powerpoint presentation - mackay

Business Plan

Copyright © 2009 MacKay Life Sciences, Inc. ALL RIGHTS RESERVED

DISCLAIMER

This presentation was prepared exclusively for the benefit and internal use, and is for the confidential use only. Of those persons to whom it is presented or transmitted. This presentation is not and does not form part of an offer, invitation or recommendation in respect of securities. The information contained in this presentation is given without any liability whatsoever to MacKay Life Sciences, Inc. (“MacKay” or the “Company”) or any of the Company’s respective directors, officers, employees or agents, and such persons disclaim any liability whatsoever (including for negligence) for any loss howsoever arising from any use of this presentation or its contents or otherwise arising in connection therewith. This presentation is not intended to constitute legal, tax or accounting advice or opinion. NO representation or warranty, expressed or implied, is made as to the accuracy, completeness or thoroughness of the content of the information. The recipient should consult with its own legal, tax or accounting advisers as to the accuracy and application of the information contained herein and should conduct its own due diligence and other enquiries in relation to such information. Reliance should not be placed on the information of the documents for any investment decision.

This presentation must not be disclosed to any other party and does not carry any right of publication. This presentation is incomplete without reference to, and should be viewed solely in conjunction with, the oral briefing provided by the Company. Neither this presentation nor any of its contents may be reproduced or used for any other purpose without the prior written consent of the Company.

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EXECUTIVE SUMMARY

Biofield Inc. (OTCBB: BZEC), has been renamed MacKay Life Sciences, Inc. (“MacKay”)

With over US$ 85 million invested in Research and Development, MacKay is a medical technology company focused on engaged in identifying, developing manufacturing, distributing and marketing non-invasive medical devices to assist in the detection of cancer.

According to World Health Organization (WHO), cancer is the leading cause of death worldwide, and accounted for 7.4 million deaths in 2004, (this figure represents around 13% of all deaths globally) with 70% of all cancer deaths occurring in low- and middle-income countries. Deaths from cancer worldwide are projected to continue rising, with an estimated 12 million annual deaths by 2030

Today, the most common types of cancer worldwide are lung, stomach, colorectal, liver, breast and cervical. WHO revealed that about one-third of the cancer burden could be decreased if cases were detected earlier and treated immediately

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COMPANY OVERVIEW

Our Vision MacKay – employs individuals from the highest echelons of science and

engineering in the fields of healthcare screening, diagnostics and treatment. The Company’s ongoing commitment is to enhance quality of life through the development and delivery of innovative medical procedures and products.

MacKay is in a position to become the premier global provider of non-invasive screening and diagnostic medical technologies for early cancer and illness detection, most currently in the field of breast and cervical cancer.

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ABOUT MACKAY LIFE SCIENCES

MacKay, is a US based listed medical company which develops, manufactures, seeks for and acquires non-invasive medical technologies in detecting and preventing cancers and other illnesses. Today the Company has reoriented and expanded its energies to focus on offering non-invasive and cost effective technologies to the world’s population on an easily accessible basis.

The company currently: Owns a state-of-the-art technology in breast cancer – the Biofield Breast Cancer

Diagnostic System (“BDS”); Is a substantial shareholder in ValiBio – a subsidiary of an UK Alternative

Investment Market (AIM) listed company ValiRx Plc.

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ABOUT VALIBIO

ValiBio – a subsidiary of the AIM listed company ValiRx Plc, is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics.

Current Prodcuts: NucleosomicsTM – blood tests for the early detection of cancer based on the

presence of epigenetic alternations to nucleosomes of blood in cancer patients; HypergenomicsTM – tissue biopsy tests for the differential, prognostic and

personalized medicine diagnostics of cancer based on the detection of epigenetic alterations in chromatin structure – hypersensitive sites;

HPV diagnostic test – Cervical cancer diagnostic test.

