|
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.
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.
2004 Press Releases
Nanobac Life Sciences�, Neva Ciftcioglu, Awarded the M. Kemal Ataturk�s daughter Science Award by the Halic Rotary Club:
Ceremony performed at NASA Johnson Space Center
TAMPA, Fla. (December 20, 2004) � Nanobac Life Sciences, Inc. (OTCBB:NNBP.OB) announces that on Monday, December 6, 2004, Nanobac�s Director of Science, Dr. Neva Ciftcioglu was presented with the M. Kemal Ataturk's Daughter Science Award by the Halic Rotary Club in Istanbul Turkey as part of the 100 year celebration of the Rotary Clubs. The Award Ceremony was organized and presented by Melih Berk, the past president of Halic Rotary Club and a member of the Advisory Board of the Turkish Forum. The timing of the award coincided with the 70th anniversary of women's suffrage in Turkey, granted under the leadership of Mustafa Kemal Ataturk.
Dr. Neva Ciftcioglu is Nanobac�s Director of Science and is on loan to NASA under a Space Act Agreement to work on Nanobacteria and exobiological research at NASA�s Johnson Space Center in Houston Texas. Dr. Ciftcioglu has won awards from institutions in Europe and the United States.
�It is especially gratifying to know that the award Neva received was named after such a visionary as Mustafa Kemal Ataturk� stated Mr. Stanton, CEO of Nanobac. He also stated, �We are pleased to have Dr. Ciftcioglu on our team and we believe Neva�s continuing pioneering work for the welfare of mankind will lead to treatments for the many pathological calcification diseases, such as heart disease, kidney stones and prostatitis.�
Nanobac Life Sciences announces New European Patent for Nanobacteria Eradication and Therapeutics
TAMPA, Fla. (December 20, 2004) � Nanobac Life Sciences, Inc. (OTCBB:NNBP) announced the allowance of the European patent (EP 1094711) associated with the detection, treatment and eradication of Nanobacterial infection and contamination. The EP patent contains additional and broader claims than its sister US Patent (6706290). Both cover methods of disinfecting articles infected with Nanobacteria, and methods of treating patients infected with Nanobacteria.
�The allowance of this broader patent increases our intellectual property estate around this unique pathogen affecting the health of individuals around the world. Our broader coverage will allow us to aggressively pursue business development strategies both in the U.S. and abroad,� said John Stanton, Chairman and CEO.
Nanobac Life Sciences Announces Publication
Linking Nanobacterial Infection and Calcified Ovarian Cancer
TAMPA, Fla. (December 7, 2004) � Nanobac Life Sciences, Inc. (OTCBB:NNBP), announced today the publication of a study entitled �Presence of nanobacteria in psammoma bodies of ovarian cancer: evidence for pathogenetic role in intratumoral biomineralization� in the peer reviewed journal Histopathology (2004) 45, 633-637.
Nanobac�s Nanobacteria-specific 8D10 antibody and nanobacterial culture technique were used in these experiments. The authors reported that 100% of calcified ovarian cancers had Nanobacteria present and 100% of uncalcified ovarian cancers lacked Nanobacteria. These findings confirm a previous study that also found that 100% of calcified ovarian cancers were positive for Nanobacteria. This may be important because calcium is known to stimulate abnormal cell growth. Further studies are needed to show if anti-nanobacterial / anti-calcific therapies could benefit these patients.
Nanobac Life Sciences, Inc. is Cleared to OTC Bulletin Board
TAMPA, Fla. (November 22, 2004) � Nanobac Life Science, Inc. (OTCBB: NNBP), is pleased to announce that on November 18, 2004, NASD cleared ThinkEquity Partners� request for listing on the OTC Bulletin Board for Nanobac Life Sciences, Inc. Common Stock. This marks a milestone in the Company�s goal to be in compliance with SEC regulations.
Commenting on the clearance, John Stanton, Chairman and CEO, stated: �We are very pleased that the NASD has cleared us to the OTC Bulletin Board. This clears the way for a new group of investors who have shown great interest in the Company, but have been unable to invest to this point. Further, we will work to create greater awareness of our underlying core technologies and value to the institutional market place.�
Nanobac Life Sciences Announces British HIV Association Publication Describing HIV and Nanobacteria
TAMPA, Fla. (November 15, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP), announced today the publication of results from a study estimating the prevalence of nanobacterial infection in HIV-infected mothers and their babies. The original research entitled �HIV and nanobacteria� was published in HIV Medicine (2004) 5, 391-393, and was performed by researchers from the University of the Free State, Bloemfontein, South Africa, University of Ulm, Ulm, Germany and University of Kuopio, Kuopio, Finland.
Results of the study suggest that nanobacteria are common opportunistic infectious agents in HIV-positive patients, which could be transmitted from HIV-positive mothers to babies. The authors stated that more data are needed to explore the possibility of an interaction between nanobacteria and HIV.
Nanobac Life Sciences Announces the Release of The Calcium Bomb
TAMPA, Fla. (November 10, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) announces the release of The Calcium Bomb, a groundbreaking book that gives general audiences an unparalleled view of the nanobacterial link to abnormal calcification affecting millions of Americans. Most importantly, the book describes in easy to understand terms how to diagnose and fight it. Written independently by a biological engineer and science journalist who produced earlier acclaimed works, and supported with an Afterword by one of the nation�s leading cardiologists, the book explains how nanobacterial calcification may lead to heart disease, prostatitis and arthritis. Critics call it �a sharply profiled and highly necessary wake-up call� about calcification. It also provides significant information on Nanobac Life Sciences technologies. Available in leading bookstores everywhere. The Calcium Bomb: The Nanobacteria Link to Heart Disease and Cancer (The Writers� Collective), by Douglas Mulhall and Katja Hansen, ISBN 1-59411-101-4. More information is at www.calcify.com.
