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September 2009

September 2009. Micromedic Company Profile.

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September 2009

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  1. September 2009 Micromedic Company Profile

  2. This document does not constitute or form part of, and should not be construed as constituting or forming part of, any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of this document nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of the Company. No reliance may be placed for any purposes whatsoever on the information contained in this document or on its completeness. No representation or warranty, express or implied, is given by or on behalf of the Company and/or its subsidiaries or any of their directors, officers or employees or any other person as to the accuracy or completeness of the information or opinions contained in this document and no liability whatsoever is accepted by the Company and/or its subsidiaries, or any of their members, directors, officers or employees or any other person for any loss howsoever arising, directly or indirectly, from any use of such information or opinions or other wise arising in connection therewith. Certain statements, beliefs and opinions in this document, are forward-looking, which reflect the Company’s or, as appropriate, the Company’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. Disclaimer 2

  3. Presentation Contents Page • About Micromedic Technologies LTD 4-14 • Biomarker for Colorectal Cancer 15-28 • Drug for Colorectal Cancer 29-30 • Biomarker for Head & Neck Cancer 31-33 • Biomarker for Carcinoma and pre-cancer 34-36 • Biomarker for Breast Cancer 37-39 • Biomarker for Diabetes 40-43 • Biomarker for Aredia and Zometa 44-50 3

  4. About Micromedic Technologies Micromedic is a publicly traded company listed on Tel Aviv Stock Exchange. The Company's main business is licensing, translating and commercializing new promising early-detection and monitoring biomarkers for various clinical conditions. Micromedic has created strategic alliances with leading research and clinical institutes in Israel and in the US. Micromedic is currently collaborating with Hadassah Medical Center in Jerusalem, Tel Aviv Medical Center, University of Florida and The Technion - Israel Institute of Technology. 4

  5. The Business Model Business Focus : Focus on the area of developing and commercializing advanced biomarkers through "Focused Portfolio" of subsidiary companies specialized in this area and operate under the umbrella of the business development of the parent company 5

  6. Micromedic PGx (BONJ) Micro-Rap 85% Bio - Gene Ltd. 95% Bio - Mark Ltd. 90% Bio Med Ltd. 100% Affiliated company: MET (20%): Micro Drug Delivery with FDA and CE approved systems (Micro Can for eye capillary drug delivery and Spider Can for spider veins) 6 * Registered in the EU in September 09, approved for selling in Germany/Europe

  7. The People Mr. Reuven Kuvent, Chairman of the Board Mr. David Solomon, CEO Prof. Nadir Arber Dr. Asher Salmon Prof. Edward Chan Prof. Nathan Karin Prof. Israel Vlodavsky Prof. Arie Durst Prof. Bernard Levin Prof. Tamar Peretz Dr. Izak Lifshiz Mr. Rami Guzman Key Scientists Prof. Yossi Katz Prof. Naim Shehadeh Advisory Board 7

  8. Strategic Collaboration Technion, Faculty of Medicine, Haifa University of Florida Hadassah Medical Center, Jerusalem Sourasky Medical Center, Tel Aviv 8

  9. Advisory Board Head of the Cancer and Vascular Biology Research Center, Rappaport Faculty of Medicine, Technion 9

  10. The Team - Lead Scientists 10

  11. The Biomarkers' Market – a growing market Direction and growth engines The market for molecular biomarkers is growing at a rate of 15% per annum Recent advances in mapping the human genome have made possible the development of a new generation of advanced biomarkers The market for biomarkers for early cancer detection has the largest growth potential: about 34% p.a. Source : Diagnogure , 2006 11

  12. 420 m tests 10 billion $ 3.5 m tests 525 million $ 20 m tests 500 million $ 10-13 m tests 250 million $ 8-10 m tests 800 million $ 2.3 m tests 575 million $ Product Pipeline Pre Clinical Small Clinical Trial Validation Clinical Trial FDA CE Market Potential Colorectal Cancer Screening Breast Cancer Risk Assessment Head & Neck Cancer Diagnostics Diabetes Diagnostics Cancer detection (next generation biopsy) Anti-cancer drugs side effect Notes : 1. Market potential estimation based on the relevant population in US, EU, Japan and 25% of India and China and projected test price. 2. Project’s stage is for Illustration only

