Corporate Review and Global Analysis
REVOLUTIONARY MEDICAL DIAGNOSTICS SYSTEM
THE WORLD DESPERATELY NEEDS A BETTER WAY TO TEST FOR INFECTIOUS DISEASE
THE BILL AND MELINDA GATES FOUNDATION HAS DONATED $30 MILLION TO HELP DEVELOP BETTER DIAGNOSTICS TESTS
Founded in March of 1997, a Nevada corporation, located in Orangevale, California has raised $4,957,840to date. These funds have been used for research, design and preliminary development of the High Throughput Screening - Magnetic Testing Platform (HTS - MTP) and corresponding immunoassays. The Company was issued its first patent (SYSTEM AND METHOD FOR BIOCHEMICAL ASSAY) on July 15, 2003. A second patent was issued on May 2, 2006 (SYSTEM AND METHOD FOR BIOCHEMICAL ASSAY). We have subsequently filed for additional PATENT
protection that continues to broaden the scope of our system. The
Company has also applied for a patent, for a new diagnostic system
designed for multi-analyte testing for blood banks titled "SYSTEM AND METHOD FOR DETECTING SPECIFIC BINDING REACTIONS USING MAGNETIC LABELS".
The Company has transitioned from a research stage to a developmental
entity and is positioning itself to perform clinical trials in Mexico,
Thailand, India and China in the fourth quarter of 2008 followed by
trials in the US and Europe. The Company will develop an ongoing
strategic portfolio of patents for a diverse range of bacterial and
viral assays for specific use with the Company's revolutionary
The first product being developed is the HTS-MTP and it is expected that Beta testing will begin in the third quarter of 2008. This will establish our identity as a leading edge developer of high technology immuno-diagnostics. All initial products from Biomagnetics Diagnostics Corp. are being developed on the Company's proprietary (patented) technology and will detect the target pathogen (viral or bacterial) by measuring the magnetic moment of a single super-paramagnetic microsphere or the magnetic field of a single paramagnetic microsphere bonded to each target molecule.
To Simplify, we detect the virus not the antibodies(depending on the virus and individual it can take up to 3 months for the body to build up enough antibodies to be detectable). We also provide qualitative (screening test) results, confirmatory results and quantitative (viral load) results in a single immunoassay. The HTS-MTP can perform these tests using any body fluid, e.g. saliva, urine, semen, hormonal fluid, spinal fluid, tear drops, etc.
Markets and Sales
The Company defines its markets for the first line of products as public and private laboratories and blood banks. According to Frost & Sullivan the global size of the "Medical Device Market" exceeds $200 billion and the U.S. retail market exceeds $56 billion.
The company has partnered with the largest social institute in Latin America, Instituto Mexicana del Seguro Social ("IMSS"), to conduct clinical trials in Mexico. The company has been assigned to Dr. Jose Dante Amato Martinez with IMSS who will be the company's coordinator, and has agreed to jointly conduct research, develop protocols and perform clinical trials to validate the company's HTS-MTP technology, leading to the commercialization of the company's products in Mexico. Amato has already introduced the company to leading IMSS doctors across Mexico that will be heading the project and developing the necessary protocols.
The company has entered into an agreement with Bangkok RIA (BRIA) Group, a laboratory, manufacturer and distributor of diagnostic services and products in Thailand. BRIA will obtain all government approvals required to commercialize the company's products as well as distribute in Thailand.
The company has signed a letter of intent with Tianjin Automatic Science & Instrument Co., Ltd. (Auto Science www.autoscience-tj.com
) to manufacture/assemble the HTS-MTP in Tianjin, China. If feasible, the company will have the rights to purchase a minority interest (up to 49%) at a price to be negotiated. Auto Science is a manufacturer of laboratory equipment in Tianjin with 2400 distributors and 10,000 laboratory customers. Auto Science will manufacture and distribute our products throughout China.