Nanobac Life Sciences Announces Presentation at American Heart Association Conference
TAMPA, Fla. (November 10, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) announces the presentation of positive results from a research study demonstrating the strong correlation between the presence of antibodies to nanobacteria and coronary artery calcification (CAC) at the American Heart Association 2004 Scientific Session in New Orleans, LA on November 9, 2004. The study, entitled �Nanobacterial Epidemiology, Inflammatory Markers and Coronary Artery Calcification in Asymptomatic Presumed Normal Patients,� was conducted by Stephen E. Epstein, MD, Director of the Cardiovascular Research Institute, Washington Hospital Center, Washington, D.C., and the presentation was given by Jian Hui Zhu, Ph.D.
Results showed that the Nanobac IgG test, which detects the presence of antibodies to nanobacteria, demonstrated a statistically significant correlation (p=0.017) with high CAC scores (75th percentile) in asymptomatic patients. CAC is the deposition of calcium plaque in the arteries of the heart. In a recent publication by Miller et. al., of a study conducted at the Mayo Clinic, it was reported that calcified arteries & heart valves stained positive for Nanobacteria.
High CAC scores are associated with increased risk of coronary artery disease (CAD). As reported by Kondos, et. al. in Circulation 2003, a patient�s risk for a future cardiac event increases as the CAC score increases. Those in the 75th percentile are at the highest risk for death, heart attack or surgery. These findings support the premise that the Company�s proprietary diagnostic test might be useful with asymptomatic cardiac patients to identify infections that could lead to calcification and heart disease.
Nanobac Life Sciences Posts New Information on Web-site to Educate Public on Nanobacteria
TAMPA, Fla. (October 18, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) has introduced a new animated video to educate the public about the newly discovered pathogen, Nanobacteria. The animated video may be viewed on the Company�s web site at www.nanobaclifesciences.com. In addition, copies of the recently published article by Jane Salodof MacNeil, from Nanobiotech News entitled, �Nanobacteria hypothesis impossible to ignore: Regimen targeting nanobacteria reduces coronary artery plaque�, may be downloaded directly from the web-site.
Nanobac Life Sciences Answers Commonly Asked Shareholder Questions
TAMPA, Fla. (October 12, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) announces the following are answers to several commonly asked questions about the organism, �Nanobacteria� and our Company, Nanobac Life Sciences, Inc. (�Nanobac�). Hopefully, this information will broaden the understanding of interested parties.
Is the detection of Nanobacteria in blood considered a risk factor for Coronary Artery Disease, such as hs-CRP, or is it related to the detection of the underlying cause of the disease, such as the detection of H. pylori and its association with peptic ulcer disease?
The scientific community has not identified the cause of Coronary Artery Disease (CAD); accordingly, we use epidemiological methods to identify the factor(s) linked to the development of CAD (like high blood pressure, gender, lifestyle characteristics and lab results). The current cardiac laboratory tests on the market measure substances that are produced by the body because of the cardiac disease. They are not measuring the underlying cause of the disease. Consider for a minute that Nanobacteria produce calcification by building a calcium-shell around each Nanobacterium. They secrete a substance that causes inflammation and swelling, causing the surrounding tissues to try and �wall off� this injured site. Many of the traditional lab tests are measuring for inflammation and other markers �associated� with cardiac disease. These markers are considered �risk factors� for CAD. Current research implicates Nanobacteria as a potential underlying cause behind CAD and other conditions involving pathological calcification (plaque).
Why isn�t Nanobacteria and Nanobac Life Sciences more well known?
There are many examples in history of how slow the medical establishment can be to embrace a new idea. One of the most recent is of Dr. Barry Marshall when he discovered H. pylori. Dr. Marshall�s research implicated H. pylori as the cause of peptic ulcer disease. It took 15 years before the medical community accepted that H. pylori was responsible for up to 90% of all peptic ulcers. During that time the medical community continued to perform risky surgeries while the patient simply needed oral medication to kill the bacteria. The U.S. Food and Drug Administration has approved several combinations of antibiotic drugs as therapy for active H. pylori infection. Nanobac Life Sciences researchers Olavi Kajander, MD, Ph.D. and Neva Ciftcioglu, Ph.D. have experienced similar frustrations as Dr. Marshall.
Do Nanobacteria exist?
Yes. Multiple independent researchers have validated Nanobac�s lead scientists, Drs. Kajander and Ciftcioglu�s, work by replicating their methods for isolation, growth, and staining of Nanobacteria. There are very good microscopic pictures of Nanobacteria but due to their small size Nanobacteria can only be seen through certain types of microscopes such as scanning electron microscopes and transmission electron microscopes.
Are Nanobacteria alive?
This may depend on the definition of �alive�. Viruses are not alive until they enter a body and use the reproductive materials of their host. Prions, such as those that cause mad cow disease, are fragments of protein and are not alive. However, both viruses and prions wreak havoc on people and cause disease. The debate is ongoing as to whether Nanobacteria are alive. Either way Nanobacteria are implicated in many diseases.
