Healthcare Industry News:  uterine fibroids 

Devices

 News Release - August 17, 2009

BioSphere Medical Announces New Journal Articles Published Discussing Uterine Fibroid Embolization

New England Journal of Medicine and American Journal of Obstetrics & Gynecology both Discuss UFE as a Choice for Appropriate Patients

ROCKLAND, Mass., Aug 17--(HSMN NewsFeed)--BioSphere Medical, Inc. (NASDAQ: BSMD ) (“BioSphere” or the “Company”) – a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – today reported two journal articles on uterine fibroid embolization (UFE): the New England Journal of Medicine has published a feature article concluding that UFE should be discussed as a choice for an appropriate patient who wishes to avoid hysterectomy for the treatment of fibroids; the American Journal of Obstetrics & Gynecology has published a review concluding that UFE is an option that all physicians may wish to discuss with all patients who are being offered surgical solutions.

The NEJM article, authored by Scott C. Goodwin, M.D. of the Department of Radiological Sciences, University of California at Irvine, Orange and James B. Spies, M.D. M.P.H, of the Department of Radiology, Georgetown University Medical Center, Washington, D.C. was published on August 13, 2009 (http://www.sirweb.org/news/newsPDF/Release_UFE_NEJM_final.pdf). The authors present a case vignette with a recommendation for treatment with UFE following a review of clinical options and adverse events for both the procedure and hysterectomy. They also note in the article that the American College of Obstetricians and Gynecologists has issued guidelines based on good and consistent Level A evidence that “uterine artery embolization is a safe and effective option for appropriately selected women who wish to retain their uteri.”

The AJOG article was authored by Linda D. Bradley, M.D. of the Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, Ohio, with partial funding from BioSphere Medical, and was published in the August 2009 issue. In the article, Dr. Bradley reviews the clinical research, discusses benefits and drawbacks and presents recommendations for patient triage prior to UFE. She also notes that “a collaborative and multidisciplinary practice between gynecologists and interventional radiologists represents state-of-the-art care for women with fibroids. With such an approach, our patients can be given a truly informed consent.”

Richard Faleschini, BioSphere’s president and chief executive officer, said, “The New England Journal of Medicine is a very prestigious journal, and its influence is far reaching. We are very pleased that uterine fibroid embolization has been highlighted in the Clinical Therapeutics feature of the Journal as a key treatment option for women with symptomatic fibroids who have been evaluated appropriately. In addition, the review article in the American Journal of Obstetrics & Gynecology is an excellent primer about UFE for gynecologists and primary care physicians, and advocates the best practice of cross-specialty consultation and collaboration to provide women with fibroids the best care. We believe that women with fibroids should be provided with meaningful comparative information on all treatment options so that they may make an informed decision and choice. And, we are confident that if nonsurgical UFE is the suitable choice, that all constituencies win because, when compared to the surgical alternatives, UFE provides safe and effective clinical outcomes, low relative complications, a quick return to the activities of daily living, and favorable economics for patients, providers, and payers. This is a great combination, particularly in the current economic and healthcare environment. Thus, we expect that as these two journal articles are disseminated to and absorbed by women’s physicians, the adoption of UFE will continue to expand.”

About BioSphere Medical, Inc.

BioSphere Medical, Inc. seeks to pioneer and commercialize 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 use of its products for 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 About Web Site References

BioSphere cautions you that this press release contains a link to a Web site that is not operated, reviewed or controlled by BioSphere. BioSphere assumes no responsibility for the information or statements found on this or other Web sites, and such information and statements are not incorporated by reference into this press release.

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, statements regarding the expected benefits of the Company’s sales and marketing strategies, the Company’s plans for growing its interventional oncology business, the Company’s expectations regarding the benefits of its agreement with Nippon Kayaku and the Company’s plans to develop its liver cancer program and grow revenue correspondingly. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intends," "looking forward," 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, including, without limitation, risks relating to:
  • the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products;
  • the failure of the Company to increase the rate of UFE procedures, and concomitant use of its products for UFE, with its sales and marketing strategies;
  • 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, including, without limitation, the risk that the Company will not gain necessary regulatory approvals to market and sell its products in Japan through its agreement with Nippon Kayaku;
  • the Company’s ability to obtain and maintain patent and other proprietary protection for its products and product candidates;
  • the absence of, or delays or cancellations of, product orders;
  • delays, difficulties or unanticipated costs in the introduction of new products;
  • competitive pressures;
  • the risk of adverse outcomes in the Company’s previously disclosed product liability claims, which could adversely impact market acceptance of products and materially adversely affect the Company’s operating results;
  • the inability of the Company to successfully execute on its plans and strategies for future growth, including its plans to grow its business in both the UFE and interventional oncology fields and its plans for international growth;
  • 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, both domestic and abroad; and
  • risk factors described in the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and the Form 10-Q for the quarter ended March 31, 2009 each 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.


Source: BioSphere Medical

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