-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QK9oAhaCYaBMqLMwgue9AgvrHm9soG8fzj08MaavkkoRsHBpqOEyRSYn3A+x8i/H dwhwAdG7xBHFbL0/KffOlw== 0000919015-01-500039.txt : 20020412 0000919015-01-500039.hdr.sgml : 20020412 ACCESSION NUMBER: 0000919015-01-500039 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20011129 ITEM INFORMATION: Other events FILED AS OF DATE: 20011207 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSPHERE MEDICAL INC CENTRAL INDEX KEY: 0000919015 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043216867 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23678 FILM NUMBER: 1808802 BUSINESS ADDRESS: STREET 1: 1050 HINGHAM STREET CITY: ROCKLAND STATE: MA ZIP: 02370 BUSINESS PHONE: 7816817900 MAIL ADDRESS: STREET 1: 1050 HINGHAM STREET CITY: ROCKLAND STATE: MA ZIP: 02370 FORMER COMPANY: FORMER CONFORMED NAME: BIOSEPRA INC DATE OF NAME CHANGE: 19940215 8-K 1 body112901.txt ITEM 5 OTHER EVENTS 1 ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C.20549 -------------- FORM 8-K CURRENT REPORT -------------- PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 -------------------------------------- Date of Report (Date of earliest event reported): November 29, 2001 BIOSPHERE MEDICAL, INC. -------------------------------------------------------------- (Exact name of registrant as specified in its Charter) Delaware 0-23678 04-3216867 ------------------------- ------------ ----------------- (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 1050 Hingham St. Rockland, Massachusetts 02370 ---------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (781) 681-7900 ---------------------------------------------------- (Former Name or Former Address if Changed Since Last Report) ================================================================================ Page 1 of 3 2 ITEM 5. OTHER EVENTS. On November 29, 2001, BioSphere Medical, Inc. issued a press release (which is attached hereto as Exhibit 99) announcing the resignation of Jean-Marie Vogel as a director and as chairman of the Board of Directors and the acquisition of an outstanding minority interest in Biosphere Medical S.A. As a result of the acquisition, the Company now ownes all of the outstanding shares of Biosphere Medical S.A. Page 2 of 3 3 SIGNATURES Pursuant to the requirements of the Securities Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BIOSPHERE MEDICAL, INC. (Registrant) Date: December 7, 2001 By: /s/ Robert M. Palladino -------------------------------- Vice President and Chief Financial Officer Page 3 of 3 EX-99 3 exhibit99.txt PRESS RELEASE DATED NOVEMBER 29, 2001 BioSphere Medical Completes Acquisition of Minority Interest in BioSphere S.A. Announces Changes to the Board ROCKLAND, Mass.--(BW HealthWire)--Nov. 29, 2001--BioSphere Medical, Inc. (Nasdaq: BSMD - news) today announced that it has acquired the remaining 15 percent ownership interest in Biosphere Medical S.A. (BMSA) for approximately $1.0 million. BMSA currently serves as European headquarters and as the Company's primary manufacturing facility. BMSA recently relocated its manufacturing plant to a new, modern facility near Charles De Gaulle Airport. Due to the increased manufacturing capacity of the new facility and improvements in the manufacturing process, the Company expects that it will have adequate capacity to meet its production needs for the foreseeable future. "Acquiring the remaining minority interest in BMSA provides us with full control over all intellectual property license agreements, manufacturing and distribution, which we expect will facilitate our ability to achieve our long-term goals," stated John M. Carnuccio, president and chief executive officer of BioSphere Medical. BioSphere Medical also announced the resignation of Jean-Marie Vogel as chairman of the board. Mr. Vogel will continue to be associated with the Company as a business advisor. "During his tenure as an officer and on the board of directors, Jean-Marie provided valuable guidance and support to management," stated Mr. Carnuccio. "We would like to thank him for his vision which drove the creation of our embolotherapy business and look forward to his contributions as an ongoing business advisor." Mr. Vogel previously served as president and chief executive officer of BioSepra Inc., a chromotography media company, until May 1999, at which time the Company strategically refocused its business on the development and commercialization of microspheres for medical applications. About BioSphere Medical, Inc. BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The Company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics. BioSphere Medical's lead products, Embosphere Microspheres and EmboGold Microspheres, have been cleared by the FDA for marketing for hypervascularized tumors and vascular malformations. The Company is currently conducting clinical trials of Embosphere Microspheres for uterine fibroid embolization (UFE) in the United States under an Investigational Device Exemption (IDE) granted by the FDA. BioSphere Medical has received CE Mark approval in the European Community and approvals in Canada and Australia which allow the Company to sell Embosphere Microspheres for use in general embolization procedures, including uterine fibroid embolization. Cautionary Statement Regarding Forward-Looking Statements - This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," 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; to successfully develop, commercialize and achieve widespread market acceptance of the Embosphere(R) Microspheres and HepaSphere SAP(TM) Microsphere technologies for uterine fibroid embolization, targeted liver embolization and other applications; to provide patent and other proprietary protection for the Company's products; 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 to finance the development, marketing, and sales of its products; general economic conditions; as well as those risk factors detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2000 filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent BioSphere's estimates as of the date of this release. BioSphere anticipates that subsequent events and developments will cause its estimates to change. However, while BioSphere may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing BioSphere's estimates or views as of any date subsequent to the date of this release. Contact: Company Contact: BioSphere Medical, Inc. Robert M. Palladino, 781-681-7925 OR Investor Relations Contact: Rx Communications Group, LLC Melody A. Carey, 917-322-2571 -----END PRIVACY-ENHANCED MESSAGE-----