

89% of Venous Ulcers with a Duration of More Than One Year Priot to VenoValve Surgery have Fully Healed or Improved

No Ulcer Recurrences

Venous Ulcer Healing

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The VenoValve® and enVVe® are investigational medical devices currently in development. Neither device is approved or cleared for any indication in any market. The VenoValve® is only available for use in the United States in pre-market clinical studies.