SAVVE^® U.S. Pivotal Trial: One Year Definitive Data

%

Clinical Meaningful Benefit Responder Rate*

Point Average rVCSS Improvement**

%

Median Reduction in Pain (VAS)

%

Median Ulcer Area Reduction

%

Target Vein Patency Rate

85% of the SAVVE Patients Went From Having Severe CVI to a More Mild Form of the Disease or No Disease At All

*Clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS)
**For the clinically meaningful benefit responder cohort

Improvement in Patient Reported Quality-of-Life Indicators

%

VEINES Symptom Score*

%

VEINES Qol Score*

*Mean (± SD): The VEINES scoring system consists of two composite scores – one for quality of life and one for symptom severity

rVCSS: Clinically Meaningful Benefit

Percentage of Patients with Clinical Meaningful Benefit at Follow Up

3 Months 71% 71%
6 Months 74% 74%
12 Months 85% 85%

rVCSS Point Improvement

Point Improvement in Average rVCSS Clinical Meaningful Benefit

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rVCSS Improvement by CEAP Class

Point Change in Average rVCSS Clinical Meaningful Benefit

Click the image to enlarge

rVCSS is a clinically validated scoring system used to track the regression or progression of venous diseases

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Pain (VAS) – One Year

Median of Percentage Improvement in VAS Scores at 12 Months

*Data dated 07 Oct. 2024, and these values calculated only for subjects with data available at baseline and visits. At 12 months n= 54.

Percentage Ulcer Reduction

%

Median Ulcer Area Reduction

Percentage Avg Ulcer Area (cm²) Reduced

Per Ulcer Duration

Patency

Procedural Outcomes

PROCEDURAL
SUCCESS RATE

INTRA-OPERATIVE
DEVICE PATENCY

%

Procedural Outcomes

PROCEDURAL
SUCCESS RATE

%

INTRA-OPERATIVE
DEVICE PATENCY

%

Major Adverse Events (MAEs) at 1 Year

One (1) Death (unrelated to the VenoValve) ⎮ Zero (0) Pulmonary Embolisms ⎮ Twelve (12) Target Vein Thromboses ⎮ Ten (10) Surgical Pocket Hematomas ⎮ Four (4) Other Bleeds ⎮ Seven (7) Deep Wound Infections
Percent (94%) of the subjects who experienced an MAE (not including the unrelated death) also experienced a clinical meaningful benefit

Patient Characteristics

The SAVVE^® US Pivotal Trail enrolled 75 patients across 21 clinical sites. Application for premarket approval is pending with the FDA and the device has not been approved for marketing or sale in the United States or elsewhere.

Active Sites

Albany Medical Center
391 Myrtle Ave,
Albany, NY 12208
PI Name: Dr. Adriana Laser
Primary Contact: Brenda Romeo

Cedars-Sinai Medical Center
La Cienega Blvd.
Beverly Hills, CA 90211
PI Name: Dr. NavYash Gupta
Primary Contact: Denice Dubuclet

Houston Methodist Hospital
6550 Fannin St.
Houston, TX 77030
PI Name: Dr. Eric Peden
Primary Contact: Kikelomo Akindoju

Indiana University
1801 North Senate Blvd., D3500
Indianapolis, IN 46202
PI Name: Dr. Raghu Motaganahalli
Primary Contact: Janet Klein

Jobst Vascular Institute /
Promedica Toledo Hospital
2109 Hughes Drive, CJT STE. 400
Toledo, OH 43606
PI Name: Dr. Gregory Kasper
Primary Contact: Christy Terrasi

Kaleidahealth/University at Buffalo
100 High St.
Buffalo, NY 14203
PI Name: Dr. Linda Harris
Primary Contact: Robin Stein

Lankenau Medical Center
100 E Lancaster Ave.
Wynnewood, PA 19096
PI Name: Dr. Vincent DiGiovanni
Primary Contact: Shefali Bansal

Miami Vascular Specialists
8950 N. Kendall Drive
Miami, FL 33176
PI Name: Dr. Michele Taubman
Primary Contact: Keivy Garcia

NYU Langone
530 1st Ave, HCC6F
New York, NY 10016
PI Name: Dr. Mikel Sadek
Primary Contact: Gina Bernardez

Pima Heart and Vascular
2404 E River Road, Suite 100
Tucson, AZ 85718
PI Name: Dr. Scott S Berman
Primary Contact: Aleksander Herber (520) 576.4133

Saint Louis University
1008 S Spring Ave.
Saint Louis, MO 63110
PI Name: Dr. Matthew Smeds
Primary Contact: (314) 977.4730

St. Peter's Vascular Associates
2 New Hampshire Ave.
Troy, NY 12180
PI Name: Dr. Kathleen Ozsvath
Primary Contact: Debbie Goodman

Sentara
600 Gresham Drive
Norfolk, VA 23507
PI Name: Dr. David Dexter
Primary Contact: Sarah Have

The Mount Sinai Hospital
1190 Fifth Avenue
New York, NY 10029
PI Name: Dr. Windsor Ting
Primary Contact: Sarah McCracken

TriHealth
375 Dixmyth Avenue
Cincinnati, OH 45220
PI Name: Dr. Patrick Muck
Primary Contact: Melody Vespie

University of Alabama at Birmingham
Vascular Surgery and Endovascular Therapy
BDB 652, 1808 7th Ave. South
Birmingham, AL 35294
PI Name: Dr. Marc Passman
Primary Contact: Rebecca St. John

University of Chicago
5841 S. Maryland Ave., MC 5028
Chicago, IL 60637
PI Name: Dr. Chelsea Dorsey
Primary Contact: MacKenton Johnson

University Hospitals Cleveland
Medical Center
11100 Euclid Ave.
Cleveland, OH 44106
PI Name: Dr. Karem Harth
Primary Contact: Emily Mullenax

University of Louisville
550 South Jackson St.
Louisville, KY 40202
PI Name: Dr. Amit Dwivedi
Primary Contact: Leslie Haysley (502) 852.2801

UPMC
5200 Centre Avenue
Pittsburgh, PA 15232
PI Name: Dr. Rabih Chaer
Primary Contact: Julianna Sheline

University of Utah
30 N. 1900 East, Room 3C344 SOM
Salt Lake City, UT 84132
PI Name: Dr. Claire L. Griffin
Primary Contact: Julie Hales

Vanderbilt University Medical Center
D-5237 Med Center North,
1161 21st Ave. South
Nashville, TN 37232
PI Name: Dr. Mark Iafrati
Primary Contact: Celia Nunez

Yale New Haven Hospital
330 Cedar St, Boardman 204
New Haven, CT 06510
PI Name: Dr. Cassius Iyad Ochoa Chaar
Primary Contact: Edgar Benitez

Participating Clinical Sites