||1910 N.E. Miami Court
Miami, Florida 33312
|Point of Contact:||Stanley Satz; President
Rosanne Satz; Vice President of Operations
Fax: (305) 573-2293
Products and Services:
Radioactive Medical Devices
During the next few years several widely used diagnostic and therapeutic radiopharmaceuticals and reagents with millions of dollars in sales will lose their patent protection. Bio-Nucleonics is uniquely positioned to develop products, obtain FDA approval and bring to market two to four generic drugs annually. To achieve this goal, the Company has secured production contracts for the delivery of a range of radioisotopes with the U.S. Department of Defense, the Department of Energy, and several large foreign nuclear reactors. Strontium-89, the Company's generic version of a new radiopharmaceutical, widely used for the long-term relief of bone pain in metastatic prostate, lung and breast cancers; Radioiodine for the diagnosis and treatment of thyroid disease and ovarian cancer; Samarium-153 for the treatment of rheumatoid arthritis; Technetiurn-99 diagnostic reagents; and other clinically useful radioisotopes. The Company has entered into a non-exclusive agreement with a major international radiopharmacy company for marketing and distribution in the United States, Latin America and Pacific Rim countries. Bio-Nucleonics also has commercial affiliations with several large health care alliances. Medications used in nuclear oncology and nuclear cardiology are amongst the most expensive of all drugs prescribed, with profit margins commensurate with the industry.
In September 1995, Bio-Nucleonics received Government regulatory agency approval and registration of its radioactive reference standards for calibration and imaging in nuclear medicine. The Company has a production cost advantage and can supply these materials profitably while, offering considerable savings to clients. Reference standards, are used at over 5,500 hospitals nationwide and are currently being tested by a major U.S. hospital chain. Bio-Nucleonics is commencing a campaign to secure a significant share of the $35 million a year replacement market for flood sources and calibration vials.
Bio-Nucleonics is in the product development stage of several novel radioisotopes for use in combination with monoclonal antibody delivery systems to treat various types of cancer, AIDS and chronic diseases. The market for monoclonal antibodies is projected to reach $2.9 billion by 1999. By using radioimunotherapeutics for oncological application in patient care, therapeutic responses many times greater are attained without administering high radiation doses, Undesirable side effects associated with conventional treatment may be eliminated, A 'fast-track' program is being implemented for routine production and delivery of alpha-emitters to clinicians and researchers. The successful application of these products will contribute to the Company a major technological strength in molecular biology and provide a significant competitive advantage.
Business Overview or History:
Bio-Nucleonics is an independent biotechnology Company that develops and supplies radiopharmaceuticals, radioactive devices, reference standards, and biopharmaceutical precursors. Its headquarters arc strategically located close to the University of Miami/Jackson Memorial Medical Center. The Company was created with the mission of providing generic radiopharmaceuticals worldwide at significantly lower prices than brand-name versions. Strategic alliances are maintained with leading research facilities worldwide for the development of new products for nuclear medicine Exceptional growth and shorter lead times to profitability are expected to be achieved in this specialized $2.6 billion a year segment of the health care market.
Bio-Nucleonics' associates are a creative group of distinguished physicians and scientists, proficient in drug development, protocol design, and radiopharmaceutical production and radioactive devices, The Company's affiliates are experienced in successfully implementing investigational and clinical trials in accord with the FDA's rigorous scrutiny and approval process.
In 1995 the Company received $200,000 in U.S. Government grants for radioactive reference standards development and has reasonable expectations of receiving additional grants in 1996 for its programs.
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