Do you have patents?
Yes. We have established a significant intellectual property estate around the growth, detection and treatment of Nanobacteria. In addition, multiple patents are pending covering additional novel applications.
What percent of people have Nanobacteria?
A large epidemiological trial is needed to answer this question with certainty. There have been small trials and the percent of people shown to have Nanobacteria in their blood appears to be age and disease dependent. Some studies show that 5-14% of normal healthy individuals are positive for Nanobacterial infections. Studies on patients with pathological calcification have shown that infection rates vary from 8-100% depending on the disease.
What research are you currently doing?
Nanobac is currently performing research with numerous academic institutions both within the US and abroad. Collaborators include US government researchers, as well as nationally renowned clinics. The company recently established a space act agreement with NASA Johnson Space Center to further study Nanobacteria.
Who is your competition?
There is no other company with our focus on the self-replicating nano particle referred to as Nanobacteria. It is easy to confuse us with the technological �nano� companies that are doing something completely different and are often evaluating computers, robotics or new nano particle drug delivery mechanisms. Those companies are not our competition. In a broader sense, the major pharmaceutical, diagnostic and medical device companies are our competition. However, these companies have not addressed the infectious role of Nanobacteria. Nanobac Life Sciences, Inc. (Nanobac) is dedicated to improving people�s health through the detection and eradication of Nanobacteria.
How does Nanobac Life Sciences generate revenue and what are our current or potential revenue sources?
Nanobacteria have been implicated in pathological calcification diseases such as heart disease, prostatitis, kidney stones, psoriasis, arthritis, gall stones, and cataracts. Americans currently spend $538 billion dollars to treat calcification diseases. The Company has revenue opportunities with respect to both the diagnostics and therapies associated with pathological calcification. With respect to diagnostics; the Company has developed two blood tests to detect the presence of Nanobacterial infection. Both tests are available today as a laboratory service to physicians. The Company also expects to file a 510K or PMA with the FDA for our ELISA assays. In addition, we are actively working on expanding our diagnostic pipeline to include molecular diagnostics. Therapeutics is the second product pipeline. We have nutraceutical products that are available today. These products include our Nanobac Supplements and an EDTA suppository. We are also developing additional mechanisms of delivery for our current products to improve compliance, as well as developing additional compounds that have anti-Nanobacterial effects.
When will Nanobac be elevated from the �Pink Sheets�, and what does that mean to the Company?
A Company whose stock trades only on the �Pink Sheets� is generally not in compliance with the reporting requirements of public companies. We believe that Nanobac is in compliance. We are currently in the process of working with the NASD to elevate the company�s trading status. There are more than 20 NASD firms currently making a market in our stock. Ultimately, we would expect the trades of all such firms to be elevated to the Bulletin Board. The significance to the Company is that large institutional investors do not trade in �Pink Sheet� stocks. The acknowledgement that our reporting status is current will increase market awareness of our Company.
About Nanobacteria
Nanobacterium sanguineum (nanobacteria) is the smallest self-replicating organism ever detected � at 50 to 500 billionths of a meter, 1/100th the size of the smallest previously known bacteria. Nanobacteria have been implicated in a variety of human diseases associated with pathological calcification.
Nanobacteria were first discovered in 1988 by a Finnish researcher, and Nanobac OY co-Founder Olavi Kajander, M.D., Ph.D. Medical microbiologist Neva Ciftcioglu, Ph.D. joined his team in 1991 and their corroborated work with nanobacteria over the past 13 years has put them at the forefront of research into this medically important pathogen. Their research established that the blood-borne nanobacteria forms slow-growing calcified colonies in arteries and organs.
Nanobac has identified two biomarkers of nanobacterial infection. These tests are being developed as the NB2 test, which is composed of the nanobacteria antigen test, and the nanobacteria IgG antibody test.
Nanobac Life Sciences Announces Manufacturing Agreement With Medicorp for Nanobacteria Test Kits
Prepares for Clinical Trials and Expanded Distribution
TAMPA, Fla. (October 4, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) is pleased to announce the signing of a Manufacturing Agreement with Medicorp, Inc., for the production of two blood tests for the detection of Nanobacteria. Nanobac is transferring production of both the Nano-Capture ELISA assay and the Nano-Sero IgG ELISA assay from its Nanobac Oy research laboratory in Kuopio, Finland to Medicorp in preparation for FDA clinical trials and expanded distribution. Medicorp is Canada's largest, independent ISO 9001-certified manufacturer and distributor of immunodiagnostic and microbiology products.
�We are pleased to be able to work with Medicorp to scale-up production of our test kits in preparation for FDA clinical trials and for our distribution of our test kits outside the U.S., commented John Stanton, Nanobac�s President and Chief Executive Officer. �This move prepares us for increased production of our test kits in an ISO-9001-certified manufacturing facility. This is a key step for the Company as we move from a research oriented company to one that rapidly develops and commercializes products.�
Nanobac has already signed a distribution agreement with Oxoid Ltd. for territories in Europe, Brazil and Australia. Oxoid is one of the world's leading manufacturers and distributors of microbiological culture media and other diagnostic products. With corporate headquarters in Basingstoke, Hampshire, Oxoid Ltd is supported by a network of wholly owned sales and distribution companies in Europe, North and South America and Australia.