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MILESTONEEstablished Biofield Corporation, Inc.Re-incorporated in Delaware, USABegan Clinical Trials in Japan, Philippines, Malaysia, Europe, and the USListed in NASDAQ / Submitted FDA PMA Application / Stock price reached US$ 33 per share (before the 10 to 1 reverse)Appointed Dr. Long as Chairman & CEOEuropean CE Mark ApprovedBegan post market surveillance EvaluationMr. James MacKay acquired Biofield / Dr. Long passed away from cancerMacKay sets up Headquarter in HKMacKay signs Distribution Agreement for HK, Macau and Philippines / MacKay opens its first Clinical Centre in Shanghai / Receives an upgrade from Pink Sheet to OTC Bulletin Board (OTCBB: BZEC) / BDS downgraded to a non-invasive Medical Device to Category IIA

Biofield acquires ValiBio and signs worldwide distribution rights for NucleosomicsTM, HypergenomicsTM, and HPV / HK renowned oncologist Dr. Louis Chow begins using BDS / MacKay Signs Distribution Agreement with Mexico, Argentina and Brazil for US$ 3 Million / Begins Screening Clinical Trial in Mexico and China / Applies for CE Mark and FDA 510K on Screening and Diagnostic / Signs MOU for Distribution Rights to Russia, Turkey and Slovakia 7


PRODUCTS - BIOFIELD DIAGNOSTIC SYSTEM (BDS)

BDS is a non-invasive, radiation free, fast and accurate diagnostic system for the detection of breast cancer in women above 15 years of age. Its technology is based on the differentiation of the different electropotential currents produced during cell differentiation and proliferation commonly associated with cancer.

BDS offers a series of distinct advantages: Completely non-invasive, radiation free, no compression and pain free. More accurate

Detects up to 30% of cancers missed by other technologies such as mammograms. Detects smaller, deeper cancers especially in younger women.

Less expensive than other current technologies. Completely portable and much easier to learn and operate. It is totally non-invasive and painless, allowing patient to avoid unnecessary

biopsies, which may be what deter some patient from seeking early detection in the first place.

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PRODUCTS - BIOFIELD DIAGNOSTIC SYSTEM (BDS) - CONT.

Unique Features BDS technology is far more effective than mammograms and other

forms of breast cancer diagnostic technology for a number of reasons including:

Accuracy: BDS can detect up to 30% of cancers (especially small tumors in younger women) missed by current technologies.

Safe and Painless: BDS is non-invasive, painless and radiation free. The procedure may be repeated as frequently as desired thus eliminating unnecessary biopsies, which up until now may have attributed towards women not seeking consultation on early detection through other means in the first place.

Portability: BDS can be used in a physician’s office and is small enough to transport to rural areas, creating opportunities for women who cannot visit a hospital or major medical centers to be screened.

Rapid Results: BDS provides accurate results immediately (15 minutes) and a trained technician rather than a physician or radiologist can perform the procedure.

Cost to Patient: BDS is ten times less expensive than mammograms, ultrasound, CT scans and MRIs.

Cost to Physician: BDS is profitable to the physician yet testing can be priced lower than diagnostic mammography and screening mammograms, with no expensive training or other lab fees.

Standalone Screening: Singapore re-analyzed the original US clinical trial data conducted by Biofield and results show a very good sensitivity, specificity, accuracy and ROC curve (AROC) by different statistical methods. This may indicate that the BDS need not be dependent on mammogram, ultrasound or physical examination and can be treated as a standalone screening device. 9


PRODUCTS - VALIBIO: CERVICAL HPV INFECTION SCREENING TEST

The ValiBio High Risk Cervical HPV Infection Screening Test is a CE marked automated test for the 15 HPV subtype cervical infections considered to be high risk for the development of cervical cancer. In addition, the presence of either HPV subtype 16 or 18, which are considered the highest risks for cervical cancer and are the subtype targets for anti-HPV vaccination programmes, are separately detected and identified.

