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BioSphere Medical Reports 2007 Fourth Quarter and Year-End Financial Results.


Highlights

* Q4 2007 total revenue up 6% to $6.7 million from Q4 2006

* Q4 2007 gross margin increased to 72.3% of sales, compared to 70.2% in Q4 2006

* $1.24 million net cash generated from operations in Q4 2007

* Embosphere[R] Microspheres to commence sales in China during Q1 2008

* Previously announced U.S. sales force expansion nearly complete

* New initiatives to expand U.S. market for 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.
 in place

ROCKLAND, Mass. -- 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 NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: BSMD) ("BioSphere"), a medical device company that has 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 minimally invasive, image-guided medical procedure called embolotherapy, today reported that total revenue for the fourth quarter of 2007 increased 6% to $6.70 million from total revenue of $6.34 million for the fourth quarter of 2006. In the fourth quarter of 2007, revenue in the U.S. was $4.79 million, an increase of 5% compared to revenue of $4.58 million in the fourth quarter of 2006. Revenue in Europe, Mid-East and Africa (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) rose 18% to $1.78 million for the fourth quarter of 2007 from $1.51 million for the same period in 2006. In markets outside of 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.  and EMEA, revenue in Rest of World (ROW) markets declined by 48% to $0.13 million for the fourth quarter of 2007 from $0.25 million for the same period in 2006.

Gross margin rose to $4.85 million, or 72.3% of revenue, for the fourth quarter of 2007, from gross margin of $4.45 million, or 70.2% of revenue, for the fourth quarter of 2006.

Operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
 for the fourth quarter of 2007 were $5.26 million, compared to $4.86 million for the fourth quarter of 2006, an increase of 8%.

The net loss applicable to common stockholders for the fourth quarter of 2007 was $0.38 million, or $0.02 per basic and diluted share, compared to a net loss applicable to common stockholders of $0.33 million, or $0.02 per basic and diluted share, in the same period last year.

For the year ended December 31, 2007, total revenue rose to $26.90 million from $22.89 million in 2006, an increase of 18%. Revenue in the U.S. was $19.39 million, an increase of 18% from 2006. Compared to full year 2006, revenue in EMEA during 2007 rose 15% to $6.55 million, and revenue in Rest of World markets was $0.96 million, an increase of 32%.

The net loss applicable to common stockholders for the year ended December 31, 2007 narrowed to $2.41 million, or $0.14 per share, from a net loss of $2.85 million, or $0.17 per share, in 2006.

At December 31, 2007, BioSphere 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 $23.58 million. During the fourth quarter of 2007, the Company generated $1.24 million in operating cash flow Operating cash flow

Earnings before depreciation minus taxes. Measures the cash generated from operations, not counting capital spending or working capital requirements.
. For the full year 2007 operating cash flow was $0.33 million.

Company Believes that Improved Reimbursement in the Hospital Outpatient Setting, Peer-Reviewed Publication of Pivotal Clinical Data for 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
, Sales and Marketing Organization Expansion, Regulatory Approvals for Drug Delivery in EMEA, and Market Clearance for Embosphere Microspheres in China Create Catalysts for Potential Accelerated Revenue Growth in 2008

Richard Faleschini, BioSphere Medical's President and Chief Executive Officer, said, "For the third consecutive year, BioSphere generated year-over-year increased annual revenues, a higher gross margin, and a narrowed net loss. There have been a number of very positive accomplishments that we believe position the Company quite well: the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and  (CMS (1) See content management system and color management system.

(2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system.
) significantly improved reimbursement for UFE in the hospital outpatient setting; several peer reviewed journals published validating clinical data on UFE and BioSphere's embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism.

em·bol·ic
adj.
1. Relating to, or caused by an embolus or embolism.

2. Relating to emboly.
 products; and, we significantly strengthened our worldwide sales and marketing organization, obtained important regulatory approvals supporting our interventional oncology business, received market clearance for Embosphere Microspheres in China, and entered into an important strategic collaboration with DuPont Applied BioSciences. We expect that these important developments may be catalysts for potential revenue growth in 2008 and beyond.

"Our primary focus in 2008 is seeking to accelerate growth in the UFE market in the United States by promoting minimally invasive, uterus-sparing UFE to our key constituents--hospitals, interventional radiologists, gynecologists, and women with symptomatic fibroids Fibroids
Benign tumors of muscle and connective tissue that develop within or are attached to the uterine wall.

Mentioned in: Menstrual Disorders
. We are systematically rolling out programs for each of these constituents that have been developed in partnership with successful interventional radiologists, high-volume referring gynecologists, hospital administrators, reimbursement experts, the Society of 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 , and service providers skilled at educating physicians and targeting patients and channeling them to physicians who are value-added resellers of UFE. In an effort to effectively execute our strategies and the associated programs, we are continuing our previously announced expansion of our U.S. sales organization from 18 to 24 sales professionals and from three regions to four. We expect this expansion will be completed by the end of this quarter. We further expect that these initiatives could increase our market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market
penetration - the act of entering into or through something; "the penetration of upper management by women"
, further advance embolotherapy as a first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy.  modality, and enhance the long-tem value of BioSphere for our shareholders."

Mr. Faleschini concluded, "BioSphere is continuing to advance toward its goal of becoming a successful global medical device company. We have the leading position in the market, a consistent record of annual sales growth, and a financial position at December 31, 2007 that is the strongest in the Company's history. We have established a solid platform from which to launch the next phase of our growth, and we are confident in our ability to successfully execute our plan."

