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Investors
are cautioned that certain statements contained in this document as
well as some statements in periodic press releases and some oral statements
of Nanobac Life Sciences, Inc. officials are "Forward-Looking Statements"
within the meaning of the Private Securities Litigation Reform Act of
1995 (the "Act"). Forward-Looking statements include statements
which are predictive in nature, which depend upon or refer to future
events or conditions, which include words such as "believes,"
"anticipates," "intends," "plans," "expects,"
and similar expressions. In addition, any statements concerning future
financial performance (including future revenues, earnings or growth
rates), ongoing business strategies or prospects, and possible future
Nanobac Life Sciences, Inc. actions, which may be provided by management,
are also forward-looking statements as defined by the Act. Forward-Looking
statements involve known and unknown risks, uncertainties, and other
factors which may cause the actual results, performance or achievements
of the Company to materially differ from any future results, performance
or achievements expressed or implied by such forward-looking statements
and to vary significantly from reporting period to reporting period.
Although management believes that the assumptions will, in fact, prove
to be correct or that actual future results will not be different from
the expectations expressed in this report. These statements are not
guarantees of future performance and Nanobac Life Sciences, Inc. has
no specific intention to update these statements.
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About Nanobac Life Sciences
Nanobac Life Sciences, Inc. is dedicated to improving people�s health through the detection and eradication of Nanobacterium sanguineum (Nanobacteria). The Company�s pioneering research is establishing the pathogenic role of Nanobacteria in calcification, particularly in coronary artery heart disease and vascular disease. Nanobac has identified two biomarkers of nanobacterial infection, and expects to file for FDA approval of its NB2� ELISA assays to detect nanobacterial antigen and IgG antibody. It is also leveraging its proprietary knowledge and intellectual property to develop the first FDA approved therapeutic to treat nanobacterial infection. The Company currently markets a patented nanobiotic regimen. For further information concerning our nanobiotic, please visit www.nanobacsciences.com.
Nanobac Life Sciences, Inc. is headquartered in Tampa, st1:State>Florida. For more information, please visit our website at: www.nanobaclifesciences.com.
2003 Press Releases
Nanobac Pharmaceuticals, Inc. announces New Patent for Nanobacteria Eradication and Therapeutics
TAMPA, Fla. (December 2, 2003) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) (�Nanobac� or �The Company�) announced the allowance of a third patent associated with the detection, treatment and eradication of Nanobacterial infection and contamination. The patent covers methods of disinfecting articles infected with Nanobacteria, and methods of treating patients infected with Nanobacteria.
�The allowance of this patent under our research and development division, Nanobac OY, completes our intellectual property matrix and will allow us to aggressively pursue business development strategies,� said John Stanton, Chairman and CEO. �In combination with the Company�s other patents we are now positioned as a preeminent Nanotechnology Bio / Life Sciences company.�
The Company already has patent protection with respect to the identification of the pathogen Nanobacteria, as well as, specific culture and detection methodology. These methodologies are specific to Nanobacteria which cannot be cultured using standard microbiological media.
Although the company possesses intellectual property with both industrial and healthcare implications, the company will focus initially on healthcare. This focus will include the further development of its NB2 clinical assay for the detection of Nanobacterial infection in human serum, and combination therapies for the treatment of Nanobacterial infections.
�The implication for a new risk metric associated with heart disease, polycystic kidney disease, adenocarcinoma, with microcalcification or any other pathological calcification is our goal.� commented Stanton. �The company is positioned to continue therapeutic developments that have the potential to treat the root cause of many degenerative diseases.�
Nanobac Pharmaceuticals, Inc. announces the Much Anticipated Release of Has Heart Disease Been Cured?
TAMPA, Fla. (November 25, 2003) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) (�Nanobac� or �The Company�) announced today that the book described in its September 15, 2003 press release, Has Heart Disease Been Cured?, an independent publication by the Writers� Collective, has been published. The book, authored by Douglas Mulhall and Katja Hansen, presents significant information about the company�s technology and the future of Nanobacteria research and development.
