ANTI-THROMBOGENIC DEVICES

Clinical Impact of Thrombosis: Thrombus related problems cost the US healthcare system an estimated $1 billion annually and can lead to over 50,000 deaths per year. The current standard of care is either uncoated products or products coated with heparin or other lubricious materials. The challenge with coatings for devices is that they are difficult to present on both the inner and outer surfaces of the device, have limited long term effectiveness due to lack of bio-durability, and are prone to stripping in vivo or during chemical and physical preparation of the device prior to its use. Furthermore, heparin can be contra-indicated in many patients with potentially fatal allergic reactions.

Endexo™ Solution: Endexo anti-thrombogenic additives are low molecular weight fluoro-oligomers that impart a passivating surface to the implantable medical devices thereby reducing platelet adhesion and thrombus formation. They have fluorinated end groups that bloom to the top 10 nanometers of the device surface during device manufacturing. The figure below illustrates the one-step process of applying Endexo technology.

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Endexo is a versatile technology platform with many different formulations that are compatible with a wide range of base polymers and manufacturing processes to provide enhanced performance features. Endexo molecules have demonstrated ability to withstand processing temperatures of up to 310 deg C. Because there is no change in the manufacturing process, Endexo provides an economically viable solution for high value products.

Endexo™ Additives vs Competition: As Endexo is an additive and not a coating, there is minimal impact on the physical and performance features of the original device. With only 0.5 to 5 weight percent of the Endexo additive, surface fluorine contents can be greater than 30 atomic percent. Due to its migratory nature, the Endexo molecules present themselves on all device/air interfaces (in both intra and extra-lumenal surfaces)

Endexo™ Features and Benefits

• Compatible with a range of polymers and devices
• No change in manufacturing processes or packaging
• Present on all device surfaces, including ID and OD
• Does not strip or elute
• Long term effectiveness

Endexo™ Applications:

Vascular Access Devices (e.g. PICCS, Ports, Dialysis Catheters and CVCs) represent more than a billion dollar U.S. market opportunity. Thrombosis leads to catheter dysfunction which can lead to inadequate blood flow, an inability to aspirate or infuse and potential for thromboemboli.

Endexo™ catheters demonstrated 73% reduction in thrombus vs. control
(Bovine Blood Loop Study, 10 experiments, n=71)

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All studies conducted at Medical Device Evaluation Corporation (MDEC) Salt Lake City, Utah

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Hollow Fiber Membranes (e.g. hemodialyzers, and blood oxygenators) represent greater than a two billion dollar U.S. market opportunity. Thrombosis within fibers and dialysis units leads to filter failure and reduced filtration efficiency. The current use of heparin solutions can result in many side effects for dialysis patients.

Endexo™ dialyzers demonstrated reduced thrombus vs. commercial controls

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