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September 2009. Micromedic Company Profile.

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september 2009
September 2009

Micromedic Company Profile

disclaimer
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

presentation contents
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

about micromedic technologies
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

the business model
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

slide6
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

the people
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

strategic collaboration
Strategic Collaboration

Technion, Faculty of Medicine, Haifa

University of Florida

Hadassah Medical Center, Jerusalem

Sourasky Medical Center, Tel Aviv

8

advisory board
Advisory Board

Head of the Cancer and Vascular Biology Research Center, Rappaport Faculty of Medicine, Technion

9

the biomarkers market a growing market
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

product pipeline
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

slide13
Selected announcements

of the past months

slide14
Selected announcements

of the past months

14

slide15
Product Pipeline

Colorectal Cancer

Early Detection

slide16
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

slide17
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

slide19
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

our new biomarker
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$.

slide21
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

slide22
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

slide23
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

slide24
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

slide25
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

slide26
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

slide27
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

slide28
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

slide29
Product Pipeline

Anti-CD24 based drug for colorectal cancer

slide30
Using CD24 as Drug Target for Colorectal Cancer

Control

Treated CD 24

Prof. Nadir Arber group, Tel Aviv Sourasky Medical Center

slide31
Product Pipeline

Head & Neck cancer Early Detection

slide32
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)

slide33
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

slide34
Product Pipeline

Carcinoma and pre-cancer detection

carcinoma
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

slide36
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

slide37
Product Pipeline

Breast Cancer Risk Assessment

37

slide38
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

slide39
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

slide40
Product Pipeline

Diabetes Detection

slide41
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

slide42
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.

slide43
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.

slide44
Product Pipeline

Pharmacogenetic marker for Aredia and Zometa

44

pharmacogenetic biomarkers
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

the problem
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

slide47
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

micromedic s discovery
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

significance and benefits
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

a comparative table between micromedic s biomarker and other genetic biomarkers
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

thank you for your time
Thank you for your time

Contact Information:

Mr. David Solomon, CEO, [email protected]

Dr. Itay Shafat, Scientific Coordinator, [email protected]

Tel 972-3-5756917

Fax 972-3-5756919

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