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PRODUCTS - VALIBIO: NUCLEOSOMICSTM DIAGNOSTIC PRODUCTS

NucleosomicsTM is a platform for non-invasive (blood) tests for early cancer diagnosis based on epigenetic signal changes associated with malignancy.

ELISA tests for global histone modifications expressed in cell free nucleosomes in blood that are characteristic of cancers are currently under development. The company expects to launch early NucleosomicsTM products for research use in 2009. Diagnostic products regulated by EMEA and the FDA will follow. Early disease focus is in lung, pancreatic and colon cancer

Unique feature: Using a small amount of blood to detect different kinds of cancers, which is

different from traditional screening methods such as PET / CT scan, CT scan and MRI.

A safe way to avoid radiation risks to medical personnel and staff Avoid time consuming and expensive costs.

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PRODUCTS - VALIBIO: HYPERGENOMICSTM DIAGNOSTIC PRODUCTS

HyperGenomicsTM is a platform for differential diagnostic and prognostic tests in cancer as well as testing for personalised medicine. Now focus is on leukaemia, prostate and colon cancer.

Unique feature: Detecting all hypersensitive sites in cells

Genome wide screening to identify all the hypersensitive sites present in cancer or healthy tissue cells.

One-off screening for result

By using ultra-sequencing all the hypersensitive sites present in several patient samples can be screened in a single run.

Distinguishing malignant cells

This technique is used to identify panels of hypersensitive sites present in aggressive malignant cancer cells but absent in other cells.

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MARKET OVERVIEW – BREAST CANCER

Breast cancer is the most common malignancy in women and the second leading cause of cancer death. Breast cancer diagnostics represents a US$6 billion global market.

Breast cancer is three times more common than all gynecologic malignancies. The incidence of breast cancer has been increasing steadily from an incidence of 1:20 in 1960 to 1:7 women today.

The National Breast Cancer Foundation estimated that each year over 200,000 new cases of breast cancer will be diagnosed and over 40,000 patients die from the disease.

Breast cancer is considered to be a heterogeneous disease, meaning that it is a different disease in different women, a different disease in different age groups and has different cell populations within the tumor itself.

Autopsy studies show that 2% of the female population has undiagnosed breast cancer at the time of death.

Nowadays, the most common methods currently being used for diagnosing breast cancer are diagnostic mammography, ultrasound and biopsy.

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MARKET OVERVIEW – BREAST CANCERMAMMOGRAPHY

Mammography is the process of emitting a low-dose X-ray beam through a portion of the breast while the breast is compressed between a plastic paddle and a film holder.

The result is a black and white negative displaying the fatty tissue, the ducts and lobes within the breast and possibly an abnormality.

Mammography may detect very small, non-palpable lesions that could be benign or malignant but there is an average of 10 to 15 percent of tumors that may not be detectable.

Mammography exposes a woman to radiation and are not as effective for women with breast implants as it will affect how much of the breast tissue can be seen on the screening mammogram which will create more challenges to radiographers to achieve clear images of the breast.

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MARKET OVERVIEW – BREAST CANCERULTRASOUND

Ultrasound Imaging of the breast produces a picture of the internal structures of the breast. During a breast ultrasound examination, the physician performing the test may use Doppler techniques to evaluate blood flow or lack of flow in any breast mass. In some cases this may provide additional information as to the cause of the mass. The sensitivity of ultrasound is only around 60% - 88% and without objective results. Therefore, ultrasound imaging is not the most accurate detection for breast cancer.

