News
BioSphere Medical Highlights Scheduled Presentations and Abstracts at the 2008 SIR 33rd Annual Scientific Meeting
ROCKLAND, Mass.-(Business Wire)-March 14, 2008 - BioSphere Medical, Inc. (NASDAQ: BSMD) today announced that a satellite symposium, podium presentations, and key abstracts related to the Company's embolic products for the treatment of symptomatic uterine fibroids, liver cancer and arteriovenous malformations have been accepted at the Society for Interventional Radiologists (SIR) 33rd Annual Scientific Meeting being held March 15-20, 2008 in Washington, D.C. BioSphere's booth number is 1213.
Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "The SIR meeting is one of the premier annual events for interventional radiologists from around the world. Attending the SIR is an important component of our overall growth strategy. We intend to use this forum to showcase the current and potential future clinical applications of BioSphere's embolic technologies and products, as well as promote our belief that good patient care and the economic interests of the key constituent providers are best aligned when hospitals, referring physicians, and interventional radiologists work collaboratively. We invite the participants of this year's SIR meeting to visit our booth, join us at our satellite symposium, and attend the presentations highlighted in this press release."
The highlights of BioSphere's participation at SIR 2008 will include:
Satellite Symposium
BioSphere will host a satellite symposium entitled "There Has Never Been a Better Time for UFE" to discuss how physicians can build a practice with uterine fibroid embolization, or UFE, as a cornerstone on Tuesday, March 18 from 6:30 p.m. to 8:00 p.m. local time. The moderator of the panel will be James B. Spies, M.D., a world-renowned authority on UFE and professor of radiology and chairman and chief of service in the Department of Radiology at Georgetown University School of Medicine. Joining Dr. Spies on the panel will be: John Lipman, M.D., FSIR, director of interventional radiology at Emory-Adventist Hospital in Atlanta, GA; Robert K. Zurawin, M.D., associate professor of Obstetrics and Gynecology at Baylor College of Medicine; and Leah Amir, MS, MHA, who is chief executive officer and president of VantageView and VantageLinks, LLC, and executive director of the Institute for Quality Resource Management.
During the symposium, supermodel Beverly Johnson will give an account of her personal experience with fibroids, and how, as a result, she has become an advocate for women and their right to know about all their treatment options before having a hysterectomy. Ms. Johnson will also share her view that there are unanticipated consequences related to surgical procedures like a hysterectomy, and that UFE is a treatment option about which the millions of women with symptomatic fibroids must know more.
An invitation to attend this satellite symposium may be obtained from any BioSphere representative at the Company's booth.
Interventional Gynecology (UFE)
— "Community Awareness of UAE as a Treatment Option for Women Suffering with Symptomatic Fibroids." J.C. Lipman. This study assesses the awareness of UFE as a treatment option for women suffering from symptomatic uterine fibroids.
— "Feasibility of Uterine Artery Embolization in an Outpatient Setting." J.C. Lipman, et al. The authors evaluate the feasibility of performing UFE to treat symptomatic uterine fibroids in an outpatient setting.
— "When Sound Fails: Efficacy of Uterine Artery Embolization for Focused Ultrasound Surgery Therapeutic Failures." A. Suzuki, et al. This study presents a retrospective evaluation of the re-treatment efficacy of UFE in patients who underwent the procedure after therapeutic failures of focused ultrasound surgery (FUS).
Interventional Oncology (Liver)
— "Chemoembolization of Unresectable HCC with Embolizing Microspheres Loaded with Chemotherapeutic Agent." M. Grosso, et al. This study presents the results of an Italian multicenter registry using BioSphere's HepaSphere(TM) Microspheres loaded with chemotherapeutic agents doxorubicin or epirubicin for transcatheter arterial chemoembolization, or TACE, in patients with unresectable hepatocellular carcinoma, or HCC.
— "Doxorubicin-Loaded QuadraSphere: Plasma Pharmacokinetics and Intratumoral Drug Concentration." K.-H. Lee, et al. Researchers evaluate the in vivo drug release of BioSphere's QuadraSphere(R) Microspheres in transcatheter arterial chemoembolization (TACE) using the Vx-2 rabbit model.
— "Hepatic Arterial Embolization with Doxrubicin-Loaded Superabsorbent Polymeric Microspheres in an Animal Model." S. Gupta, et al. This study reports on the preliminary experience of researchers using hepatic arterial embolization with superabsorbent polymeric microspheres - BioSphere's QuadraSphere Microspheres - loaded with doxorubicin in a rabbit liver tumor model.
