1-Year Data Presented From enVVeno’s VenoValve Pivotal Trial

November 20, 2024—enVVeno Medical Corporation announced 1-year data on all patients from SAVVE, the United States pivotal trial of the company’s VenoValve, a surgical replacement venous valve being developed for the treatment of deep venous chronic venous insufficiency (CVI).

The findings were presented at the 51st annual VEITHsymposium held November 19-23, 2024, in New York, New York.

enVVeno also announced that on November 19, it submitted a premarket approval (PMA) application to the FDA to commercialize the VenoValve in the United States. The company advised that four of five modules of the PMA application have been submitted and been reviewed and approved by the FDA. The fifth and final module of the application contains the clinical data from the SAVVE pivotal trial as well as proposed labeling for the device. The definitive 1-year data supports the PMA application for VenoValve, stated enVVeno.

As outlined by the company, the 1-year SAVVE data presented at the VEITHsymposium included the following key findings:

• 85% of patients achieved a clinically meaningful benefit of a ≥ 3-point improvement in revised Venous Clinical Severity Score (rVCSS).
• A 7.91-point average rVCSS improvement was seen in the rVCSS responder cohort.
• Clinical meaningful benefit was shown across all CEAP (clinical, etiology, anatomy, pathophysiology) diagnostic classes of patients enrolled in the study—CEAP C4(b), C4(c), C5, C6.
• The target vein patency rate was 97%.
• Hemodynamic data from the study showed a positive correlation between rVCSS improvement and systemic reflux time improvement

According to enVVeno, the FDA previously indicated to the company that a ≥ 3-point improvement in rVCSS would be evidence of the VenoValve’s clinical meaningful benefit.

Other findings at 1 year included the following:

• 75% median reduction of pain as measured by Visual Analog Scale
• 87% reduction of median ulcer area in patients with venous ulcers (CEAP C6)
• Patient-reported improvements in quality of life and disease symptoms (VEINES-QOL/Sym questionnaire, EQ-5D)

Regarding the safety profile of the VenoValve, the study reported that major adverse events (MAEs) through 1 year included one death (unrelated to the VenoValve), zero pulmonary embolisms, 12 target vein thromboses, 10 surgical pocket hematomas, four other bleeds, and seven deep wound infections.

Finally, there was no long-term negative impact on clinical improvements in the patients who experienced an MAE; 94% of these patients (not including the unrelated death) experienced a clinical meaningful benefit (3-point rVCSS improvement) at 1 year compared to baseline, noted enVVeno.