  13. Selected announcements of the past months

  14. Selected announcements of the past months 14

  15. Product Pipeline Colorectal Cancer Early Detection

  16. Incidence of colorectal cancer (age-related, per 100,000) Colorectal Cancer – a Worldwide Epidemic The third commonest form of cancer occurring worldwide, with 1,000,000 new cases and 500,000 deaths annually Sources: Frost & Sullivan Healthcare Practice (left), Globocan 2002 database (middle) and MedScape (right) 16

  17. CRC Screening Issues • The American Cancer Society’s goal is to screen 75% of the average risk population 50 years and above by 20151 • Currently, only 50% of the population is being screened according to the guideline recommendations1 • Today, 61% of patients are first diagnosed with late stage disease2 • 5 year survival is 90% if the disease is diagnosed while still localized, but only 68% for regional disease only 10% if distant metastases are present3 • Experts believe that a blood based alternative test would increase patient acceptance of testing4 17 1. American Cancer Society; 2. Liang et al, 2006; 3. Levin B., 2006; 4. Ries et al, 2007

  18. Tests that can Detect Adenomatous Polyps and Cancer 18 Table from Levin et al, 2008

  19. Micromedic CD24 Test for Colorectal Adenoma Screening Section two - CD24 - a novel biomarker for colorectal adenoma screening • About CD24 • Phase I: Preclinical Exploratory • Phase II: Clinical Assay and Validation • Phase III: Retrospective Longitudinal. First clinical trial. • First clinical trial – second site • Clinical trial – improved exclusion criteria 19

  20. Our New Biomarker Intended Use: The Micromedic CD24 Device is intended for the qualitative detection of elevated levels of CD24 in blood, which may be indicative of gastrointestinal abnormalities such as colon polyps, colon adenomas and colorectal carcinoma. Type of test : Blood test based on Peripheral Blood Lymphocytes (PBL). Technology : Currently Western Blot, ELISA is under development. The Benefits: Compliance: Blood-based tests are widely accepted by the public, a problem with both fecal-based tests and invasive tests. Sensitivity of the test (about 80% for adenomatous polyps) allows for detection of many patients at an early, easily curable stage. Price [Cost Benefits] expected price 50-100$.

  21. Protein core About CD 24 • CD24 is a cell surface, heavily glycosylated phosphatidylinositol (GPI)-anchored mucin-like protein. • The protein core consists of 31 amino acids, with 16 potential O- and N-glycosylation sites. Its final Mw varies between 28-75 kDa. • Physiologically, CD24 is expressed mainly on premature lymphocytes, epithelial and neural cells. It plays a crucial role in cell selection and maturation during hematopoiesis. • CD24 was identified as an alternative ligand of P-selectin, an adhesion receptor on activated endothelial cells and platelets. 21

  22. Expression level (normalized) Phase I: Preclinical Exploratory • Gene expression profiling (Affimetrixrat [RG-U34] GeneChip) was performed in normal (IEC18) and transformed (IEC18-Ras; R1) enterocytes following treatment with Celecoxib (COX-2 inhibitor). • 71 target genes with altered gene expression in transformed cells reverted back tonormal levels upon Celecoxib treatment. • CD24 gene was identified as being over expressed in R1 relative to IEC18 cells and in reduced expression following exposure to Celecoxib. 22 * Phases according to Pepe et al, JNCI, 2001

  23. Normal Adenoma Carcinoma A Immunohistochemical Staining of CD24 in Colonic Tissue Tissue Analysis Sensitivity = 88.3% Specificity = 83.3% 23 Prof. Nadir Arber group, Tel Aviv Sourasky Medical Center

