We are a development-stage manufacturer of minimally invasive endovascular medical devices for treatment of thrombosis-related conditions in the vascular system

We are a development-stage manufacturer of minimally invasive endovascular medical devices for the treatment of vascular thrombosis. ALFAJET, our versatile proprietary platform technology, is a thrombectomy device designed for safe and effective thrombus removal from veins, arteries and arteriovenous dialysis conduits. Thrombosis is a steadily growing burden for health care systems globally, involving more than 70 million patients annually and growing every year. Our disruptive and scalable platform technology has the potential to offer distinct advantages over current thrombus removal methods. It does not require dedicated capital equipment or specialized on-site support, allowing easy utilization at any clinic worldwide. Its innovative design allows removal of large, semi organized clots without significant complications. Its low production and support cost allows fast market penetration. Our first product is designed to remove thrombus from peripheral veins, a $1.8 billion annual market. Our unique technology can be scaled for different-size vessels. The peripheral venous product can be followed by products designed to remove thrombus from Peripheral Arteries, Arteriovenous dialysis conduits, Coronary arteries etc.

Flow Medical is committed to meeting our customers’ requirements by continuously improving product performance and product quality by monitoring quality objectives, complying with all applicable worldwide standards for medical devices and maintaining the effectiveness of the company’s Quality Management System. Flow Medical Quality System complies with applicable standards and laws in the United States (US), European Union (EU) and other countries where we do business. The applicable standards include, but are not limited to: Medical Devices-Quality management systems-Requirements for regulatory purposes (ISO 13485:2016), the European Medical Device Regulation (Regulation [EU] 2017/45 of the European Parliament and Council, referred to as MDR), and the US FDA Quality System Regulations (21 CFR 820, referred to as QSR).