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BioSphere Medical Appoints Alain Brunier President, European Operations; Pioneers in Embolotherapy Enhance Global Commercialization Efforts.


Business/Technology Editors

ROCKLAND, Mass.--(BW HealthWire)--June 6, 2000

BioSphere 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 Alain Brunier as the Company's president of its European operations. Brunier, who was formerly the managing director of France and North Africa for St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , brings to BioSphere Medical more than 30 years of experience in managing the European businesses of several medical device companies.

Brunier will assume his role effective June 26th and report to John Carnuccio, BioSphere Medical's president and chief executive officer, and will be responsible for managing the Company's sales, marketing, financial and manufacturing operations throughout Europe, the Middle East and Africa Europe, the Middle East and Africa, usually abbreviated to EMEA, is a regional designation used for government, marketing and business purposes. It is particularly common amongst North American based companies, who often divide their international operations into the . BioSphere Medical has received CE Mark approval for its product Embosphere(R) Microspheres in Europe, which allows the Company to sell the product 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
  • 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. ), in the 19 countries of the European Economic Area European Economic Area: see European Free Trade Association; European Union. . UAE is the occlusion 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.

Carnuccio stated, "The addition of Alain Brunier further strengthens our management team and should go far in enhancing BioSphere Medical's position as a leader in the growing European embolotherapy market. His knowledge of the European medical device market and his experience in building effective distribution channels will be valuable assets in our efforts to grow the presence of Embosphere(R) Microspheres in Europe."

Said Brunier, "I am very excited to be joining BioSphere at a time when the Company is aggressively implementing its global commercialization strategy. I look forward to using my experience to help the Company penetrate many emerging, high-volume embolization markets in Europe."

Brunier most recently served as managing director, France and North Africa at St. Jude Medical, a manufacturer of pacemakers and other medical devices used by cardiologists. Prior to that, he was the vice president and chief executive of Europe, Middle East and Africa for Telectronics, a manufacturer of pacemakers and implantable defibrillators. He also served as managing director, France for Oticon, a manufacturer of hearing aids. Brunier also has held senior management positions at SMAD SMAD Sowjetische Militäradministration in Deutschland (Soviet Military Administration in Germany)
SMAD School of Media Arts and Design (James Madison University)
SMAD Stella Maris Academy of Davao
 - HEMO France and Baxter - Travenol.

In addition to its CE Mark approval in Europe, BioSphere Medical received 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.
 510(k) clearance in April 2000 for Embosphere(R) Microspheres to treat hypervascularized tumors and arteriovenous malformations. In January 2000, BioSphere Medical received approvals which allow the Company to sell the product for use in general embolization procedures, including UAE, in Australia and Canada. In January 2000, the Company began Phase I clinical evaluations of Embosphere(R) 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.

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, including uterine fibroids, 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(R) Microspheres in Europe. 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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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Publication:Business Wire
Date:Jun 6, 2000
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