-----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, AfVJujG31K/7kjCwebXOZ81DOjyae6e3QXT43lP3W2yAvgpv0UwOp2f0s8Hdms81 l3ynq1T1rtaJZ7k37HFVLg== 0001072613-02-000662.txt : 20020417 0001072613-02-000662.hdr.sgml : 20020417 ACCESSION NUMBER: 0001072613-02-000662 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020416 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020417 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPIRE CORP CENTRAL INDEX KEY: 0000731657 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 042457335 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-12742 FILM NUMBER: 02613249 BUSINESS ADDRESS: STREET 1: ONE PATRIOTS PARK CITY: BEDFORD STATE: MA ZIP: 01730-2396 BUSINESS PHONE: 6172756000 MAIL ADDRESS: STREET 2: ONE PATRIOTS PARK CITY: BEDFORD STATE: MA ZIP: 01730-2396 8-K 1 form8k_11193.txt FORM 8-K DATED APRIL 16, 2002 2002 ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITTIES EXCHANGE ACT OF 1934 Date of report (Date of earliest event reported) April 16, 2002 ------------------------------- SPIRE CORPORATION - -------------------------------------------------------------------------------- (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Massachusetts - -------------------------------------------------------------------------------- (STATE OR OTHER JURISDICTION OF INCORPORATION) 0-12742 04-2457335 - -------------------------------------------------------------------------------- (COMMISSION FILE NUMBER) (I.R.S. EMPLOYER IDENTIFICATION NO.) One Patriots Park, Bedford, Massachusetts 01730-2396 - -------------------------------------------------------------------------------- (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE) 781-275-6000 - -------------------------------------------------------------------------------- (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) ================================================================================ ITEM 5. OTHER EVENTS - --------------------- Spire Corporation (the "Company") announced on April 16, 2002 that Spire Biomedical, Inc., its wholly-owned subsidiary, has received 510(k) clearance from the U.S. Food and Drug Administration to market its patented Pourchez XpressO(TM) hemodialysis catheter with separated tips. Additional information is set forth in Exhibit (99) to this Current Report on Form 8-K. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS. - ------------------------------------------ (c) Exhibits 99 News Release of the Company dated April 16, 2002. 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. SPIRE CORPORATION (Registrant) Date: April 16, 2002 By: /s/ Roger G. Little ---------------------------------- Roger G. Little President, Chief Executive Officer and Chairman of the Board 2 EXHIBIT INDEX Exhibit Description Page Number - ------- ----------- ----------- 99 News Release of the Company dated April 16, 2002. 4 3 EX-99 3 exh99_11193.txt NEWS RELEASE EXHIBIT 99 ---------- SPIRE CORPORATION FOR IMMEDIATE RELEASE NEWS RELEASE CONTACT: SPIRE BIOMEDICAL, INC. MARK C. LITTLE CHIEF EXECUTIVE OFFICER (781) 275-6000, MLITTLE@SPIRECORP.COM SPIRE COPORATIN RECEIVES FDA CLEARANCE TO MARKET HEMODIALYSIS CATHETER POURCHEZ XPRESSO(TM) PATENTED SEPARATED-TIP CATHETER DESIGN OFFERS SUPERIOR KINK-RESISTANCE AND HIGHER FLOWS AT LOWER PRESSURES Bedford, MA -- April 16, 2002 -- Spire Corporation (Nasdaq: SPIR) announced today that Spire Biomedical, Inc., its wholly-owned subsidiary, has received 510(k) clearance from the U.S. FDA to market its patented Pourchez XpressO hemodialysis catheter with separated tips. The Company estimates that the dialysis catheter market is over $100 million in the U.S. and $250 million worldwide. The Company plans to begin selling the product immediately through a nationwide network of specialty medical product distributors. Dialysis therapy is the only treatment available for kidney failure, other than a kidney transplant. Currently, there are nearly 300,000 end-stage renal disease (ESRD) patients in the U.S. and nearly one million worldwide. In the U.S. alone, nearly $15 billion is spent annually to care for ESRD patients, most of whom rely on a catheter for blood access at some point in their treatment. Pourchez Xpresso Designed to Improve Patient Care - ------------------------------------------------- The innovative Pourchez XpressO catheter was designed to improve long-term vascular access and enhance therapy for dialysis patients suffering from ESRD. The catheter provides higher blood flows at lower pressures compared to competing catheters, kink resistance and minimal recirculation, all clinically desired features. Thomas M. Vesely, M.D., commented, "There is a dire need for advances in hemodialysis catheter design. I am very excited by the unique combination of benefits offered by the Pourchez XpressO and look forward to using it in my practice." Dr. Vesely is Associate Professor of Radiology and Surgery at The Mallinckrodt Institute of Radiology, which is part of the School of Medicine at Washington University in St. Louis, MO. Spire Biomedical, Inc.'s Medical Products Group - ----------------------------------------------- Mark Little, Chief Executive Officer of Spire Biomedical, Inc., said, "The 510(k) clearance represents a significant milestone in the expansion of Spire Biomedical, Inc.'s business into the medical products marketplace. For over fifteen years, we have provided biotechnology surface treatment services to makers of orthopedic joint implants, catheters, guidewires and other medical devices. Manufacturing our own medical products will allow us to realize the higher margins associated with these devices." PJ. Anand, Spire Biomedical's Vice President of Business Development, who is leading the Company's drive into finished medical devices, noted, "Standard catheters can kink during or after insertion, resulting in obstruction of blood flow and the need for additional intervention. The Pourchez XpressO catheter's kink-resistant design with free-floating separated tips increases placement flexibility, reduces recirculation of dialyzed blood and minimizes complications that may arise in competitors' catheters. The advanced Sil-o-Flex(TM) silicone material and the patented one-piece fabrication process improve patient comfort and minimize vessel trauma. We believe the product is an ideal platform to incorporate our surface bio-engineering technologies to reduce complications due to inflammatory response, thrombosis and infection." Dr. Thierry Pourchez, inventor of the Pourchez XpressO catheter, stated, "I am extremely pleased that this catheter design will soon become available for dialysis treatment. I believe that it will be of tremendous benefit to ESRD patients worldwide." About Spire Biomedical, Inc. - ---------------------------- Spire Biomedical, Inc., a wholly-owned subsidiary of Spire Corporation, provides premium medical products and biotechnology services for improving the performance of implantable medical devices. For more information, visit Spire Biomedical, Inc.'s web site at www.spirebiomedical.com. Spire Corporation also provides solar electric systems for distributed power generation and is a leading supplier of solar electric module manufacturing equipment and turnkey solar energy businesses. For more information, please visit Spire Corporation's web site at www.spirecorp.com. Certain matters discussed in this news release may be forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the risk of dependence on market growth, competition and dependence on government agencies and other third parties for funding contract research and services, as well as other factors described in the Company's Form 10-KSB filed with the Securities and Exchange Commission. -----END PRIVACY-ENHANCED MESSAGE-----