Nanobac recently announced that an abstract entitled �Increased serum levels of Nanobacteria antibodies are associated with high coronary calcification score� has been accepted for presentation in an oral session at the American Heart Association (AHA) Scientific Sessions 2004 conference in New Orleans, LA, Nov 7-10, 2004. The research was performed by Stephen Epstein, MD and Jianhui Zhu, PhD at the Washington Hospital Center, Washington, DC.
Nanobac Life Sciences, Inc. Completes Financing Private Placement will potentially bring $5 million over next four quarters
TAMPA, Fla. (August 17, 2004) � Nanobac Life Science, Inc. (OTCPK:NNBP) (�Nanobac� or �the Company�), announces the completion of a private placement of its common stock led by the Nutmeg Group of Northbrook, Illinois that potentially will bring $5 million to the company over the next four quarters. The Company also announced that most of its indebtedness to related parties has been converted to equity at a premium to the current market price. This conversion eliminates approximately $8 million of debt, resulting in a debt-free balance sheet, except for trade debt in the ordinary course of business.
These two transactions (details to be described in a formal 8-K filing) will enable the company to continue to aggressively pursue its long-term plan of sales, marketing and product development.
�We are excited to have capitalized the company with the needed funds to achieve profitability,� said John Stanton, Chairman and Chief Executive Officer. �The elimination of all non-trade debt substantially strengthens the Company�s financial position.�
With more than $30 million under management, the Chicago-based Nutmeg Group, L.L.C. is a value-added private capital investment firm and a full service investment and financial consulting organization dedicated to helping growth companies emerge as industry leaders. Staffed with an impressive array of diverse talents and a robust infrastructure, Nutmeg stands committed to facilitating Nanobac�s success, as it is for all of its portfolio companies. Loren Comitor, President of CCM&A, Nutmeg�s advertising and marketing affiliate, will endeavor to facilitate new marketing arrangements for Nanobac and assure that Nanobac�s image will reflect and be commensurate with, Nanobac�s outstanding advanced and medically critical technologies.
NANOBAC LIFE SCIENCES ANNOUNCES SPACE ACT AGREEMENT WITH NASA: NASA�s Johnson Space Center to Study Nanobacteria
TAMPA, Fla. (September 13, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) is pleased to announce the signing of a Space Act Agreement with NASA�s Johnson Space Center (JSC), Houston Texas, to collaborate on research on Nanobacteria and its nature and role in pathological calcification, including the detection and treatment of the pathogen. Since Astronauts may be more prone to an increased rate of pathological calcification while in a zero gravity environment, the collaboration will bring a new approach to NASA�s need to better understand the effects of long-term space travel on humans. In addition, Nanobac�s work provides a model for studying mineralized organic matters that could aid NASA in the search for extraterrestrial life.
Nanobac co-founder and Director of Science, Neva Ciftcioglu, Ph.D. will remain at NASA JSC as Senior Scientist and principal researcher. Under the agreement, NASA will provide workspace at JSC for Nanobac�s personnel located at JSC. The agreement further provides Nanobac the opportunity to work together with a multidisciplinary team of NASA researchers while having access to basic laboratory services for nanobacteria science, including electron microscopy, molecular biology and geology-mineralogy research facilities. Projects ranging from searching for nanobacteria biosignatures in earth fossils and in Mars meteorites to diagnosing and treating nanobacteria infection are anticipated. Nanobac will provide JSC with equipment and specialty supplies for nanobacteria research and apply its pioneering diagnostic and treatment experience in the field.
�We are pleased to be able to provide our Director of Science to NASA for these important projects,� commented John Stanton, Nanobac�s President and Chief Executive Officer. �We look forward to a very rich and rewarding research collaboration with NASA. We appreciate the opportunity to work with some of the country�s most talented scientists.�
This announcement shall not be construed to imply that NASA currently or in the future endorses or sponsors any NANOBAC product or service.
Nanobac Life Sciences, Inc. Announces Acceptance of Nanobacterial Abstract for Oral Presentation at American Heart Association Scientific Sessions
TAMPA, Fla. (August 16, 2004) � Nanobac Life Science, Inc. (OTCPK:NNBP), announced today the abstract titled �Increased serum levels of Nanobacteria antibodies are associated with high coronary calcification score� has been accepted for presentation in an oral session at the American Heart Association (AHA) Scientific Sessions 2004 conference in New Orleans, LA, Nov 7-10, 2004. The research was performed by Stephen Epstein, MD and Jianhui Zhu, PhD at the Washington Hospital Center, Washington, DC.
�AHA is the leading cardiac organization and we are privileged to have a nanobacterial talk at a conference of this caliber,� said John Stanton, Nanobac�s CEO. �Having our NB2 test results discussed in an oral session shows growing acceptance of nanobacteria in the cardiology field and validates the hard work our researchers and collaborators have been performing in novel area of pathological calcification due to nanobacteria infections.�
Nanobac Life Sciences, Inc. Announces International Journal of Pathophysiology Publication Demonstrating Reversal of Coronary Artery Calcification
TAMPA, Fla. (July 29, 2004) � Nanobac Life Science, Inc. (OTCPK:NNBP), announced today the publication of a study titled �Calcification in Coronary Artery Disease Can Be Reversed by EDTA � Tetracycline Long-Term Chemotherapy� in the peer reviewed International Journal of Pathophysiology (DOI 10.1016/J.Pathophys.2004.06.001, www.sciencedirect.com). The observational study, conducted by Benedict Maniscalco, M.D., F.A.C.C. of St. Joseph�s Hospital, Tampa Florida, demonstrated a statistically significant reversal in the coronary artery calcium (CAC) scores of patients with stable coronary artery disease (CAD) taking Nanobac�s proprietary comET nanobiotic regimen. CAC is the deposition of calcium plaque in the arteries of the heart.