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MARKET OVERVIEW – BREAST CANCERBIOPSY

A breast biopsy involves the removal of some tissues—usually by a procedure performed under anesthesia utilizing a needle which can take small pieces of tissue from the suspicious area in the breast so that the tissue may be examined under a microscope to confirm a diagnosis. Occasionally a surgical biopsy is needed to make a diagnosis. Many of the areas that are thought to be of concern turn out to be non-cancerous on biopsy

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MARKET OVERVIEW – BREAST CANCERTECHNOLOGY DETECTION COMPARISON

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Non-invasive Painless Objective Result Instant Report Sensitivity Estimated Cost

BDS 90-95% US$35

Mammography 78-90% US$120-350

Ultrasound 60-80% US$80-120

Biopsy 65-98% US$320-650


MARKET OVERVIEW – CERVICAL CANCER

From the research of Oncology Channel®, Cancer of the cervix is the second most common cancer in women worldwide and is a leading cause of cancer-related death in women in underdeveloped countries. Worldwide, approximately 500,000 cases of cervical cancer are diagnosed each year.

Routine screening has decreased the incidence of invasive cervical cancer in the United States, where approximately 13,000 cases of invasive cervical cancer and 50,000 cases of cervical carcinoma in situ (i.e., localized cancer) are diagnosed yearly.

Cervical cancer detection represents a sales opportunity in excess of US$ 1 billion per year.

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MARKET OVERVIEW – CANCER SCREENING

It is estimated that 1.3 million people in the U.S. were diagnosed with cancer in 2003, and that 1 in 4 deaths was due to the disease. In the fight against cancer, which is the second-leading cause of death in the U.S. after heart disease, remarkable advances have been made in developing sophisticated tools to detect malignancies at their earliest and most treatable stages.

In 2002 more than 172.5 million cancer screening and diagnostic procedures were performed utilizing imaging, in vitro diagnostic testing, and tissue biopsy. These procedures generated approximately US$ 2.7 billion in corresponding product sales, with oncology-related imaging system sales accounting for 53.5% of the total, imaging contrast agents and biopharmaceuticals for 20.4%, biomolecular cancer marker testing products for 11.6%, automated Pap smear preparation/screening systems for 9.1%, and minimally invasive biopsy devices for 5.4%. Nucleosomic™ diagnostic is believed to be able to penetrate these different sectors in the field of cancer screening after product launch. 19


MARKET OVERVIEW – PERSONALIZED MEDICINE

Current research into pharmacogenetics is concentrating on identifying the genes that cause variations in the way that people to respond to existing drugs.

Pharmaceutical giants focus on totally new drugs designed with specific genetic profiles in mind. Instead of pharmaceutical companies pursuing a 'one drug fits all' philosophy, there will be subsets of drugs, each designed with specific individuals or populations in mind. Currently, it is estimated that to develop a new drug, US$ 500 million has to be invested. Although, the prospect of more drugs, each with a smaller market share, may seem to be still in the early stage of development, the pharmaceutical giants are happy to invest and refine the target audience of their existing drugs. Therefore, they require substantial lab testing tools to develop new drugs with only genetic minority 'customers' in mind.

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5 YEAR BUSINESS DEVELOPMENT PLAN –DISTRIBUTION

The MacKay Medical Group Limited Singed Exclusive Distribution Agreement for Hong Kong and Macau Working with Dr. Louis Chow – Executive Director of Organization for

Oncology and Translational Research Limited (“OOTR”), on clinical trials for Screening and Diagnostic on the BDS in HK and plans to expand the trials to Taiwan, Beijing, Shanghai and Guangdong.

Organizing a “Breast Cancer Awareness” campaign with HK Cancer Funds, and Financial Times.

Organizing a “Macau Breast Cancer Awareness” campaign with Melco Crown Entertainment and OOTR.

Aligning with All China Women’s Federation to co-ordinate a nationwide road show on the BDS screening technology and HPV diagnostic test.

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5 YEAR BUSINESS DEVELOPMENT PLAN –DISTRIBUTION CONT.

The MacKay Eastern Limited Singed Exclusive Distribution Agreement for Philippines Working and lobbying with The Quezon City Health Department to launch a

public breast cancer detection program for civil servants sponsored by the Government.

Negotiation with X-Pharma to formalize a distribution platform to create a panel doctor scheme with over 1,200 doctors via their nationwide pharmacy-health stores and health centers.

