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July 18, 2006 July 18- July 24 July 18th: FDA Approves IMPLANON(TM) (etonogestrel implant) 68mg, the First and Only Single-Rod Implantable Contraceptive Organon announced today that the U.S. Food and Drug Administration (FDA) approved IMPLANON(TM) (etonogestrel implant) 68mg, the first and only single-rod implantable contraceptive that is effective for up to three years. IMPLANON(TM), about the size of a matchstick, is made of a soft medical polymer and is inserted subdermally just beneath the skin on the inner side of a woman's upper arm by a healthcare provider during an in-office procedure. IMPLANON(TM) continually releases a low, steady dose of progestin (etonogestrel) for a period of up to three years via a unique, state of the art implantable technology. After insertion, IMPLANON(TM) generally is not visible, making it a discreet method of birth control. The efficacy of IMPLANON(TM) does not depend on patient self-administration. Removal can occur at any time at the request of the user, after which the woman's fertility returns to her pre-existing fertility level. IMPLANON(TM) has been used worldwide by approximately 2.5 million women in more than 30 countries since 1998. Recognizing that IMPLANON(TM) is unlike anything currently available in the U.S., Organon USA will be sponsoring a national clinical training program to train healthcare providers on the insertion and removal procedures. Only healthcare providers trained through the Organon-sponsored programs will be able to order IMPLANON(TM). The clinical training program is scheduled to begin later this year. As the training program progresses, IMPLANON(TM) will become more widely available in 2007. Organon -- with shared head offices in Roseland, NJ, USA and Oss, The Netherlands -- creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel. July 18th: Smith & Nephew Receives FDA Approval for EXOGEN 4000+(TM) Bone Healing System Smith & Nephew's Orthopaedic Trauma & Clinical Therapies division today announced FDA approval for its EXOGEN 4000+(TM) Bone Healing System. The EXOGEN 4000+ Bone Healing System is a low-intensity pulsed ultrasound device that is externally applied 20 minutes a day over the site of a broken bone. It is the only bone stimulator: - using ultrasound technology approved to treat fractures that that have failed to heal; - approved to heal specific fresh fractures faster The EXOGEN 4000+ is medically proven to promote the body's natural healing process, speeding the repair of a broken bone. The system is also clinically proven to speed up the healing of certain new fractures by 38 percent and effectively healing 86 percent of hard-to-heal bone fractures. The system will launch in domestic and International markets in the fall of 2006, and will replace the EXOGEN 2000+(TM). The EXOGEN 4000+ Bone Healing System offers the same patented ultrasound signal and same great results, but is easier to use and more compact. This device comes complete with a larger screen for easier visibility, a simple one-button operation, and a much louder audio beep to signal operation. Smith & Nephew is a global medical technology business, specializing in Orthopaedic Trauma & Clinical Therapies, Orthopaedic Reconstruction, Endoscopy and Advanced Wound Management products. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies. Smith & Nephew is dedicated to helping improve people's lives. The company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust. The company has more than 8,500 employees and operates in 33 countries around the world and generated sales of nearly $2.6 billion. July 18th: Abbott Announces Approval of First Fully-Automated Blood Screening Tests for Hepatitis B Surface Antigen Abbott announced today it received approval from the U.S. Food and Drug Administration for its ABBOTT PRISM® hepatitis B surface antigen (HBsAg) and its PRISM® HBsAg Confirmatory test. These tests can be used by laboratory technicians to screen donated blood for HBsAg. Used in more than 30 countries, the PRISM system was recently approved for use in the United States with its first hepatitis B test, PRISM® HBcore, introduced in October. Additional hepatitis and retrovirus screening tests are currently under FDA review. Abbott is a leader in ensuring the safety of the world's blood supply. In 1985, Abbott developed the first HIV blood-screening test approved in the United States. The PRISM instrument consolidates testing into a single system, automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The PRISM system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift. Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. July 24th: TyRx Pharma, Inc Announces FDA Clearance of PIVIT(TM) AB, a Novel Antimicrobial-Coated Surgical Mesh TyRx Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for PIVIT(TM) AB, a new surgical mesh product coated with a proprietary bioresorbable polymer containing the antimicrobial agents rifampin and minocycline. TyRx expects to launch this new surgical mesh during the 3rd quarter of 2006. PIVIT(TM) AB is indicated for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The antimicrobial coating is designed to help provide protection from microbial colonization of the device during surgical implantation. According to Infection Control Today (8/2003), the average cost of each infection related to invasive medical devices varies from $34,000 to $56,000; these infections incur an annual financial burden up to $2.3 billion to the American healthcare system. The New England Journal of Medicine (N Engl J Med 2004;350:1422-9) states about half of the 2 million cases of nosocomial infection that occur each year in the United States are associated with indwelling devices. Infections associated with surgical implants are generally more difficult to manage because they require a longer period of antibiotic therapy and repeated surgical procedures. TyRx was organized in 1998 to commercialize a novel combinatorial chemistry-based biomaterials technology licensed exclusively from Rutgers, The State University of New Jersey, using substances such as tyrosine to build medical-grade biodegradable polymers. Using proprietary polymerization processes, TyRx efficiently creates customized polymers to meet precise product specifications. TyRx is deploying its capabilities across a broad range of combination products. The combination products sector (products incorporating both a drug & a device component) is expected to be the highest growth segment of the medical products industry and TyRx is positioned to be an innovative applications leader in the space.
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