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BZEC.OB > SEC Filings for BZEC.OB > Form 10-Q on 19-Aug-2008All Recent SEC Filings

Show all filings for BIOFIELD CORP \DE\ | Request a Trial to NEW EDGAR Online Pro

Form 10-Q for BIOFIELD CORP \DE\


19-Aug-2008

Quarterly Report


ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION

The following discussion and analysis should be read in conjunction with our Financial Statements and Notes thereto appearing elsewhere in this document.

Certain statements contained in this "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this report are forward-looking statements that involve risks and uncertainties. These statements relate to future events or our future financial performance. In some cases, forward-looking statements can be identified by terminology such as "may," "will", "should", "expect", "anticipate", "intend", "plan", "believe", "estimate", "potential", or "continue", the negative of these terms or other comparable terminology. These statements involve a number of risks and uncertainties. Actual events or results may differ materially from any forward-looking statement as a result of various factors, including those described above and in the Company's last Form 10-KSB for 2006 and 2005 under "Risk Factors". We have no obligation to release publicly the result of any revisions to any of our "forward-looking statements" to reflect events or circumstances that occur after the date of this Report or to reflect the occurrence of other unanticipated events.

THE COMPANY'S FOCUS ON FOREIGN MARKETS UNDER MKG

Prior management's focus was on securing U.S. Food and Drug Administration ("FDA") approval to distribute the BDS in the U.S. Under MKG, the Company has reoriented its energies towards generating sales in foreign markets with significant populations of women, where MKG has significant industry and government relationships, where the need for the BDS appears compelling, and where the regulatory hurdles are not as burdensome. Included among the foreign markets are China (including Hong Kong, Taiwan and Macau), India, the Philippines, Indonesia, Malaysia, Singapore, Vietnam, and other parts of Asia, Mexico, Latin America, the Caribbean, Africa, Europe, and the Middle East. The initial countries MKG are focusing on account for approximately one half of the world's female population. As articulated in the recent October 15, 2007 Time article, MKG recognized from the outset that breast cancer is no


longer an affliction which only concerns certain segments of women in the U.S. and Western Europe but is tragically a global challenge. Given the nature of the BDS, the Company believes that the BDS can play a role to help save lives in foreign countries, which for a variety of reasons may not have the detection technologies present in the U.S. and Western Europe.

Since 2007, MKG has been working with leading government, medical, distribution, and manufacturing representatives, agencies, and institutions in China, India, the Philippines and other parts of Asia to incorporate the BDS as part of early detection and awareness initiatives. Since 2007, MKG has also been working with those representatives, agencies, and institutions to manufacture the BDS device and sensors overseas; to conduct clinical trials, including joint U.S.-Asian trials; to further develop the BDS device and sensors for screening purposes; and to further develop the BDS device and sensors for cancers other than breast cancer.

Under MKG, the Company is continuing its efforts to secure U.S. FDA approval and since 2007 worked with regulatory, clinical, medical, legal and other experts towards that end. The Company believes that the government and industry relationships, the possible significant clinical data and research and development (including as it may pertain to screening and other cancers), and revenues it secures abroad will facilitate its efforts to secure U.S. FDA approval.

MKG Initiatives in Foreign Markets

Since 2007, MKG continued to meet with significant government, healthcare, distribution, and manufacturing contacts to distribute, manufacture, and develop the BDS in foreign markets. MKG strategy is to form strategic alliances, in the form of a joint venture or sublicense, with entities with significant funding, government relationships and distribution networks, especially those associated with hospital systems, regulatory expertise, and manufacturing capabilities. The joint venture assumes all responsibilities and expenses within the designated territory to distribute the BDS, secure regulatory approval for the BDS, conduct clinical trials and development, and in some cases to manufacture the BDS.

To help ongoing strategic initiatives in Asia, the Company and MKG opened an office in Hong Kong in April 2008. The office oversees and is responsible for our ongoing demonstrations and our sales, regulatory, and other strategic initiatives in Asia, including the People's Republic of China, Hong Kong, Taiwan, India, the Philippines, Japan, Indonesia, South Korea, Vietnam, Singapore, and Malaysia. The new office is located at 3412, China Merchants Tower, 168-200 Connaught Road, Sheung Wan, Hong Kong. The new office is headed by David Hong, who will head Biofield operations for all of Asia. Educated in the United States and England, Mr. Hong previously helped oversee distribution, sales and business development for Asian and multinational companies in a variety of diverse industries in the People's Republic of China, Hong Kong, Macau, Taiwan, Philippines, Thailand, Malaysia, Indonesia, Japan and the United States, serving as CEO, a board member, director for the Asian-Pacific Region, director for business development, and other capacities. He helped oversee distribution, sales, promotions, and business development in the Asian-Pacific Region for such companies as 7-Eleven, KFC, Sands, 3M, Audi, Budweiser, Citibank, J. Walter Thompson, and Nestle, among others. He was also a licensed financial controller within the insurance industry for more than 10 years, and has extensive logistic management experience. Mr. Hong is working with significant contacts within the Chinese healthcare industry, including Chinese health and other officials, hospitals, doctors, pharmaceutical and insurance companies to promote and demonstrate Biofield's technology.

