Kfar Saba, Israel, April 23, 2023 / VVT Medical, a global medical technology company, announced today it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the ScleroSafe™ System.  

ScleroSafe™ is an innovative medical device that has been designed to effectively manage and treat varicosities in superficial veins. Our product offers a non-thermal non-tumescent (NT-NT) solution that provides long-term results and improves the overall quality of life of patients suffering from this condition.

We are pleased to note that ScleroSafe™ is already approved across Europe, Australia, Southeast Asia, and South America. It has a proven track record of safety and effectiveness in managing varicosities in superficial veins and has already helped many patients around the world. Varicose veins are a common condition that affects millions of people in the United States, and they can cause significant discomfort, pain, and even disability in some cases. According to studies, about 50% of ages 50 and above are suffering from varicose veins. This highlights the significant need for effective solutions for the treatment of this condition. “We are proud to be at the forefront of developing a solution for varicose veins. ScleroSafe™ has the potential to revolutionize the treatment of varicose veins by offering patients a safe, effective, and simple solution”, says Erez Tetro, the CEO of VVT Medical.

Mr. Tetro continues: “Our team at VVT Medical is committed to ensuring that ScleroSafe™ is accessible to all patients who need it. We believe that our product has the potential to positively impact the lives of millions of people in the United States and around the world”.

Erez Tetro CEO of VVT Medical

Erez Tetro CEO of VVT Medical

Erez Tetro

 CEO of VVT Medical

About VVT Medical

VVT Medical is an Israeli Biotechnology company, founded with the aim of becoming the new standard of care in vein treatments, by introducing novel solutions for both aesthetic and medical indications. VVT Medical has been dedicated to offering simpler, faster and more efficient minimally invasive non-thermal non-tumescent (NT-NT) procedures, maximizing safety and patient comfort and achieving superior clinical results. The company specializes in the research, development, manufacturing, and commercialization of its products and is dedicated to improving patients’ lives!

Forward Looking Statements

This notification includes forward-looking statements about VVT Medical’s 510(k) premarket notification to the FDA for the ScleroSafe™ System. These statements carry risks and uncertainties that may cause actual results to differ from what is expressed or implied. It is uncertain if VVT Medical will receive 510(k) clearance from the FDA for the ScleroSafe™ system or when that clearance will occur. The company has little control over many of these risks and uncertainties, such as regulatory clearance and market acceptance. VVT Medical disclaims any commitment to update these forward-looking statements, except as required by law.