ROCKLAND, Mass. - (Business Wire)
BioSphere Medical, Inc. (NASDAQ: BSMD), a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, announced today that it supports the recent American College of Obstetricians and Gynecologists (ACOG) Committee on Ethics Opinion (Opinion No. 395, January 2008) entitled
“Surgery and Patient Choice.
” The Opinion recognizes growing patient autonomy, and acknowledges that
“increased patient access to information has prompted more patient-generated requests for surgical interventions not necessarily recommended by their physicians.
” “Patient autonomy and the concept of informed consent or refusal are central to issues regarding patient choice to have or not have a surgical procedure,” states the Committee. “It is the obligation of the obstetrician-gynecologist to fully inform the patient regarding treatment options and the potential risks and benefits of those options.” The Committee also states that physicians must have “a good understanding of the scientific evidence for and against” a procedure that a patient may request. “Once the physician is satisfied that the patient fully comprehends the options,” opines the Committee, “her autonomous decision ordinarily should be respected and supported.”
Richard Faleschini, BioSphere Medical’s president and chief executive officer, commented, “We appreciate the Committee’s guidance on this subject. Our opinion is consistent with theirs, particularly as it relates to the role of the ob/gyn in counseling patients on the various therapeutic options available to treat symptomatic uterine fibroids, including minimally invasive uterine fibroid embolization (UFE), and surgical options, such as hysterectomy and myomectomy.”
In the section titled “The Process of Decision Making,” the Committee on Ethics notes that the practice of evidence-based medicine involves physicians understanding the scientific basis of treatment and the strength of the evidence and applying the results of the strongest evidence available to medical decision making. They refer to the surgical treatment options for menorrhagia (heavy menstrual bleeding) associated with leiomyoma (uterine fibroids) as an example of how this process of decision making may be applied. The Opinion states:
- “When working with a patient to make decisions about surgery, it is important for obstetricians and gynecologists to take a broad view of the consequences of surgical treatment and to acknowledge the lack of firm evidence for the benefit of one approach over another when evidence is limited. For example, a discussion of treatment options for menorrhagia associated with leiomyoma should include the fact that the long-term risks and benefits of some treatment options have not been compared directly. Recommendation for a particular option is dictated by many factors, including patient age, leiomyoma size, bleeding severity, and coexisting medical conditions, but in many cases two or more therapeutic options probably would be regarded as equally medically sound. Comparing possible long-term complications of hysterectomy, such as bowel obstruction and loss of vaginal support, with the risks of more conservative surgical approaches, such as the possible need for future treatment of recurrent leiomyomata, is an important part of informed consent. Helping patients understand potential long- and short-term consequences of any given decision as well as giving patients an appreciation of the quality of evidence on which each option is based are critical parts of informed consent.”
Mr. Faleschini continued, “We believe that, in general, women’s sources of health care-related information are expanding, and that in many instances the quality of their information is improving. We also believe that women with fibroids are becoming better informed about the options available to treat symptomatic fibroids. We think, further, that better informed patients may stimulate more frank and open discussions between physicians and their patients and can foster the kind of approach to decision making that is advocated for in the Opinion. An important aspect of our marketing strategy for UFE for 2008 is centered on educating ob/gyns about UFE and its place in the treatment algorithm. We have developed several tools to take an evidence-based message about UFE directly to gynecologists by gynecologists, with a special emphasis on the peer-reviewed journal articles that have been published in the last three years, as well as the substantive benefits we believe ob/gyns gain by working collaboratively with their interventional radiology colleagues.”
About Uterine Fibroids
Benign fibroids are the most common types of tumor in a woman’s pelvis. According to the American College of Obstetricians and Gynecologists (ACOG), uterine fibroids occur in approximately 25% to 50% of all women, with the highest incidence reported in women aged 30 to 40 years. Uterine fibroids may cause abdominal, lower back, or rectal pain, abnormal bleeding, frequent urination, infertility, and other symptoms. Symptomatic uterine fibroids lead to approximately one third of all hysterectomies in the United States and to about 200,000 hysterectomies annually. More than 25% of all women will have a hysterectomy by the time they are 60 years old, making it the second most frequently performed surgical procedure (after cesarean delivery) for women of reproductive age in the United States.
About BioSphere Medical, Inc.
BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, seeks to pioneer and commercialize minimally invasive diagnostic and therapeutic applications based on its 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, or UFE. The Company's products continue to gain acceptance in this rapidly emerging procedure as well as in 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 expectation that its sales and marketing strategies will be effective in increasing awareness among patients, ob/gyn practitioners, and interventional radiologists of the availability and benefits of UFE as a treatment option for uterine fibroids. 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 both domestically and abroad, including, without limitation, widespread market acceptance of its lead products, Embosphere® Microspheres, HepaSphere™ Microspheres, QuadraSphere® Microspheres and its delivery system products, in each case for the specific indications for which such product has been cleared for marketing;
- 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 and delays, difficulties or unanticipated costs in the introduction of new products;
- 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;
- 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 failure of the Company to successfully execute on its business plans and strategies;
- 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-K for the year ended December 31, 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.
The forward-looking statements in this press release are made as of the date of this press release and the Company disclaims any obligation to update these forward-looking statements as a result of changed events, circumstances or otherwise.
BioSphere Medical, Inc.
Martin Joyce, 781-681-7925
Executive Vice President and
Chief Financial Officer
or
Investor Relations:
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President
