-----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, G/twRLaZgXKVrS/jwOJpJL5L5vIzvNKIUIxUw92XdUU0u6HNuvRpc4j2lnzCVE+8 2upSTCUQNG4/UNmEuB9jIA== 0000830736-01-000002.txt : 20010214 0000830736-01-000002.hdr.sgml : 20010214 ACCESSION NUMBER: 0000830736-01-000002 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20010208 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20010213 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOPOOL INTERNATIONAL INC CENTRAL INDEX KEY: 0000830736 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 581729436 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 001-14257 FILM NUMBER: 1535256 BUSINESS ADDRESS: STREET 1: 6025 NICOLLE ST SUITE A CITY: VENTURA STATE: CA ZIP: 93003 BUSINESS PHONE: 8056540643 MAIL ADDRESS: STREET 1: 6025 NICOLLE STREET CITY: VENTURA STATE: CA ZIP: 93003 FORMER COMPANY: FORMER CONFORMED NAME: CYTRX BIOPOOL LTD DATE OF NAME CHANGE: 19890716 8-K 1 0001.txt 8-K DATED FEBRUARY 8, 2001 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 8, 2001 BIOPOOL INTERNATIONAL, INC. (Exact Name of Registrant as Specified in Charter) Delaware 0-17714 58-1729436 (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 370 Interlocken Blvd. Broomfield, Colorado 80021 (Address of Principal Executive Offices) (303) 474-2131 (Registrant's Telephone Number) ITEM 5. OTHER EVENTS Reference is made to the press release of Biopool International, Inc., d/b/a XTRANA Inc. (the "Registrant"), issued on February 8, 2001, announcing FDA clearance of the Registrant's MiniQuant(TM) D-dimer assay system. A copy of the press release, which contains information meeting the requirements of this Item 5, is attached to this Form 8-K as Exhibit 99.1 and is incorporated herein by this reference. Further reference is made to the press release of the Registrant issued on February 9, 2001, announcing the resignation of John H. Wheeler, the Registrant's Chief Executive Officer. A copy of the press release, which contains information meeting the requirements of this Item 5, is attached to this Form 8-K as Exhibit 99.2 and is incorporated herein by this reference. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS (a) Financial Statements. None. (b) Pro Forma Financial Information. None. (c) Exhibits. Exhibit 99.1 Press Release of the Registrant dated February 8, 2001, announcing FDA clearance of the Registrant's MiniQuant(TM) D-dimer Assay System. Exhibit 99.2 Press Release of the Registrant dated February 9, 2001, announcing the resignation of John H. Wheeler. 2 SIGNATURES 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 hereunto duly authorized. February 12, 2001 BIOPOOL INTERNATIONAL, INC. By: ------------------------ Timothy Dahltorp Chief Financial Officer 3 EXHIBIT INDEX EXHIBIT PAGE NUMBER - ------- ----------- 99.1 Press Release of the Registrant Dated 5 February 8, 2001, Announcing FDA Clearance of the Registrant's MiniQuant(TM) D-dimer Assay System 99.2 Press Release of the Registrant Dated 7 February 9, 2001 Announcing the Resignation of John H. Wheeler 4 EX-99 2 0002.txt PRESS RELEASE DATED FEBRUARY 8, 2001 EXHIBIT 99.1 THURSDAY FEBRUARY 8, 7:01 AM EASTERN TIME PRESS RELEASE BIOPOOL INTERNATIONAL/XTRANA ANNOUNCES FDA CLEARANCE TO MARKET NEW MINIQUANT D-DIMER ASSAY SYSTEM VENTURA, Calif. - (BW HealthWire) - Feb. 8, 2001 - Biopool International Inc./Xtrana (OTCBB:BIPL - NEWS) today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new MiniQuant(TM) D-dimer Assay System. Designed for optimal sensitivity and broad assay range, the MiniQuant(TM) D-dimer Assay System is a rapid, quantitative method for determining D-dimer containing fragments in plasma. Elevated levels of D-dimer are found in such clinical conditions as deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC). DVT is a potentially fatal condition in which blood clots form in the lower extremities. According to a recent statement from the Council on Thrombosis of the American Heart Association: "DVT is a common but elusive illness that can result in suffering and death if not recognized and treated effectively. DVT occurs in about 2 million Americans each year. Death can occur when the venous thrombi break off and form pulmonary emboli that pass to and obstruct the arteries of the lungs. . . . It is estimated that each year 600,000 patients develop PE and that 60,000 die of this complication." Recent studies have confirmed the importance of D-dimer testing and, in particular, the effectiveness of Biopool's first generation assay, Minutex(R) D-dimer, in evaluating patients with thrombotic disorders such as DVT and PE. In fact, D-dimer has proven to be one of the best in vitro diagnostic markers for the exclusion of DVT and PE. D-dimer assays, therefore, provide the potential to avoid complex, expensive, often painful, and potentially hazardous additional testing for many patients with suspected DVT or PE. The MiniQuant(TM) D-dimer Assay System includes Biopool's MiniQuant(TM) latex agglutination reagent and the Company's MiniQuant(TM)-1, a