FibriLyzer

Critical Health Diagnostics in 30 Seconds

The FibriLyzer™ is expected to be the first handheld Point-of-Care diagnostic test that measures fibrinolysis (the process by which blood clots are dissolved) in as little as 30 seconds using just a drop of blood. Compared to the alternatives requiring several vials of venous blood to return results between 20 minutes to several hours, the FibriLyzer can fill a significant void.

Exclusive Intellectual Property Rights for the U.S. and Europe

The FibriLyzer technology has been licensed exclusively by Exactus for commercialization in the US and the EU. Exactus retains the right to license the FibriLyzer technology in all other territories worldwide.

Substantial and Growing Target Market

The FibriLyzer fills a major gap of real-time Point-of-Care data on fibrinolysis. The FibriLyzer is designed to be used in operating rooms, emergency rooms and in the field in situations where the rapid monitoring of hemostasis is critical. Procedures where this device is applicable include cardiovascular surgery, neurosurgery, orthopedic surgery, trauma and obstetrics.

In total, the peak U.S. market opportunity exceeds $1 billion. The European market is approximately equal to the U.S.

Significant Benefits at the Point-of-Care

Uncontrolled bleeding in the clinical and emergency settings must be treated quickly and effectively based on the underlying disorder. In the case of hyperfibrinolysis, the administration of whole blood and/or platelets and other clotting factors will be ineffective. The FibriLyzer is the only diagnostic test that provides information regarding the fibrinolytic status of a patient within the time frame in which most treatment decisions are made. If the patient is hyperfibrinolytic, drugs such as tranexamic acid can be use, rather than wasting valuable resources such as whole blood or platelets.

Demonstrated Potential in Clinical Beta-Test

In a preliminary clinical study, the FibriLyzer technology was able to stratify patients based on risk of hyperfibrinolysis, confirming that it should move to formal clinical trials to obtain regulatory clearance and CLIA waiver. The FibriLyzer produces data with speed and accuracy that enables a range of functions appropriate for field diagnostics, surgical monitoring and other patient management scenarios. After successfully completing formal clinical trials, the FibriLyzer technology can advance standards of care in many settings.

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A Future Critical Resource for the treatment of Acute "Thrombotic" Events

Acute thrombotic events include heart attacks, embolisms and strokes and are a leading cause of death and burden on the healthcare system. Thrombolytic drugs act to quickly eliminate clots in the cardiovascular system by supplementing fibrinolysis activity when necessary.

However, there is no way for physicians to accurately measure fibrinolytic activity at the point-of-care and thrombolytic drugs can cause fatal hemorrhage if overdosed. As a result, the use of thrombolytics has steadily declined in the U.S. and physicians are resorting to more costly and invasive procedures. Doctors are relying on empirical and conservative approaches after perhaps significant damage has been done simply due to the lack of timely point-of-care diagnostics.

Physicians have asked for better technologies to guide their decisions during the administration of thrombolytics, Exactus is currently planning future clinical studies that will be designed to help guide the administration of effective doses of thrombolytic drugs.

Reliable Technology That Delivers Actionable Data

The proprietary technology powering the FibriLyzer™ device determines fibrinolytic activity by the rate at which a synthetic fibrin matrix is degraded by enzymes in the blood.

In practice, a biosensor strip is inserted into the FibriLyzer device and a drop of blood is placed in the biosensor. The blood is transported by capillary pressure to the synthetic clot, where the test begins. As the synthetic matrix dissolves, a proprietary electro-active polymer is released that increases the electrical current across the biosensor. The fibrinolytic activity is determined by the current reading at 30 seconds.

The device bar scanner fits with hospital LIM systems and the USB port allows for the rapid download of all data.

What are the Coagulation and Fibrinolysis Processes and why do they matter?

The hemostatic and fibrinolytic systems protect the integrity of the vasculature and surrounding tissue. Hemostasis, the physiological control of bleeding, is a complex process incorporating the vasculature, platelets, coagulation factors and fibrin. Each of these elements plays an important role in activating/deactivating the others, and the appropriate stimuli are necessary to prevent excessive blood loss without causing inappropriate clotting. The hallmark of hemostasis is the formation of fibrin-reinforced clot that forms at the site of injury and prevents excessive blood loss.

Fibrin is an essential component of hemostasis as both the primary product of the coagulation cascade and the ultimate substrate for fibrinolysis. Once the injured tissue has the opportunity to heal the clot is dissolved by plasmin, an enzyme that degrades fibrin.

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