  24. Signal strength (arbitrary units) Healthy Adenoma CRC Phase II: Retrospective Longitudinal ROC curve Clinical Trial - Basic Inclusion Criteria : age >50 Exclusion Criteria : High Genetic Risk Gold Standard : Colonoscopy Type of test : PBL sample Sensitivity AUC=0.785 Sensitivity 82.54% Specificity 73.53% 100-Specificity 24 Prof. Nadir Arber group, Tel Aviv Sourasky Medical Center

  25. Phase III: Validation Trial ROC curve (adenoma) Clinical Trial – Validation (second site) Inclusion Criteria : age >50 Exclusion Criteria : High Genetic Risk Gold Standard : Colonoscopy Type of test : PBL sample Sensitivity AUC=0.798 Sensitivity 81% Specificity 76.7% 100-Specificity 25 Dr. Itay Shafat, Faculty of Medicine, the Technion

  26. ROC curve - CRC ROC curve – CRC+ad Sensitivity Sensitivity AUC=0.908 Sensitivity 92.3% Specificity 86.8% AUC=0.851 Sensitivity 77.1% Specificity 86.8% 100-Specificity 100-Specificity Phase III: Second Validation Trial Clinical Trial – Validation Inclusion Criteria: age >50 Exclusion Criteria: High Genetic Risk Elevated CRP Gold Standard : Colonoscopy Type of test: PBL sample *from 3mm and above 26 Prof. Nadir Arber group, Tel Aviv Sourasky Medical Center

  27. CD24 Biomarker take home message • CD24 is a promising new biomarker for colorectal adenoma screening with high sensitivity and specificity • Micromedic believes that improvement of the assay and better inclusion/exclusion criteria will improve the assay performance • As blood tests are well accepted by the public, Micromedic believes CD24 test will assist in achieving the 75% population screening target defined by the American Cancer Society 27

  28. Colorectal cancer screening: the IVD field 1) Davies. RJ et al. (2005). Nat Rev Cancer 5:199-209. 2)Allison , JF et al. (1996). N Eng J Med 334:155-159 3) Imperial, TF et al. (2004). N EnglJ Med.351:2704-14. 4) Lofton-Day, C et al. (2007) AACR Annual Meeting 2007. “it is clear that the convenience and simplicity Of a plasma assay would be considerable” Levin, B. “Molecular screening testing for colorectal cancer”, Clin. Cancer Res. 12(17), sept 1, 2006 28

  29. Product Pipeline Anti-CD24 based drug for colorectal cancer

  30. Using CD24 as Drug Target for Colorectal Cancer Control Treated CD 24 Prof. Nadir Arber group, Tel Aviv Sourasky Medical Center

  31. Product Pipeline Head & Neck cancer Early Detection

  32. Highest incidence rates worldwide Head and Neck Cancer The sixth commonest form of cancer occurring worldwide, with 350-500 thousand new cases annually Worldwide incidence rates as related to age and sex 32 Source: Cancer research UK (left) and Oral Cancer Foundation (right)

  33. P90 – A new Biomarker for Head and Neck Cancer A positive stain for P90 of a biopsy from a patient with head and neck cancer 33 Source: University of Florida

  34. Product Pipeline Carcinoma and pre-cancer detection

  35. Carcinoma • Carcinoma is any cancer arising from epithelial cells. • There are approx. 8 to 10 million new cases of carcinoma worldwide, mostly in the colon, lung and breast. • Diagnosis is usually through imaging techniques (such as CT and MRI) and biopsy. • These tools lack in the ability to detect pre-cancerous cells. 35

  36. Usage of the P90 Biomarker for Carcinoma and Pre-Cancer Detection Full blown cancer (Head and Neck carcinoma). • 100% of cancer cases detected • 85% of pre-malignant cases detected. • Thus far the biomarker detected cancers of the colon, breast, various head and neck cancers and cancer of the uterus. Dysplasia (pre-cancer). The edges are clearly visible. 36 36 Source: University of Florida