The results indicate that Nanobac�s comET, a proprietary therapeutic method comprised of a nutraceutical powder, EDTA and tetracycline, caused a statistically significant decrease in the CAC score of patients with stable CAD. Patients tolerated the therapy well and their angina and lipid profiles also improved.
77 patients completed the study and all patients were positive for nanobacteria serology, antigen or both. Among those patients, 57% had a statistically significant decrease in their CAC score as measured using cardiac computerized tomography, the average decrease being 14% (p=0.001). In addition, 84% of patients with angina, or chest pain, had improvement or total resolution of pain. Many of these patients (86%) were on continuous statin medication before the trial and there was still a marked improvement in their cholesterol and triglyceride levels on comET. Nanobac�s NB2, antigen and antibody blood test was used to evaluate the patients nanobacterial levels and all of these cardiac patients were positive for nanobacterial infection. Since CAC scores decreased during the therapy in most patients, the study suggests that the heart arteries have become less clogged while on this proposed anti-nanobacterial therapy. CAC scores are thought to increase by 20% annually. There are no previous reports showing a significant decrease in CAC scores with any regimen found in literature.
�It is quite remarkable to see an improvement in CAC scores and lipid levels in any group of patients, but especially in this group in which many had severe refractory heart disease,� said Benedict Maniscalco, MD, FACC, study principal investigator. �The association between calcium and heart disease has been known for some time but we now have a probable link between nanobacteria, calcium and heart disease. This has the potential to change the way cardiologists practice medicine and merits further study in controlled clinical trials to confirm and expand the findings from this observational study.�
�Heart disease is the number one killer in America and unfortunately a fatal heart attack is often the first warning sign. That is why much attention has been given to the testing for cardiac risk factors, like cholesterol and Hs-CRP,� said John Stanton, Nanobac�s CEO. ��Our NB2 test may prove to be another tool to help predict a patient�s cardiac risk by allowing physicians to conveniently measure a patients CAC score with a simple blood test. Further, continued study of our proprietary nanobiotic regimen could provide a way to measurably improve a patient�s cardiac health.�
Nanobac Life Sciences, Inc. announces Appointment of Dr. Neva Ciftcioglu as Adjunct Assistant Professor at the University of Texas, Health Science Center at Houston
TAMPA, Fla. (July 23, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) (�Nanobac� or �The Company�) is pleased to announce the appointment of Neva Ciftcioglu, PhD as Adjunct Assistant Professor in the Department of Surgery, at The University of Texas, Health Science Center at Houston http://www.uth.tmc.edu/. Her appointment will expand Nanobac�s reach into a world renowned medical science community and provide access to additional laboratory facilities and grant opportunities.
Dr. Ciftcioglu is currently Nanobac�s Director of Science and a senior scientist and director of nanobacterial research for the Universities Space Research Association, NASA Johnson Space Center, Houston, Texas. She is a Docent (full professor) of biochemistry at the University of Kuopio in Kuopio, Finland. She also works in partnership with Nanobac�s Chief Research Office, Olavi Kajander, MD, PhD, to coordinate nanobacterial research projects at more than 100 sites.
Dr. Ciftcioglu�s work has been recognized through a number of scientific awards including the 1993, 1996 and 1998 Savon Korkean Teknologian Saatio Award (Finland) and the 1997 and 1998 Jenny ja Antti Wihurin Rahasto Award (Finland). She was also awarded the 1999 Minerva, Medix Prize for the most prominent Finnish biomedical paper of 1998. More recent awards include the International Space Medicine Branch Young Investigator Award (second) (15 May 2002, Canada), the Special Scientific Achievement Award/Astrobiology Laboratory Team/ NASA JSC. 2003/USA, and the Special Scientific Achievement Award/Astrobiology Institute Proposal Team/ NASA JSC. 2003/USA. Dr. Ciftcioglu has authored or co-authored 47 scientific publications and 27 scientific abstract communications.
She is a professional member of NABI (NASA Astrobiology Institute), the American Society for Microbiology, the American Society for Cell Biology, the Societas biochemical et microbiological Fenniae and the Societas Physiologica Finlandiae. She lectures to professional societies and universities worldwide on the subject of nanobacteria.
�We are extremely pleased to have our Director of Science be able to be part of The University of Texas, Health Science Center at Houston team�, stated John Stanton, CEO of Nanobac. Mr. Stanton further stated �the continuing recognition of renowned scientific and medical communities on the potential importance of Nanobacteria is important to the continuing success of Nanobac Life Sciences�.
NANOBAC LIFE SCIENCES ANNOUNCES PAST YEAR�S ACCOMPLISHMENTS AND FUTURE GOALS
TAMPA, Fla. (July 23, 2004) � Nanobac Life Sciences, Inc. (OTCPK: NNBP) (�Nanobac� or �the Company�) has completed its first year as a public Company. The events and discoveries of the past year have reinforced our belief that we are at the forefront in the search for the causes and treatments of infectious diseases associated with pathological calcification. This sets forth the accomplishments of the last year, as well as our goals and expectations for the future.