Significant highlights, activities and developments in the fourth quarter of 2007 and subsequent weeks included:

* Fourth quarter 2007 worldwide sales of embolics used in interventional gynecology or UFE rose 3% to $4.52 million from the fourth quarter of 2006, which was comprised of U.S. sales of $3.79 million, an increase of 2%, and sales outside of the U.S. of $0.73 million, an increase of 9%, compared to the fourth quarter of 2006.

* Fourth quarter 2007 worldwide sales of embolics used in interventional oncology rose 23% to $1.18 million compared to the same period last year, which was comprised of U.S. sales of $0.80 million, an increase of 20%, and sales outside of the U.S. of $0.38 million, an increase of 27%, compared to the fourth quarter of 2006.

* Full-year 2007 total revenue for embolics, delivery systems and licensing was $24.43 million, an increase of 19%.

* CMS issued a Final Rule on November 1, 2007 regarding hospital outpatient reimbursement for UFE that increased such reimbursement by 113% to $5,639 per procedure from $2,642 per procedure, effective January 1, 2008.

* Publication of three-year outcomes data from the SIR's 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 in the January 2008 issue of Obstetrics & Gynecology that concluded that over the long term, and in a broad range of practice settings, UFE produces a high level of durable symptom control and results in a significant improvement in a woman's health-related quality of life. This paper is the fourth and last in the series on this 3000+-patient registry. Seventy-three percent of procedures performed used Embosphere Microspheres, thus providing what we believe is a strong validation of BioSphere's product.

* Publication in the January 2008 issue of the Journal of Vascular and Interventional Radiology that concluded that UFE/UAE performed using BioSphere's Embosphere Microspheres showed significantly better results in blocking the flow of blood from arteries that feed benign uterine fibroids compared to procedures performed using Boston Scientific's Contour SE[TM] polyvinyl alcohol polyvinyl alcohol,
n a complex alcohol that is soluble in water and is used as an emulsifier and adhe-sive.
 (PVA PVA

polyvinyl alcohol.
) embolic administered in accordance with Boston Scientific's newly refined treatment protocol. The study's authors concluded that Embosphere Microspheres "should be the preferred agent for 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.  at this time."

* Approval by the Medical Device Department of the State Food and Drug Administration The State Food and Drug Administration (SFDA Simplified Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration.  of the People's Republic People's Republic
n.
A political organization founded and controlled by a national Communist party.
 of China for Embosphere Microspheres for clinical use for vascular embolizations, arteriovenous malformations Arteriovenous Malformations Definition

Arteriovenous malformations are blood vessel defects that occur before birth when the fetus is growing in the uterus (prenatal development). The blood vessels appear as a tangled mass of arteries and veins.
, hypervascularized tumors (such as primary liver cancer Liver Cancer Definition

Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types.
), and symptomatic fibroids. BioSphere expects to commence the shipment of Embosphere Microspheres to China in Quarter 1, 2008.

* The receipt of CE Mark approval for Transarterial Chemoembolization (TACE n. 1. The cross, or church, of St. Antony. See Illust. (6), under Cross,

n. os>
1. See Tasse.
) of Hepatocellular Carcinoma hep·a·to·cel·lu·lar carcinoma
n.
A carcinoma derived from parenchymal cells of the liver. Also called hepatocarcinoma, malignant hepatoma.
 (HCC HCC Hepatocellular Carcinoma (liver cancer)
HCC Hertfordshire County Council (administrative region of south eastern England UK)
HCC Harford Community College (Maryland) 
) using HepaSphere[TM] Microspheres and Doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased . As a follow-up to this approval, BioSphere will conduct a 100-patient, post-market registry study in 10-15 European centers.

* The appointment of Melodie R. Domurad, Ph.D. as Vice President of Regulatory, Medical Affairs, and Quality Systems.

* The appointment of Joel B. Weinstein as Vice President of Global Marketing and Sales.

* The appointment of Joseph D. Storer as Director of Rest of World Marketing and Sales.

* The signing of a strategic collaboration agreement with DuPont Applied BioSciences under which DuPont and BioSphere intend to evaluate potential peripheral vascular and embolotherapy research, development, and manufacturing engineering Manufacturing engineering

Engineering activities involved in the creation and operation of the technical and economic processes that convert raw materials, energy, and purchased items into components for sale to other manufacturers or into end products for
 projects.

Conference Call and Web Cast with Slide Presentation

The Company will host its quarterly conference call on January 31, 2008 at 8:30 a.m. Eastern Time. The number to dial is 888-563-6275 (US/Canada) or 706-643-3137 (International), and the conference ID is 22721977. Please call in approximately ten minutes before the call is scheduled to begin. The live webcast with integrated slide presentation, as well as a stand-alone copy of the slide presentation, will be available at the "Investors" section of BioSphere's Web site at www.biospheremed.com. A replay of the webcast will also be available at BioSphere's Web site.

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 proprietary bioengineered 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. 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 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 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 expected positioning for future growth and development, including revenue growth in 2008 and beyond, the Company's ability to successfully execute on its business plan in future periods and the potential benefits of the Company's strategies and initiatives, and the expected completion of the sales force expansion and launch of Embosphere Microspheres in China in Q1 2008. 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 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 Microspheres, for the treatment of UFE, its HepaSphere Microsphere and QuadraSphere[R] Microsphere products, and its delivery system product line;

* the failure of the Company to increase the rate of UFE procedures, and concomitant use of its products for UFE, with its expanded sales force;

* 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 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 inability of the Company to successfully execute on its plans and strategies for future 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; and

* risk factors described in the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended September 30, 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.

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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