D. DESCRIPTION AND OPERATION OF THE DEVICE

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E. RISK ANALYSIS

1. Electromagnetic Radiation Comparison to Surgical Diathermies.
The radio frequency (RF) field produced by the PAP IMI's probe is comparable in form and average power (~100 watts) to the exposure of an electrosurgical diathermy in coagulation mode, a device used safely by surgeons in operating rooms around the world, exposing them at much closer proximity to much higher field concentrations. The field strength from the probe drops inversely proportional to the third power of the distance. This means that the magnetic and electric effects extinguish very quickly with distance. Compared with a surgical diathermy the present device drops its power much faster with distance, is far more dispersed and far less concentrated.

2. Reports of Adverse Consequences.

a) Reports from the November 1995 Teleconference :
A further indication of the safety of the device was received in November of 1995 when eight physicians from the U.S., Mexico, Greece, and Austria who had experience giving treatments with the PAP IMI convened through a teleconference link up. During the teleconference the doctors were asked if any had any bad experiences with the machine, had any safety concerns, or could think of any conditions that the machine should not be used for. None of the doctors had anything negative to report.

b) Random Reports:
Out of more than 100,000 treatments that have been given with the PAP IMI over the past 6 years, including exposures lasting up to an hour per day for several days at full power, we know of only three cases where adverse consequences or side effects were reported that might be specifically related to treatment with the device. Two cases report tachycardia and one patient reported an infected catherter (see contraindications under 4-a and 4-c).

Thus far, no side effects have been observed for assistants or operators, operating the device. Nevertheless after placing the probe and pressing the start button, operators are advised to stand at least 1 meter (or 3 feet) away from the probe to avoid continuous daily exposures.

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* Standard thermodynamics teaches that atomic emission and absorption processes are mutually related. For example, Kirchoff's law holds that if an atom emits a particular frequency, it will also efficiently absorb this same frequency. The same applies to the PAP IMI pulses. Oxygen and nitrogen atoms in the treated tissue region, being of the same chemical composition as the radio emitting atoms in the excited plasma of the PAP IMI, will tend to preferentially absorb energy delivered by the administered pulses.

3. Animal Studies.

Dr. S. D. Kottaridis, Director of the Hellenic Anticancer Institute, Papanicolaou Research Center of Oncology in Athens, Greece has conducted a study of PAP IMI treatments of rats and mice. The study lasted almost two years (3 / 15 / 91 to 12/ 15 /92) and studied a total population of 604 animals. This consisted of :

Target population:

Placebo population:

The animals were exposed with the probe held at a distance of 8 cm, with about 7 joules per pulse at a rate of 5 pulses per second. They were exposed every other day for 10 to 15 minutes over a period ranging from one to three months.

42 days after the beginning of the study, one wistar rat receiving 15 minute exposures developed an adverse reaction consisting of tremor and unsteady coordination. Also during the course of the experiment two other animals receiving 10 minute exposures (age and gender not specified) died from some unknown etiology. Neither on autopsy nor on histology were there any findings that would lead to the etiology. So their deaths could not be attributed to the PAP IMI treatments.

Blood chemistry revealed that the treated animals had about 12% higher triglyceride levels than the untreated animals. No other differences were apparent either in the blood chemistry or blood count data of the two populations. A reprint of this study is presented in Appendix G.^*

4. Reports of Favorable Treatment Results.

a) International Pain Research Institute study indicating efficacy for pain reduction:
A 20 patient published clinical study conducted at the International Pain Research Institute in Los Angeles, CA, which describes the benefits of PAP IMI treatment to women suffering from various pelvic maladies, provides a further indication of the safety of the device. This study found that the PAP IMI had a 90% success rate in alleviating chronic gynecological pelvic pain. ³³ The treated patients presented the following conditions: 12 patients had ruptured ovarian cysts, 2 had postoperative pelvic hematornas, 2 had chronic pelvic pain due to urinary tract infection of several years duration, 2 had uterine fibroids, 3 had dyspareunia, 5 had dysmenorrhoea, 3 had endometriosis. Some patients had combinations of the above. PAP IMI exposures lasted 15 to 20 minutes given 2 to 3 times per week, with total treatments ranging from 2 to possibly as many as 15 for more serious cases. In a number of cases, the treatments enabled the patients to avoid surgical intervention.

