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HepaSphere(TM) Microsphere Initial European Clinical Experience to Be Presented at the International Symposium on Endovascular Therapy.


ROCKLAND, Mass. & ROISSY, France -- BioSphere Medical (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) (or "the Company") announced today that Dr. Mark Ryan, Consultant, Interventional Radiologist, Department of Radiology, St. James Hospital and Trinity College Dublin, will present "HepaSphere: A new Embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism.

em·bol·ic
adj.
1. Relating to, or caused by an embolus or embolism.

2. Relating to emboly.
 for the Treatment of Liver Cancer Liver Cancer Definition

Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types.
," at the International Symposium on Endovascular Therapy The International Symposium on Endovascular Therapy (ISET) is an educational meeting for physicians, scientists, engineers and allied health professionals working in the multidisciplinary field of peripheral and cardiac interventional medicine.  on January 25, 2006 in Miami, Florida. Dr. Ryan's presentation will focus on HepaSphere 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.
 product attributes, animal data, early clinical experience, and the HepaSphere patient registry in Europe.

Recently, physicians in Europe have utilized the Company's proprietary HepaSphere Microspheres in treatment protocols for patients with primary liver cancer. These initial clinical cases follow the September 2005 introduction of HepaSphere Microspheres to European interventional radiologists at the meeting of the Cardiovascular and Interventional Radiological Society of Europe The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is the professional body of European interventional radiologists. The Society, which has its headquarters in Vienna, Austria, was founded in 1985 and currently comprises approximately 1,300 members from  (CIRSE CIRSE Cardiovascular and Interventional Radiological Society of Europe ). The Company has CE Mark approval in Europe for HepaSphere Microspheres for the 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.
 of liver tumors.

Richard Faleschini, president and chief executive officer of BioSphere Medical, commented, "Although early, we are pleased with the initial responses we have received from the European medical community regarding the use of HepaSphere Microspheres in the treatment of liver cancer. The rising incidence of primary liver cancer in Europe mirrors its growth around the world, where an estimated 600,000 patients are afflicted. We expect HepaSphere Microspheres will provide physicians flexibility and additional options in treating the large number of patients with liver cancer, which we believe will drive market acceptance."

HepaSphere Microspheres are designed to embolize hypervascularized tumors via a minimally invasive, catheter-based procedure. The purpose of the procedure is to occlude (programming) occlude - (Or "shadow") To make a variable inaccessible by declaring another with the same name within the scope of the first.  the blood vessels Blood vessels

Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names.
 feeding the tumor, causing tumor infarction.

Gary Saxton, executive vice president and chief operating officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 of BioSphere, added, "We are encouraged by the initial experience that European interventional radiologists are having with HepaSphere Microspheres for use in the treatment of liver cancer. Its ease of use and handling characteristics appear to be favorable and fit well within existing embolization protocols."

BioSphere filed a 510(k) notification in the third quarter of 2005 with the U.S. Food and Drug Administration, or 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.
, seeking regulatory approval for use of the product in the United States for embolization of hypervascularized tumors and peripheral arteriovenous malformations. The Company expects marketing clearance in the United States in the first half of 2006.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, pioneers and commercializes minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization Uterine Fibroid Embolization Definition

Uterine fibroids are growths in the muscular tissue of the womb (uterus). Uterine fibroid embolization is non-surgical removal of the growths through the use of a tubular device called a catheter.
, or UFE UFE Uterine Fibroid Embolization
UFE United for a Fair Economy
UFE Ufficio Federale dell'Energia
UFE Uniform Final Examination
UFE Urban Challenge Final Event (DARPA)
UFE Unidentified Flags and Ensigns
UFE Unrestricted Free Agent
. The Company's products continue to gain acceptance in this rapidly emerging procedure as well as in a number of other new and established medical treatments.

BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, the European Community and Latin America, which allow the Company to sell its products for use in general embolization procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) 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
  • Embolization
 (UAE (Uninterruptible Application Error) The name given to a crash in Windows 3.0. In subsequent versions of Windows, a crash was called a "General Protection Fault," "Application Error" or "Illegal Operation." See crash in Windows and abend. ) are generally used interchangeably in the literature. The most common side effect of UFE is "post-embolization syndrome," a collection of symptoms including abdominal pain, discomfort, low-grade fever and nausea. UFE is currently contraindicated for women who are, or who intend to become, pregnant, because the effects of UFE on the ability of a woman to conceive, and to carry a fetus to term, have not been determined.

Cautionary Statement Regarding Forward-Looking Statements - This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including, without limitation, statements regarding the Company's expectations with regard to market acceptance and market penetration for its HepaSphere Microsphere product, expectations as to the percentage of cases in which the product could be used and the expected receipt and timing of marketing approval from the FDA regarding the Company's HepaSphere product. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should" and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. There are a number of important factors that may affect the Company's actual performance and results and the accuracy of its forward-looking statements, many of which are beyond the Company's control and are difficult to predict. These important factors include, without limitation, risks relating to: the failure of the Company and its distributors to successfully market and sell the Company's products; 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 and product candidates; the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of its lead product, Embosphere(R) Microspheres for the treatment of UFE and its HepaSphere Microspheres product for the treatment of liver cancer; risks relating to the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates; the absence of or delays and cancellations of, product orders; delays, difficulties or unanticipated costs in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds in the near term to finance the development, marketing, and sales of its products; and general economic and market conditions, as well as the risk factors described in the section titled "Factors That May Affect Future Results" in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company anticipates that subsequent events and developments may cause its forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances after the date of this press release.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jan 19, 2006
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