China

In 2007, MKG had discussions with representatives of Chinese government, including those associated with China's state and military hospitals, about potential orders of the BDS and sensors. Chinese representatives expressed significant interest in the BDS and discussed, among other things, potential orders for Chinese hospitals; designating top Chinese medical institutions and doctors to work with the Company on additional clinical trials and R&D including joint U.S.-Chinese trials and including on screening and cancers other than breast cancer; incorporating the BDS into Chinese early detection initiatives and a cancer fund established for the indigent.


From the middle of 2007 to the first part of 2008, significant discussions occurred in Shanghai, Beijing, Hong Kong, Guangdong Province, Tianjin, Guangxi Province, Taiwan and Macau with leading Chinese healthcare bureaus, officials, medical institutions, and physicians. Successful demonstrations were conducted in Shanghai, Beijing, and Hong Kong. Several Chinese government and hospital representatives also attended the Company's well received breast cancer symposium in Manila in the fall of 2007. In March-April 2008, an initial demonstration of the BDS was successfully conducted in Shanghai at the facilities of a division of Chinese government organization which is a leading testing center in Shanghai involved with reviewing and bringing new healthcare technologies to China. Additional demonstrations are planned in Shanghai for training, studies and data collection-related purposes. The Company has received significant interest from leading Chinese entities interested in distributing the BDS in China and is evaluating each opportunity. The Company believes that orders for the BDS device and sensors will be placed in Shanghai, Beijing, Hong Kong, Guangdong Province, Guangxi Province, Taiwan and Macau commencing the fall of 2008 and is working with facilities in the United States and China to manufacture the BDS device and sensors. The Company is also working with leading Chinese representatives to secure the governmental authorization to distribute and possibly manufacture the BDS device and sensors in China.

In April-May 2008, demonstrations of the BDS were conducted in Shanghai before Shanghai Jiashen Lifecare Investment Management Company Limited (CareLife) at the Shanghai International Medical Exchange Centre, a division under the Shanghai Municipal Health Bureau (SIMEC), a leading testing center in Shanghai for new medical technologies for China. Patients with known malign and benign tumors were tested; each time BDS accurately identified the nature of the tumor. A follow-up trip was arranged to train doctors and technicians closely related to SIMEC and to begin to collect data for studies in Shanghai, China's largest city considered the heart of China's medical community.

As result of the Shanghai demonstrations, MKG has signed a memorandum of understanding (MOU) with Carelife's appointed agent, China International Medical Exchange Ltd (CIME), to form a joint venture in China with Carelife. Carelife works with the Shanghai Municipal Health Bureau and leading Chinese medical testing centers, insurance companies, financial institutions, businesses (domestic and foreign), hospitals, and doctors to provide healthcare coverage for persons referred by banks and insurance companies in China and is setting up medical centers throughout China. One of Carelife's focuses is to provide health coverage for cancer. Carelife is also setting up an electronic data collection system to collect critical medical data to help early detection. CareLife is working with insurance company and banking partners mandating at least 1 BDS test per year as part of its members' policy eligibility/renewal. The tests can be paid utilizing smartcards provided by MKG affiliate, Versa Card, Inc, which can also aid Carelife's data collection system by recording individual usage, medical history and other information. Given China's challenges with counterfeit or substandard medical technology, Carelife has also asked MKG to protect each of the BDS devices, 18 single-use sensors needed for each BDS test, and smartcards used to pay for each BDS test with a leading anti-counterfeiting technology. MKG has appointed True Product ID, Inc. (TPID) as the exclusive provider for the anti-counterfeiting solutions for the Carelife joint venture, and TPID has accepted the appointment and agrees to provide such anti-counterfeiting solutions.

The closing documents were executed at the June 16 signing ceremony covered by media in mainland China and Hong Kong for the new Chinese national healthcare JV arranged by James MacKay and MKG -- Worldwide Lifecare Limited (the Carelife JV) -- which will provide Biofield's Breast Cancer technology and other comprehensive medical technology and services in China.