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5 YEAR BUSINESS DEVELOPMENT PLAN –DISTRIBUTION CONT.

Palex Medical, SA. Signed Letter of Intent to develop a two month Clinical Trial Road Show through

Spain for the BDS screening and diagnostic technology. Palex has agreed to sign an Exclusive Distribution Agreement for Spain, Portugal

and Adorra.

The MacKay Life Sciences de Mexico S.A. de C.V. (“MILSM”) Signed an Exclusive Distribution Agreement for US$ 1 Million covering the

following countries: Aruba / Belize / Costa Rica / Cuba / Dominican Republic / El Salvador / Guadeloupe /

Guatemala / Haiti / Honduras / Martinique / Mexico / Netherlands Antilles / Nicaragua / Puerto Rico / Saint Martin / Saint Pierre & Miquelon

Conducted a presentation to the Ministry of Health, the Sanitary Regulation Commissioner of COFERIS the Mexican Regulatory Approvals Authority, the Medical Director of Social Security and The National Cancer Institute which resulted in full support from all the participants and the plan is to establish and prepare four test sites for testing the screening and diagnostic effectiveness of the BDS technology.

Signed a Distribution MOU for Argentina and Brazil for US$ 2 Million.23


5 YEAR BUSINESS DEVELOPMENT PLAN –FUTURE DEVELOPMENT

Manufacturing: To setup in China Distribution Roll-out:

In negotiation: ASEAN / Russia / Turkey, Slovakia / United Arab Emirates Five Year Roll-out Plan: South Korea / Japan / India / Other Middle Eastern

Countries / South Africa / Australia / New Zealand / France / Italy / Germany / United Kingdom / United States of America

Research and Development MacKay is working with ValiRx Plc to build its own R & D centres in China and

the Philippines.

Distribution Rights: Guided Therapeutics, Inc. Infrascan, DNC. Premier Heart, LLC.

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ABOUT GUDIED THERAPEUTICS, INC.

LightTouchTM – a non-invasive test that has the potential to improve significantly the early detection of cervical pre-cancers and cancers. It is a fast, painless test that, unlike Pap smears and HPV testing, does not require a tissue sample or the delay of obtaining laboratory analysis.

A pre-pivotal clinical study of LightTouchTM, sponsored by the National Cancer Institute in the U.S. indicated that the non-invasive test could reduce by 55% the number of unnecessary follow-up procedures as a result of false positive Pap test results. The potential saving to the U.S. healthcare system could be as high as US$ 181 million annually if the technology is widely adopted.

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ABOUT INFRASCAN DNC.

The Infrascanner™ is a hand-held, non-invasive, near-infrared (NIR) based mobile imaging device designed to detect brain hematoma at the site of injury within the “golden hour”. This refers to the period following head trauma when pre-hospital analysis is needed to assess rapidly the neurological condition of a victim. Pending FDA clearance, the Infrascanner™ will be an affordable, accurate and clinically effective screening solution for head trauma patients in settings where timely triage is critical. It is intended to aid the decision whether to proceed with other tests such as head Computed Tomography (CT) scans. In environments where access to CT scanning is restricted or not available, Infrascanner™ will facilitate surgical intervention decisions.

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ABOUT PREMIER HEART, LLC.

Premier Heart's MCG System represents a radical departure from traditional resting and stress ECG techniques. Where historically medicine has taken a reductionistic view, ECG Premier Heart's MCG technology uses an integrative approach, building a mathematical model of the entire cardiac system. This approach allows MCG to obtain accurate diagnoses from a simple, non-invasive test.

When compared to other diagnostic modalities MCG is extremely accurate and reliable, surpassing many established clinical techniques in both sensitivity and specificity. In addition, MCG is capable of accurately detecting coronary artery disease at an early stage (<70% lumen encroachment), exceeding the capabilities of many other techniques and allowing intervention at early stages where coronary disease may be controlled by lifestyle changes or medication.

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OUR PARTNERS

Lead-Lok, Inc.

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