Inamed Demonstrates Execution of Growth Plan; BioEnterics Corp. Initiates Shipments of the Lap-Band System in the United States.Business Editors & Health/Medical Writers SANTA BARBARA, Calif.--(BUSINESS WIRE)--July 19, 2001 McGhan and DTA DTA Drive Through Appraisal DTA Data (File Name Extension) DTA Differential Thermal Analysis DTA Department of Transitional Assistance (Massachusetts) DTA Development Trusts Association have Received Registration Approval for Silicone Gel Breast Implants Breast Implants Definition Breast implantation is a surgical procedure for enlarging the breast. Breast-shaped sacks made of a silicone outer shell and filled with silicone gel or saline (salt water), called implants, are used. in Australia; FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Has Granted Approval for Production At Inamed's Los Carneros Plant Inamed Corp. (Nasdaq:IMDC IMDC Illinois Medical District (Chicago, IL) IMDC Integrated Mission Design Center (NASA) IMDC Isolated, Missing, Detained, or Captured (personnel recovery) ) today announced three significant business developments that further position the company for continued growth: BioEnterics Corp. initiated shipments of the Lap-Band(R) System in the United States; McGhan has received registration approval for silicone gel breast implants in Australia; and the FDA has granted approval for production at the Los Carneros plant. "This is an extremely exciting time for Inamed," said Richard G. Babbitt, Inamed's chairman and chief executive officer. "We are well-positioned to sustain our global franchise position in breast augmentation/reconstruction devices and dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. fillers, and expect our new obesity product -- the Lap-Band(R) System -- to have a significant impact to 2002 earnings. We will continue to focus on the growth of our strong and promising product portfolio while controlling costs, in order to increase shareholder value." Inamed's subsidiary, BioEnterics Corp., has begun shipping the Lap-Band(R) System Adjustable Gastric Banding System to United States hospitals. Babbitt said, "BioEnterics has supplied the FDA with the final product labeling as required by the premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) letter of June 5, 2001. The company has quickly and efficiently prepared for introduction of this innovative product, developing both patient and surgeon information as well as training materials." The Lap-Band(R) System is a minimally invasive approach to obesity surgery Obesity Surgery Definition Obesity surgery is an operation that reduces or bypasses the stomach or small intestine so that severely overweight people can achieve significant and permanent weight loss. . The band is inflatable and can be adjusted after surgery to customize patient treatment. The procedure is reversible and, unlike gastric bypass gastric bypass n. A surgical procedure used for treatment of morbid obesity, consisting of the severance of the upper stomach, anastomosis of the small upper pouch of the stomach to the jejunum, and closure of the distal part of the stomach. procedures, does not require cutting or stapling of the stomach, or gastrointestinal re-routing to bypass normal digestion. Patient benefits include reduced surgical trauma, complications, pain, scarring, and shorter hospitalization and recovery time compared with more invasive obesity surgeries. After surgery, patients can achieve significant and sustained weight loss, which has been demonstrated to improve health and quality of life. Ellen Duke, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BioEnterics, noted: "This concept has been under development and studied in the United States for 15 years. Internationally, where the Lap-Band(R) System has been used extensively since 1994, its positive impact on health and quality of life has been impressive and well documented. This experience has demonstrated the importance of the qualification and training of surgical centers, which is now required in the U.S. by the condition of FDA approval and the approved labeling." Obesity is the second-leading cause of preventable death in the United States, and an estimated 11 million American adults are severely obese. U.S. health care costs for treating obese adults have reached $238 billion, according to a 1999 study by the Lewin Group.(a) McGhan Medical International, a subsidiary of Inamed, and Device Technologies Australia, distributor of McGhan's breast implants, have received Australian Therapeutic Goods Administration The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. (TGA See TARGA. TGA - Targa Graphics Adaptor ) registration approval of McGhan's silicone gel breast implants. The company is the only approved source in Australia for silicone breast implants. The registration application, which was submitted to the Australian regulators in 1997, included in-depth data evaluating design, materials and testing, manufacture and quality control, biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. and human clinical experience. McGhan's saline breast implants have previously received registration in Australia. In addition, the FDA has reviewed McGhan Medical's submission for the Los Carneros plant in California and granted approval to commence production of breast implants at the new facility. The company expects production to begin during the third quarter of 2001. The new facility will allow Inamed to increase its manufacturing capacity while also increasing manufacturing efficiency. As previously announced, Nicholas Teti, formerly president and CEO of DuPont Pharmaceuticals Co., will join Inamed as president and CEO, and an Inamed board member, effective Aug. 1, 2001. Babbitt will remain chairman of the board. Babbitt continued, "We have outstanding prospects for continued growth, and under the leadership of Nick, who is very excited about these developments, and the rest of the management team, we will continue to take full advantage of the company's superb platform and increase shareholder value." About Inamed Corp. Inamed is a global surgical and medical device company engaged in the development, manufacturing and marketing of products for the plastic and reconstructive surgery, aesthetic medicine and obesity markets. Inamed sells a variety of lifestyle products used to make people look younger and more attractive, including breast implants for cosmetic augmentation and collagen-based facial implants to correct facial wrinkles and to improve lip definition. Inamed also sells products that address women's health issues, including breast implants for reconstructive surgery following a mastectomy mastectomy (măstĕk`təmē), surgical removal of breast tissue, usually done as treatment for breast cancer. There are many types of mastectomy. In general, the farther the cancer has spread, the more tissue is taken. , and devices that treat severe obesity and urinary incontinence. Note (a): Lewin Group, Costs of Obesity, American Obesity Association This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. Obesity Conference, September 1999 Forward Looking Statements This release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ or differ materially from those described in the forward-looking statements. For a full discussion of the risks and uncertainties, refer to recent SEC filings made by the company including, without limitation, the company's annual report on SEC form 10-K for fiscal 2000. |
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