-----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, PzWn50HkhNVtssnd92i2kAGcZO3Gyb2OHWqCY2lfiwY4tns+z5WEsIqLO5kAkOZi XIXWp+MDG6rN2/ELsDsAPA== 0000919015-01-500012.txt : 20010223 0000919015-01-500012.hdr.sgml : 20010223 ACCESSION NUMBER: 0000919015-01-500012 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20010215 ITEM INFORMATION: FILED AS OF DATE: 20010215 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: SEC FILE NUMBER: 000-23678 FILM NUMBER: 1547363 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 body20901.txt 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): February 9, 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 6 2 ITEM 5. OTHER EVENTS. On February 9, 2001, BioSphere Medical, Inc. issued a press release (which is attached hereto as Exhibit 99) announcing that it had learned that Artes Medical USA, Inc., had filed a complaint alleging patent infringement ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS (C) Exhibits. 99 The Registrant's Press Release dated February 9, 2001. Page 2 of 6 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereto duly authorized. BioSphere Medical, Inc. (Registrant) Date: February 13, 2001 /s/ Robert M. Palladino -------------------------------- Vice President and Chief Financial Officer Page 3 of 6 4 EXHIBIT INDEX Exhibit Sequential Number Description Page Number(s) 99 The Registrant's Press Release dated February 9, 2001 5 Page 4 of 6 EX-99 2 exhibit20901.txt REGISTRANT'S PRESS RELEASE DATED FEBRUARY 9, 2001 1 Exhibit 99 BioSphere Medical Announces Artes Medical Files Complaint Alleging Patent Infringement ROCKLAND, Mass.--(BW HealthWire)--Feb. 9, 2001--BioSphere Medical, Inc. (Nasdaq:BSMD - news) and its subsidiary BSMD Ventures, Inc. learned yesterday that Artes Medical USA, Inc., based in California, filed a suit in the United States District Court for the Central District of California against BioSphere Medical, Inc. The complaint alleges that the company's microspheres infringe United States Patent No. 5,344,452, allegedly assigned to Artes. As previously announced, BioSphere received a letter from Artes, on Friday, February 2nd, alleging its products infringe the Artes patent. Subsequently, BioSphere filed suit in the United States District Court for the District of Delaware about the same issue. ``We anticipated this action by Artes,'' stated John Carnuccio, BioSphere Medical's president and chief executive officer. ``It is one of the reasons we took affirmative action earlier this week to file a complaint in Delaware seeking a declaration that the Artes patent is invalid and that our microspheres do not infringe the Artes patent. Our belief remains strong that the allegations are without merit. We do not believe our product infringes any claim of this patent and, furthermore, we believe the patent will be found to be invalid.'' The company's Embosphere(R) Microspheres are the subject of United States Patent numbers 5,635,215, 5,648,100 and 4,452,916. 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. This press release contains forward-looking statements that involve risks and uncertainties, including those relating to the success of the company in its lawsuit related to United States Patent No. 5,344,452. Among the important factors that could cause actual events to differ materially from those indicated by forward-looking statements in this release are the failure to obtain and defend patents and other proprietary protection for the company's products; 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; failure to successfully develop and commercialize the Embosphere(R) Microspheres and HepaSphere SAP(TM) Microsphere technologies for uterine artery embolization, targeted liver embolization and other applications; the absence of or delays and cancellations of, product orders; the delay in the introduction of new products; competitive pressures; the inability of the company to raise additional funds, if needed, 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, 1999, Form 10-Q for the quarter ended September 30, 2000 and other periodic reports filed by the company with the Securities and Exchange Commission. - --------------------------- Contact: BioSphere Medical, Inc. Robert Palladino 781-681-7900 -----END PRIVACY-ENHANCED MESSAGE-----