BioSphere Medical Appoints Donald G. Anderson Vice President, U.S. Marketing; Pioneers in Embolotherapy Strengthen U.S. Commercialization Efforts.Business/Technology Editors & Health/Medical Writers ROCKLAND, Mass.--(BW HealthWire)--June 16, 2000 BioSphere biosphere, irregularly shaped envelope of the earth's air, water, and land encompassing the heights and depths at which living things exist. The biosphere is a closed and self-regulating system (see ecology), sustained by grand-scale cycles of energy and of Medical, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BSMD), a medical device company that is pioneering the use of bioengineered microspheres to treat tumors and vascular malformations by occluding their blood supply, announced today that it has named Donald G. Anderson as the Company's vice president of U.S. Marketing. Anderson, formerly the vice president of sales and marketing for Implemed, Inc., brings to BioSphere Medical more than 20 years of senior sales and marketing management experience with various medical device companies. Anderson assumed his role on June 12 and reports to John Carnuccio, BioSphere Medical's president and chief executive officer. He is responsible for managing the Company's marketing operations in the United States. BioSphere Medical has received 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. 510(k) clearance for its product Embosphere(R) Microspheres, which allows the Company to sell the product in the United States for use in hypervascularized tumors and arteriovenous malformations Arteriovenous Malformations Definition Arteriovenous malformations are blood vessel defects that occur before birth when the fetus is growing in the uterus (prenatal development). The blood vessels appear as a tangled mass of arteries and veins. . "With Don Anderson heading up our marketing organization in the U.S., we expect to advance BioSphere Medical's position as a leader in the growing market for embolotherapy in the United States," stated Carnuccio. His knowledge of the medical device market and his experience in building effective marketing teams and successfully opening distribution channels will be valuable in our efforts to grow the presence of Embosphere Microspheres in the United States." Said Anderson, "I look forward to using my experience to help the Company aggressively implement its commercialization strategy for the Embosphere Microspheres and to penetrate this explosive market." Anderson most recently served as vice president, sales and marketing for Implemed, Inc., a development stage medical company with antimicrobial technology. Prior to that, he held several sales and marketing management positions including vice president of worldwide sales at Strato/Unfusaid Inc., a manufacturer of vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing and implantable drug delivery systems. In addition to its FDA 510(k) clearance for Embosphere Microspheres, BioSphere Medical has received CE Mark approval in Europe and approvals in Australia and Canada, which allow the Company to sell Embosphere Microspheres for use in general embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun) 1. the process or condition of becoming an embolus. 2. therapeutic introduction of a substance into a vessel in order to occlude it. procedures, including uterine artery embolization Uterine artery embolization (UAE) or Uterine Fibroid Embolization (UFE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the fibroids. See also
1. obstruction. 2. the trapping of a liquid or gas within cavities in a solid or on its surface. 3. of the blood supply to uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. to reduce their size and alleviate associated symptoms. In January 2000, the Company began Phase I clinical evaluations of Embosphere Microspheres for use in UAE pursuant to the approval by the FDA of its separate Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) application. As of the date of this press release, patient enrollment in Phase I has been completed. BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company that is pioneering the use of proprietary bioengineered microspheres in embolotherapy - the occlusion of the blood supply to tumors and vascular malformations. Embolization is a procedure performed primarily by interventional radiologists to treat hypervascularized tumors and arteriovenous malformations throughout the body. This press release contains forward-looking statements that involve risks and uncertainties, including but not limited to the Company's ability to grow sales of Embosphere Microspheres in the United States, Europe, Canada and Australia. Among the important factors that could cause actual events to differ materially from those indicated by forward-looking statements in this release are the failure of the Company to achieve or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its products; to successfully develop and commercialize the Embosphere Microsphere Not to be confused with Glass microphere. This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life. technology for uterine artery embolization and other applications; to provide patent and other proprietary protection for the Company's products; the absence of, or delays and cancellations of, product orders; the delay in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds, if needed, to finance the development, marketing, and sales of its products; general economic conditions; as well as those risk factors detailed in the periodic reports filed by the Company with the Securities and Exchange Commission. |
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