— "Arterial Patency Following Repeated Hepatic Artery Particle Embolization." J.P. Erinjeri, et al. The authors evaluate hepatic arterial patency following serial bland embolization procedures in patients with HCC.
— "Management of Hepatic Neuroendocrine Metastases with Bland Hepatic Arterial Embolization." C.T. Sofocleous, et al. This study updates the clinical outcome of bland hepatic arterial embolization in the management of neuroendocrine metastases.
— "Radiofrequency Ablation Combined with Chemoembolization for the Treatment of Large Hepatocellular Carcinomas." H. Takaki, et al. This study evaluates whether radiofrequency ablation combined with chemoembolization is a useful therapeutic option for the treatment of large HCC measuring greater than 5 cm.
— "Distribution of Iron Oxide Embospheres after TAE in the Vx-2 Liver Tumor: Evaluation with MR Imaging and Pathology." K.-H. Lee, et al. This study investigates the distribution of two different sizes (100-300 and 300-500 um) of Iron Oxide Embospheres in an animal model of liver cancer by MR imaging and histopathology.
Other Topics
— "Prostatic Artery Embolization as a Primary Treatment for Benign Prostatic Hyperplasia in a Canine Model." S. Faintuch, et al. The authors assess the feasibility, safety and outcomes of prostatic artery embolization (PAE) as a treatment modality for benign prostatic hyperplasia (BPH) in a canine model, and envision a near-term human study.
— "Hospital-IR Relations—'Are You a Profit Center or a Cost Center?'" David Lawrence, The Advisory Board Company, and Curtis Lewis, M.D., MBA, JD, and a fellow of the Society of Interventional Radiology. This presentation shows how interventional radiology can provide excellent clinical care and outcomes and a compelling economic value proposition to the hospital and the community they serve.
— "Percutaneous Varicocele Embolization in Symptomatic and Subfertile Populations: A Single Institution Experience." Mujoomdar, et al. The study assesses: a) the technical success rates of percutaneous varicocele embolization, b) clinical success rates in a population with symptomatic varicoceles, and c) changes in seminal parameters in those undergoing the procedure for infertility.
— "How Far Do They Go? A Direct Comparison of Two Spherical Embolic Agents in Porcine Kidneys." C. Reilly, et al. Spherical embolic agents are a relatively new emergence for embolization procedures. The authors evaluate and directly compare the sites of occlusion of spherical tris-acryl gelatin microspheres (BioSphere's Embosphere(R) Microspheres) with spherical PVA particles (Boston Scientific's Contour PVA) in a porcine model.
— "Free-Standing IR Practice Business Model in Interventional Radiology." J.L. Friese, et al. The authors examine the benefits and risks of the freestanding IR practice and business model.
— Evolution of the Inflammatory Response on Two Acrylic Embolics. Typing and Quantification by IHC." J. Namur, et al. This study compares the different cell types of the foreign body reactions, which develop on acrylic glue and acrylic microspheres during time, and to detect a long-term toxicity.
In addition to the published agenda, the SIR will hold two press conferences highlighting topics of important interest to the public and the latest advances in interventional radiology at the Walter E. Washington Convention Center, press conference room 203B on Monday, March 17, 9:00 a.m. to 10:30 a.m. ET and Tuesday, March 18, 9:00 a.m. to 10:30 a.m. ET.
About BioSphere Medical, Inc.
BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, seeks to develop and commercialize minimally invasive diagnostic and therapeutic applications based upon its pioneering 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 that are designed for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. 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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, the company's expectations regarding the current and potential clinical applications and patient and provider benefits of its embolic technologies and the expected benefits of its presence at the SIR meeting. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intends," 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's products to demonstrate adequate safety, efficacy and cost-effectiveness in clinical trials, post-clearance studies and commercial use;
— the failure of the Company to successfully achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of its lead product, Embosphere Microspheres, for the treatment of UFE, its HepaSphere Microsphere and QuadraSphere Microsphere products, and its delivery system product line;
— 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 develop and commercialize new applications for its technologies;
— 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 and the risk of product liability claims, either of which may impact market acceptance of products and adversely affect the Company's operating results;
— the inability of the Company to raise additional funds in the near term to finance the development, marketing, and sales of its products;
— general economic and market conditions; and
— statements set forth in the section titled "Risk Factors" in BioSphere's Quarterly Report on Form 10-Q for the quarter ended September 30, 2007, 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.
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