The following is reprinted with permission from the Writers� Collective:
NEWS ADVISORY FROM THE WRITERS� COLLECTIVE PUBLISHERS EMBARGOED UNTIL NOVEMBER 20, 2003 �HAS HEART DISEASE BEEN CURED?�
What may be the most revolutionizing discovery in the history of heart disease treatment is chronicled in a new book, Has Heart Disease Been Cured? by acclaimed science journalist Douglas Mulhall and biological engineer co-author Katja Hansen.
The Foreword is written by one of America�s leading conservative cardiologists, Dr. Benedict S. Maniscalco, founder of St. Joseph�s Hospital Heart Institute.
Doctors have long suspected that infection plays a role in heart disease, but while many germs are known to accompany it, treating them did not halt the illness. Until now. Researchers have since identified a �stealth� infection and developed a compound of surprisingly well-known drugs that gradually get rid of it.
The sub-microscopic invader was discovered in 1985, but only isolated in heart disease in 1999. That finding was just published in 2002. A treatment was developed and has been prescribed to thousands of seriously ill patients since 2001 by physicians across the United States, with encouraging results.
�The most persistent question about this book,� explains publisher Lisa Grant, �will undoubtedly be� why didn�t we hear about the discovery earlier?�
�Here�s a clue. According to the Center for Disease Control, for years the medical community was slow to acknowledge that in the 1980�s bacteria were found to be responsible for most stomach ulcers. Until the mid-1990�s, surgeons continued operating on patients unnecessarily, despite the existence of a known drug treatment.�
�This book warns that we risk repeating history if an infection of such deep importance for heart disease is given low priority.�
The thoroughly annotated work is written in plain language for lay readers. It contains a glossary of technical terms, along with illustrations, a chronology of related discoveries, and a �who�s who� of participants in the breakthrough. These are additional to the customary bibliography, endnotes, and index.
The book has already been featured on syndicated radio talk shows, and will be introduced at a Special Presentation sponsored by community health authorities and the Palm Beach County Library System in Palm Beach Florida in early December.
Has Heart Disease Been Cured? (Writers� Collective, 2003) Douglas Mulhall and Katja Hansen Foreword by Benedict S. Manicalco, M.D., F.A.C.C. ISBN 1-932133-73-9 288 pages, Trade Paperback, Illustrations, Index, Bibliography, Endnotes, Glossary
Publishing date: November 21, 2003
Douglas Mulhall�s previous work Our Molecular Future: How Nanotechnology, Robotics, Genetics and Artificial Intelligence Will Transform our World was selected by New Scientist for the magazine�s �must read� list, praised by the American Library Association as an �Outstanding Academic Title,� and put on the �recommended� lists of several national booksellers. International media such as Financial Times Publications, NewsDay, The Futurist, Futures Research Quarterly, and National Post have published his articles. For years, he and Katja Hansen managed scientific research on eliminating water-borne infections.
To order a reviewers copy or arrange an interview with authors:
Fritz Stork 21st Century Eloquence, Distributors email: Stork@calcify.com Tel. 1-800-245-2133
To contact the publisher:
Lisa Grant, Publisher The Writers� Collective, Cranston Rhode Island, www.writerscollective.org Email: lgrant@writerscollective.org
For more information about the topic, and to order the book, log onto www.calcify.com
Nanobac Pharmaceuticals, Inc. announces Scientists Discover Nanobacterium in Ovarian Cancer Patients
TAMPA, Fla. (November 24, 2003) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) (�Nanobac� or �The Company�). Austrian Scientists from University Hospital in Vienna, utilizing diagnostics developed and provided by Nanobac OY, reported finding Nanobacterium in Ovarian cancer patients. The discovery was published in the APMIS (Acta Pathologica, Microbiologica et Immunologica Scandinavica) Journal; APMIS 111: 951-4, 2003. This study investigated whether nanobacteria are associated with microcalcifications (i.e., psammoma bodies) found in ovarian cancers. Positive nanobacterial results were found in all 7 microcalcificed specimens by immunohistochemical staining, transmission electron microscopy, ELISA, and infrared spectroscopy. Control cases of ovarian adenocarcinomas without microcalcifications were negative for Nanobacteria. The scientists concluded that Nanobacterial infection may be of clinical importance as these bacteria are related to microcalcifications in ovarian cancer.
