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

Setting New Standards for Venous Care

The VenoValve® is a first-in-class surgically implanted solution being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve to help restore proper blood flow up the leg, to return sufficient blood back to the heart. The VenoValve is currently being evaluated in the SAVVE® pivotal study.

Product
Highlights

  • FDA Breakthrough Device Designation

  • First device to receive IDE approval from the
    FDA for the treatment of deep venous CVI

Product
Highlights

  • FDA Breakthrough Device Designation

  • First device to receive IDE approval from the
    FDA for the treatment of deep venous CVI

Patient Experience From Pivotal SAVVE® Study

Interviews from the 50th Annual VEITH Symposium

Initial Topline Results from SAVVE® U.S. Pivotal Trial

Topline Efficacy Data 

Clinical Improvement

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

Clinical Meaningful Benefit

≥ 3 Point Improvement in rVCSS
  • 72% 72%
72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery (Improvement in rVCSS of 3 or More Points)

Average rVCSS Improvement per Patient Showing Clinical Meaningful Benefit of 8.46 Points, More Than Two and a Half Times the Amount Needed to Show the VenoValve’s Clinically Meaningful Benefit

Compelling Device Related Safety Profile at 30 Days:*  

0

No
Deaths

0

No Pulmonary
Embolisms

8%

Deep Vein Thrombosis
(DVT)**

*A higher than expected rate of procedure related pocket wound hematomas and wound infections was observed, with no negative impact on clinical improvement. 
**Adjudication: 4 Mild; 2 Moderate. 5 of 6 DVT patients showing clinical improvement

Ulcer Healing

Overview:

Preliminary 11 Month Efficacy Data

Preliminary Efficacy Data:

Clinical Meaningful Benefit Cohorts

Preliminary Efficacy Data:

rVCSS Cohorts Subanalyses

Patients with C4b/c, C5 and C6 are all benefiting from the VenoValve at 11 months compared to baseline. 

Implantation Procedure

Chronic Venous Insufficiency

Scientific Publications
and Presentations

SAVVE® Clinical Study
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.