The major accomplishments during the last 12 months include:
Completing the acquisition of Nanobac Oy, our Finland-based subsidiary that provided the foundation for the Company�s intellectual property;
The issuance of patent coverage to expand and further protect the Company�s intellectual property;
The discovery by independent researchers of a strong correlation between Nanobacteria infection and coronary artery calcification (�CAC�) in asymptomatic individuals. This discovery was especially significant because it suggests that a simple blood test (provided by the Company and protected by its patents) might have predictive value for the future development of CAC. This could be similar to the PSA (�prostate specific antigen�) test as a predictor of prostate cancer;
The discoveries by more than one independent researcher of Nanobacteria and/or Nanobacteria-like structures in calcified human arteries and cardiac valves. These discoveries provide continuing evidence of the Company�s underlying premise that Nanobacteria is an infectious agent that ultimately causes pathological calcification;
The discovery by Mayo Clinic that Nanobacteria contain genetic material, an essential component for life. This discovery provides evidence relative to an ongoing scientific debate about whether or not Nanobacteria is a unique form of life. The existence of genetic material would confirm that it is a unique life form. However, the ultimate resolution of the debate is not necessarily relevant to the Company. Many infectious agents (such as viruses) have a parasitic existence in the human body and are thus not unique forms of life;
The discovery by independent researchers of nano-size organisms (with the presence of genetic material) and characterized as Nanobacteria, in kidney stones;
The discoveries by independent researchers of Nanobacteria in ovarian cancer cells; and,
The continued beneficial results of patients using the various therapies developed by the Company.
The major goals for the future include:
To evaluate and define the research and development objectives of the Company that will accommodate, as a high priority, the introduction of our products and technology to the marketplace;
To determine and obtain the capital needed to accomplish the Company�s mission; and,
To find strategic partners to accelerate the commercialization of the Company�s products and technologies.
Alexander Edwards and I have worked together to �set the table� for the Company�s future. Alex�s contributions to the Company have been invaluable in the achievements of the last year, as well as in defining our future goals. He has brought the appropriate people to the Company to complete our mission. Alex has decided to resign as the CEO of Nanobac. I will resume the CEO duties and look forward to working with our team to accomplish our goals. Alex will continue to assist the Company in a consultative capacity.
NANOBAC LIFE SCIENCES ANNOUNCES REACQUISITION OF RIGHTS TO MARKET AND SELL ITS NANOBIOTIC REGIMEN
- Company Also Announces Acceptance of Manuscript for Publication in Peer Reviewed Journal -
TAMPA, Fla. (June 18, 2004) � Nanobac Life Sciences, Inc. (OTCPK: NNBP) today announced that it exercised its right to take over the marketing and sales activity of its proprietary nanobiotic regimen from Pegasus Worldwide, Inc. Nanobacteria are associated with pathologic calcification in a variety of degenerative diseases including atherosclerosis (hardening of the arteries) and coronary heart disease. The company also announced that the International Journal of Pathophysiology accepted for publication the manuscript entitled �Calcification in Coronary Artery Disease can be reversed by EDTA � Tetracycline long-term chemotherapy� (DOI 10.1016/J.Pathophys.2004.06.001). The manuscript presents compelling data about the potential reversal of coronary artery calcification.
Supported by the International Journal of Pathophysiology manuscript, Nanobac will implement an ambitious and strategic sales and marketing effort for the nanobiotic through its wholly owned subsidiary, Nanobac Sciences. The Company anticipates recognizing revenue from this new sales initiative in the current quarter and also would expect strong sales growth over the next eighteen months.
Alex Edwards, Nanobac�s President & Chief Executive Officer, stated, �The acceptance of this paper for publication in a peer reviewed journal is an important milestone; coupled with the clinical data we announced on April 27, it adds to the scientific foundation we are building to better understand the nature and role of nanobacteria in pathological calcification, as well as its detection and treatment.� Mr. Edwards continued, �While we are retaining our focus on further defining the cause and effect relationship between Nanobacteria and vascular calcification, as well as other human diseases associated with pathological calcification, we are now positioned to pursue a combination diagnostic and therapeutic solution and anticipate immediate revenue from a new sales initiative for the nanobiotic.�
Nanobac Life Sciences notes publication of evidence of Nanobacterial-like structures in human vascular tissue in American Journal of Physiology-Heart and Circulatory Physiology
TAMPA, Fla. (May 25, 2004) � Nanobac Life Sciences, Inc. (OTCPK:NNBP) noted the recent publication �Evidence of Nanobacterial-like structures in human calcified arteries and cardiac valves�, in the recent issue of American Journal of Physiology - Heart and Circulatory Physiology (Articles in Press; May 13, 2004. 10.1152/ajpheart.00075.2004). Drs. Kajander and Ciftcioglu�s methodology for isolating, culturing and staining Nanobacteria was reproduced by an independent team lead by the Mayo Clinic Rochester. The experiments, using an antibody 8D10, developed and manufactured by Nanobac, confirmed that the Nanobacteria can be visualized in and cultured from human calcified arteries and heart valves. The experiments also provided evidence that Nanobacteria contain DNA, an essential component for life.
