Emboline

Emboline, Inc. is a privately held medical technology company, founded in 2011 by serial entrepreneur Dr. Amir Belson, who has founded several other medical device companies including NeoGuide Systems and Vascular Pathways. Based in Santa Cruz, California, the firm is focused on developing solutions to mitigate the risk of stroke and other ischemic damage caused by embolic debris released during transcatheter heart procedures.

The company's business revolves around the design, manufacturing, and sale of its flagship product, the Emboliner® Embolic Protection Catheter. This device is targeted at interventional cardiologists and hospitals performing transcatheter aortic valve replacement (TAVR) and other structural heart procedures. The business model is based on selling this single-use medical device to healthcare providers. Emboline has pursued a robust funding strategy, raising a total of $81.9 million over four rounds, including a significant $55.4 million Series D in May 2021 led by Matrix Capital Management. This capital is being used to fund a pivotal U.S. clinical trial for FDA approval and to scale manufacturing and commercial operations.

The Emboliner® is designed to provide comprehensive embolic protection for the entire body. During procedures like TAVR, debris can be dislodged and travel through the bloodstream, potentially causing strokes or damaging vital organs. The Emboliner catheter is inserted through the same femoral artery access site used for the primary procedure. It features a cylindrical nitinol mesh filter that conforms to the aortic arch, covering all three major cerebral arteries as well as the descending aorta, which protects the kidneys and other lower-body organs. A key feature is an expandable port within the filter that allows procedural devices to pass through while maintaining continuous protection. Unlike competing devices that may offer only partial or deflection-based protection, the Emboliner is designed to capture and remove all embolic particles from the patient's body. Clinical studies have shown the device captures a significantly higher amount of debris compared to other systems.

Emboline is actively pursuing regulatory approvals to bring its product to market. The company initiated its first human clinical cases in 2018 as part of the SafePass trial in Europe. After successful feasibility studies, Emboline received an Investigational Device Exemption (IDE) from the FDA in December 2022 to begin its pivotal "Protect the Head to Head" trial. This randomized study, which began enrollment in May 2023, compares the Emboliner to the commercially available Sentinel device and is expected to enroll 500 patients, with completion anticipated in 2025. The device is currently for investigational use only and is not yet commercially available. Keywords: Embolic protection device, TAVR safety, transcatheter aortic valve replacement, stroke prevention, cerebral protection, medical device, structural heart, interventional cardiology, embolic filter, aortic arch filtration, SafePass trial, Protect the Head to Head trial, nitinol mesh filter, full-body embolic protection, cardiovascular procedures, medical technology, ischemic damage prevention, embolic debris removal, catheter-based intervention, aortic embolic protection