-----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, N2L0FO11mpX4XC0G3CEQWHxp2gMs5T/Xb74qgC2Focr2XNm90WCyCOupTTobo+u+ RRz94wdB5w+o4EuSML2h/g== 0000919015-01-500022.txt : 20010627 0000919015-01-500022.hdr.sgml : 20010627 ACCESSION NUMBER: 0000919015-01-500022 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20010423 ITEM INFORMATION: FILED AS OF DATE: 20010524 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: 1647007 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 body42301.txt ARTES SETTLEMENT 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): May 22, 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 5 2 ITEM 5. OTHER EVENTS. On May 22, 2001, BioSphere Medical, Inc. issued a press release (which is attached hereto as Exhibit 99) announcing that it had entered into a settlement agreement with Artes Medical USA, Inc. to conclude their respective lawsuits regarding alleged patent infringement. In conjunction with this agreement, BioSphere Medical also announced an agreement to immediately end its supply agreement with Inamed Corporation. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS (C) Exhibits. 99 The Registrant's Press Release dated May 22, 2001. Page 2 of 5 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: May 24, 2001 /s/ Robert M. Palladino -------------------------------- Vice President and Chief Financial Officer Page 3 of 5 4 EXHIBIT INDEX Exhibit Sequential Number Description Page Number(s) 99 The Registrant's Press Release dated May 22, 2001 5 Page 4 of 5 EX-99 2 exhibit42201.txt ARTES SETTLEMENT PRESS RELEASE 1 Exhibit 99 BioSphere Medical Announces Litigation Settlement In Conjunction with Agreement with Artes Medical USA to Settle Their Respective Lawsuits Regarding Alleged Patent Infringement, Biosphere Medical and Inamed Agree to Discontinue Supply Agreement ROCKLAND, Mass.--(BUSINESS WIRE)--May 22, 2001-- BioSphere Medical, Inc. (Nasdaq: BSMD - news), and its subsidiary, BSMD Ventures, Inc., today announced a settlement agreement with Artes Medical USA, Inc. to conclude their respective lawsuits regarding alleged patent infringement. The companies had each filed lawsuits in early February regarding United States Patent No. 5,344,452. In conjunction with this agreement, BioSphere Medical also announced an agreement to immediately end its supply agreement with Inamed Corporation (Nasdaq: IMDC - news). As announced in January, BioSphere Medical had agreed to supply Inamed with microspheres for possible use in dermal augmentation applications. "We are very pleased to have resolved these issues so quickly," said John Carnuccio, BioSphere Medical's president and chief executive officer. "Needless to say, we are also pleased to be putting the distractions of the lawsuits behind us and to be refocusing our efforts toward implementing our business strategies. These agreements do not affect our current financial guidance for BioSphere Medical, and we plan to continue our efforts to leverage our microsphere technology into non-embolotherapy markets." According to the agreement with Artes, the companies will jointly move to dismiss the pending cases; BioSphere Medical will obtain rights to the Artes patent and pay Artes an undisclosed sum. Under the other agreement, Inamed will pay an undisclosed sum to BioSphere Medical to fulfill its current obligations and will be released from all future obligations under the supply agreement. 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. 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's words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," and similar expressions identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. These forward-looking statements include the Company's expectations regarding the Company's ability to commercialize its products for an array of embolotherapy and non-embolotherapy applications, the ability of the Company to sign strategic partners and commercialize microspheres for non-embolotherapy applications, and the market penetration of the Company's embolotherapy and non-embolotherapy products. 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 and commercialize 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; the delay 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. Contact: BioSphere Medical, Inc. Robert Palladino 781.681.7925 Page 5 of 5 -----END PRIVACY-ENHANCED MESSAGE-----