This study provides further evidence for the existence of nanoparticles in calcified human tissue. It also strengthens the knowledge of the pathogen Nanobacteria and their association with heart disease, particularly about ways vessels may become calcified. Vascular calcification is the buildup of calcium in the arteries of the heart and is associated with increased risk of heart disease. Nanobacteria were found in early stage diseased tissue, supporting the hypothesis that nanobacteria are involved in the calcification process. The authors tested the 8D10 antibody, provided by Nanobac, and found it to be specific.
�Last month, Nanobac announced findings from an epidemiological research study demonstrating the strong correlation between the presence of antibodies to Nanobacteria, detected through a simple blood test, and coronary artery calcification in asymptomatic individuals,� said Alex Edwards, Nanobac�s Chief Executive Officer and President. �The results of that study, conducted by Dr. Stephen Epstein from Washington Hospital Center, and these newly published results further support the proposition that nanometer scale pathogens, termed Nanobacteria, are associated with calcium plaque formation in human vascular tissue and hence an increased risk for coronary artery disease. We are actively working with a number of cardiology thought leaders to develop novel methods for the detection and treatment of Nanobacteria.�
�While continuing studies are needed, the potential for a simple blood test which could identify patients at an increased risk for a coronary event would be a great benefit to the every day practice of cardiology,� commented Alan Miller, MD, Cardiology Department University of Florida, Jacksonville. �Further, this work published by Mayo Clinic provides new evidence that suggests coronary artery calcification is a response to an infectious agent, as has been postulated for many years.�
�Nanobac was pleased to provide our proprietary antibody test for use by the scientists in this study, which the authors deemed specific to the detection of Nanobacteria,� stated Mr. Edwards. �We look forward to continuing our relationship with these researchers, and work more closely to better define the cause and effect relationship between Nanobacteria and vascular calcification, as well as, other human diseases associated with pathological calcification.�
Nanobac Life Sciences Announces Positive Results of its Nanobacterial Antibody Test For Coronary Artery Disease
Simple Blood Test Shows Correlation with Coronary Artery Calcification
TAMPA, Fla. (April 27, 2004) - Nanobac Life Sciences, Inc. (OTCPK: NNBP) announced today positive results from an epidemiological research study demonstrating the strong correlation between the presence of antibodies to nanobacteria and coronary artery calcification (CAC) in asymptomatic individuals. CAC is the deposition of calcium plaque in the arteries of the heart. High CAC scores are associated with increased risk of coronary artery disease (CAD).
Results showed that the Nanobac IgG test, which detects the presence of antibodies to nanobacteria, demonstrated a statistically significant correlation (p=0.017) with high CAC scores (75th percentile) in asymptomatic patients. After adjustment for the established risk factors of CAD such as gender, smoking status, hypercholesterolemia, hypertension, family history of CAD, and levels of C-Reactive Protein (CRP), the IgG test was found to be an independent predictor of CAC.
The study, entitled �Nanobacterial Epidemiology, Inflammatory Markers and Coronary Artery Calcification in Asymptomatic Presumed Normal Patients,� was conducted by Stephen E. Epstein, MD, Director of the Cardiovascular Research Institute, Washington Hospital Center, Washington, DC, and his associate Dr. Jianhui Zhu. It was carried out in a cohort of 198 patients screened for the presence or absence of coronary calcifications using Electron Beam Computed Tomography. They were also previously analyzed for markers of coronary artery disease (CAD).
According to principal investigator Dr. Stephen Epstein, �I am encouraged by the results of this study. The findings suggest that this simple blood test may provide information about the likelihood of CAC. Since high CAC scores are associated with coronary artery disease and significant coronary events, the test could also add to our ability to identify individuals at higher risk for coronary heart disease and its life-threatening events.�
�We are very pleased to be working with Dr. Epstein and the Washington Hospital Center. Drs. Epstein and Zhu are considered leading researchers of coronary artery disease and have pioneered research exploring the relationship between pathogenic bacteria and coronary artery disease,� commented Alex Edwards, Nanobac�s President & Chief Executive Officer. �As Nanobac continues its efforts to establish the role of nanobacteria in CAD, we will be pursuing FDA approval to commercialize our antibody test, and additional activities directed at detecting and treating nanobacterial infections.�
Dr. Epstein further commented, �I am looking forward to conducting additional studies in cooperation with Nanobac to confirm these results in a larger sample size, and to shed more light on the relationship between nanobacteria and coronary artery calcification.�
Nanobac Pharmaceuticals, Inc. Changes Name to Nanobac Life Sciences, Inc.
TAMPA, Fla. (April 20, 2004) � Nanobac Pharmaceuticals, Inc. (OTC:NNBP) (�Nanobac� or �The Company�) today announced that it re-named the company Nanobac Life Sciences, Inc. The revised name reflects Nanobac�s mission to fully exploit its leading portfolio of Nanobacteria intellectual property to develop diagnostics and therapeutics to detect and treat Nanobacterial infections, as well as continue research into the role of Nanobacteria in the formation of disease-causing calcified plaque in the circulatory system and vital organs.
�Currently, we are researching Nanobacterial infection as a risk factor for the development of atherosclerosis and coronary heart disease. We are also developing an antibody and antigen serum test for Nanobacterial infection for which we will seek FDA marketing approval, and we plan to further leverage our patent estate through the development of therapeutics and additional diagnostic tests,� said Alex Edwards, Nanobac�s CEO and President. �There are several other potential applications in the Bio-medical and Bio-industrial areas, such as sterilization of vaccines, growth mediums and equipment, being considered. In light of the breadth of potential applications that we seek to develop, it was proper to change the name of the company,� Mr. Edwards concluded.