�Because Nanobacteria are the only known self replicating crystallizing molecule, and a significant percentage of degenerative human diseases involve pathological calcifications, these findings represent significant validation of our company�s intellectual property,� said John Stanton, Chairman and CEO. �Further, we are on a path to rapidly explore all research, development and collaborative opportunities involving Nanobacteria science.�
Nanobac OY is the Research and Development arm of the Company and is located in Kuopio, Finland. The discovery of Nanobacteria was originally documented and patented by Dr.�s Olavi Kajander and Neva Ciftcioglu, the Founders of Nanobac OY. Nanobac OY provides the principal scientific research support and diagnostic technology segment of Nanobac.
Nanobac is a leader in the research of diagnosis and treatment of degenerative diseases stemming from nanobacterial infections. This infection is implicated in the formation of disease-causing calcification and plaque in the circulatory system and vital organs. Nanobac markets diagnostics and prescription nanobiotic medications demonstrated to safely and effectively treat an underlying cause of atherosclerosis, coronary heart disease and other degenerative diseases.
Nanobac Pharmaceuticals, Inc. Announces Two New Nanobacterial Research Studies with Stephen E. Epstein, MD, Director of the Cardiovascular Research Institute at Washington Hospital Center, Washington, DC
TAMPA, Fla. (Oct. 21, 2003) - Nanobac Pharmaceuticals, Inc. (OTCPK: NNBP), announces two new epidemiological research studies on Nanobacteria with Stephen E. Epstein, MD, Director of the Cardiovascular Research Institute, Washington Hospital Center, Washington, D.C. Both studies will be conducted by the Principal Investigators Stephen E. Epstein, MD and E. Olavi Kajander, MD, PhD.
One study, entitle �Nanobacterial Epidemiology, Inflammation & Coronary Artery Disease Risk� is designed to evaluate the hypotheses that Antibodies and/or Antigens to Nanobacteria are associated with; A) chronic inflammation, B) are present more frequently in patients with documented (by coronary angiography) coronary artery disease than in patients with normal coronary arteries and C) when considered singularly and in conjunction with positive responses to six other pathogens, the odds ratio of predicting coronary artery disease is increased.
The second study, entitled �Nanobacterial Epidemiology, Inflammatory Markers and Coronary Artery Calcification in Asymptomatic Presumed Normal Patients� is designed to evaluate the hypotheses that Antibodies and/or Antigens to Nanobacteria are; A) associated with Coronary Artery Calcification Scores [by Electron Beam Computed Tomography (EBCT)] in a group of �normal� individuals, B) are associated with elevated inflammatory markers and C) when considered individually and in conjunction with positive responses to six other pathogens and inflammatory markers, the odds ratio of predicting Coronary Artery Calcification is increased.
Dr. Stephen E. Epstein has already analyzed extensively this group of patients for six pathogens, inflammatory markers and other markers of coronary artery disease risk- factors such as age, male sex, smoking, diabetes, cholesterol, hypertension and has published his pioneering research in multiple journals (ie: Circulation; Circulation Research; Atherosclerosis, Thrombosis & Vascular Biology) and is well established as one of the pre-eminent researchers of the coronary artery disease, inflammation in atherosclerosis, cardiovascular inflammation and cardiovascular risk factors. Dr. Epstein was formerly the head of the Cardiology Branch of the National Heart, Lung and Blood Institute.
Dr. E. Olavi Kajander is the discoverer of Nanobacteria and is the Director of Scientific Research at the NanobacLabs Research Institute (Tampa, Florida) and Nanobac OY (Kuopio, Finland). NanobacLabs Research Institute and Nanobac OY are subsidiaries of Nanobac Pharmaceuticals, Inc. Dr. Kajander is the developer of Nanobac�s NanobacTEST-S� blood test for Nanobacteria which will be used in the studies to detect Nanobacterial Antigen and Antibodies in Dr. Epstein�s group of patients. Having authored over 90 scientific research papers, Dr. Kajander is well-established as the world expert on Nanobacteria and Nanobacterial infectious diseases.
