Electromagnetic Prostate Cancer Detector

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1 Electromagnetic Prostate Cancer Detector A new electromagnetic diagnostic system for early screening of prostate cancer Automatic Non-Invasive No side effects No undressing Fast examination Immediate results Ideal for early screening & follow-up

2 Cancer detection system Introduction A new automatic electromagnetic system that performs non-invasive diagnosis for prostate cancer detection ESO-Prost is a new generation of diagnostic systems for non-invasive, extracorporeal diagnosis of prostate cancer. ESO-Prost is a complement to other conventional imaging methods for prostate cancer detection. ESO-Prost high sensitivity and specificity can help to reduce the number of unnecessary biopsies. ESO-Prost not only can be used for diagnosis but can be frequently used in the follow-up of prostate cancer treatments. The Prostate examination is very easy, do not require patient undressing and the outcome is immediately available. The technology is patented, its effectiveness has been proven by scientific publications and it is mature for detection of prostate cancer. 2 MEDIELMA Srl Via Ippolito Nievo, 28/ Milano, Italy tel info@medielma.it

3 Cancer detection system Advantages Advantages, an ideal device for prostate cancer screening and clinical follow-up Automatic ESO-Prost performs prostate cancer detection automatically by simply pushing a button. Non-Invasive No side effects No undressing Fast examination Immediate results No image processing High Resolution High Sensitivity & Specificity Low cost of ownership No introduction of devices and instruments into the patient body. No harm because it uses electromagnetic waves which are non ionizing. The electromagnetic waves have very low intensity and are comparable to one of a domestic remote control. The Exploring Probe is placed near the patient s body. No need for the patient to undress completely. Just dressed with underwear. Typically the examination session requires three to five minutes. The diagnostic outcomes are available in real time and are presented in a easy-to-read graphical presentation. ESO-Prost has detection capability of cancer without any need of imaging. ESO-Prost is able to detect cancer with a resolution equivalent or better than imaging systems. ESO-Prost is ideal for low-cost massive screening to assist and complement conventional morphological analysis. Riskless repeated examinations are also possible for clinical follow-up. ESO-Prost cost of ownership is very low, thanks to its simple and reliable technology. 3

4 Cancer detection system How it works & System Components How it works performs ECD Electromagnetic Cancer Detection Cancer tissues are characterized by several forms of atypical behaviours. is able to detect different electromagnetic properties of malignant tissues in contrast to normal tissues. Diagnostic Station Exploring Probe Receiver exams are non-invasive and free of any side effects. System Components is comprised of three components: an Exploring Probe, a Receiver and a Diagnostic Station 1. Exploring Probe The Exploring Probe generates radio frequency waves of very low intensity Receiver The Receiver is located under the examination couch and detects the radio frequencies generated by the Exploring Probe. After processing the signal, the Receiver sends the information to a Diagnostic Station Diagnostic Station The Diagnostic Station is a Medical PC with a Diagnostic Software that provides the clinician with an easy-to-read diagnostic outcome report. 4

5 Cancer detection system How to use How to use 1. Patient in lithotomy position 2. Exploring Probe to the Perineum 3. Start automatic scan1, then scan 2 Outcome Green Red Low risk of Prostate cancer High risk of Prostate cancer 5 MEDIELMA Srl Via Ippolito Nievo, 28/ Milano, Italy tel info@medielma.it

6 Cancer detection system FAQ Frequently Asked Questions Does the ESO-Prost test exclude other type of exams? Is a patient preparation required? How long it takes for an examination session? Is the exam useful when PSA Value is high? No, ESO-Prost is a complement to other conventional imaging methods for cancer detection. For example, if a patient results negative to prostate ESO-Prost exam, very likely there is no need of additional morphological analysis. On the contrary, if a patient has a positive ESO-Prost exam, a biopsy or ecography are recommended. No, normally no patient preparation is required. Typically the examination session requires from three to five minutes. Yes. ESO-Prost is a good complement to PSA examination to determine if a biopsy is necessary or not. Is the exam useful also when PSA value is close to zero? How accurate is the ESO-Prost Test? What are Sensitivity and Specificity? Are the ESO-Prost electromagnetic waves harmful to the patient? How reliable is the technology? Is it possible to use ESO-Prost for remote examination? Yes. ESO-Prost is able to detect some form of cancer that do not cause PSA value to increase substantially. ESO-Prost exam result is PSA independent. ESO-Prost has Sensitivity and Specificity percentage determined from many trials. Below the average values: Sensitivity Specificity 81,8 % 95,8% Sensitivity is the fraction of patients with diseases currently identified as positive by the test (pathology correctly diagnosed). Specificity is the fraction of patients without diseases currently identified as negative by the test (healthy patients correctly diagnosed). No, ESO-Prost generates electromagnetic waves of very low power. They are 100 times less harmful than the waves generated by a mobile phone. This allows repeated examinations. After four years of technological improvement on a five year old product for a total of almost ten years of development / trials we can state that technology is at a good stage of maturity. Yes, it is possible to conduct remote examinations via Web: the doctor specialist can guide the clinician during the examination using a Webcam. 6

7 Cancer detection system Technical Data Exploring Probe The Exploring Probe generates electromagnetic waves of very low intensity. The Exploring Probe is mounted on a sledge lying on the examination couch. Exploring Probe p/n Dimensions (mm) Weight IEP H, 215 W, 620 L 10 Kg Sledge Receiver The Receiver is located under the examination couch and detects the radio frequencies generated by the Exploring Probe. p/n Dimensions (mm) Weight RXS H, 423 W, 588 L 4 Kg Diagnostic Station The Diagnostic Station is a Medical PC with a Diagnostic Software that provides the clinician with an easy-to-read diagnostic outcome report. p/n Dimensions (mm) Weight DST-xx Depending on PC type Depending on PC type Examination Couch The examination couch is optional. It provides the appropriate mechanical allocation of sledge and receiver. p/n Dimensions (mm) Weight EXC L, 750 W, 780 H 40 Kg Certifications & Risk Classification - Test report compliance with international standards EN , EN , EN , EN Manufacturer certified according to UNI CEI EN ISO 13485: 2012 and UNI EN ISO 9001: Risk Classification Class IIa, Directive 93 / 42 / EEC - CE Certification - Kiwa-CERMET (Italy) approved

8 Cancer detection system ESO-MED Family & History of Technology ESO-MED 9A Family is part of the ESO-MED 9A Family ESO-MED 9A Family is composed by different models: ESO-Breast 9A ESO-Thyr 9A Mono Specialist Prostate Breast Thyroid ESO-Colon 9A Colon, Rectum Multi Specialist ESO-MED 9A Breast, Thyroid, Pancreas, Prostate, Colon, Rectum. History of Technology Research on the interaction of electromagnetic with biological tissues dates back to 1920, almost one hundred years ago. In 1920 the pioneers in the field of radio frequency reported that malignant cancer tissue has a different behavior than normal tissues or benign tumors. The technological advances following the Second World War made it possible to evaluate the biological interaction between blood cells and other biological tissues with radio frequency and microwaves. In 1970s and 1980s studies continued on comparing malignant cancer tissue relative to the normal adjacent tissues in rats. In early 2000s a first diagnostic device was designed and made available to the market. Since then, for over ten years, many trials have been done on thousands of patients and several new products were introduced into the market. is patented and it is the result of over fifteen years of trials and improvements. MEDIELMA Srl Headquarters: Via Ippolito Nievo, 28/ Milano, Italy Tel Fax VAT info@medielma.it