Nanobac, through its wholly owned subsidiary, Nanobac OY, owns patents pertaining to culture and detection methodologies as well as methods for eradication of Nanobacteria. These patents apply to In Vivo, In Vitro and Industrial applications. Healthcare � A majority of the current literature suggests that Nanobacteria is one of the causes of pathological calcification. Pathological calcification is implicated in numerous diseases including Atherosclerosis, Polycystic Kidney Disease, Dental Stone and numerous other stones and cysts. Further, Nanobacteria has been cultured out of a number of solid tumor pathologies and chronic infections associated with glands and joints.
As a Bio Technology company, Nanobac is currently finishing statistical analysis of the performance of its serum based Biomarker for the detection of both active and latent Nanobacterial infection. As previously announced, Nanobac is working with a leading Biomarker Clinical Research Organizations to help guide the Company through the Biomarker analysis and the FDA approval process. The Company�s goal is a new serum based risk metric which will be clinically significant as a tool for the identification of potential calcification in vital organs.
Additionally, Nanobac is currently evaluating multiple combination therapeutics which both, In Vivo and In Vitro, have shown tremendous potential for the reversal of pathological calcification of the coronary artery and prostate. The Company is aggressively pursuing a strategy of therapeutic development which will identify specific combinations of therapeutics that can be targeted to a disease site. The Company is also actively working on an accelerated FDA approval process.
Bio-medical � The Company�s research and development team has presented data associated with Nanobacterial contamination of cell culture lines as well as a number of other Bio Medical medias. This contamination represents a growing concern to the Bio Medical industry. Nanobac will actively deploy its Intellectual Property to work for the eradication of this contamination. These activities will be both independent and with potential strategic partners.
Bio-industrial � Nanobac will pursue strategic partnerships associated with the detection and eradication of Nanobacterial infestation in the Bio Industrial market. The Company will vigorously protect its Intellectual Property in this area and identify ways to decontaminate industrial activities from a sterile filterable autonomously replicating biological particle; Nanobacteria.
Nanobac Pharmaceuticals, Inc. Announces the Sale of its Healthcentrics Subsidiary
TAMPA, Fla. (March 31, 2004) � Nanobac Pharmaceuticals, Inc. (OTC:NNBP) (�Nanobac� or �The Company�) announces the sale of its medical practice management software subsidiary, Healthcentrics, to Escape Velocity of Tampa Bay (�Escape�). Escape, a related party and significant shareholder of the Company, is controlled by John Stanton, Nanobac�s Chairman of the Board. Escape is acquiring Healthcentrics by assuming all liabilities of Healthcentrics and reducing its debt position in Nanobac by $250,000.
�Nanobac is focused on the development of its multi-layer Intellectual Property associated with Nanobacteria infection and infestation,� said Alex Edwards, Nanobac�s CEO and President. �By selling Healthcentrics, the Company will be reducing its debt, as well as eliminating all non-Nanobacteria related initiatives and expenditures.� The transaction is described in detail in the Company�s Form 10KSB filed March 30, 2004.
Nanobac Pharmaceuticals, Inc. Announces New Patent
TAMPA, Fla. (March 23, 2004) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) (�Nanobac� or �The Company�) announces the printing of U.S. Patent 6,706,290 �Methods for Eradication of Nanobacteria�. This Patent, issued to Drs. Kajander and Ciftcioglu of Nanobac�s wholly owned subsidiary, Nanobac OY, along with previous U.S. Patent 5,135,851 �Culture and Detection Method for Sterile-Filterable Autonomously replicating Biological Particles�, completes the Intellectual Property Estate for the Company with respect to Nanobacterial Science.
These Patents, in combination, represent a significant advancement in the Company�s ability to aggressively pursue its business plan, and protect its Intellectual Property.
Nanobacteria has been shown as a potential causal agent of pathological calcification associated with Atherosclerosis, Polycystic Kidney Disease, Kidney Stones and other degenerative diseases. Nanobacteria is also being investigated in association with other potential causal agents of microcalcific structures identified with solid tumors or cancer. The Company�s Intellectual Property supports diagnostic methodologies and/or therapeutic combinations indicated for the aforementioned diseases.
�We are in the final stages of initial validation of the Company�s serum diagnostic Biomarker for the Coronary Artery Calcification,� said Alex Edwards, CEO and President. �With our Intellectual Property Estate now secure, we will aggressively pursue both diagnostics and therapeutic solutions for multiple diseases.�
Further, Nanobac is evaluating the Company�s business opportunities in the Bio-Medical and Bio-Industrial arenas. This new patent allows for methods of sterilization of articles contaminated with Nanobacteria.
�These new areas of opportunity are being evaluated by our team and could potentially be an area of strategic partnership for the Company,� Edwards added.
Nanobac Pharmaceuticals, Inc. Announces a Presentation on Nanostructures in Human Aneurysms
TAMPA, Fla. (March 17, 2004) � Nanobac Pharmaceuticals, Inc. (OTCPK:NNBP) (�Nanobac� or �The Company�) announced today that a Poster Presentation was made by the MAYO Clinic Rochester last week at the American College of Cardiology Annual Scientific Session 2004 in New Orleans, LA. This presentation, by Dr. John Lieske et. al. MAYO Clinic Rochester, was titled �Detection and Propagation of Calcified Nanostructures from Human Aneurysms.�
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