The Carelife JV will open a network across China of medical clinic centers, call centers and data centers for R&D. The first medical clinic center will open in October 2008 at Carelife's China Headquarters in Shanghai. In partnership with China's National Labor Union and funded with an investment by Chinese Government and others of approximately US$363 million, the Carelife JV will open more than 500 medical clinic centers across China before 2012 at


different Labor Union centers covering 60% of China's urban population. This national network will be part of China's national healthcare program to instill best healthcare management practices and to address critical problems related to its aging population. China's top insurance companies (China Life Insurance and Ping An Insurance) and top bank, China Industrial Commercial Bank, have agreed to refer subscribers, employees, and clients to join the Carelife network.

The Carelife JV will provide Biofield's BDS technology, among others, through this national 500+ medical clinic center network. The medical clinic centers will also introduce BDS to hospitals and government-owned medical care units for China's general population. Carelife's target diagnostic penetration rate in urban China is 20% - representing at least 25 million diagnoses per year by 2012. The Carelife JV will also help arrange for the BDS device to be manufactured in China.

This National Healthcare Network will also provide its members the latest smartcard and anti-counterfeiting technology from Versa Card Inc. and True Product ID, Inc. Versa Card's medical smartcards will allow Carelife members to make membership, healthcare-related and other payments and will also provide an electronic data base for members' medical records and history. TPID's S-DNA and KMACK technology will protect members' medical smartcards as well as the medical devices, sensors and other products provided to members against the counterfeiting and substandard quality epidemic in China.

In response to the critical demand in China for quality elderly healthcare, the Carelife JV will also develop the first medical and elderly care integrated community in China. The exclusive community will be set up on a 450 acre site in Shanghai and will provide housing, a resort and a medical center for the elderly and their families in China. China looks for this project to be the model solution for its aging population which can be replicated across China. The communities will act as a gateway to introduce the latest medical technology to China and provide valuable medical information. These exclusive communities hope to attract clientele not just in China but from other parts of Asia and the world.

A lease has been signed for a new China HQ at an exclusive government owned building in Shanghai. The new China HQ will oversee and manage the Carelife JVs, which will distribute, test, further develop, and gather critical medical data from the Biofield Diagnostic System (BDS) and other medical technology in conjunction with leading Chinese governmental healthcare organizations, hospitals, testing centers, doctors, medical organizations, insurance companies, and banks.

Extensive discussions are taking place with the Chinese Ministry of Health and Chinese Food and Drug Administration to form a strategic alliance between them and MKG which would expand the distribution of the BDS device and sensors in China from the 500 Bio Centers to China's state-owned and military hospitals.

MKG has also signed a memorandum of understanding with Fame Star Investment Limited (FSIL) to form a new JV to distribute, test, further develop, and gather medical data from BDS and other medical technology in Hong Kong and Macau. With FSIL's strategic relationships within the healthcare community in Hong Kong and Macau, the new JV will work with, and distribute BDS to, leading clinical testing centers, hospitals, and medical institutions in Hong Kong and Macau to prepare a medical study and clinical trial for BDS in Hong Kong, which published results can be recognized throughout Hong Kong, Macau and elsewhere.

On June 23, 2008, the Company reported that world renown biotech expert and entrepreneur, Dr. Dominic Lam, has accepted its Board's invitation to become its new chairman. Dr. Lam takes over for James MacKay, who will remain on the Board. Dr. Lam's achievements have been recognized at the highest levels in China and the United States. Dr. Lam has received the Presidential Medal of Merit from President Bush who also appointed him to a Presidential Committee in 1989. Dr. Lam obtained his bachelor, masters and doctorate degrees by the age of 22, studied under two Nobel Laureates at Harvard Medical School before joining the Harvard Faculty at Harvard and subsequently at Texas Medical Center in Houston. In 1985, he started the first biotech company in Texas, took it public in 1988 and was widely recognized as the Father of Texas Biotechnology. In 1989, he was invited to establish the Hong Kong


Institute of Biotechnology to help Hong Kong's high tech development. In 1993, Dr. Lam founded LifeTech Group to develop, manufacture and market the best Eastern and Western healthcare products. Dr. Lam is also a well-known philanthropist who first brought "Project Orbis", the flying eye hospital, to China in 1982. To pursue his charitable mission, Dr. Lam moved back to Hong Kong in 1999 and founded the World Eye Organization to prevent and treat eye diseases for the poor, initially in China and subsequently around the world. Dr. Lam has authored over 100 research articles, some of them in prestigious journals such as Nature, 6 books published by MIT and holds over 17 U.S. and international patents. In 2001, one of Dr. Lam's patents entitled "Edible Vaccines" was named by MIT as one of "five patents that will transform business and technology" and by Time Magazine as one of ten most important developments in the 21st century. Dr. Lam has received numerous honors and awards, including honorary professor at the Chinese Academy of Science (1985), the US High Tech Entrepreneur of the Year
(1989) and Asian Society Man of the Year (1991).

