BioSphere Medical Announces Study of Gynecologist-Interventional Radiologist Referral Relationships Published in Journal of Minimally Invasive Gynecology

ROCKLAND, Mass.--(BUSINESS WIRE)--

BioSphere Medical, Inc. 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 that the Journal of Minimally Invasive Gynecology (JMIG) has published a study in its March/April issue which concluded that establishing a referral relationship with an interventional radiologist for comprehensive uterine myoma (fibroid) treatment supports a trusting, collaborative, long-term, noncompetitive ‘‘win-win’’ relationship between the gynecologist and radiologist, meets the patient’s desire for full disclosure of all myoma treatment options, improves the patient’s overall medical care and physician/patient experience, and has been demonstrated to improve patient flow to a gynecologist practice.

The JMIG article was authored by Robert K. Zurawin, M.D., John H. Fisher, II, M.D. and Leah Amir, M.S., M.H.A. of, respectively, the Department of Obstetrics and Gynecology, St. Lukes Episcopal Hospital, Baylor College of Medicine, Houston, Texas, and the Institute for Quality Resource Management, VantageView LLC, St. Louis, Missouri. The authors conducted a prospective study of referral sources, uterine artery embolization (also known as uterine fibroid embolization, or UFE) evaluation, patient decisions, and follow-up on 226 women presenting to an interventional radiologist seeking UFE for treatment of uterine fibroids, of which 138 were referred by a gynecologist and 88 self-referred. The purpose of the study was to investigate the course of fibroid treatment in these patients and to determine the effect of a cooperative referral network of interventional radiologists and gynecologists that informs patients about the options of UAE and minimally invasive surgical alternatives for fibroid treatment.

All patients in the study initially evaluated by the interventional radiologist were referred to a gynecologist. Overall, 62% of patients were candidates for UAE, and 38% underwent the procedure during the study period. Patients who did not receive UAE were returned to the referring gynecologist for further evaluation and treatment. Patients who underwent UAE were referred to a gynecologist for ongoing care. In all, 70% of self-referred patients and 92% of gynecologist-referred patients expressed satisfaction with their original gynecologist and were referred back to that physician. Patients who did not have a gynecologist or who were dissatisfied with their original gynecologist were referred to a network gynecologist for continued gynecologic care. In the study, 26 self-referred women were sent as new patients to gynecologists in the interventional radiologist's referral network, resulting in a 119% return on the original 138 gynecologist-to-interventional radiologist-referred patients. Among the 8% of gynecologist-referred women who switched to a different gynecologist within the referral network, the primary reason for dissatisfaction was the gynecologist's failure to fully disclose treatment options or offer desired minimally invasive procedures. On follow-up with a network gynecologist, eight newly referred patients underwent myoma surgery, and eight newly referred patients continued to be seen by that gynecologist. Four patients referred to the gynecologist for treatment were originally referred by the gynecologist to the interventional radiologist for UAE evaluation. Ten patients switched from their named gynecologist to a different gynecologist willing to disclose all treatment options for uterine myomas and able to provide minimally invasive surgical treatment as medically indicated. Of the 10 women who switched to this network gynecologist, eight underwent myoma surgery.

“The findings of our study emphasize the need for doctors to offer patients the full range of options available for the treatment of uterine fibroids. We hope that this paper will help educate both radiologists and gynecologists in achieving better ways of working together to provide the best care possible for women,” said Dr. Zurawin.

Richard Faleschini, BioSphere’s president and chief executive officer, said, “This study underscores the important benefits that women gain when their physicians collaborate to provide them all available treatment options and the best care. In addition, this study demonstrated, as we have observed in similar practice environments, that the benefits to the patients and the physicians can be quantified in terms of patient satisfaction and loyalty, as well as patient-referral flow. We hope that these data will encourage better collaboration between gynecologists and interventional radiologists, and strengthen the resolve of women to insist that physicians collaborate to provide them the best care, as reported in this study,” Mr. Faleschini concluded.

Robert K. Zurawin, M.D. is a current and active member of BioSphere’s Medical Advisory Board, and Leah Amir, M.S., M.H.A. is a health-care policy and reimbursement consultant for the Company. BioSphere Medical has compensated Dr. Zurawin as a member of the Company’s Medical Advisory Board, and Leah Amir for collection of data for this study.

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 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 patient care and UAE utilization benefits of gynecologist-interventional radiologist referral networks. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," “expects,” "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 development, commercialization, 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, and risks related to the Company’s ability to successfully obtain approval for and commence its planned pivotal clinical trial of QuadraSphere^® Microspheres loaded with doxorubicin for the treatment of primary liver cancer;
• 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 product liability claims against the Company;
• 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, 2009, 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.