The ultimate purpose of the above studies is to formally establish Nanobacterial infection as a risk factor for the development of atherosclerosis and coronary heart disease as well as to quantify Nanobacterial Antigen and Antibody relationships with other established cardiovascular disease risk factors. It is Nanobac�s theory that the calcification in coronary artery plaque is actually an active manifestation of calcified Nanobacterial infection within atherosclerotic plaques that results in coronary artery disease. Nanobacteria have been isolated and cultured from atherosclerotic plaques and have the unique ability to cause tissue calcification and inflammation in those calcified tissues.
If the Nanobac theory is correct, their NanobacTEST-S� blood test for Nanobacterial Antigen and Antibodies may serve as another tool for physicians in evaluating patients� cardiovascular risk status. Moreover, if Nanobacterial infection is shown in coronary heart disease patients, Nanobac�s studies have shown that their nanobiotic prescription, NanobacTX�, may be able to decrease the severity of atherosclerotic cardiovascular disease of the incidence of death from the coronary artery disease.
The Studies with Drs. Epstein and Kajander will encompass a minimum of 450 patients and are designed to conclude in several months. �We are very excited about this research project with NanobacLabs. If Nanobac�s theories prove to be correct, the implications could have a far-reaching impact in the diagnosis and treatment of heart disease�, said Dr. Epstein.
Nanobac Pharmaceuticals, Inc. is the leader in nanobacterial infectious disease research and development, and owns the proprietary methods for detection and treatment of nanobacterial infections. The Company�s nanobacterial diagnostics and prescription nanobiotic medications, demonstrated to safely and effectively treat nanobacterial infections in coronary artery heart disease and vascular disease, are available to qualified physicians.
A Message to Shareholders and Other Interested Parties Nanobac Pharmaceuticals, Inc.
During the last four months, the company has embarked on a course that places it at the forefront of one of the most intriguing medical discovery adventures in history.
Through the acquisition of NanobacLabs Pharmaceuticals, Inc. (�NanobacLabs�) the company has become a leader in �the hunt� for the cause and cure of infectious diseases associated with calcification and plaque. The discovery, diagnosis, and cure of Nanobacteria and associated diseases, at a philosophical level, is a great detective story. The company will now focus its efforts entirely on initiatives associated with Nanobacteria.
Because of the decision to focus on Nanobacteria, the company has decided to sell or �spin-off� its Healthcentrics, Inc. subsidiary. In addition, earlier plans to develop multiple initiatives in healthcare, building products, and waste solutions will not be pursued. The company believes that a total focus on Nanobacteria will maximize shareholder value.
The company is actively searching for the right team to realize its promise. Our research scientists have dedicated most of their lives to develop the science and medicine to this point. We plan to install a first class business and advisory team to implement our business plan.
Our primary business in both the short and long term is the development and implementation of nanobacterial technologies. To this end we have defined very specific short term objectives for both our diagnostics (NanobacTEST-S� and NanobacTEST-U/A�) and nanobiotic technologies (NanobacTX� and UroBac�).
Diagnostics (NanobacTEST-S� and NanobacTEST-U/A�): We have brought on board expertise in assay development and validation. We are finishing the appropriate protocols and standard controls associated with a clinical assay, and we are taking the appropriate steps with regard to quality and reproducibility of the assay. Our short term goal is to capitalize on the outstanding work done by Drs. Kajander and Ciftcioglu at Nanobac OY to create highly reliable clinical assays for nanobacterial infections. Our long term goal is to create a valuable metric for physicians treating patients with any number of implications for nanobacterial infection.
Nanobiotic therapeutics (NanobacTX�, UroBac� and others): We have sold, and continue to sell, NanobacTX� under the compounding pharmaceutical triad for clinical research. This approach has proven tremendously successful and has made this revolutionary new Nanobiotic available to thousands of patients with heart disease. While we remain committed to this approach, we have engaged an FDA law firm in Washington, DC to consult with us on our strategy with regards to the FDA. This strategy is evolving very quickly and we anticipate being in discussions with the FDA very soon, with a new drug application filed by the company when appropriate. Our long term goal is to follow this same process for multiple indications with the next potential indication being Urobac�.