The company is completing its due diligence on Shanghai Jing Ying Biotechnology Co., Ltd, a Chinese government owned biotechnology, immunoassay Development Company, to develop the company's immunoassays and perform clinical trials with the PLA Hospital 304, known for its burn trauma center and its infectious disease department as well as 3-4 other clinics. These trials will be under the supervision of Dr. Chen and Li Jian Ling, Director and General Manager of Shanghai Jing Ying Biotechnology Co., Ltd.
Clayton M. Hardman, Founder & CEO:
Mr. Hardman has held several executive-level positions during his business career. He has served as CEO of Woodbridge Capital Group Inc., CEO of Communicationscom, Inc, and President of the Board of Panamerican Enterprises, S.A. de C.V. In addition to leading these businesses and boards, Mr. Hardman also has a successful career as an innovative inventor, with two patents issued and two others pending. Mr. Hardman retired from Naval Special Warfare, (after 17 years of active duty and 13 years in the naval reserves) as a "Navy SEAL".
Sanjay Mishra, Ph.D., Physics, Advisor
To advise the Company on matters of Physics in Thin Film Spectroscopy is Sanjay Mishra, Ph.D. He received his Masters of Science in Physics from Pittsburgh State University, Pittsburgh, Kansas, and his Ph.D. in Physics from the University of Missouri in Rolla, Missouri. Dr. Mishra participated in the design and implementation of electron spin polarization detectors at the Advance Light Source facility, Lawrence Berkeley National Laboratory completing his third year of postdoctoral research. He currently holds the position of Associate Professor, Dept. of Physics, University of Tennessee, Memphis.
Kuldip Sra, Ph.D., Chemistry, Advisor
To advise the Company on matters of analytical assay development and drug discovery using chemical combinatorial peptide libraries synthesis methods is Kuldip Sra, Ph.D. Previously he was engaged in immunodiagnostics development with Chiron Corporation in Emeryville, California where he served as lead scientist in the development of RIBA(TM) Assays for infectious diseases. Dr. Sra has also distinguished himself as a Senior Protein Chemist at Sangstat Medical Department of Protein Chemistry in Menlo Park, California, where he designed and developed point of care, one step assays for HIV-1/HIV-2, HTLV-I/II and CMV to include clinical trial and protocols on HTLV-I/II tests. He received a Master of Science degree from Punjab University in India, in Organic Chemistry, a Master of Science degree and a Ph.D. in Biochemistry from Seton Hall University in So. Orange, New Jersey.
Jaspal Singh Mahal, MS, Microbiology, Advisor
To advise the Company on matters of Microbiology Jaspal Mahal's education includes a Masters of Science in Microbiology with a minor in Biochemistry and Immunology. Mr. Mahal left his position as a research chemist with Boehringer-Mannheim Corporation in the development of homogeneous enzyme assays for the medical diagnostic industry using CEDIA technology to come to work with Bio-Spectrum. His work accomplishments include the development of a novel confirmation assay for drugs of abuse, antibody screening and evaluation for immunoassays, and protein/antibody purification and conjugation.
Dr. Hai Shiene Chen, China Advisor
Dr. Chen was educated at the Second Military Medical University, Shanghai, China. He received his Medical Degree in 1983, graduating in the top 2% of his class. Between 1986 and 1988, Dr. Chen trained at Harvard Medical School in the field of cancer research. In 1990, Dr. Chen obtained a M.Sc. Degree from the University of Toronto and while there, directed a research project on HIV. From 1991 to 1996, Dr. Chen was Managing Director for the Canadian Genetic Disease Network's Core Facility. In 1995, Dr. Chen founded ACGT Corporation, which in four short years has become a leader in Canada's DNA industry.
Ninlawan (Pichayayothin) Petcharaburanin, Ph.D.
President/CEO and founder of Bangkok R.I.A. (BRIA) Group the largest privately owned laboratory in Thailand. BRIA was founded in 1989 to provide medical services laboratory diagnostics services to hospitals, clinics and other medical care units. Dr. Pichayayothin currently hold the position of Vice Chairman "The Federation of Thai Industry - Chairman Biotechnology Development".