compact, hand-held, two-channel LED photo-optical detection instrument suitable for both routine and emergency testing. The assay system is configured to provide quantitative results to yield even more useful diagnostic data than provided by the Company's Minutex(R) D-dimer assay. In each of the 5 last three years, Biopool's Minutex(R) D-dimer assay has been the Company's largest selling hemostasis product. Patrick J. O'Leary, Ph.D., vice president and general manager of Biopool International/Xtrana, commented, "The MiniQuant(TM) D-dimer Assay System represents a very significant addition to our hemostasis product line and our first venture in being able to provide our customers with an all-inclusive assay system. We believe this new test system more than aptly addresses our commitment to provide our customers with new, innovative formats of this important diagnostic test while, at the same time, addressing the rapidly growing global market for these tests, which is currently estimated to exceed $50 million. It is particularly notable that the ease of use of the MiniQuant(TM) Assay System and its ability to provide rapid quantitative results has the potential to offer significant reductions in hospitalization costs and avoid unnecessary invasive procedures. The MiniQuant(TM) D-dimer Assay System is currently in inventory and ready for sale." Founded in 1987, Biopool International develops, manufactures and markets a full range of test kits to assess and diagnose disorders of blood coagulation, thrombotic risk factors, fibrinolysis, platelet function and the vascular system. Effective with the Company's merger with Xtrana, the Company also develops nucleic acid-based tests for use in drug discovery, detection of environmental and food contaminants, forensics and identity testing, human and animal diseases, genetic predisposition to disease and other applications. To learn more about Biopool International and Xtrana, visit their Web sites at WWW.BIOPOOL.COM and www.xtrana.com. NOTE: This news release contains forward-looking statements, which are based upon current expectations that involve a number of risks and uncertainties including, but not limited to, technological innovations of competitors, changes in health care regulations, litigation claims, foreign currency fluctuation, product acceptance or changes in government regulation of the Company's products, as well as other factors discussed in the Company's last Report on Form 10-K-SB under "Risk Factors." CONTACT: Biopool International Timothy J. Dahltorp, 303/474-2133 (Chief Operating Officer) or Carol Hill, 805/654-0643 (Corporate Communications) 6 EX-99 3 0003.txt PRESS RELEASE DATED FEBRUARY 9, 2001 EXHIBIT 99.2 FRIDAY FEBRUARY 9, 5:00 PM EASTERN TIME PRESS RELEASE BIOPOOL INTERNATIONAL/XTRANA ANNOUNCES RESIGNATION OF JOHN H. WHEELER VENTURA, Calif. -(BUSINESS WIRE)- Feb. 9, 2001- Biopool International Inc./Xtrana (OTCBB:BIPL - NEWS) today announced the resignation of its chief executive officer, John H. Wheeler. Wheeler resigned because of philosophical differences with the board after the merger of the two companies. Timothy J. Dahltorp, chief financial officer of the company, has been appointed interim chief operating officer. The board has also created an executive management committee consisting of board members Michael Bick, Ph.D., and James H. Chamberlain. The company also announced that a search is underway for a successor president and CEO of the company. Michael Bick, chairman of the board, stated: "We are grateful to Jack for his contributions to the founding and building of the Xtrana business, a key component of our future growth strategy, and his vision will be missed. We wish Jack well in his future projects." James H. Chamberlain was the founder of Biosource International Inc. (Nasdaq:BIOI - NEWS), a California-based company dedicated to the research, development, manufacturing, and marketing of biomedical products to the diagnostic and research markets. Prior to founding Biosource, Chamberlain was the manager of Business Development for Amgen Inc. Chamberlain received a bachelor of science degree in biology and chemistry from West Virginia University in 1969 and completed an MBA Executive Program at Pepperdine University in 1981. Founded in 1987, Biopool International develops, manufactures, and markets a full range of test kits to assess and diagnose disorders of blood coagulation, thrombotic risk factors, fibrinolysis, platelet function and the vascular system. Effective with the company's merger with Xtrana, the company also develops nucleic acid-based tests for use in drug discovery, detection of environmental and food contaminants, forensics and identity testing, human and animal diseases, genetic predisposition to disease and other applications. To learn more about Biopool International and Xtrana, visit their Web sites at WWW.BIOPOOL.COM and www.xtrana.com. CONTACT: Biopool International Inc./Xtrana Timothy Dahltorp, 303/474-2133 Carol Hill, 805/654-0643 7 -----END PRIVACY-ENHANCED MESSAGE-----