Further, as a consolidated Nanobac Pharmaceutical we have multiple business units in both the operating and research areas. One of our main critical pathways for the calendar forth quarter is to combine, streamline, or discharge our business units.
We will consolidate all of the Nanobac entities (excluding Nanobac OY) into one entity. This combined streamlined organization will be responsible for finishing the current development of our therapeutic and diagnostic, as well as setting the direction for our short and long term clinical studies.
John Stanton,
Chairman/CEO
Nanobac Pharmaceuticals Announces New Research Study Evaluating Nanobacterial Endotoxin in Patients Undergoing Coronary Artery Angioplasty
TAMPA, Fla. (Sept. 23, 2003) - Nanobac Pharmaceuticals, Inc. (OTCPK: NNBP), announces approval of their Percutaneous Coronary Intervention (PCI) angioplasty research protocol by the Western Independent Review Board (WIRB�, Seattle, WA). The Multi-Center PCI Study will be coordinated by the NanobacLabs Research Institute (Tampa, FL), the research subsidiary of Nanobac Pharmaceuticals, Inc., and will involve cardiologists at the University of Florida at Jacksonville, and Miami Heart Center.
The PCI study is being conducted to evaluate the presence of nanobacterial endotoxin, antigen and antibodies in patients undergoing cardiac catheterization and coronary artery angioplasty intervention. Coronary Angioplasty (PCI) involves the use of a coronary artery catheter with a balloon device. When an angioplasty catheter balloon is expanded in the coronary artery, it compresses coronary artery plaque. The purpose of the angioplasty procedure is to improve blood flow through the affected coronary artery. Calcification has been shown in other studies to comprise approximately 20% of coronary artery plaque volume. It is Nanobac�s theory that the calcification in coronary artery plaque is actually calcified Nanobacterial infection within the plaque. Nanobacteria have been isolated and cultured from atherosclerotic plaque and have the unique capacity to cause calcification and inflammation in tissues.
Nanobac researchers want to answer: Does the coronary angioplasty balloon smash calcified Nanobacteria dwelling in coronary plaque? Does angioplasty cause a release of Nanobacterial endotoxin leading to inflammation and swelling in the operated coronary artery?
By testing blood samples for Nanobacteria before, during and after PCI angioplasty, Nanobac hopes to answer these questions. If the Nanobac theory is correct, nanobiotic� treatment before coronary intervention procedures may be able to decrease the incidence of restenosis (early closure) of coronary arteries after PCI angioplasty and/or coronary stent placement. The Study will encompass 200 patients and is designed to conclude in several months.
Researchers Describe Links between Nanobacterial Infections, Dental Plaque, Periodontal Disease and Peripheral Arterial Vascular Disease
TAMPA, Fla. (Sept. 19, 2003) - In a letter to the editor of the American Heart Associaton�s Circulation magazine, researchers from Nanobac Oy, a research group in Kuopio, Finland and subsidiary of Nanobac Pharmaceuticals, Inc. (OTCPK: NNBP), announced that their findings show an association between nanobacterial infection, dental plaque and periodontal disease.
Nanobac OY scientists, Neva Ciftcioglu, Ph.D. and E. Olavi Kajander, M.D., Ph.D., with David S. McKay, Ph.D. at NASA Johnson Space Center, Houston, Texas, described their findings in a letter in the August 26, 2003 issue. Their letter was in response to a study by Harvard public health epidemiologists, Hung, Willet, Merchant, et al published in an earlier issue of the magazine. The Harvard Study showed a relationship between periodontal disease and the development of peripheral arterial vascular disease. In response, the Harvard epidemiologists agreed that the association of nanobacterial infections, dental plaque, periodontal disease and peripheral arterial vascular disease is worthy of further study.
Nanobacteria, through infection of human tissues, have the unique ability to cause both calcification deposits and inflammation inside infected tissues. They have been shown in multiple, previously published studies to be present in dental plaque, periodontal plaque, coronary artery plaque, aortic plaque, kidney stones, gallstones and in other tissues.
