VVT Med publishes ScleroSafe peer-reviewed trial data
VVT Med Inc. has announced the publication of a prospective observational study evaluating its ScleroSafe catheter-directed sclerotherapy system in the Indian Journal of Vascular and Endovascular Surgery, a peer-reviewed journal indexed with Wolters Kluwer Medknow. The study, authored by vascular surgeons at Holy Spirit Hospital and Medical Research Centre in Mumbai, represents the company's first substantive independent clinical data from a published, peer-reviewed source.
The trial enrolled 30 patients with symptomatic primary varicose veins — CEAP class C2 to C5 — treated between March and July 2025. All procedures were performed under ultrasound guidance by a single experienced vascular surgeon. The small cohort and single-operator design are typical of early-stage observational work, and the study is not a randomised controlled trial.
Clinical outcomes
Reported results were encouraging within the study's scope. Technical and clinical success was achieved in all 30 patients. Vein occlusion rates were 95% at 30 days and 92% at 90 days. Symptom relief within 24 hours was reported for leg heaviness in 80% of patients, pain in 65%, and swelling in 40%. Crucially, no serious adverse events — including deep vein thrombosis, thrombophlebitis, skin necrosis, nerve injury, or new pigmentation — were recorded during the 90-day follow-up period.
Chief executive Erez Tetro said the publication "provides meaningful external support for the efficacy and safety profile we have observed across our global commercial deployments," and argued it strengthens the clinical evidence base supporting the company's non-thermal, non-tumescent (NT-NT) approach.
Market context and competitive landscape
The varicose vein treatment market is populated by several established modalities, including endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and ultrasound-guided foam sclerotherapy, all of which carry substantial clinical evidence bases built over more than two decades. NT-NT approaches — which aim to remove the requirement for tumescent anaesthesia — represent a narrower sub-segment, positioning primarily on patient convenience and suitability for office-based settings.
VVT Med claims to be the only FDA-cleared standalone company focused exclusively on NT-NT varicose vein technology, a positioning that, if durable, offers a degree of regulatory moat. The company's ScleroSafe device holds both FDA clearance and CE marking, giving it access to major markets on both sides of the Atlantic. Its V-Block device rounds out the portfolio. The company trades on the TSX Venture Exchange under the ticker VVTM, indicating it remains a small-cap entity for which each incremental evidence publication carries commercial significance.
The 30-patient study published here is modest by the standards required for guideline inclusion in European or North American vascular surgery societies, where randomised data with longer follow-up windows — typically 12 months or more — are generally expected before formal recommendation. Investors and potential physician adopters will be watching for whether VVT Med can commission or facilitate larger, multi-centre studies that meet those thresholds. The 90-day follow-up window reported here leaves open questions about durability of occlusion, which is a key endpoint in the varicose vein space where recanalisation rates beyond six months can materially affect a device's clinical standing.