DIVISION OF HEMOSTASIS

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The body controls bleeding (hemostasis) by two methods in the body: (a) soluble coagulation factors

(e.g. Factor VIII) and (b) cellular mechanisms (e.g. platelets).

We invented a product that combines the best features from both mechanisms: the spheres made from

human serum albumin provides the “mass” to plug up leaks, and fibrinogen molecules (Coagulation

Factor I) on the surface of the spheres to form therapeutic clots to stop bleeding whether the wound is a

clean-cut wound (e.g. surgery) or a diffused wound (e.g. from total body irradiation).

Control over Bleeding from Low Platelet Count Due To Any Cause

The Fibrinogen-coated Albumin Spheres are typically smaller than 0.2 micron. They form co-aggregates

with activated platelets only at wound sites on the endothelium of the blood vessels and they do not

form random clots elsewhere in the body. The product improves bleeding time and bleeding volume

even at platelet counts below 5% that of normal concentrations in vivo.

Control over Bleeding from Trauma in Patients with Normal Platelet Count

Trauma to soft organs such as the liver is not a “normal condition.” Data from animal models have

shown that bleeding in the liver can be reduced from administrations of our product even when the

patient has a “normal” platelet count.

Reduced Bleeding for Patients with An Overdose of Anti-Platelet Medication

For patients taking anti-platelet medication, their bleeding time is abnormal due to platelet inhibition,

even though platelet count is normal. If they need emergency surgery, they have to wait or get an

emergency infusion of donor platelets. Data from animal models showed that bleeding time can be

improved by administration of Fibrinogen-coated Albumin Spheres because our product can form

therapeutic co-aggregates with the minimal concentration of platelets that have some normal function.

Reduced Bleeding For Patients with Platelet-Transfusion Refractoriness

The Company Product has an active ingredient called Fibrinogen-coated Albumin Sphere (FAS). Just like "hamburger helper" is not meat but can taste like meat and is cheaper, FAS can help the patient stop bleeding by forming co-aggregates with the patient's own activated platelets at a wound site without causing random clots.

Patients with low platelet count tend to bleed. They are often transfused with platelets from donors. Unfortunately, platelet transfusions can lead to a condition called "platelet-transfusion refractoriness" meaning the body destroys the infused platelets. The Company Product is effective even under such a dire condition because it cannot be destroyed by anti-platelet antibodies.

The body reacts to all kinds of injuries with a process called Inflammation. The cell-to-cell

biochemical signals are called cytokines. Over-reactions from cytokines can be very dangerous

to the body.

We have found in animal models that injuries such as from irradiation over a large portion of the

body can induce inflammation. Administration of our product to mitigate the harm from

irradiation can produce unexpected results such as control of pro-inflammatory cytokines, and

elevation of calming cytokines. This can greatly benefit patients suffering from multiple

traumas.