According to the U.N., there are over 172 million women in mainland China, Hong Kong, and Macau ages 40-70 years old. According to the International Agency for Research on Cancer, the breast cancer incidence rate in China is 18.7 per 100,000.

India

Since 2007, MKG has had discussions with hospital, medical and distribution representatives from India, including those associated with certain national, regional and municipal government entities and leading hospital systems and distribution networks in India, about the distribution of the BDS in India. Following the successful demonstration of the BDS at the October 24, 2007 major breast cancer detection symposium in Manila, which was attended by leading Indian representatives, there was significant interest from Indian representatives about potential significant orders and about distributing and securing regulatory approval for the BDS in India and other countries in the Indian subcontinent including Nepal and Bangladesh. The Company expects to conclude a distribution arrangement in India in 2008 and to generate purchase orders for 2009.

According to the U.N., there are over 103 million women in India ages 40-70 years old. According to the International Agency for Research on Cancer, the breast cancer incidence rate in India is 19.1 per 100,000.

The Philippines, Indonesia and Malaysia

In 2007, MKG had repeated meetings with, and have conducted demonstrations for, significant government, church, healthcare, and distribution representatives in the Philippines. On March 8, 2007, MKG delivered a BDS device and three cases of sensors to a hospital in the Philippines. The hospital has started to take the unit to the provinces as part of their mobile health systems services. MKG believes that the Filipino Government and the Catholic Church in the Philippines will publicly endorse the BDS as part of national initiatives promoting early detection of breast cancer. In 2007 certain bills were introduced before the Filipino Congress (S.B. No. 78, The Breast Cancer Detection Act of 2007, and S.B. 1815, an Act Creating a Center for Breast Cancer Control and Prevention), which would require local government units to conduct a quarterly breast cancer detection program and would establish the Center for Breast Cancer Control and Prevention.

In October 2007, MKG formed a joint venture with Eastern Petroleum Corporation, one of the leading business and petroleum companies in the Philippines. The joint venture is called the MacKay Eastern Medical Group ("MacKay Eastern") and will bear the exclusive responsibility and expense to distribute, market, gain regulatory approval for, and further develop the BDS and related technologies in the Philippines, Indonesia and Malaysia. In October 2007, an initial order of 10 devices and 20 cases of sensors was sold and delivered to the joint venture.

On October 24, 2007, the joint venture presented the BDS at a major breast cancer detection symposium in Manila attended by approximately 200 guests, including representatives from 100 of the top hospitals and medical institutions in the Philippines and government and industry representatives from the Philippines, China and India.


Following the successful demonstration of the BDS at the October 24, 2007 major breast cancer detection symposium in Manila, discussions are taking place about potential significant orders to be delivered in 2008.

In late 2007 through the middle of 2008, MacKay Eastern began launching and conducting demonstrations and testing of the BDS device and sensors in parts of the Philippines. In December 2007, MacKay Eastern launched the BDS device and sensors in General Santos City. In 2007, it also began working with certain hospitals and clinics in the Philippines. In 2007, it also began setting up centers in shopping malls where there was significant consumer traffic. The ideal for these centers was that Filipinos could readily receive the 20 minute Biofield Breast Examination while they attended to their routine purchases. Since late 2007, MacKay Eastern has worked closely with leading national and city representatives regarding government initiatives to provide breast cancer detection for government employees.

The Company anticipates receiving purchase orders for the BDS devices and sensors in 2008, including from representatives associated with national, city, and municipal Filipino government, including the Congress of the Philippines. These potential purchase orders would be associated with the possible enactment of the new breast cancer detection legislation and national initiatives discussed above by the Congress of the Philippines, which believes that the Company and its technology can play a significant role in the national initiatives.

According to the U.N., there are over 22.45, 8.5, and 3 million women ages 40-70 years old in Indonesia, the Philippines and Malaysia respectively. According to the International Agency for Research on Cancer, the breast cancer incidence rate in Indonesia, the Philippines, and Malaysia.

