Mr. Erez Tetro reports

VVT MED ANNOUNCES POSITIVE CLINICAL DATA FOR SCLEROSAFE PUBLISHED IN PEER-REVIEWED INDIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY

VVT Med Inc. has published a peer-reviewed clinical study evaluating the short-term efficacy and safety of its ScleroSafe catheter-directed sclerotherapy system. The study, writen by Dr. Aniruddha Sanjoy Bhuiyan and Dr. Meet Taral Sheth of the departments of vascular and endovascular surgery and general surgery at Holy Spirit Hospital and Medical Research Centre in Mumbai, India, was published in the Indian Journal of Vascular and Endovascular Surgery (2026; 13:64-66), a peer-reviewed journal published by Wolters Kluwer Medknow.

The study, titled "Efficacy and Safety of ScleroSafe Catheter-directed Sclerotherapy for Varicose Veins: A Prospective Observational Study," was published on-line recently, on the Indian Journal of Vascular and Endovascular Surgery, which is the official publication of the Vascular Society of India and is indexed with Wolters Kluwer Medknow.

The prospective observational study enrolled 30 patients treated between March, 2025, and July, 2025, for symptomatic primary varicose veins at Holy Spirit Hospital and Medical Research Centre in Mumbai. Eligible patients had CEAP class C2 to C5 disease with duplex-confirmed reflux in the great or small saphenous vein and no prior venous interventions on the treated limb. All procedures were performed under ultrasound guidance by a single experienced vascular surgeon. Technical success was defined as successful cannulation, catheter advancement to the sapheno-femoral or saphenopopliteal junction, and uniform sclerosant delivery with immediate vein wall contact confirmed on ultrasound.

Clinical results

The study reported the following outcomes:

• Clinical success: achieved in all 30 patients (100 per cent);
• Vein occlusion rate: 95 per cent at day 30 and 92 per cent at day 90;
• Symptom relief: immediate postprocedure improvement was reported for leg heaviness in 80 per cent of patients, pain in 65 per cent and swelling in 40 per cent, within 24 hours of the procedure;
• Safety profile: no cases of deep vein thrombosis, thrombophlebitis, skin necrosis, nerve injury or new pigmentation were observed throughout the 90-day follow-up period.

The authors concluded that ScleroSafe catheter-directed sclerotherapy achieved high early closure rates and significant symptom improvement, describing it as a safe, effective and reproducible non-thermal alternative for managing superficial venous reflux.

"The publication of this peer-reviewed study in an indexed, internationally recognized journal represents an important milestone for VVT Med," said Erez Tetro, chief executive officer of VVT Med. "Independent clinical data generated by vascular surgeons in routine practice and validated through a rigorous peer-review process provides meaningful external support for the efficacy and safety profile we have observed across our global commercial deployments. We believe this publication strengthens the clinical evidence base for ScleroSafe and supports the growing adoption of our NT-NT approach by physicians worldwide."

About VVT Med Inc.

VVT Medical develops, manufactures and distributes minimally invasive, non-thermal, non-tumescent (NT-NT) solutions for the treatment of vein diseases, starting with varicose veins. VVT is the only FDA-cleared (U.S. Food and Drug Administration), stand-alone company offering NT-NT varicose vein treatment technology. VVT's FDA-cleared and CE-marked (Conformite Europeenne) catheter-based technologies, ScleroSafe and V-Block, enable safe, office-based procedures with no anesthesia, no downtime, and minimal pain and side effects. Addressing the widest range of vein diameters, VVT's solutions empower patients by treating both the medical and aesthetic aspects of vein disease while enabling physicians to deliver effective, efficient and cost-saving treatments through proprietary, simultaneous sclerosant injection and blood aspiration. The company's patented technology portfolio includes 55 patents from 14 patent families across 20 countries, providing broad global intellectual property protection through 2038.

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