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 Prior to VenoValve Surgery Have Fully Healed or Improved
No Ulcer Recurrences
Company on Track to File Application Seeking VenoValve FDA Approval in Q4 2024
IRVINE, CA / ACCESSWIRE / June 21, 2024 / enVVeno Medical Corporation (NASFAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that positive interim venous ulcer healing data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve will be presented today at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago.
The data being presented includes twenty-one venous ulcer patients who have now reached the one-year milestone, representing thirty venous ulcers. Overall, 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or ulcers that have improved. Of that group, 100% of venous ulcers with a duration of one year or less prior to VenoValve surgery have fully healed, with the majority (67%) fully healed 90 days after VenoValve surgery. For venous ulcers with a duration of more than one year prior to VenoValve surgery, 89% have either fully healed or improved at one year, representing a decrease in average of total ulcer of 85%. In addition, none of the patients with a fully healed venous ulcer have experienced an ulcer recurrence.
"We are very pleased with the interim VenoValve ulcer healing data, especially when you consider this very difficult to treat population of patients who all failed conventional treatments such as wound care and compression therapy, and many of which did not respond to more invasive treatments for CVI such as ablation therapy for superficial disease and/or stenting for iliofemoral obstruction," said Robert Berman, enVVeno Medical's CEO. "Our data shows the importance of the deep venous system to ulcer healing, supports the VenoValve as a part of a new treatment paradigm for the large population of patients with venous ulcers who have deep venous disease, and provides evidence that it is better to treat venous ulcer patients with the VenoValve sooner after ulcer occurrence (within one year, if possible), for faster and complete ulcer healing."
Venous ulcers in the SAVVE study were evaluated with the help of an U.S. Food and Drug Administration (FDA) registered scientific calibrant applied to each venous ulcer image to track wound healing over time. The technology relies on artificial intelligence to accurately measure wound circumference and progress.
Severe Chronic Venous insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve.
The Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled at 21 U.S. sites. The FDA has asked the Company to collect a minimum of one year of data on all SAVVE patients prior to filing its PMA application seeking FDA approval, which the Company expects to file in Q4 of this year. As of March 31, 2024, the Company had cash and investments of $42.9 million on hand, which the Company expects to be sufficient capital to fund operations through an FDA decision on the VenoValve and the end of 2025.
Today's presentation, entitled The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux,which will be made by primary investigator Dr. Cassius Iyad Ochoa Chaar, Associate Professor Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery. Excerpts will be made available after the presentation on the Company's website.
