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BioSphere Medical Reports First Quarter 2005 Financial Results.


ROCKLAND, Mass. -- Company records highest quarterly sales to date with sales growth of 39% in the first quarter of 2005 compared to the first quarter of 2004

BioSphere biosphere, irregularly shaped envelope of the earth's air, water, and land encompassing the heights and depths at which living things exist. The biosphere is a closed and self-regulating system (see ecology), sustained by grand-scale cycles of energy and of  Medical, Inc. (Nasdaq: BSMD), a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids Uterine Fibroids Definition

Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer.
, hypervascularized tumors and vascular malformations by a procedure called embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun)
1. the process or condition of becoming an embolus.

2. therapeutic introduction of a substance into a vessel in order to occlude it.
, today reported that total revenues for the first quarter of 2005 were $4.43 million, compared with total revenues of $3.18 million for the corresponding period in 2004, an increase of 39.3%. In the first quarter of 2005 revenues in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  were $2.92 million compared to revenues of $1.97 million in the first quarter of 2004. Revenues outside of the United States were $1.51 million for the first quarter of 2005, compared to revenues of $1.21 million for the first quarter of 2004.

Selling, general and administrative expenses increased to $3.06 million for the first quarter of 2005 compared to $2.49 million for the first quarter of 2004, reflecting increased spending in sales and marketing expenses related to the Company's utilization, penetration and conversion marketing initiatives. Research and development expenses were $.80 million for the first quarter of 2005, compared to $.59 million for the first quarter of 2004 due to increased spending for the Hepasphere SAP(TM), TempRx(TM) and next generation delivery system development programs.

The net loss applicable to common stockholders for the first quarter of 2005 was $1.35 million, or $0.09 per basic and diluted share. This compares with a net loss of $1.56 million, or $0.11 per basic and diluted share, for the first quarter of 2004.

At March 31, 2005, the Company had cash, cash equivalents and marketable securities Marketable Securities

Very liquid securities that can be converted into cash quickly at a reasonable price.

Notes:
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has
 of $8.68 million.

"We are pleased with our sequential revenue growth over quarter 4, 2004 " said Richard Faleschini, BioSphere Medical's President and Chief Executive Officer. " Focused local sales and market development initiatives resulted in especially strong sales performance in the United States, with 48% revenue growth over the same period last year. Our revenues outside the United States showed strong double digit Noun 1. double digit - a two-digit integer; from 10 to 99
integer, whole number - any of the natural numbers (positive or negative) or zero; "an integer is a number that is not a fraction"
 growth as well," said Faleschini.

Significant activities in the first quarter of 2005 and subsequent weeks include:

--Record quarterly worldwide revenues increase 39.3% year-over-year.

--Publication in the January 2005 issue of Obstetrics and Gynecology obstetrics and gynecology

Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system.
 of the 555 patient uterine artery embolization Uterine artery embolization (UAE) or Uterine Fibroid Embolization (UFE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the fibroids. See also
  • Uterine fibroids
  • Embolization
 (UAE (Uninterruptible Application Error) The name given to a crash in Windows 3.0. In subsequent versions of Windows, a crash was called a "General Protection Fault," "Application Error" or "Illegal Operation." See crash in Windows and abend. ) study conducted by the Ontario UFE UFE Uterine Fibroid Embolization
UFE United for a Fair Economy
UFE Ufficio Federale dell'Energia
UFE Uniform Final Examination
UFE Urban Challenge Final Event (DARPA)
UFE Unidentified Flags and Ensigns
UFE Unrestricted Free Agent
 Collaborative Group (Pron et el) which reported 21 of 35 women (60%) actively seeking to become pregnant conceived.

--Inclusion of uterine artery embolization in the new American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S.  (ACOG ACOG American College of Obstetricians and Gynecologists.
ACOG American College of Obstetricians & Gynecologists
) patient education brochure as a treatment option for women with symptomatic uterine fibroids.

