Biosphere Medical Signs Strategic Supply Agreement With Inamed Corporation to Provide Microspheres for Dermal Applications.Business Editors and Health/Medical Writers ROCKLAND, Mass.--(BW HealthWire)--Jan. 4, 2001 Company Achieves Important Milestone in Developing Non-Embolotherapy Applications for its Proprietary 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 BioSphere Medical, Inc. (Nasdaq:BSMD), a medical device company that is pioneering the use of bioengineered microspheres in embolotherapy, today announced that it has entered into a strategic agreement with Inamed Corporation (Nasdaq:IMDC IMDC Illinois Medical District (Chicago, IL) IMDC Integrated Mission Design Center (NASA) IMDC Isolated, Missing, Detained, or Captured (personnel recovery) ) of Santa Barbara, California Santa Barbara is a city in California, United States. It is the county seat of Santa Barbara County, California. As of the 2000 census, the city had a total population of 92,325. to supply its microsphere technology for use in 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. applications. "We are very pleased with this significant technology milestone," said John Carnuccio, BioSphere Medical's president and chief executive officer. "Our strategic agreement with Inamed supports our strategy to use our proprietary microspheres as a platform technology for an array of high-growth, non-embolotherapy applications. Inamed, a major player in the dermal augmentation market, is an ideal partner for BioSphere Medical in this area." "Leveraging our platform technology is a key component of our long-term strategy. This agreement provides us an opportunity to immediately participate in non-embolotherapy markets while maintaining focus on our current embolotherapy market opportunities. In addition to the dermal market, we believe our microspheres may have potential uses in areas such as urinary incontinence Urinary Incontinence Definition Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. , gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. , gene therapy and cancer," concluded Carnuccio. Biosphere Medical currently markets its leading product, Embosphere(R) Microspheres, for 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. therapy in the United States. In addition, the company markets Embosphere(R) Microspheres for general and 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
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. . This clinical trial is being conducted under an 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) granted by the U.S. 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. . About BioSphere Medical, Inc. BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics. About Inamed Corp. Inamed Corp., based in Santa Barbara, California, is a global surgical and medical device company engaged in the development, manufacturing and marketing of products for plastic and reconstructive surgery, aesthetic medicine and obesity markets. Safe Harbor Statement This press release contains forward-looking statements that involve risks and uncertainties, including those relating to the ability of the Company to achieve necessary regulatory approvals for UAE, the success of its strategic alliance with Inamed Corporation, and the ability of the Company to successfully develop and commercialize its products for an array of applications, including without limitation the dermal market, urinary incontinence, gastroesophageal reflux disease, gene therapy and cancer. 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; failure to successfully develop and commercialize the Embosphere(R) Microspheres and HepaSphere SAP(TM) Microsphere technologies for uterine artery embolization, targeted liver embolization and other applications; failure 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 Company's Annual Report on form 10-K for the year ended December 31, 1999, the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2000, and other periodic reports filed by the Company with the Securities and Exchange Commission. |
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