BioSphere Medical Announces Study of Gynecologist-Interventional Radiologist Referral Relationships Published in Journal of M...
2010年4月13日 - 8:30PM
ビジネスワイヤ(英語)
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 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.
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