--February 2005 presentation by James B. Spies, M.D. of one-year follow-up on 1701 patients from the 72- site FIBROID fibroid /fi·broid/ (fi´broid)
1. having a fibrous structure; resembling a fibroma.

2. fibroma.

3. leiomyoma.

4. in the plural, a colloquial term for leiomyoma of the uterus.
 Registry (Fibroid Registry for Outcomes Data) at the Advances in Uterine uterine /uter·ine/ (u´ter-in) pertaining to the uterus.

u·ter·ine
adj.
Of, relating to, or in the region of the uterus.
 Leiomyoma Research: 2nd NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
 International Congress, which reported substantial improvement in symptoms and quality of life in more than 85% of patients (to be submitted for publication).

--A study published in the February issue of Journal of Vascular and Interventional Radiology interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade  (JVIR JVIR Journal of Vascular and Interventional Radiology ) described the use of Embosphere(R) Microspheres for portal vein portal vein
n.
A wide short vein that is formed by the superior mesenteric and splenic veins behind the pancreas, ascends in front of the inferior vena cava, and divides into right and left branches that ramify within the liver.
 embolization. Portal vein embolization is a preoperative pre·op·er·a·tive
adj.
Preceding a surgical operation.



preoperative

preceding an operation.


preoperative care
the preparation of a patient before operation.
 procedure that causes an increase in the volume of the nonembolized portion of the liver, resulting in decreased postoperative morbidity, and an increased number of patients who are eligible for potentially curative liver resection Liver resection refers to the removal of the whole liver (which would be fatal in a living person) or one or more of its vascular segments. It is commonly done as a treatment for malignant tumors, such as hepatoma (liver cancer) or metastases from other cancers. . The authors concluded that Embosphere(R) Microspheres provided significantly improved volumetric volumetric /vol·u·met·ric/ (vol?u-met´rik) pertaining to or accompanied by measurement in volumes.

vol·u·met·ric
adj.
Of or relating to measurement by volume.
 outcomes and resection rates, compared with nonspherical PVA PVA

polyvinyl alcohol.
 particles.

--Publication in the March BJOG BJOG British Journal of Obstetrics and Gynaecology  (Carpenter and Walker) of a study evaluating pregnancy following uterine artery embolization concluded, "This series adds to the growing number of reported cases of pregnancy following uterine artery uterine artery
n.
An artery with its origin in the internal iliac artery, with distribution to the uterus, the upper part of the vagina, the round ligament, and part of the uterine tube.
 embolisation for fibroids Fibroids
Benign tumors of muscle and connective tissue that develop within or are attached to the uterine wall.

Mentioned in: Menstrual Disorders
. Although small, there is certainly an increase in delivery by caesarean section caesarean section: see cesarean section. . There does not appear to be any other major excess obstetric ob·stet·ric or ob·stet·ri·cal
adj.
Of or relating to the profession of obstetrics or the care of women during and after pregnancy.



obstetrical, obstetric

pertaining to or emanating from obstetrics.
 risk associated with these pregnancies when the demographics of the population in question is considered."

--Long-term data presented by James B. Spies, M.D. at the recent Society of Interventional Radiology (SIR) meeting showed UFE is an effective long-term treatment (73% success rate at five years), and the duration of symptom control is equal or better than myomectomy.

--Established a second distributor in Japan, DVx Inc., to obtain approval for and market our delivery systems products in this strategically important market.

The Company will host its quarterly conference call today at 11 A.M. (ET). The number to dial into the call is 1-888-603-7990 or 1-706-679-7298 and the conference ID is 5555828. Please call in approximately ten minutes before the call is scheduled to begin. A live web cast of the conference call will also be available on the BioSphere Medical web site. A replay of this conference call will be available from 2:00 P.M. (ET) today through 2:00 P.M. on May 12, 2005. The replay can be accessed by dialing 1-800-642-1687 or 1-706-645-9291 access code 5555828 or you can visit the "Investor" section of our company web site at www.biospheremed.com.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on applying its proprietary microsphere Not to be confused with Glass microphere.
This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life.
 technology to medical applications using embolotherapy techniques. The Company's core technologies, patented bio-engineered polymers and manufacturing methods, are used to produce miniature spherical beads with uniquely 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 Uterine Fibroid Embolization Definition

Uterine fibroids are growths in the muscular tissue of the womb (uterus). Uterine fibroid embolization is non-surgical removal of the growths through the use of a tubular device called a catheter.
, 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.

BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, the European Community, and Latin America which allows the Company to sell its products for use in general embolization procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) and uterine artery embolization (UAE) are generally used inter-changeably in the literature. The most common side-effect of uterine fibroid embolization (UFE) is "post-embolization syndrome", a collection of symptoms including abdominal pain, discomfort, low grade fever, and nausea. UFE is currently contraindicated for women who are, or who intend to become, pregnant, because the effects of UFE on the ability of a woman to conceive, and to carry a fetus to term, have not been determined.

Cautionary Statement Regarding Forward-Looking Statements - This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including without limitation statements regarding the Company's expectations with regard to the expected benefits of the Company's sales and marketing strategies. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should" 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 and its distributors to successfully market and sell the Company's products; 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 successfully develop, commercialize and achieve widespread market acceptance of its products, including without limitation, widespread market acceptance of its lead product, Embosphere(R) Microspheres for the treatment of UFE; risks relating to 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; the inability of the Company to raise additional funds in the near term to finance the development, marketing, and sales of its products; and general economic and market conditions, as well as the risk factors described in the section titled " Factors That May Affect Future Results " in the Company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2004, 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.
Financial Tables Follow

                        BioSphere Medical, Inc.
----------------------------------------------------------------------
                    SELECTED FINANCIAL INFORMATION

                 CONSOLIDATED CONDENSED BALANCE SHEETS
              As of March 31, 2005 and December 31, 2004
                       (in thousands, unaudited)
----------------------------------------------------------------------

                                               March 31,  December 31,
                                                   2005          2004
                                            ------------  ------------
ASSETS

   Cash, cash equivalents and marketable
    securities                                 $  8,675      $ 10,222
   Accounts receivable, net                       3,127         2,999
   Inventories, net                               3,078         3,311
   Prepaid and other current assets                 424           222
   Property and equipment, net                    1,055         1,134
   Goodwill, net                                  1,443         1,443
   Other assets                                      62            60
                                            ------------  ------------

                     Total assets              $ 17,864      $ 19,391
                                            ============  ============

LIABILITIES AND STOCKHOLDERS' EQUITY
   Accounts payable and accrued expenses       $  3,663      $  4,188
   Debt and capital lease obligations               307           367
   Stockholders' equity                          13,894        14,836
                                            ------------  ------------

                     Total liabilities and
                      stockholders' equity     $ 17,864      $ 19,391
                                            ============  ============




            CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
          For the three months ended March 31, 2005 and 2004
          (in thousands, except per share amounts, unaudited)
----------------------------------------------------------------------


                                               Three Months Ended
                                                    March 31,
                                             -----------------------
                                                2005         2004
                                             ----------   ----------

Revenues                                     $  4,429     $  3,180

Costs and expenses:
   Cost of revenues                             1,541        1,562
   Research and development                       802          589
   Sales                                        1,503        1,296
   Marketing                                      617          391
   General and administrative                     943          805
                                             ----------   ----------

   Total costs and expenses                     5,406        4,643
                                             ----------   ----------

Loss from operations                             (977)      (1,463)
   Other income and expenses, net                (248)         (93)
                                             ----------   ----------

Net loss                                       (1,225)      (1,556)

   Preferred stock dividends                     (121)           -
                                             ----------   ----------

Net loss applicable to common stockholders   $ (1,346)    $ (1,556)
                                             ==========   ==========

Net loss per common share
   Basic and diluted                         $  (0.09)    $  (0.11)
                                             ==========   ==========

Weighted average common shares outstanding
   Basic and diluted                           14,391       13,976
                                             ==========   ==========
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Geographic Code:1USA
Date:Apr 28, 2005
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