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* This study is not likely to have been in compliance with all good laboratory practices.

In the two pelvic hematoma cases, the authors attributed the resulting rapid relief to the ability of the PAP IMI to accelerate the rate of blood and fluid resorption in the pelvic cavity. A reprint of this article is presented as Appendix H. Note the term "magnetic induction device (MIG)" used in the article refers to the PAP IMI.

b) Other reports of efficacious treatment:
Several doctors have reported successfully treating a variety of maladies using the PAP IMI. A few of these include:

Provided that the precautions listed below are heeded, there should be no risk to a patient undergoing PAP IMI therapy:

5. Precautions.

a) Pacemakers. As with all diathermies, the device should not be operated within ten feet of an individual with a cardiac pacemaker or other bin-electronic device.

b) Insulation. The patient should be placed on a well insulated, non metallic or non conductive bench, table, or bed.

c) Water spills. As with all electrical appliances, contact with water or conducting liquids should be avoided. If a water or liquid spill should occur on the insulating platform or in the device area, the machine should be immediately switched off and disconnected from the mains power until the area is completely dry.

d) Divestiture of metal objects and electronic devices. Both the patient and the operator must divest themselves of all metal objects before treatment, including watches, jewelry, keys, credit cards, and any metallic pocket contents. Even a small mass of metal can reduce the output of the probe and the safety of the treatment. Electronic beepers, calculators, mobile phones, tape recorders, key chain car openers, and credit cards with magnetic strips should be kept at least three feet from the probe during operation.

e) Use of two machines. Do not use two devices on the same patient simultaneously.

6. Contraindications for Special Medical Conditions (applicable to all diathermies).

a) Blood pressure. As with other pulsed diathermies, blood pressure may belowered after treatment due to dilation of small blood vessels; this is a transient condition that quickly passes, but a short post-treatment rest period is suggested for hypotensive patients.

b) Hemorrhagic tendencies. Caution should be used in treating patients with hemorrhagic tendencies or within 24 hours of surgery on internal organs to avoid a possible increase in bleeding or edema. Also exposure near areas where catheters are inserted is not advised. Diathermy is also contraindicated for patients with purpure and hemophilia. It should not be applied to the back or abdomen of patients who have peptic ulcers which have bled recently. Although no problem has been encountered in the many effective treatments of dysmenorrhea, the possible increase in menstrual blood flow should be considered.

c) Hormone levels. As with other pulsed diathermies, some organs may temporarily increase their hormone output after receiving a diathermy treatment. This factor should be considered in evaluating the patient and establishing treatment protocols. For example, due to the possibility of increased secretion of estrogen (as yet unconfirmed), patients diagnosed with breast cancer should not receive treatment in the pelvic area.

d) Medication. As with other pulsed diathermies, exposures may tend to enhance the effectiveness of drugs. So this is a factor to consider in patients where over- medication may be contraindicated. For example, if PAP IMI treatments were conducted during chemotherapy treatment, the toxicity of the chemotherapeutic agent would increase in the treated area negatively impacting the patient's tissues in that region.

e) Metallic implants. As with all diathermies, patients with large surgical metallic implants (e.g., loops or semi-closed loops >1 square inch in size) or having metallic intrauterine devices should not be treated in the areas where those devices are implanted. Otherwise, these metal components might overheat and cause thermal damage to adjacent cells.

f) Pregnancy and Epiphyseal centers. Diathermy is contraindicated over the womb of a pregnant patient and over epiphyseal centers in children.

Although the energy attenuation is extremely high (inversely proportional to the cube of distance),the same precautions as above should be observed for operators or technicians exposed to very weak EMF pulses for prolonged periods of time.

7. Safety Features.

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8. Low Risk to High-Voltage Exposure.

This section refers to proprietary technical information and is not available on the Internet