Our Overall Strategy

Reveal's plan of action for moving the "TRAC-EM™" techniques from the lab, is to go into full animal trials, in dogs, under FDA IDE safety rules; and by extension, opening the technology up to pets, within six months. This will allow us to build better data and establish a full body of evidence for predictable, repeatable: reliability and scalability; very quickly. The second round of actions will take the device through the full FDA IDE process to market approval, as well as an international CE mark, and develop the BioPACK™ for miniaturization using microfluidics within 15-18 months. The third round of actions will open-up the device into direct human treatment and establish its presence in centers of excellence, expand the synergistic medical educational mechanism, and through the completion of microfluidic miniaturization, radically expand its presence and cost effectiveness for both humans and pets.

Initial Strategy

Our first generation of prototype products are placed inline, in aphaeresis machines, and in some cases, require on-site overnight incubation of cells. And these will go directly into the veterinarian use, in dogs, under FDA supervision and guidelines. There are four primary reasons for this choice:

1. Dogs are the best and most cost-effective physiological models we have to refine these techniques – much better than mice.
2. There is a very large demand for cancer treatments in dogs – giving us many opportunities to refine the technology for people.
3. The canine market allows us to develop expertise and revenue to move more quickly for humans.
4. We can start helping dogs very quickly, and establish a track-record much faster, which won't be able to be ignored.

This first generation prototype product takes the form of either a fluidized bed or immobilized surface in a cylindrical container that can easily be connected to an aphaeresis machine exposing either the cell fraction or the plasma fraction of the blood to the therapeutic surfaces.

The Reveal’s “dendritic cell vaccine”, and “macrophage activation”, can be done with standard IV bags and known cytokines with either short-term exposure, or through incubation that runs from overnight up to about a week.

Second Generation Strategy

Second generation of "TRAC-EM™" techniques will produce the Reveal Therapies BioPACK™, which should be available toward the end of the 2nd year, and will be based on the mature technology of microfluidics. In microfluidics, fluids such as blood, are separated and manipulated in microscopic channels. The technology is analogous to microcircuits reducing computers from the size of a room to the size of the Apple iPhone.

This second generation approach to our therapy approach is crucial to long-term success.  Microfluidics enables us not only to be many times cheaper, but also to be even more effective, with much greater patient comfort.  The average system will be wearable and operate on the patient either in 7 days by 16 hour mode or by 7 days by 24 hour mode, constantly beating back the tumor, inducing vaccine effects while letting the patient live a normal life-style. It will be about the size of an Apple iPhone, but about twice as thick.

Rollout Strategy

The Rollout Strategy for both the human and veterinary markets is to work through Channel Partners and their Distribution Network customers. Reveal will become a provider of education, training, certification and auditing in regards to the prescription, treatment and follow-on care of its products. This will tie Reveal's success to the success of its Channel Partner clients and their customers, eliminating the need for Reveal to make the considerable investment associated with building patient care centers, hiring and staffing nurses and doctors, and the costs associated with employment training and oversight. Additionally, our therapy and science can be propagated and knowledge of our treatment profile can be dramatically increased through our strategy of allying with reputable non-profit advocates.

Reveal's Initial focus is on Solid Tumor Cancer therapy

The solid tumor of the skin, the esophagus, stomach, small intestine, large intestine, the colon, the pancreas, the lung, the liver, the kidney, the breast, the cervix, the ovary and the uterus, and some lymphomas, are all amenable to this treatment. Unlike molecular target style drugs that are aimed at particular cancers the Reveal Therapies approaches are all based on fundamental mechanisms shared by the immune system against the solid tumors. While some tumor types will be more resistant to treatment than others, all the mentioned solid tumors will see a response and a remission. Some will even be cured. We expect the 3-year remission rate for at least 50% of patients, hopefully growing to better than 90% by the time we are in micro fluidic device deployment.

Unfortunately, our approach will not currently work for leukemia and for solid tumors of the brain. In the case of brain tumors, we neither have a way of controlling the environment on the other side of the blood-brain barrier nor can we carefully control the breakdown of the tumor. Both aspects may lead to a lethal outcome in a patient with a brain tumor. In regards to leukemia, the immune system mechanisms must be controlled in a different manner, and what applies to solid tumors does NOT apply to the leukemia condition. As such, we are ineffective against leukemia and this disease will be an area of future R&D effort once we are well established in the solid tumor field.

Other long-term "likely" uses for Reveal's BioPACK™

In the longer term, at 5 to 7 years, the "TRAC-EM™" techniques embedded into the BioPACK™ platform will be evolved by Reveal into a device that can function as an artificial organ, adding extra physiologic functions to any patient that requires them. These have many potential uses in the medium and longer term. Some of these include:

Obesity Treatment
Reveal Therapies' platform can be used to target TGF-beta as a means of impacting morbid obesity. This is Reveal Therapies' most recent patent filing based on the latest scientific news. Up to now, removal of TGF-beta was considered a target solely for aggressive treatment of lung cancers. However, the blocking of TGF-beta by antibody in rats has been shown to convert white fat cells [bad] to brown fat cells [good] with concomitant drop in body-fat, and hence obesity. This effect in rats, which will almost certainly carry over to all major mammals including man, provides a radically new alternative to treatment of obesity. Reveal can achieve the same result by removal of TGF-beta from the body for the class of patients that are morbidly obese which would benefit greatly from a new non-surgical approach to their disease. Given that the development and testing of a suitable antibody for drug use is a 7-year billion-dollar proposition, the ability to achieve the same result through the use of a Subtractive Therapy approach in about 1-2 years, and at a tiny fraction of the drug cost, is a considerable strategic advantage.

Liver Disease
As the Reveal platform technology can remove small molecular weight toxins, it is ideal for liver dialysis. Liver dialysis provides a crucial detoxification function of the liver of patients with severe liver disease or those liver patients waiting for a liver transplant. Second generation products based on micro fluidic technology will provide a 24-hour a day wearable device that can act as a liver-assist artificial organ, with minimal discomfort to the patient.

Autoimmune Diseases
In a very real sense, the Reveal platform technology is a system to manipulate both immune system cell populations and immune system chemical messengers. Patients with autoimmune diseases have an immune system caught in "war on self" mode. The Reveal platform, given a map of the immune system, can be used to ameliorate and in some cases shut down these "war on self" modes that the immune system sometimes gets trapped in. We are hopeful, for example, to eventually use this approach in Type I diabetes.

Viral (Hepatitis)
Yammamoto's work in macrophage activation indicates that the macrophage activation part of Reveal Therapies' platform can also be used to target all the known variants of Hepatitis. Hepatitis is an inflammation of the liver, caused by a DNA-based virus, that can run from mild - to extremely serious and lethal. In recent years, many have become infected by the Hepatitis C virus, which can induce cancer as well. In the area of hepatitis, we believe that eradication of the virus can be induced by judicious use of the Reveal Therapies' macrophage activation component of the platform in a rather straightforward manner. Reveal Therapies will inevitably treat cancer patients that have hepatitis and such data will give us insight into how rapidly to move into this area of treatment.