  37. Product Pipeline Breast Cancer Risk Assessment 37

  38. Breast cancer The commonest cancer in females (1 in 7-10), second commonest overall, with over million cases worldwide. 5-10% of cases are attributed to hereditary breast cancer. Mutations in BRCA1 and BRCA2 are not related exclusively to breast and ovarian cancer! Mutation in BRCA1 may lead to prostate cancer, mutations in BRCA2 are related to many more types of cancer. 38 Sources: American Cancer Society

  39. Genetic risk profiling for Breast Cancer A preliminary test of 38 blood samples from women carrying mutations in the BRCA1 or BRCA2 genes vs. healthy controls, 21 genes were identified as marking these mutations. 39 Source: Hadassah Medical Center

  40. Product Pipeline Diabetes Detection

  41. Diabetes – a Worldwide epidemic Diabetes presents a huge health issue. In 2007, over 240 million people worldwide suffered from the disease. The number is expected to rise to over 380 million people by 2025. Increase in Worldwide diabetes incidence rates 41 Source : Data from the website of the International Diabetes Federation

  42. A new biomarker (CCL3) for type 1 diabetes ROC curve Sensitivity Cut off>9: AUC=0.946 Sensitivity: 87.4% Specificity: 94.4% 100-Specificity Log 2 Ab titer Source: the Technion and Rambam hospital, Haifa.

  43. A new biomarker (CCL3) for type 1 diabetes CIAA ICA GAD CCL3 Existing tests used in the clinics Source: the Technion and Rambam hospital, Haifa.

  44. Product Pipeline Pharmacogenetic marker for Aredia and Zometa 44

  45. Pharmacogenetic Biomarkers Pharmacogenetic biomarkers - Genetic biomarkers based on identification of mutations in specific genes. These markers aid in adjusting drug prescription (type and dose) to the patient Genetic markers - Aid both the pharma industry and the patient, by increasing efficacy and safety of the drug Genetic markers are the cutting edge of new generation drugs (Personalized Medicine) 45

  46. The Problem Many [up to 13%1,2] cancer patients treated with drugs of the bisphosphonate family develop a severe and morbid side effect which causes breakage of jaw bones (BONJ) The disease is reported mostly for users of Aredia and Zometa [both by Novartis, Zometa annual sales are at 1.4Bn$3] The disease is well documented, but underlying mechanisms are unknown • Durie GM, N Engl J Med. 2005 • Cafro AM, Blood 2005 • http://www.novartis.com/investors/product-sales.shtml 46

  47. Drug Labeling Warnings From Aredia warning about Osteonecrosis of the jaw (BONJ): “Osteonecrosis of the jaw has been reported predominantly in cancer patients treated with bisphosphonates, including Aredia. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction…While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw… “ Zometa warning about possible side effects: “Uncommonly, in some patients bone damage in the jaw (osteonecrosis) may occur. Signs of this condition can be pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a "heavy jaw feeling", or loosening of a tooth..". 47

  48. Micromedic’s Discovery A genetic test [a blood test] will identify carriers of specific mutations, whose carriers are at increased risk to develop BONJ Successful results in preliminary trial In a preliminary trial of 47 patients treated with Aredia or Zometa, those carrying the mutations had 11.6 times higher risk of developing BONJ than those who do not carry the mutations [Odds ratio1=11.6] 1. The odds ratio is the ratio of the odds of an event occurring in one group to the odds of it occurring in another group 48

  49. Significance and Benefits Clinical Implications A simple genetic test will identify those who are at risk to develop BONJ. These patients may receive alternative therapy Expected Benefits Significantly higher safety in taking the drugs Increasing patient and physician satisfaction Significant positioning improvement for pharmaceutical companies [higher drug efficacy] 49

  50. A comparative table between Micromedic’s biomarker and other genetic biomarkers • Toffoli et al, Journal of Clinical Oncology, Vol 24, No 19 (July 1), 2006: pp. 3061-3068 • Aital et al, The Lancet, Volume 353, Issue 9154, Pages 717 - 719, 27 February 1999 • González Della Valle et al, Clin Orthop Relat Res. 2008 Nov 26 50

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