Founded by NLC, OccluNova is developing an implantable LAA closure device for people with chronic atrial fibrillation (AF)
Atrial fibrillation (AF) affects 4.5 million people in Europe and more than 3 million in the US. It has seen a 33% rise over the last 20 years and almost 12 million people in the US alone are predicted to develop AF by 2030. In patients with AF, blood can pool and form thrombi in the left atrial appendage (LAA). These situations increase the risk of an ischemic stroke because the thrombi can enter the circulation and become lodged in the brain’s vasculature.
Lifetime oral anticoagulant medication, which has several side effects, is the current gold standard for preventing strokes in AF patients. Because of the risk of uncontrolled bleeding, patients on anticoagulation therapy (OAT) should avoid high-risk activities. Many patients who are administered with OAT do not have therapeutic amounts of the blood thinner to lower risk of stroke. Treatment for significant bleeding episodes caused by OAT (gastrointestinal bleeding and cerebral hemorrhage) cost between $7,584 to $193,804 over the course of a year.
Currently available LAA closure technology, e.g., the Watchman, is constructed of a rigid nitinol frame, which can be forced through the atrial wall during placement, causing potentially serious pericardial effusions. The rigid frame also does not accommodate all sizes or irregularly shaped appendages, sometimes resulting in incomplete occlusion.
The OccluNova technology is designed to more completely occlude the appendage by utilizing a pliable balloon to completely fill the entrance of the appendage. OccluNova’s technology eliminates the rigid nitinol frame and, instead, is made from a polyurethane balloon, designed to provide complete LAA closure regardless of appendage size or shape. Finally, there is no exposed metal on the OccluNova implant, reducing or eliminating the risk of thrombus formation.
“The fact that more patients can have the appendage safely and fully occluded, allowing them to quit taking OAT, is a huge public health benefit.”Chris Pulling, CEO of OccluNova
Currently, OccluNova is an early-stage venture with advanced prototypes and has been tested in animal studies. The next stages involve officially transferring the technology from the licensee, building a manufacturing facility, securing Series A funding, testing and refining the device, and starting a first-in-human study by Q3/4 of 2024.
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Chris Pulling, CEO OccluNova