Reprints of the article, �Association between Nanobacteria and Periodontal Disease�, Circulation, Volume 108, No 8, August 26, 2003, e58-e59, may be obtained online from the American Heart Association at www.circulation.com.
Nanobac Pharmaceuticals, Inc. Announces Publication
TAMPA, Fla.--(BUSINESS WIRE)--Sept. 15, 2003--Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) announced today that an upcoming independent book chronicles the discoveries of an infectious trigger for heart disease and drugs known as "nanobiotics" to treat it. In plain language, the book shows how the discoveries occurred and why finding this trigger took so many years. Has Heart Disease Been Cured? has its Foreword contributed by one of America's leading cardiologists. Galleys are available from the publisher now. Contact Fritz Stork, 1-800-245-2133 or stork@calcify.com . More information: www.calcify.com. Has Heart Disease Been Cured? by Douglas Mulhall, Katja Hansen, Foreword by Benedict Maniscalco, M.D. F.A.C.C. (Rhode Island: The Writers' Collective, Nov. 2003)
Nanobac Pharmaceuticals, Inc. Concludes Acquisition of Nanobac OY
TAMPA, Fla. (Sept 8, 2003) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) is pleased to announce the conclusion of the acquisition of majority ownership of Nanobac OY. This acquisition, which began in September 2002 and was completed on August 28, 2003, represents the unification of all of the Nanobacteria-related technologies under Nanobac Pharmaceuticals.
Nanobac OY is a Research and Development company located in Kuopio, Finland, that was created in partnership with the Finnish government. The discovery of Nanobacteria was originally documented and patented by Dr.�s Olavi Kajander and Neva Ciftcioglu, the Founders of Nanobac OY. Nanobac OY has been a long time research partner of NanobacLabs Pharmaceuticals and provides the diagnostic technology segment of NanobacLabs Pharmaceuticals� revenue.
�Completing the acquisition of Nanobac OY was the number one priority after consolidating Nanobac Pharmaceuticals and NanobacLabs Pharmaceuticals�, said John Stanton, Chairman and CEO of Nanobac Pharmaceuticals, �Having Dr. Kajander and Dr. Ciftcioglu solidifies our team going forward; bringing their family of patents associated with Nanobacteria�s culture and detection methods, eradication, and immunological assays. This also positions Nanobac as the leader in the research and development of Nanobacteria applications and utilization. The technologies contained in Nanobac OY, in conjunction with our family of Nanobiotics�, the first being NanobacTX�, our patent pending treatment for Nanobacterial infection, positions the company to implement its strategic plan,� Stanton concluded.
�We will continue to operate Nanobac OY as one of our principal sites of research and development,� said Gary Mezo, Founder of NanobacLabs Pharmaceuticals and Chief Research Officer at Nanobac Pharmaceuticals, �The unique position of Nanobac OY in Kuopio, and its superb relationship with the University of Kuopio, make it an ideal platform for more discovery in the emerging field of Nanobacteria-related diseases.�
Nanobac Pharmaceuticals, Inc. Reports Second Quarter Financial Results and Pro Forma Consolidated Financials
TAMPA, Fla. (Sept 3, 2003) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) announces the filing of its 10Q for the period ending June 30, 2003, as well as an 8K/A required by the company�s acquisition of NanobacLabs Pharmaceuticals. The company had revenues of $84,049 and $88,926 for the three-month and six-month periods ending June 30, 2003 respectively, and a net loss of $449,924 and $1,034,007 for the same periods. This represents a loss of $.01 and $.025 per share, respectively, on both a basic and fully diluted basis. It is significant to note that these results include only one month of financial performance on a consolidated basis since the acquisition of NanobacLabs Pharmaceuticals on June 2, 2003.
On a Pro Forma basis, the company had $2,572,468 in revenue for the period ending December 31, 2002 with a net loss of $1,803,903, or a loss of $.13 per share. Also on a Pro Forma basis, the company had revenues of $730,558 for the period ending June 30, 2003, with a net loss of $2,124,725, or a loss of $.046 per share.
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