Mexico

In January 2007, on behalf of the Company, certain representatives successfully conducted patient demonstrations and seminars of the BDS in Mexico City before more than 50 OB/GYN and other physicians, nurses, officials, and representatives from leading hospitals, clinics, laboratories, pharmaceutical companies, and other health providers based in Mexico and other countries in Latin America. The demonstrations and seminars were conducted by a noted physician in Mexico City on female patients with pre-confirmed malignant and benign tumors. Biofield's device tested successfully in the patient demonstrations, generating substantial interest among Mexican OBY/GYN and healthcare communities. The purpose of the demonstrations and seminars was to introduce Biofield's technology to leading opinion makers in the Mexican healthcare community and to seek to secure purchase orders for the device and sensors. Subsequent meetings and discussions have taken place with leading hospitals, clinics, physicians, and other opinion leaders in Mexico, many of which also have clinics, stores, or other facilities in other Latin American countries. Presentations of Biofield's technology were also made on Mexican TV. (See Company's press release dated February 23, 2007, a copy of which is available online at www.biofield.com.)

Continued discussions have taken place with the Mexican representatives who conducted the Mexico City demonstration (as well as with other representatives). Discussions have taken place about sublicensing the BDS for Mexico and Spanish-speaking countries in Latin America, purchase orders for the BDS devices and sensors and securing regulatory approval and establishing manufacturing facilities for the BDS in Mexico. Significant interest has been generated from Mexico. MKG has been discussing sublicense arrangements with certain Mexican representatives who were proceeding to secure the necessary funding to conduct manufacturing, distribution and regulatory approval in Mexico.

According to the U.N., there are over 11.6 million women ages 40-70 years old in Mexico. According to the International Agency for Research on Cancer, the breast cancer incidence rate in Mexico is 26.4 per 100,000 respectively.


The Singapore Sale
On February 28, 2007, Biofield sold a BDS device and three cases of sensors to leading distributor in Singapore. The gross proceeds totaled $24,950. The distributor is an industry leader in Singapore in biomedical engineering, which serves all the major medical centers and hospitals in Singapore. The end user is a nationally and internationally acclaimed institution in Singapore, which is recognized as an innovator for cutting edge technologies, including those in the biomedical science industry and medical device field, and for its commitment to public and community service. The sale was the result of a tender which was awarded to the Company. In addition to using the BDS for diagnostic purposes, the end user is conducting significant research which may impact the use of the BDS for screening purposes. The distributor believes its clients may be interested in buying the BDS devices and sensors. (See Company's press release dated February 28, 2007, a copy of which is available online at www.biofield.com.)

According to the U.N., there are over 645,000 women ages 40-70 years old in Singapore.

Other Foreign Markets

Since 2007, MKG has had discussions with representatives in other foreign countries concerning South Africa, Japan, and other countries in the Middle East and Africa. The Company under prior management presented the BDS to leading government, hospital, and medical representatives from South Africa, including First Lady Mbeki. During the same trip, the Company met with leading government representatives from Botswana. Significant interest was received including interest about transporting the BDS through mobile van units. There are currently several BDS devices in South Africa. The Company has also conducted demonstrations for leading Japanese representatives. One of the Company's prior clinical trials took place in Japan. Discussions have also taken place about distributing the BDS in Middle Eastern countries such as Iraq, Saudi Arabia, United Arab Emirates, Kuwait, Jordan, and Lebanon. According to the U.N., there are over 5.1 and 25 million women ages 40-70 years old in South Africa and Japan respectively. According to the International Agency for Research on Cancer, the breast cancer incidence rate in South Africa and Japan is 35 and 32.7 per 100,000 respectively.

The Company also has had discussions with significant entities interested in distributing and possibly manufacturing the BDS device and sensors in Europe. Many of the Company's clinical trials occurred in Europe and were conducted by and at some of the leading breast cancer experts and institutions in Europe. According to the European Network of Cancer Registries, breast cancer is also the most common cancer in females in Europe. It is estimated that in the year 2000 there were 350,000 new breast cancer cases in Europe, while the number of deaths from breast cancer was estimated at 130,000. Breast cancer is responsible for 26.5% of all new cancer cases among women in Europe, and 17.5% of cancer deaths.

THE MKG MASTER LICENSE

As reported in and attached to its Form 8-K filed July 31, 2007 available online at http://www.sec.gov/
Archives/edgar/data/1007018/000112178107000222/0001121781-07-000222-index.htm, which the reader is urged to read in its entirety, on July 27, 2007, the Company signed a master license agreement (the "Agreement") with MKG. Pursuant to the . . .

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